Pharm IV Lab Manual

PHARMACEUTICS
Pharmaceutics is the branch of pharmacy deals with the science and technology of
dosage form design.
Formulative and Industrial Pharmacy
Formulative and Industrial Pharmacy is a wing of pharmacy deals with the

formulation of dosage forms in large scale or industrially oriented.
Qualities and accessories to be maintained by the student

a. Wear neat white apron
b. Observation book and record
c. Working sheet
d. Lighter/match box
e. Calculator
f. Fractional Weight box
g. Butter paper – for weighing ingredients & powder packing
h. Blue/black, red & green dot pens
i. Scale/Ruler
j. Gum
k. Stapler – for crimping ointment, paste tubes
l. Blade – for leveling lipsticks etc.
m. Napkins /Towel
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Criteria’s to be followed
1. Working space and lab should be kept clean, dry and free of litter. Leave the
place where you worked a little better than how you found it.
2. Ingredients should be handled carefully without spillage and wastage.
3. Experiments should be completed within a time frame but make haste slowly.
4. Students should not enter the preparation room at any time.
5. Cross-talking and asking for help is strictly prohibited. Think when you face a
problem. Ask the staff concerned for help.
6. In case of any accident, immediately alert the faculty or lab attender.
7. Off Bunsen burner and water tap immediately after use to avoid wastage.
8. Lab is a place for serious work and strict punctuality should be maintained.
DAILY TASK
The preceding day’s work should be neatly recorded in the Record book and
submitted during practical class in the following day. Complete record books with
index filled should be presented for viva-voce during every practical class.
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TABLETS
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TABLETS
Tablets are unit solid dosage form of medicament or medicaments with or without
excipients (additives or adjuvants) and prepared either by moulding or
compression method.
Characteristics of tablets:
• Tablets may vary in size, shape and weight. They are stable in nature.
• Disc shaped tablets are most common, also available in round, oval,
cylindrical etc…
• Weight of tablets may vary from 0.2 gm to 0.8 gm.
• Brocken don, an Englishman carries the credit of tablet fabrication in

1843.He was granted a patent for a device which initially consisted of a die
made by boring a hole through a piece of metal within which powders could
be compressed into tablets with the help of two cylindrical punches.
• The real revolution in tablet making can be attributed to the arrival of rotary
machines which with their multiple dies and punches could produce tablets
at fantastic rates.
• Compressed tablets offer a number of advantages to the patients as well as

the physicians and the pharmacists and that is why their popularity continues
to increase.
• Easy to carry by patients.
• Marketed mainly in strip and blister packagings.
Advantages of tablets:
▪ It provides a sealed covering which protects the tablets from atmospheric
conditions like air, moisture, light etc…
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▪ Some of the tablets are divided into halves and quarters while drawing lines
during manufacturing to facilitate breakage whenever a fractional dose is
required.
▪ An accurate amount of medicament even if very small can be incorporated.
▪ Less incompatibility problems than all other dosage forms.
▪ Since tablets are produced on a large scale cost of production is relatively

low, hence economical.
▪ Tablets are available as coated, sugar coated, film coated etc…
▪ Even lakhs of tablets can be prepared per day in a pharmaceutical industry.
Disadvantages of tablets:
▪ Weight variations are rarely observed in tablets.
▪ Discoloration, chipping, sticking, picking etc. are observed in certain tablets.
▪ Swallowing difficulty.
▪ Less preference for pediatrics and geriatrics.
▪ Water or fluid is required for swallowing tablet.
▪ For unconscious and mental patients oral route administration of tablets was
not feasible.
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Types of tablets:
Tablets are classified as compressed tablets and molded tablets. Compressed
tablets are usually prepared in large scale and includes oral, chewable,
buccal/sublingual,lozenge,soluble,effervescent,vaginal,rectal,entericcoated,sustaine
d release, sugar coated, implants, film coated, layered and press coated tablets.
Molded tablets (tablet triturates) includes hypodermic and dispensing tablets .
Formulation of tablets:
Compressed tablets constitutes active medicament (s) with a number of inert
substances known as excipients or additives or adjuvants. The adjuvants include
diluents (lactose, sucrose),binders (starch paste, methyl cellulose),granulating
agents(water, acacia mucilage, liquid glucose),disintegrating agents (maize starch,
veegum), lubricants or glidants (magnesium stearate, purified talc), coloring agents
(quinozoline, tartrazine yellow), flavoring agents (fruit flavors, volatile oils) and
sweetening agents (mannitol, sucrose).
Compressed tablets can be prepared by wet granulation method, dry
granulation method and direct compression methods. Tablet punching or making or
presses are used for the formulation of tablets. The machines may be of single
punch, multi punch, and rotary or high speed rotary and multi layer rotary tablet
machines. Processing problems or manufacturing defects in tablets include
capping, lamination, chipping, picking, sticking, mottling, binding in the die,
splitting, weight variation, hardness variation and double impression.
Evaluation of tablets:
Various standards or quality control tests are carried out on compressed tablets are
diameter size and shape, uniformity of weight, hardness testing, thickness testing,
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friability testing, percentage of medicament, color dispersion assessment,
disintegration test and dissolution test.
REFERENCE:
1. The Theory and Practice of Industrial Pharmacy by Leon Lachman, Herbert A
Lieberman, Joseph L Kanig, 3rd edition,pg.no:293-342.
2. Pharmaceutics: The Science of dosage form design by Michael E Aulton.
3.Bentleys text book of Pharmaceutics by E.A Rawlins.
4. A text book of Pharmaceutical formulation, B.M.Mithal, pg.no:147-164.
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FORMULATION OF PARACETAMOL TABLETS
AIM
To prepare and submit 50 paracetamol tablets IP, each containing 500mg of paracetamol.
Requirements
• Paracetamol
• Lactose
• Starch paste (5%)
• Purified talc
• Magnesium stearate
• Mortar
• Pestle
• Tablet compression machine
• Hot air oven
• Sieves
• Common glassware’s
PRINCIPLE
Paracetamol tablets are used as analgesic and antipyretic agent. Lactose acts as diluent, starch
paste acts as a binding agent, purified talc and magnesium stearate acts as glidants and
lubricants. Paracetamol is not susceptible to moisture and temperature. Therefore wet granulation
method is suitable for granulation.
FORMULA
Sl.No Ingredients Formula for 1 Formula for 100

tablet tablets
1 Paracetamol 300mg
2 Lactose 150mg
3 Starch paste (5%) q. s
8
4 Purified talc 15mg
5 Magnesium stearate 15mg
6 Dried starch 20mg
PROCEDU P
PREFORMULATION STUDIES
Angle of repose
It is defined as the maximum angle possible between the surface of the pile of
granule and the horizontal plane. The angle of repose is designated by the given
equation.
tanθ = h/r
θ = tan-1(h/r)
where h = height of the pile

r = radius of base of pile
θ = angle of repose
Relationship between angle of repose and powder flow
Angle of repose Powder flow

<25 Excellent
25-30 Good
30-40 Passable
>40 Very poor
Bulk density
The bulk density denotes the total density of the material as it exist. The bulk
volume includes the true volume, volume of internal pores.
Bulk density is defined as the ratio of the weight of powder to
the bulk volume. It is calculated by the equation.
9
Bulk density= weight of granules/bulk volume of granules
Tapped density
It is defined as the ratio of weight of the granule to the tapped volume.
Tapped density= weight of granule/ tapped

volume
Compressibility index
It is the measure of flow property of granule, compressibility is defined as the
density held within a confined space to reduce the volume. The percentage
compressibility can be determined by using the formula
%compressibility = (St- So/St)×100
Where St= tapped bulk density

So= initial bulk density
Loss on drying
Loss on drying is the loss of weight expressed as percentage weight. It can be
determined by using the equation.
%loss on drying =weight before drying/weight after drying

×100
PROCEDURE
Wet granulation method
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anulation met 1. Granulated paracetamol and lactose using starch binder.
2. Passed the dough mass through sieve no: 8 and completely dried at 60ºC.
3. Passed the dried granules through Sieve no: 20 superimposed on Sieve no: 44.
4. Collected granules that are passed through Sieve no: 20
5. The fines are collected which are passed from sieve no: 44 and about 10%
fines were mixed with the above granules.
6. Mixed the other additives like glidants, antiadherants, sweetening agents etc..
7. The granules are then taken for compression.
Angle of repose
10g of powder was transferred into a funnel keeping the orifice of the funnel
blocked by thumb. As the thumb was removed a gap was maintained between the
bottom of the stem and top of the powder pile. When the powder is emptied from
the funnel, a heap was formed and found out the angle of repose.
Bulk density
20g of powder is weighed and transferred to100ml of dried graded cylinder. Tap
the cylinder for 100 times. The volume occupied by the powder is noted after 100
tapings. Further 50 tapings may be continued and final volume differs from first
are, continue for 100 tapings.
Determination of packed density, hausner’s ratio, carr’s index

Tapped density- this was calculated by the weight of powder/tapped volume from
the two values (tapped and bulk density) porosity, carr’s index and hausner’s
ratio can be calculated.
Hausner’s ratio volume <1:25 indicates good flow whereas > 5:25 indicates poor
flow and values between 1.25-1.5 indicates moderate flow.
REPORT
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FORMULATION OF DICLOFENAC SODIUM TABLETS
AIM
To prepare and submit Diclofenac sodium tablets.
REQUIREMENTS
• Diclofenac sodium
• Lactose
• Starch paste(5%)
• Purified talc
• Mortar
• Pestle
• Hot air oven
• Sieves
• Common glasswares
PRINCIPLE
Diclofenac sodium tablets are used as analgesic and antipyretic agent. Lactose acts as diluent,
starch paste acts as a binding agent, purified talc and magnesium stearate acts as glidants and
lubricants.
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FORMULA
SL.NO INGREDIENTS FORMULA FOR 1 FORMULA

TABLET FOR 100
TABLETS
1 Diclofenac sodium 250mg
2 Lactose 70mg
3 Starch paste(5%) q.s
Angle of repose
It is defined as the maximum angle possible between the surface of the pile of granule and the
horizontal plane. The angle of repose is designated by the given equation.
tanθ = h/r
θ = tan-1(h/r)
Where
h = height of the pile

<25 Excellent
25-30 Good
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30-40 Passable
>40 Very poor
Bulk density
The bulk density denotes the total density of the material as it exist. The bulk volume includes
the true volume, volume of internal pores.
Bulk density is defined as the ratio of the weight of powder to the bulk
volume. It is calculated by the equation.
Tapped density

volume
It is the measure of flow property of granule, compressibility is defined as the density held
within a confined space to reduce the volume. The percentage compressibility can be determined
by using the formula

Loss on drying
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Loss on drying is the loss of weight expressed as percentage weight. It can be determined by
using the equation.
%loss on drying =weight before drying/weight after drying

×100
PROCEDURE
1. Granulated diclofenac sodium and lactose using starch binder.
5. The fines are collected which are passed from sieve no:44 and about 10% fines were mixed
with the above granules.
6. Mixed the other additives like glidants, antiadherants, sweetening agents etc..
Angle of repose
10g of powder was transferred into a funnel keeping the orifice of the funnel blocked by thumb.
As the thumb was removed a gap was maintained between the bottom of the stem and top of the
powder pile. When the powder is emptied from the funnel, a heap was formed and found out the
angle of repose.
Bulk density
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20g of powder is weighed and transferred to100ml of dried graded cylinder. Tap the cylinder for
100 times. The volume occupied by the powder is noted after 100 tapings. Further 50 tapings
may be continued and final volume differ from first are, continue for 100 tapings.

Tapped density- this was calculated by the weight of powder/tapped volume from the two
values(tapped and bulk density) porosity, carr’s index and hausner’s ratio can be calculated.
Hausner’s ratio volume <1:25 indicates good flow whereas > 5:25 indicates poor flow and values
between 1.25-1.5 indicates moderate flow.
REPORT
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PREPARATION OF SODIUM SULPHATE EFFERVESCENT GRANULES
AIM
To prepare and submit sodium sulphate effervescent granules.
REQUIREMENTS
• Sodium sulphate 500g
• Sodium bicarbonate 250g
• Tartaric acid 240g
• Citric acid 10g
• Sieves
PRINCIPLE
Acid-base reaction takes place between alkali metal bicarbonates and acid like citric acid and
tartaric acid when added to water the acid and the bases react to liberate carbon dioxide resulting
in effervescence. The resulting carbon dioxide solution or carbonate solution makes undesirable
taste of any medicinal agent present. The coarse powder or granules control the effervescence
and fine powder which produces the rapid effervescence here.
Sodium sulphate- active drug act as laxative

Sodium bicarbonate- source of carbon dioxide
Tartaric acid and citric acid- acid material react with alkali produce effervescence
H3C6H5O7.H2O+3NaHCO3 – Na3C6H5O7 + 3H2O+ 3CO2

H2C4H4O6 + 2NaHCO3 – Na3C4H4O6 + 2H2O + 2CO2
FORMULA
Sl.no Ingredients Master formula for Working
1000g formula
1 Sodium sulphate 500g
2 Sodium carbonate 250g
3 Tartaric acid 240g
4 Citric acid 10g
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Angle of repose
tanθ = h/r
θ = tan-1(h/r)

<25 Excellent
25-30 Good
30-40 Passable
>40 Very poor
Bulk density
The bulk density denotes the total density of the material as it exist. The bulk volume includes
the true volume, volume of internal pores.
Bulk density is defined as the ratio of the weight of powder to the bulk
volume. It is calculated by the equation.
Tapped density
18

volume
It is the measure of flow property of granule, compressibility is defined as the density held

Loss on drying
Loss on drying is the loss of weight expressed as percentage weight. It can be determined by
using the equation.
%loss on drying =weight before drying/weight after drying ×100
PROCEDURE
Heat a porcelain dish on a water bath to a melting point of powder. Powder the ingredients
expect citric acid and pass through sieve no: 100. Powder citric acid mixed with other powder
ingredients, place the powder on a pre-heated dish in the temperature at 34-40˚c. press the
powder mixture by acid resistant spatula until it become soft loose cake, the heating takes place
for 2-5min. Pass the cake through sieve no:8, when it is superimposed the sieve no:20. Reject the
fine powder and spread the granules on the tray and dry at temperature not exceeding 50˚c and
place in a suitable container.
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Angle of repose
angle of repose.
Bulk density
may be continued and final volume differs from first are, continue for 100 tapings.

CATEGORY
Saline purgative
STORAGE
To be stored in a well closed container.
DOSE
5-15g or directed by the physician
DIRECTION
1-2 teaspoon full is added to a tumbler of water and taken while it is effervescing.
REPORT
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FORMULATION OF ASPIRIN TABLETS
AIM
To prepare and submit 50 aspirin tablets IP, each containing 300 mg of aspirin.
REQUIREMENTS
• Aspirin
• Citric acid
• Calcium carbonate
• Saccharin sodium
• Lactose
• Starch paste (5%)
• Purified talc
• Mortar
• Pestle
• Hot air oven
• Sieves
• Common glassware’s
PRINCIPLE
Aspirin tablets are used to treat rheumatoid arthritis, fever, mild pain for temporary relief of head
ache and pain associated with common cold or flu. It has analgesic, antipyretic and anti-
inflammatory action. Solution tablets are meant to dissolve completely in specified liquid to
produce solution of definite concentration. For ingestion orally for use as mouth washes, gargle
and used externally as lotions, douches etc.
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SL.NO INGREDIENTS FORMULA FOR 1 FORMULA
TABLET FOR 100
TABLET
1 Aspirin 200mg
2 Citric acid 50mg
3 Saccharin sodium 30mg
4 Starch (5%) q.s
7 lactose 45.5mg
8 Calcium carbonate 30mg
Angle of repose
tanθ = h/r
θ = tan-1(h/r)
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<25 Excellent
25-30 Good
30-40 Passable
>40 Very poor
Bulk density
The bulk density denotes the total density of the material as it exists. The bulk volume includes the true
volume, volume of internal pores.
Bulk density is defined as the ratio of the weight of powder to the bulk volume. It is
calculated by the equation.
Tapped density

volume
It is the measure of flow property of granule; compressibility is defined as the density held

23
Loss on drying
Loss on drying is the loss of weight expressed as percentage weight. It can be determined by using the
equation.
%loss on drying =weight before drying/weight after drying ×100
PROCEDURE
1. Granulated aspirin, citric acid, lactose and starch using starch binder.
5. The fines are collected which are passed from sieve no:44 and about 10% fines were mixed
with the above granules.
6. Mixed the other additives like glidants, antiadherants, sweetening agents etc.
Angle of repose
angle of repose.
Bulk density
24
may be continued and final volume differs from first are, continue for 100 tapings.

CATEGORY
Analgesic, antipyretic, antirheumatic and antithrombotic
DOSE
As analgesic and antipyretic, 300 to 600mg, 4 to 6 times a day
As antirheumatic, 1 to 2 g, 4 to 6 times a day, up to 10g daily
As antithrombotic, 75mg daily
AUXILIARY LABEL
Not to be used in children below 12 years of age except under medical advice
REPORT
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FORMULATION OF PARACETAMOL MATRIX TABLETS
AIM
To formulate and submit paracetamol matrix tablets.
REQUIREMENTS
• Paracetamol
• Hydroxy propyl methyl cellulose
• Lactose
• Sodium lauryl sulphate
• Poly vinyl pyrrolidone
• Purified talc
• Isopropyl alcohol
PRINCIPLE
Matrix tablet is a modified extended release dosage form. The system shows the release kinetics
model in accordance with Higuchi’s model with a linear release rate as a function of time. That
is, it is following zero order release kinetics. The principle in this experiment involved in the
preparation of paracetamol matrix tablets is by the wet granulation method using hydroxyl
propyl methyl cellulose (HPMC) as extended release former. In this, magnesium stearate and
purified talc can be added as the lubricant. The ingredient poly vinyl pyrrolidone (PVP) acts as a
binding agent and lactose act as a diluent.
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FORMULA
Sl. Ingredients Formula for 1 tablet Formula for

no 100 tablets
1 Paracetamol 200mg
2 Hydroxy propyl methyl cellulose 70mg
3 Lactose 45.5mg
4 Sodium lauryl sulphate 5.25mg
5 Poly vinyl pyrrolidone 10mg
7 Purified talc 5mg
8 Isopropyl alcohol q. s
PROCEDURE
➢ Weighed all the ingredients according to the formula.

➢ Sifted paracetamol, HPMC and lactose through Sieve No.22.
➢ Mixed the major ingredients.
➢ Binder solution used was PVP solution.(Dissolve PVP in isopropyl alcohol with constant
stirring).
➢ Slowly added binder solution to the mixed powders.
➢ The wet mass was passed through sieve No.10.
➢ If granulation is not to be completed then use extra isopropyl alcohol based on the need.
➢ Dried the granules at 40ºC.
➢ The dried granules were then passed through sieve No.16.
➢ Suitable quantity of lubricants like magnesium stearate and purified talc was then added.
➢ Calculate the weight of granules and subjected for tablet compression.
REPORT
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PREPARATION OF READY MELT TABLETS OF ASPIRIN
AIM
To prepare and submit ready melt tablets of aspirin
REQUIREMENTS
• Aspirin
• Mannitol
• Poly vinyl pyrrolidone
• Purified talc
PRINCIPLE
Oral drug delivery system remains the preferred route of administration of various drugs.
Dysphagia is a common problem encountered in all age groups, in relation with solid dosage
forms. In order to solve the problem of dysphagia, the dispersible tablets (ready melt tablet) have
emerged as an alternative to conventional oral dosage forms. The oral dispersible tablets can
quickly disintegrates or dissolve upon contact with saliva and also produce good mouth feel. The
tablets can be prepared by wet granulation method. In this case, aspirin is used as the active
agent who is having the analgesic action. Mannitol is having diluents property. The other agents
like purified talc and magnesium stearate is used as lubricants whereas poly vinyl pyrrolidone
acting as a disintegrating agent.
FORMULA
Sl. Ingredients Formula for 1 Formula for
no tablet 100 tablets
1 Aspirin 300mg
2 Mannitol 50mg
3 Poly vinyl pyrrolidone 2%
4 Purified talc 1%
5 Magnesium stearate 1%
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PROCEDURE
1. Weighed all the ingredients according to the formula.
2. Sifted aspirin, mannitol, PVP through Sieve No.22.
3. Mixed the major ingredients.
4. Binder solution used was PVP solution (Dissolve PVP in alcohol with constant stirring).
5. Slowly added binder solution to the mixed powders.
6. The wet mass was passed through sieve No.10.
7. If granulation is not to be completed then use extra isopropyl alcohol based on the need.
8. Dried the granules at 40ºC.
9. The dried granules were then passed through sieve No.16.
10. Suitable quantity of lubricants like magnesium stearate and purified talc was then added.
11. Calculate the weight of granules and subjected for tablet compression.
REPORT
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INPROCESS ANALYSIS OF PARACETAMOL TABLET IP
AIM
To evaluate the uncoated tablets for process quality control test
REQUIREMENTS
Paracetamol tablet 500mg
Hardness tester
Friabilator
PRINCIPLE
A variety of test are conducted in tablet, in order to make sure that the manufactured tablets are
best possible quality.
Appearance
The dimensions of tablet are thickness and diameter. The tablet should have uniform thickness
and diameter. Thickness and diameter of tablet are measured using Vernier caliper or screw
gauge. These dimensions are related to hardness and friability.
Weight variation test

Any variation in the weight of tablets leads to either wider medication or overdose. Improper
flow of granules from hopper to the dyes is responsible for weight variation. Lubricants, glidants
and adhesives are added for the proper flow of granules.
Hardness
Hardness is a force require to break a tablet across the diameter. It initiate tablet strength. It is
tested by using hardness tester as Monsanto tester, Pfizer hardness tester.
Friability test
It is the loss of weight of tablet in the container or package due to the removal of the particle
from the surface.
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It causes the ability of the tablet or tablet to withstand to stock during the process,
handling and transportation. It is indicated in chipping, capping or breaking. It is estimated by
using friabilator, the allowed limit is less than 8%.
PROCEDURE
Determination of average weight of tablets:
Dedust the 20 tablets. Weighed accurately and noted down the weight of 20 tablets using the
following formula.
Average weight = Weight of 20 tablets/20
Determination of diameter and thickness of tablets:

Randomly selected 5 tablets and measured the diameter and thickness of the tablets by means of
previously calibrated vernier calipers.
Determination of hardness of tablets:

Randomly selected 5 tablets. One tablet was placed on the tablet hardness tester, which was
already set to zero. Applied a pressure by pressing the start button of tablet hardness tester till the
tablet breaks. Noted down the reading on the tester i.e. the hardness of the tablet in newtons.
Took the average of 5 such tablets and calculated the average hardness of the tablet.
Determination of Friability:
Dedust 10 tablets. Weighed accurately and noted down the weight of 10 tablets(X).Added these
tablets to the friability test apparatus, rotate at 25 rpm for 4 minutes. After the completion of 4
minutes, the tablets are collected, dedust and noted down the weight of tablets(Y).
The percentage (%) friability can be calculated by the following formula
% Friability = X-Y/X x 100
REPORT
31
EVALUATION OF UNCOATED PARACETAMOL TABLET
AIM
To evaluate uncoated paracetamol tablet
REQUIREMENTS
Hardness tester
Fribilator
PRINCIPLE
Appearance

Hardness
Hardness is a force require to break a tablet across the diameter. It initiate tablet strength. It is
Friability test
from the surface.
32
PROCEDURE
following formula.


tablet breaks. Noted down the reading on the tester i.e. the hardness of the tablet in Newton.
REPORT
33
EVALUATION OF UNCOATED DICLOFENAC TABLET
AIM
To evaluate uncoated diclofenac tablet
REQUIREMENTS
Diclofenac tablet 350mg
Hardness tester
Fribilator
PRINCIPLE
Appearance

Hardness
Hardness is a force requires to break a tablet across the diameter. It initiates tablet strength. It is
Friability test
from the surface.
34
PROCEDURE
following formula.


tablet breaks. Noted down the reading on the tester i.e. the hardness of the tablet in Newton.
REPORT
35
DISINTEGRATION TEST FOR UNCOATED PARACETAMOL TABLETS
AIM
To determine the disintegration time of given uncoated tablets.
REQUIREMENTS
Disintegration test apparatus
Principle
Disintegration is the breakdown of tablets to smaller granules in contact with the disintegration
medium. The time taken by a tablet to disintegrate is called disintegration time. This is to
determine whether the tablet disintegrate into given dissolution medium. This is done by using
disintegration test apparatus.
PROCEDURE
Placed 1 tablet in each of the basket and if the tablet as a soluble external coating, immerse it in
water and at a room temperature for 5 min. then add a disc to each tube and suspend the
assembly in water maintained at 37±2˚c and operate the apparatus for 60min, unless otherwise
indicated in individual monograph. The tablets have no disintegration; repeat the test on further 6
tablets replacing with 0.1N Hcl. The tablet pass the test if all the 6 tablets have disintegrated in
acid medium, if one or two tablets fails, repeat the test on additional 12 tablets not less than 16 of
total 18 tablets should be disintegrated.
REPORT
36
DISINTEGRATION TEST FOR SUGARCOATED TABLETS
AIM
To determine the disintegration time of given sugarcoated tablets.
REQUIREMENTS
Ibuprofen and Phenylbutazone tablet
Principle
PROCEDURE
indicated in individual monograph. The tablet have no disintegration, repeat the test on further 6
REPORT
37
DISINTEGRATION TEST FOR FILMCOATED TABLETS
AIM
To determine the disintegration time of given film coated tablets.
REQUIREMENTS
Ranitidine tablet
PRINCIPLE
PROCEDURE
REPORT
38
DISINTEGRATION TEST FOR ENTERIC COATED TABLETS
AIM
To determine the disintegration time of given enteric coated tablets.
REQUIREMENTS
Bisacodyl tablet
PRINCIPLE
PROCEDURE
REPORT
39
CAPSULES
40
FORMULATION AND EVALUATION OF COMPOUND SALICYLIC
ACID CAPSULE
AIM
To formulate and evaluate compound salicylic acid capsule.
Requirements
Acetyl salicylic acid 800mg
Paracetamol 150mg
Caffeine 50mg
PRINCIPLE
Capsules are unit solid dosage forms equal the tablets in their popularity and usage. They are
convenient means of dispensing a variety of solids, semi solids and liquids. All capsules
basically consist of soluble shells of a material like gelatin. Drugs can be filled manually or using
instruments. The solid substances are dispensed in hard capsules while for dispensation of liquids
and semi solids soft capsules are preferred. Capsules are generally employed for enclosing
materials meant for oral administration and are swallowed as a whole.
Acetyl salicylic acid is known as aspirin, used as analgesic, antipyretic and
antirheumatic. Paracetamol act as an analgesic and antipyretic. Caffeine can act as CNS
stimulant.
PROCEDURE
Powdered a slight excess of ingredients if not in powder form. Weighed the calculated quantity
of each ingredients. Mixed them in the ascending order of their weight in a layer about 1/3 by the
height of the capsule thickness. Remove the cap from the shell and repeatedly press the inverted
base of capsule as the powder. Replace the top over the base and check the weight. Fill the
required number of capsule. Remove the powder sticks around the capsule.
41
EVALUATION
In this 10 filled capsules are weighed individually and removing the contents and weigh the
empty capsule shell. The difference between the two part weights gives the weight of contents.
Weight of powder = filled capsule weight – empty capsule shell weight
Average weight of % deviation

capsule
<300mg 10%
300mg or more >5%
Disintegration test
6 capsules are placed into each of 6 tubes of apparatus. Take 900ml of buffer or water in a beaker
and maintain the temperature at 37±2˚c. Place the lid over the capsule to prevent the floating of
capsule in water. Switch on the apparatus, note the time for complete disintegration of capsule.
Types of capsule Time

Hard gelatin capsule 30min
Soft gelatin capsule 60min
Enteric coated capsule 120min in Hcl
60min in 6.8pH
REPORT
42
PARENTERALS
43
PARENTERAL PREPARATIONS
Sterile products are dosage forms of therapeutic agents that are free of viable microorganisms.
Principally, these include Parenteral, ophthalmic and irrigating preparations. Of these, Parenteral
products are unique among dosage forms of drugs because they are injected through the skin or
mucous membranes into internal body compartments. The term ‘Parenteral’ means those
preparations administered by injection through one or more layers of skin tissues. It is a Greek
word, derived from ‘para’ and ‘enteron’, meaning outside the intestine. This indicates that the
preparation administered through a route other than oral route is a parenteral product.
Parenterals are defined as sterile, pyrogen–free preparations intended for administration by
injection under or through one or more layers of skin or mucous membrane. Parenterals include
sterile solutions, powders, suspensions and emulsions.
ADVANTAGES
❖ An immediate physiologic response can be achieved, if necessary, e.g. in case of cardiac
arrest, asthma and shock.
❖ They are useful for those drugs which are not effectively orally or are destroyed in the
alimentary canal in lieu of various enzymatic attack and pH environment,eg. Insulin.
❖ Parenteral therapy is very much useful for treating uncooperative, nauseous or

unconscious patients.
❖ Parenterals give the doctors control of the drug, since the patient must return for
continued treatment.
❖ They are used sometimes for showing local effects too, eg. in dentistry and
anaesthiology.
❖ They are only the means for immediate balancing of electrolyte of the body.
❖ They are useful for hospitalized patients who cannot take food by mouth.
DISADVANTAGES
❖ Administration of the dose is carried out by trained personnel’s.
❖ Requirement of absolute aseptic procedures for their administration.

44
❖ Painful administration. Some degree of pain on injection is inevitable.
❖ Reversal of physiological effect is difficult, once the drug is administered parenterally.
❖ Production cost of parenterals is high.
Intradermal(I.D),subcutaneous(S.C),intramuscular(I.M),intravenous(I.V),intrarterial,intrathecal
are the major types. Other less commonly routes include intracardiac, intraarticular, intra-
spinal,intra-synovial,intra-cisternal and peridural injection. Water for injection(WFI) is the most
widely used solvent for the preparation of parenteral dosage forms. It is specially prepared,
collected and stored in order to ensure requirements of purity and freedom from pyrogens. Non
aqueous vehicles for parenterals include oils, alcohol, propylene glycol etc…
Pyrogens are the metabolic products of microbial growth causing rise in body
temperature. Water containing pyrogens is called pyrogenic water while free from pyrogens is
called apyrogenic water. The presence of pyrogens might be from the sources like solvent, the
medicament, the apparatus and the method of storage between preparation and sterilization.
REFERENCE:
1. The Theory and Practice of Industrial Pharmacy by Leon Lachman, Herbert A Lieberman,
Joseph L Kanig, 3rd edition,pg.no:639-676.
3. Bentleys text book of Pharmaceutics by E A Rawlins.
4. A text book of Pharmaceutical formulation, B.M.Mithal, pg.no: 248-267.
45
PREPARATION OF DEXTROSE INJECTION I P
AIM
To prepare and submit dextrose injection
REQUIREMENTS
• Anhydrous dextrose
• Water for injection
• Ampoules
• Burners
• Holding devices
PRINCIPLE
Dextrose solution is a sterile solution of anhydrous dextrose. If the concentration of the solution
is not reported, a 10% w/v solution should be prepared because it is isotonic with blood serum.
The dextrose decomposes on heating the rate of sterilization depends on sterilization temperature
duration of sterilization and presence of other substances. Decomposition of dextrose is reduced
by adjusting the pH between 3.5-6.5 using acids and heated. It should be cool as quickly as
possible after sterilization of the solution; solution should not adhere to the neck of ampoules.
During the process of sealing, it is converted into black form. Injection should not be used if
which contain a precipitated or any suspended particles.
PROCEDURE
Cleaning of ampoules
Four ampoules of Type I (or Type II) glass are cleaned thoroughly with detergent solution,
followed by tap water and finally with distilled water. The ampoules are kept in an inverted
position in a beaker containing distilled water. The water is boiled for 15 minutes. The ampoules
are removed and are dried in a hot-air oven.
46
Preparation of dextrose solution
Dextrose solution is prepared as follows;
• 2/3rd of total volume of water was placed in a beaker.
• Dextrose was weighed and suspended in water with continuous stirring.
• The process was continued till complete addition and solubility of dextrose.
• The pH was adjusted to 5.7
• The solution is filtered by a filter paper.
Filling of ampoules
The syringe was rinsed with water for injection followed by rinsing with drug solution. The
syringe is loaded with drug solution. Air bubbles (if any) are removed. This can be achieved by
tapping the syringe with finger, while holding it in perfectly vertical position. (After expelling
the air, at least one drop of drug solution should be expelled. After this adjustment, the volume
indicates the desired quantity of liquid in ml). Then the drug solution was transferred into the
ampoules slowly by inserting the needle up to the bottom of the container. Therefore, a needle
larger than the length of ampoule is necessary. This prevents the rim (or neck) from
contamination by drug solution and also prevents the charring of the solution.
Sealing of ampoules
Ampoules can be sealed by two methods
• Tip sealing method
Ampoules can be sealed by this method using two Bunsen burners kept at suitable positions. The
ampoule is rotated almost horizontally (slight inclination) with about 1 cm of the neck in the
non-luminous flame. The ampoule is slowly withdrawn from the flame, when the tip starts
bending. Ampoule should be appropriately rotated to correct the bending. The resulting seal is
elegant and very strong. This method of sealing requires considerable practice to perfect. In
industries, usually two or four station tip sealing is done using a good flame system.
• Pull sealing method

The procedure was simillar as tip sealing. After filling drug solution ampoule was taken in the
left hand and ampoule holder on the right hand. The ampoule was heated supported along with
47
the holder or forcep. The tip of the ampoule was allowed to move .The tip should be smoothly
and perfectly rounded with a small flat glass in the centre.
COMPOSITION: Each 5ml contains 500mg of dextrose.
CATEGORY: Fluid and nutrient replenisher
STORAGE: Store in a cool dark place and exceeding the temperature of 25ºC
.
AUXILLIARY LABEL: Discard it if any particulate matter is present.
DATE OF EXPIRY: 2 years from date of manufacture

.
REPORT
48
PREPARATION OF SODIUM CHLORIDE INJECTION
AIM
To prepare and submit sodium chloride injection.
PRINCIPLE
Injections are sterile products intended for administration of drugs by injection under or through
one or more layers of skin or mucous membrane. 0.9% Sodium Chloride Injection is sterile and
nonpyrogenic. It is a parenteral solution containing sodium chloride in water for injection
intended for intravenous administration. When administered intravenously, these solutions
provide a source of water and electrolytes. Solutions which provide combinations of hypotonic
or isotonic concentrations of sodium chloride are suitable for parenteral maintenance or
replacement of water and electrolyte requirements.
PROCEDURE
Preparation of sodium chloride solution

Sodium chloride solution is prepared as follows;
➢ 2/3rd of total volume of water was placed in a beaker.
➢ Dextrose was weighed and suspended in water with continuous stirring.
➢ The process was continued till complete addition and solubility of dextrose.
➢ The pH was adjusted to 5.7
➢ The solution is filtered by a filter paper.
49
Filling of ampoules
Sealing of ampoules

COMPOSITION: Each 10ml contains 0.09g of sodium chloride.
CATEGORY: Electrolyte
STORAGE: Store in a cool dark place and exceeding the temperature of 25ºC.
AUXILLIARY LABEL: Discard it if any particulate matter is present
DATE OF EXPIRY: 2 years from date of manufacture.

REPORT
50
PREPARATION OF ASCORBIC ACID INJECTION IP
AIM
To prepare and submit three ampoules each containing 5 ml of ascorbic acid injection IP.
REQUIREMENTS
• Ascorbic acid
• Sodium bicarbonate
• p – chloro meta cresol
• Ampoules
• Burners
• Holding device
PRINCIPLE
Ascorbic acid closely resembles monosaccharides in structure. It is a strong antioxidant
(reducing agent). Ascorbic acid in solution is rapidly oxidized in air and alkaline media. L-
ascorbic acid undergoes oxidation to form dehydro ascorbic acid and this reaction is reversible.
Both ascorbic acid and dehydro ascorbic acid are biologically active. On hydration,
dehydroascorbic acid is irreversibly converted to 2, 3-diketo gluconic acid, which is inactive.
Ascorbic acid is freely soluble in water. Ascorbic acid solutions exhibit maximum
stability at about pH 5.4. As it undergoes oxidation in acidic pH, sodium bicarbonate is added to
adjust the pH to 5.7 (limit is 5.5 – 6.4).
Sterilization by autoclaving is not possible owing to its decomposition. Hence, aseptic
filtration and filling is advisable. However, steaming of ampoules is done terminally. To prevent
decomposition of ascorbic acid during steaming, a preservative is added. Intra muscular injection
of ascorbic acid is preferred, but it may also be given subcutaneously or intravenously.
51
PROCEDURE
Preparation of ascorbic acid solution

Ascorbic acid solution is prepared as follows;
• 2/3rd of total volume of water is placed in a beaker.
• Ascorbic acid is weighed and suspended in water with continuous stirring.
• Sodium bicarbonate is slowly added with vigorous stirring, the effervescence get
produced.
• After subsiding the effervescence, remaining sodium bicarbonate is added. This process
is continued till ascorbic acid completely dissolves.
• Para chloro meta cresol is added and stirred to dissolve
• The pH was adjusted to 5.7
• The solution is filtered through a filter.
Filling of ampoules
Sealing of ampoules
52

Composition: Each ml contains 250 mg of ascorbic acid
Category: Antiscorbutic (Ascorbic acid is used in the prevention and the treatment of scurvy).
Storage: Store in a cool dark place and exceeding the temperature of 25ºC.
Auxiliary label: Discard it if any particulate matter is present
Date of expiry: 2 years from date of manufacture.
REPORT
53
PREPARATION OF CALCIUM GLUCONATE INJECTION IP
AIM
To prepare and submit three ampoules, each containing 10ml of calcium gluconate injection
REQUIREMENTS
• Calcium gluconate
• Calcium D-saccharate
• Ampoules
• Burners
• Holding device
PRINCIPLE
Calcium gluconate is slowly soluble in about 30 parts of water and soluble in about 5 parts of
boiling water. Calcium in the form of calcium gluconate is used in the strength of 10%w/v. Any
temperature fluctuations during storage yield crystallization of calcium gluconate. Therefore a
combination of calcium gluconate and Calcium D- saccharate was used.
Sterilisation by autoclaving is not possible owing to its decomposition. Hence, aseptic
filtration and filling is advisable. However steaming of ampoule is done terminally. To prevent
decomposition of calcium gluconate during steaming, a preservative is added. Intra venous
injection of calcium gluconate is preferred but it may also be given subcutaneously or intra
muscularly.
PROCEDURE
are removed and are dried in a hot-air oven
54
Preparation of Calcium gluconate solution
Calcium gluconate solution is prepared as follows;
➢ 2/3rd of total volume of water was placed in a beaker.
➢ Calcium gluconate is weighed and dissolved in water with the aid of heat.
➢ Calcium D- saccharate is dissolved in the above solution.
➢ The solution is allowed to cool
➢ The pH was adjusted to 6 .0 -8.2
➢ The solution is filtered to a filter.

Filling of ampoules
Sealing of ampoules

The procedure was simillar as tip sealing. After filling drug solution ampoule was taken
in the left hand and ampoule holder on the right hand. The ampoule was heated supported
55
along with the holder or forcep. The tip of the ampoule was allowed to move .The tip
should be smoothly and perfectly rounded with a small flat glass in the centre
.
Composition:
Each ml contains 100 mg of total calcium
Category:
Treatment of scurvy.
Storage:
Store in a cool place.
Dose:
1- 2 g
Auxillary label:
Discard it if any particulate matter present.
Date of expiry:
3 years from date of manufacture.
REPORT
56
PREPARATION OF COMPOUND SODIUM LACTATE INJECTION
AIM
To prepare and submit 2 ampoules, each containing 5ml of compound sodium lactate injection.
REQUIREMENTS
• Lactic acid - 2.4ml

• Sodium hydroxide - 1.15g
• Calcium chloride - 0.27g
• Sodium chloride – 6.0g
• Potassium chloride – 0.4g
• Dil. Hydrochloric acid q.s
• Water for injection- q.s 100ml
PRINCIPLE
Large volume parenterals contains 100ml or more injectable solutions. They are generally
administered by IV route. It is used as a fluid and electrolyte replenisher, compound sodium
lactate injection is a sterile preparation.
PROCEDURE
are removed and are dried in a hot-air oven
Preparation of compound sodium lactate injection
Dissolve sodium hydroxide in 200ml of WFI. Add lactic acid and dissolve it. Heat it on a
autoclave at 115˚c - 116˚c for 1hr. Cool and add dil. Hcl until few drops of solution gives an
57
orange colour with solution of phenol red. Dissolve other additives in separate flask and mix
these two solutions, fiter it and immediately sterilized by autoclave or by filteration.
CATEGORY:
Fluid and electrolyte replenisher.
STORAGE:
Store in a cool dark place and exceeding the temperature of 25˚c.
ROUTE OF ADMINISTRATION:
Intravenous route
DATE OF EXPIRY:
1 year from the date of manufacture.
REPORT
58
ELECTROLYTE MAINTENANCE IV FLUID SOLUTION
AIM
To prepare electrolyte maintenance IV fluid solution.
REQUIREMENTS
• Dextrose anhydrous -5%

• Potassium chloride – 0.15%
• Sodium acetate – 0.28%
• Sodium chloride – 0.09%
• Dibasic calcium phosphate – 0.13%
• Sodium metabisulphate – 0.2%
• Acetic acid – q.s
• Water for injection – q.s to 100ml
PRINCIPLE
Large volume parenterals contains 100ml or more injectable solutions. They are generally
administered by IV route. It is used as a fluid and electrolyte replenisher, electrolye maintenance
IV fluid solution is a sterile preparation.
PROCEDURE: Dissolve sodium acetate, potassium chloride, sodium chloride and dibasic
potassium phosphate in WFI. Adjust the pH to 5 using glacial acetic acid. To this add dextrose
anhydrous and sodium metabisulphate. Make up the volume and adjust the pH between 4.8-5.
Filter it by using 0.45µm membrane filter. Sterilize at 121˚c for 30min.
CATEGORY: Fluid and electrolyte replenisher.
STORAGE: Store in a cool dark place and exceeding the temperature of 25˚c.
REPORT
59
QUALITY CONTROL TEST FOR PARENTERALS
AIM
To perform the quality control test for parenteral preparations
REQUIREMENTS
• Atropine sulphate injection

• Frusemide injection
• Methylene blue
• Vaccum chamber
PRINCIPLE
Quality control system is designed to provide check and safeguards from the moment only raw
material is delivered and continuous until the product reaches the user. Quality control test does
not begin with finished product. But which is a stepwise control of the product during all process
of manufacturing. Although finished parenteral products are subjected to sterility, clarity,
pyrogen and leak testing after manufacturing.
PROCEDURE
Leakage test
This test is performed only for ampoules which have been sealed by fusion method to see that
the ampoules are sealed properly and they may not leak to outside to spoil the package if sealing
is not perfect. The contents may be detoriated by atmospheric contaminants.
Leakage test is performed in vacuum chamber. Ampoules are dipped

in methylene blue solution in vacuum chamber and vacuum is applied. After sometimes vacuum
is released and the entry of dye to the parenteral preparation is checked. The presence of dye in
the product confirms the leakage and hence it rejected.
60
Particular matter test
Particular matter is primarily concerned in the parenteral product given by iv route, parenteral
product should be free from insoluble particle. The entire container usually inspected and that
with visible particle should be discarded.
This test is performed by holding the neck of the filled container against stringly
illuminated screen. Then it is slowly rotated, inverted and examine to exclude the possibility of
foreign particle. If any particulate matter is visible, that injection was rejected.
REPORT
61
COSMETICS
62
COSMETICS
Now a day, cosmetic is not an uncommon thing for human beings. It has become more or
less a necessary requirement in daily life for any part of the body, may be of skin, hair or nails.
People have been using cosmetics since ancient times for beautifying, promoting attractiveness,
altering the appearance and for the care of body, eyes, teeth, hair, face etc. Thus cosmetics are
mainly used for two purposes i.e. care of body parts and enhancing personal appeal of human
beings.
The consumption of cosmetics becomes immensely large since toilet soaps and dental
preparations such as tooth powders and paste have been included in cosmetics. Recently more
and more people are becoming regular user of the cosmetic preparations. Thus for legal control,
its manufacturing has been governed under the Drugs and cosmetics Act, 1940 and defined as
follows:
‘Any article intended to be rubbed, poured, sprinkled or sprayed on or introduced into or
otherwise applied to the human body or over part thereof for cleaning, beautifying, promoting
attractiveness or altering the appearance.’
Classification of Cosmetics:
Cosmetics are classified under two main groups:
Group 1: According to the part of organ of the body on which they are to be used.
Group 2: According to their physical nature.
Group 1 is further sub classified as follows:

a. For skin: e.g. powders, creams, lotions, deodorants, bath and cleansing preparation, make-up,
suntan preparations etc.
b. For hair: e.g. Shampoos, hair dressings and brilliantine’s, beard softener, shaving media,
depilatories etc.
c. For nails: e.g. Nail polish and its removers, manicure preparations.
d. For teeth and mouth: e.g. dentifrices, mouth washes etc.
Group 2 is further divided as follows:

a. Aerosols: e.g. .Perfumes, hair set hair sprays etc.
63
b. Cakes: e.g. Rouge, compact shaving cake, toilet soap etc.
c. Emulsions: e.g. cold cream, vanishing cream, cleansing cream etc.
d. Jellies: e.g. Hand jelly, wave set jelly, brilliantine jelly etc.
e. Mucilage: e.g. hand lotion
f. Oils; e.g. Hair oil, brilliantine
g. Pastes: e.g. tooth paste, deodorant paste
h. Powders: e.g. face powder, tooth powder, talcum powder etc.
i. Solutions: e.g. shampoos, after shave lotion, astringent lotion etc.
j. Sticks: e.g. Lipsticks, deodorant sticks etc.
k. Suspensions; e.g. Liquid powder, lotions etc.
REFERENCE:
1. Harrys Cosmeticology
2. Cosmetics: Science and technology by M S Balsam.
3. Pharmaceutics by Dr. A. K. Seth, pg. no: 322-366.
64
COLD CREAM
AIM
To prepare and submit 20 g of cold cream
REQUIREMENTS
• White bees wax
• Liquid paraffin
• Borax
• Rose oil
• Purified water
• Common glass wares
PRINCIPLE
Cold creams are typically bees wax – borax emulsions. They are called as cold cream because on
application to skin the evaporation of water leads to cooling effect. When a solution of borax is
added to molten bees wax emulsifying agent is formed because of wax acid and borax. i.e. wax
acid is saponified by borax forming Na – soap (i.e. Na soap of wax acid).This agent is formed at
the interface between oil and water, which emulsifies the mineral oil in water. It is because of
bees wax cream is able to contain appreciable amount of water. These are typically white creams
of higher – class free from greasiness, which has firm consistency and on application they
liquefy and spread easily.
This cream can be either o/w type or w/o type depending upon the ratio of water phase. 45% is
considered to be the critical level of water phase, cream- containing water less than 45% is w/o
type and cream with water phase more than 45% is o/w type of emulsion. Percentage of bees
wax used ranges from 5- 15% and borax 5-6% of weight of beeswax. Lesser amount of bees wax
gives softer cream and higher amount give stiffer cream.
Both w/o type and o/w type emulsion can be obtained by beeswax-borax which depends upon,
❖ Ratio of oil to water phase
❖ Temperature of preparation
65
❖ Amount of bees wax saponified
FORMULA
Sl.no Ingredients Master Working

formula formula
1 White beeswax 10g
2 Liquid paraffin 30g
3 Borax 0.5g
4 Rose oil 0.1ml
5 Purified water q.s
PROCEDURE
White bees wax and liquid paraffin was melted on a china dish. In a separate china dish borax
and water was heated. The temperature should not exceed 70ºC.Gradually added borax solution
to the melted oily base with continuous stirring and added rose oil. The semi solid emulsion
formed was then cooled to 40ºC and during hot the mass was transferred into a container and
tapped the container for the leveling of cream.
Category:
Emollient
Storage:
Store in a cool and dry place.
Direction:
For external use only.
REPORT
66
VANISHING CREAM
AIM
To prepare and submit 20 g of cold cream
REQUIREMENTS
• Stearic acid
• Potassium hydroxide
• Glycerin
• Purified water
• Rose oil
PRINCIPLE
Vanishing creams are oil-in-water emulsions with stearic acid or one of its fat like hydrophilic
esters as the major emulsified ingredients. They are mainly used to provide fairness to the skin
and as a component of make-up to hold face powder and improve its adhesion. The main
ingredients of vanishing creams are excess stearic acid, a soap and water. The choice of alkali is
an important criteria in preparing vanishing creams. Potassium hydroxide is widely used as an
alkali because, it is the most suitable and it makes a cream of fine texture and excellent
consistency. Since vanishing creams are o/w type of emulsion, there is possibility of drying out
of the cream due to evaporation of water from the external phase of emulsion. To check this, five
to ten percent of glycerin and other polyols are added to the creams as humectants.
67
FORMULA
Sl. Ingredients Official formula Required

no formula
1 Stearic acid 24g
2 Potassium hydroxide 0.99g
3 glycerin 10.5g
4 Purified water 64ml
5 Rose oil 0.5ml
PROCEDURE
Stearic acid was melted on a china dish kept on a water bath of temperature70ºC.Dissolved
potassium hydroxide in a beaker with little amount of water, added glycerin and heated at a
temperature of 70ºC.Poured the oily stearic acid phase into aqueous phase with continuous
stirring and added rose oil. The semi solid emulsion formed was then cooled to 40ºC and during
hot the mass was transferred into a container and tapped the container for the leveling of cream.
CATEGORY:
Emollient
STORAGE:
DIRECTION:
REPORT
68
BRUSHLESS SHAVING CREAM
AIM
To prepare and submit brushless shaving cream.
REQUIREMENTS
• Borax
• Stearic acid
• Lanolin
• Alcohol
• Triethanolamine
• Glycerin
• Purified water
• Perfume
PRINCIPLE
Brushless shaving creams are most popular shaving media because of their convenience and
more comfort in shaving. They require no brush for application, occupy less space in travelling
shaving kit and may be applied to the face more rapidly. They provide more comfortable shave
because they soften the beard facilitating shaving operation. They leave the face with a thin
coating of the oil or grease after shaving.
69
FORMULA:
Sl. no Ingredients Official formula Required
formula
1 Borax 0.5g
2 Stearic acid 25g
3 Lanolin 3g
4 Alcohol 2ml
5 Triethanolamine 1g
6 Glycerine 3ml
8 Perfume q.s
PROCEDURE
Melt stearic acid and anhydrous lanolin in water bath at a temperature of 60 -70ºC. A hot liquid
i.e. borax dissolved in water, triethanolamine, glycerin are added and heated at a temperature of
60 - 70ºC. Added these mass onto the another one with continuous stirring to get a smooth
cream, added perfume which dissolved in alcohol and transferred to the container during hot.
CATEGORY:
Shaving purpose
DIRECTION:
For external use only
STORAGE:
Store in a cool place
REPORT
70
LATHER SHAVING CREAM
AIM
To prepare and submit lather shaving cream.
REQUIREMENTS
• Arachis oil
• Stearic acid
• Coconut oil
• Sodium hydroxide
• Glycerin
• Purified water
• Rose oil
PRINCIPLE
Lather shaving creams are semisolid preparations having proper consistency in order to exude
from the collapsible tube easily without losing their physical form. They possess a unique
property of producing abundant lather that does not dry on face too rapidly, in addition to the
characteristics of softening the beard and holding individual hair erect for close shaving. During
shaving, lubricity for the razor is maintained thus making the shaving smooth and comfortable.
They are economical for the user as less amount of cream per shave is required. They might have
some other properties to improve their appeal like cooling sensation, antiseptic and astringent
effects.
71
FORMULA
Sl. no Ingredients Official formula Working
formula
1 Arachis oil 6g
2 Stearic acid 20.5g
3 Coconut oil 8.2ml
4 Potassium hydroxide 9.75g
5 Sodium hydroxide 1.95g
6 Sodium lauryl sulphate 0.06g
7 Glycerin 13.32ml
8 Purified water 40.22ml
9 Rose oil q.s
PROCEDURE
❖ Half of amount of stearic acid and arachis oil are mixed along with coconut oil at 70ºC.
❖ To this add alkali ( NaOH, KOH) with continuous stirring to saponify the oils.
❖ After saponification, add the remaining stearic acid.
❖ Separately warm the glycerol and SLS in half amount of water up to 70ºc.
❖ This solution is slowly added to the saponified liquid with continuous stirring, until a
creamy paste is formed.
❖ Heat the remaining amount of water to above 44ºc and add quickly to the cream with
continuous stirring.
❖ Add perfume and preservatives, so as to mix thoroughly.
CATEGORY: Shaving and cleansing agent
DIRECTION: For external use only
STORAGE: Store in a cool place
REPORT
72
FOUNDATION CREAM
AIM
To prepare and submit foundation cream.
REQUIREMENTS
• Stearic acid
• Cetyl alcohol
• Glycerine
• Purified water
• Preservative
• Perfume
• Glass wares
PRINCIPLE
Foundation cream can be applied to the skin to provide smooth emollient, hence for foundation
before the application of pure powder and other makeup preparation. They help to the powder to
adhere to the skin due to potassium hydroxide. Grey based dry powder should be non-greasy and
should have no occlusion film on the face. Foundation cream has two types.
• Pigmented cream which has color

• Unpigmented cream
73
FORMULA
INGREDIENTS MASTER WORKING

FORMULA FORMULA
Stearic acid 3.6g
Potassium hydroxide 1.04g
Sodium hydroxide 0.36g
Cetyl alcohol 0.1g
Glycerin 3.7g
Purified water 12.4g
Preservative 0.04g
Perfume q.s
PROCEDURE
Weigh the ingredients and take the stearic acid in a china dish and heated at 60°c. Take
potassium hydroxide, sodium hydroxide, glycerine in a beaker containing water heated to 60°c.
add liquid phase to oil phase with continuous stirring.
CATEGORY:
Skin cosmetic
STORAGE:
Store in a well closed and wide mouth container
REPORT
74
ALL PURPOSE CREAM
AIM
To prepare and submit all purpose cream
REQUIREMENTS
• Stearic acid
• Lanolin
• Emulsifying wax
• Mineral oil
• Tween 80
• Glycerine
• Water
• Preservatives
• Perfume
PRINCIPLE
All purpose cream is also known as sports cream. They are used by sportsman on skin during
outdoor activities. These are somewhat oily but non greasy type hence spreads easily as the skin
to give a protective film. When applied excessively they can be used as skin food or nourishing
cream or night creamer protective cream for prevention of sunburn or for treatment of roughened
area. When applied sparingly the function has hand cream or foundation cream. Thus they are
called as all purpose cream.
75
FORMULA

FORMULA FORMULA
Stearic acid 12g
Lanolin 4g
Emulsifying wax 5g
Mineral oil 23g
Tween 80 1g
Glycerine 10g
Water 45g
Preservatives qs
Perfumes qs
PROCEDURE
Melted the required quantity of stearic acid, lanolin, emulsifying wax and add mineral oil. Add
oil phase to aqueous phase after heating to some temperature, stired until cool and added
perfume at temperature 40◦c.
STORAGE
Stored in a cool place in a well closed container
REPORT
76
COCONUT OIL SHAMPOO
AIM
To prepare and submit coconut oil shampoo
REQUIREMENTS
• Coconut oil
• EDTA
• Boric acid
• Glycerol
• Perfume
• Purified water
• Glass wares
PRINCIPLE
Shampoo may be defined as a preparation containing surface active agents, which is used to
remove dirt, oil and debris from the hair, scalp without affecting the natural gloss of hair. It also
helps to keep the hair fragrant, lustrous, soft and manageable. Shampoo is prepared by dissolving
detergents in suitable liquid along with other ingredients like cleansing, flavoring agents and
preservatives.
Ideal qualities of shampoo

❖ It should remove dirt, grease (oil) debris from the hair and scalp.
❖ It should be non-toxic.
❖ It should be non-irritant.
❖ It should provide sufficient fragrance to the hair after its use.
❖ It should be effective in small amounts.
❖ It should be easily removed by washing with water.
❖ It should make the hair soft and shining.
77
All the fatty acids oil content, which reacts with potassium hydroxide to form soap. In this
formulation, potassium hydroxide saponifies coconut oil. It helps to improve clarity and
transparency.
Glycerol is used as solubilising agent and as a viscosity enhancer. EDTA act as a sequestering
agent and it prevents the formation of divalent cations. Perfume is added to improve sale appeal
of the shampoo.
FORMULA
FORMULA(100ml) FORMULA
Coconut oil 15ml
Potassium hydroxide 5g
Glycerine 2ml
EDTA 500mg
Boric acid q.s
Purified water q.s to 100ml
Perfume q.s
PROCEDURE
Heat oil and potassium hydroxide at (85˚c) in a beaker on a water bath to form soap. Stir well
until complete saponification occurs. Dissolve glycerin in a small portion of water and mix with
prepared soap. Dissolve the soap in water, adjust the pH with boric acid, the pH of the
preparation should be checked by using pH paper. Finally add EDTA and packed in a shampoo
bottle, kept in a refrigerator for chilling.
PACKAGING
Shampoos are packed in a mounted bottle or sachets.
CATEGORY
For cleansing the hair and scalp
REPORT
78
CASTOR OIL SHAMPOO
AIM
To prepare and submit castor oil shampoo
REQUIREMENTS
• Castor oil
• EDTA
• Boric acid
• Glycerol
• Perfume
• Purified water
• Glass wares
PRINCIPLE
preservatives.
79
formulation, potassium hydroxide saponifies coconut oil. It helps to improve clarity and
transparency.
Glycerol is used as solubilising agent and as a viscosity enhancer. EDTA act as a sequestering
agent and it prevents the formation of divalent cations. Perfume is added to improve sale appeal
of the shampoo.
FORMULA
FORMULA(100ml) FORMULA
Castor oil 15ml
Potassium hydroxide 5g
Glycerine 2ml
EDTA 500mg
Boric acid q.s
Purified water q.s to 100ml
Perfume q.s
PROCEDURE
Heat oil and potassium hydroxide at (85˚c) in a beaker on a water bath to form soap. Stir well
until complete saponification occurs. Dissolve glycerin in a small portion of water and mix with
prepared soap. Dissolve the soap in water, adjust the pH with boric acid, the pH of the
preparation should be checked by using pH paper. Finally add EDTA and packed in a shampoo
bottle, kept in a refrigerator for chilling.
PACKAGING
CATEGORY
REPORT
80
CREAM SHAMPOO
AIM
To prepare and submit cream shampoo.
REQUIREMENTS
• Stearic acid
• Lanolin
• Cetyl alcohol
• Purified water
• Perfume
PRINCIPLE
preservatives.
❖ It should make the hair soft and shining
Cream shampoos are also known as shampoo paste. They packed in collapsible tubes. This may
produce foam continuously. Caustic soda and SLS helps in the formation of translucent cream.
81
FORMULA

FORMULA FORMULA
Stearic acid 1.3g
Lanolin 5g
Cetyl alcohol 10g
Caustic soda 2g
SLS 13.2g
Purified water 68.5ml
Perfume q.s
PROCEDURE
Melt stearic acid, lanolin and cetyl alcohol on a china dish and add half the quantity of water.
Dissolve caustic soda and SLS in remaining quantity of water. Heat this mixture with gentle
stirring.
PACKAGING
CATEGORY
REPORT
82
LIQUID CLEAR SHAMPOO
AIM
To prepare and submit liquid clear shampoo
REQUIREMENTS
• Coconut oil
• Palm oil
• Ethyl alcohol
• Perfume
PRINCIPLE
preservatives.

formulation, potassium hydroxide saponifies coconut oil. Ethyl alcohol helps to dissolve oil. It
83
also acts as clarifying agent. It helps to improve clarity and transparency. Sodium lauryl sulphate
acts as a sequestering agent and it prevents the formation of divalent cations, which when
formed, deposit on hair and scalp giving it a dull appearance. Perfume is added to improve sale
appeal of the shampoo.
FORMULA

FORMULA FORMULA
Coconut oil (A) 15ml
Palm oil (A) 5ml
Potassium 3ml
hydroxide(B)
Sodium 1ml
hydroxide(B)
SLS(B) 67g
Ethyl alcohol(C) 7ml
Perfume(C) q.s
PROCEDURE
Heat A and B components separately and add A to B with slow agitation. Cool, then add alcohol
and perfume.
PACKAGING
CATEGORY
REPORT
84
LIPSTICK
AIM
To formulate and submit lipstick
REQUIREMENTS
• Carnauba wax
• Beeswax
• Lanolin
• Castor oil
• Cetyl alcohol
• Color
• Lipstick mould
• Beaker
• Glass rod
PRINCIPLE
Carnauba wax and beeswax combination used to achieve desired melting point, viscosity and
other physical properties of lipstick (strength and hardness). Lanolin is used to improve the
covering properties of colors. Castor oil are stabilized against oxidation producing a viscous
liquid matrix due to its high viscosity delaying the setting of pigments from moulded lipstick
mass. Cetyl alcohol gives emollient action.
FORMULA:
Sl.no Ingredients Official quantity Working

quantity
1 Carnauba wax 1g
2 Beeswax 1.5g
3 Lanolin 0.5g
4 Castor oil 0.5g
5 Cetyl alcohol 0.5g
6 Colour q.s
85
PROCEDURE
❖ Melt carnauba wax and beeswax on a china dish on a water bath at 90ºc.
❖ Add lanolin and cetyl alcohol to the mixture and heat to 50-85ºc.
❖ Add castor oil to above mixture and heat to 80-85ºc.
❖ Color or perfume is finally added, mix well.
❖ Pour into prelubricated lipstick mould.
CATEGORY
Cosmetic
REPORT
86
AFTER SHAVE LOTION
AIM
To prepare and submit after shave lotion
REQUIREMENTS
• Boric acid
• Aluminum hydroxide
• Menthol
• Glycerin
• Ethanol
• Perfume
• Purified water

PRINCIPLE
Afer shave lotion is used by men after a thorough shaving. It acts as smoothening, softening,
antiseptic action. Boric acid acts as antiseptic agent, aluminum hydroxide, menthol acts as
protectant and cooling agent. Glycerin is used as humectant, ethanol preservative and cooling
agent.
FORMULA
Sl.no Ingredients Master formula Working

formula
1 Boric acid 20g
2 Aluminum hydroxide 1.5g
3 Menthol 0.1ml
4 Glycerin 2.5ml
5 Ethanol 50ml
6 Perfume q.s
7 Purified water q.s to 100ml
87
PROCEDURE
Boric acid and aluminium hydroxide were powdered in a clean mortar. Add menthol slowly to
this with continuous trituration and add ethanol. Add glycerin and make up to the final volume
with distilled water.
CATEGORY:
Facial cosmetic
STORAGE:
Store in a well close container
DIRECTION:
REPORT
88
PASTE DEPILATORY
AIM
To prepare and submit paste depilatory.
REQUIREMENTS
• Sodium sulphate
• Kaolin
• Glycerin
• Calcium hydroxide
• Purified water
• Peppermint oil
PRINCIPLE
Depilatories are preparations employed for temporarily removing any undesired hair above the
outer surface of the skin. Women are the main user of such type of the preparation for removing
their unwanted hair of the skin. The action of depilatories is to dissolve the hair. Initially, it is
softened, swelled and dispersed by the action of the chemical. These chemicals may have
irritating effect on the epidermis if applied and remained on the skin for long time
Thus, the preparations must be so formulated as to complete their action is not more than
five minutes. After the action has been completed, depilatories must be washed properly with
soapy water and then skin is nourished with cold cream. To ensure the safety, the user should be
advised to do the sensitivity test on a part of her arm which is devoid of hair ,by applying a little
depilatory and leaving it on for about five minutes. If the subject finds sensitivity towards the
depilatory, she must not use it.
Sodium sulphate is the active ingredient and it having depilatory action. Kaolin acts as
binding agent. Glycerin acts as a humectant. Calcium hydroxide increases alkalinity. Peppermint
oil acts as flavoring agent. Purified water acts as a vehicle.
89
FORMULA
Sl.no Ingredients Official quantity Required
quantity
1 Sodium sulphate 40g
2 kaolin 600g
3 glycerin 19.5g
4 Calcium hydroxide 40ml
6 Peppermint oil 6.5ml
PROCEDURE
Sodium sulphate and kaolin was triturated in a mortar to get a fine powder. To this added
calcium hydroxide solution. Glycerin and purified water was then added. Triturated well and
finally suitable quantity of peppermint oil was added, mixed well to get a smooth paste and the
preparation was weighed, packed and submitted.
CATEGORY:
Hair remover
STORAGE:
Store in a well closed container
DIRECTION:
REPORT
90
ROUGE POWDER
AIM
To prepare and submit rouge powder
REQUIREMENTS
• Light magnesium carbonate
• Precipitated chalk
• Zinc oxide
• Starch
• Purified talc
• Pigment
• Perfume
PRINCIPLE
Rouges are specially applied on the cheeks for enhancing the entire look of the face. They impart
sparked touch and stimulate the freshness of the skin. They are prepared by the mixture of oils, fats,
waxes, suitably colored. They are available in various forms like paste, cream and dry solid.
FORMULA
Sl.no Ingredients Master formula Required

formula
1 Light magnesium carbonate 12g
2 Precipitated chalk 20.6g
3 Zinc oxide 8g
4 starch 12.4g
5 Purified talc 42g
6 pigment q.s
7 perfume q.s
91
PROCEDURE
❖ Added perfume to light magnesium carbonate and mixed well.
❖ Kept this mixture in a clean container for half an hour.
❖ Added precipitated chalk, zinc oxide, starch, purified talc and pigment.
❖ Powdered well and sieve the powders to get a smooth flowing powder.
CATEGORY:
Cosmetic for face
DIRECTION:
STORAGE:
REPORT
92
FACE POWDER
AIM
To prepare and submit face powder.
REQUIREMENTS
• Boric acid
• Salicylic acid
• Starch
• Purified talc
PRINCIPLE
Powders are the solid dosage forms. They are considered as the oldest and simplest dosage forms
since supplied either in the bulk or as an individual doses in the fine state of sub division of drug
or drugs with or without the diluents. Usually bulk powders are supplied for external used
purposes and individual doses for internally used purposes.
The function of face powder is to impart smooth finishing to skin and mask minor visible spots
and make the skin shining. Boric acid acts as a protecting agent, salicylic acid acting as
keratolytic agent, starch is added to absorb moisture, purified talc acts as a lubricant and also
helps to spread the powder and impart the characteristic smooth feeling to the skin.
FORMULA

quantity
1 Boric acid 5g
2 Salicylic acid 3g
3 Starch 50g
4 Purified talc 42g
93
PROCEDURE
Weigh required quantity of boric acid, salicylic acid and starch and place it on a clean dried
mortar. Finally add purified talc and mix it thoroughly. The mass was then passed through Sieve
No: 120 to get a very fine powder of desired consistency.
CATEGORY:
Protectant
STORAGE:
Store in a cool and dry place
DIRECTION:
REPORT
94
BABY FACE POWDER
AIM
To prepare and submit baby face powder
REQUIREMENTS
• Talc
• Magnesium carbonate (light)
• Boric acid
• Perfume oil
• Sieves
• Mortar & pestle
PRINCIPLE
Baby face powder is a bulk powder for external use and are not so much different from that of
ordinary talcum powders except that these are not highly perfumed, may contain an antiseptic
ingredient and it has excellent slip and good adhesion. Particle size and shape are important
characteristics of face powder. Addition of zinc stearate or magnesium stearate improves water
repellant properties. These metallic stearates provide smoothness and greater attraction to this
powder.
95
FORMULA

FORMULA FORMULA
Talc 87g
Magnesium stearate 5g
Magnesium 5g
carbonate
Boric acid 2.5g
Perfume oil 0.5g
PROCEDURE
Finely powder all materials. Add perfume oil with magnesium carbonate and keep it aside for
sometimes. Mix talc with finely powdered ingredients thoroughly and lastly add perfumed
powder. Pass the powder mixture through silk mesh or old washed nylon cloth and then pack.
CATEGORY:
Antiseptic, disinfectant powder
REPORT
96
TOOTH PASTE
AIM
To prepare and submit tooth paste
REQUIREMENTS
• Carboxy methyl cellulose

• Propylene glycol
• Purified water
• Methyl paraben
• Peppermint oil
• Glycerin
• Mineral oil
• Dicalcium phosphate
• Mortar and pestle
• Glasswares
PRINCIPLE
Tooth paste is most valuable and widely used preparation for cleaning the teeth. Toothpaste are
formulated using various materials like abrasive detergents, foaming materials, humectants,
sweetening agent, flavoring agent, preservative and therapeutic agents.
97
FORMULA
INGREDIENTS MASTER FORMULA WORKING

FORMULA
Propylene glycol 18g
Purified water 13.5g
Methyl paraben 0.1g
Saccharin sodium 0.1g
Peppermint oil 0.3g
Carboxy methyl 0.9g
cellulose
Sodum lauryl 2.5g
sulphate
glycerin 1g
Mineral oil 1g
Dicalcium phosphate 62.6g
PROCEDURE
Soak carboxy methyl cellulose in water containing SLS. To this add mixture of glycerin,
propylene glycol, sodium saccharin solution and peppermint oil. Add mineral oil with constant
stirring. It is triturated with previously mixed homogenous mixture of paraben and dicalcium
phosphate.
CATEGORY: Dentifrices
DIRECTION: For external use only.
STORAGE: Stored in a cool and dry place.
REPORT
98
TOOTH POWDER
AIM
To prepare and submit tooth powder
REQUIREMENTS
• Hard soap
• Precipitated calcium carbonate
• Peppermint oil
• Cinnamon oil
• Methyl salicylate
• Glasswares
PRINCIPLE
Primary function of a tooth powder is maintenance of oral hygiene. A tooth powder ingredient
will be mild abrasive, foaming agent, sweetening agent and a flavoring agent. Dicalcium
phosphate and precipitated calcium carbonate are used as abrasive agent. Sodium lauryl sulphate
helps in removing food debris and also acts as foaming agent and has psychological effect.
Sodium saccharin is used as sweetening agent.
99
FORMULA

FORMULA FORMULA
Hard soap 5g
Precipitated 79g
calcium carbonate
Saccharin sodium 2g
Peppermint oil 4ml
Cinnamon oil 2ml
Methyl salicylate 8ml
PROCEDURE
Pass all the ingredients through sieve no 60 and mix thoroughly. Divide the powder into
approximately 4 parts. Incorporate the oil in the 1/4th of total bulk by trituration, mixed
thoroughly. Passed into sieve no 60 mixed thoroughly flavored part with another 1/4th of the
powder and pass through the sieve, continued the process still all of them are mixed well.
CATEGORY:
Dentifiers
STORAGE:
Stored in a cool place.
REPORT
100
ZINC CHLORIDE AND ZINC SULPHATE MOUTH WASH
AIM
To prepare and submit zinc chloride and zinc sulphate mouth wash
REQUIREMENTS
• Zinc chloride
• Zinc sulphate
• Hydrochloric acid
• Chloroform
• Water
• Mortar and pestle
• Glasswares
PRINCIPLE
Mouth washes are utilized to remove loose food or debris from the mouth. They provide deodorant,
refreshing, local analgesic or astringent effects. They are able to clean the deposited debris in the teeth
cavities. In the ulceration of mouth it is employed as an astringent and for wound healing. Zinc chloride
and zinc sulphate act as astringent
PROCEDURE
Dissolves zinc sulphate and zinc chloride in ¾ th quantity of purified water. To this solution, add dil Hcl
and mix with continuous stirring until turbidity disappears. Add compound tartazine solution and
chloroform water. Mix well, filter and finally make up the volume.
CATEGORY: Astringent
STORAGE: Stored in well closed container in a cool place
REPORT
101
COMPOUND SODIUM CHLORIDE MOUTH WASH
AIM
To prepare and submit Compound Sodium Chloride mouth wash.
REQUIREMENTS
• Sodium chloride
• Concentrated peppermint emulsion
• Double strength chloroform water
• Purified water
• Beaker
• Glass rod
PRINCIPLE
Mouth washes are utilized to remove loose food or debris from the mouth. They provide
deodorant, refreshing, local analgesic or astringent effects. They are able to clean the deposited
debris in the teeth cavities. Sodium chloride and sodium bicarbonate are used to remove the
debris from the mouth and leaving the deodorant effect in the mouth cavity. Concentrated
peppermint emulsion provides flavor, double strength chloroform water provides sweet taste and
preservative function. Purified water acts as a solvent and vehicle.
102
FORMULA
Sl.no Ingredients Official quantity Working

quantity
1 Sodium chloride 15g
2 Sodium bicarbonate 10g
3 Peppermint water q.s to 100ml
PROCEDURE
Sodium chloride and sodium carbonate are dissolved in sufficient quantity of purified water.
Added concentrated peppermint emulsion, double strength chloroform water and purified water
to produce the required volume.
CATEGORY:
Mouth refreshner
STORAGE
DIRECTION:
REPORT
103
OPHTHALAMIC PREPARATIONS
104
OPHTHALMIC PREPARATIONS
Preparations used for the eye refer to the ophthalmic preparations. They may be sterile
solutions, suspensions and ointments. These products may be instilled into the eye by either in
the form of drops, sprays or mists, continuous streams for irrigation and applied as ointments.
Ophthalmic products may be of various types like eye drops, eye lotions, contact lens solutions,
eye ointments and ophthalmic inserts. The human eye is a very sensitive organ. It can be quickly
affected by any change in environment. Thus ophthalmic products require many precautions to
be taken while their preparation so as to get good qualities likes sterility, free from foreign
particles etc. Sterile products are dosage forms of therapeutic agents that are free of viable
microorganisms.
Eye drops are sterile aqueous or oily solutions or suspensions for instilling into the
conjunctival sac. They usually contain anesthetic, anti inflammatory, antiseptic, diagnostic,
miotic and mydriatic agents. Eye lotions are sterile aqueous solutions intended for washing the
eyes, with the help of eye bath (eye cup) to remove any irritant or foreign body from the eye.
Contact solutions are used for making the contact lens clean, wetted, soaked and disinfected
while fixing into the eyes. Contact lenses are of two types namely hard contact lens and soft
contact lens.
Eye ointments are sterile ointments meant for the application to the eyes. Ointment bases
used to formulate eye ointments should be sterilized by heating method, should be free from
irritation, should diffuse drug uniformly throughout the secretion of eye, and melt close to the
body temperature. The advantage of eye ointments over eye drops is the increased ocular contact
time of the drug. One disadvantage is that it provides blurred vision on application.
Recently, a new drug delivery of drugs to the eyes has been developed called ophthalmic
inserts. It is a polymeric membrane, flexible in nature and consists of multilayered structure
consisting of a drug-containing core surrounded on each side by a layer of copolymer
membranes through the drug diffuses at a constant rate. It provides predetermined and
predictable constant rate of drug diffusion. The rate is controlled by polymer composition,
membrane thickness and solubility of the drug. It must be sterilized and no preservative should
be added.
105
REFERENCE
1. The Theory and Practice of Industrial Pharmacy by Leon Lachman, Herbert A Lieberman,
Joseph L Kanig, 3rd edition,pg.no:639-676.
3. Pharmaceutics by A.K. Seth, pg. no: 406-422
106
BORIC ACID EYE DROPS
AIM
To prepare and submit 15 ml of boric acid eye drops
REQUIREMENTS
• Boric acid
• Phenyl mercuric nitrate
• Purified water
• Sterile glass wares
PRINCIPLE
Eye drops are sterile aqueous or oily solutions or suspensions for instilling into the conjunctival
sac. They usually contain anti-inflammatory, antiseptic, anesthetic, diagnostic, miotic and
mydriatic agents. Boric acid acting as a antiseptic agent. Phenyl mercuric nitrate acts as a
ophthalmic preservative.
FORMULA

quantity
1 Boric acid 2g
2 Phenyl mercuric nitrate 0.1g
PROCEDURE
Boric acid was dissolved in suitable quantity of purified water which was previously boiled and
cooled. Mix well. Added phenyl mercuric nitrate, mix well and final volume was made up with
remaining purified water.
107
CATEGORY:
Antiseptic
STORAGE:
REPORT
108
SODIUM CHLORIDE EYE LOTION
AIM
To prepare and submit 10 ml of sodium chloride lotion.
REQUIREMENTS
• Sodium chloride
• Phenyl mercuric acetate
• Purified water
PRINCIPLE
Eye lotions are sterile aqueous solutions intended for washing the eyes, with the help of eye bath
(eye cup) to remove any irritant or foreign body from the eye. Sodium chloride acts as a
cleansing agent and was isotonic with lachrymal secretion. Phenyl mercuric nitrate act as a
ophthalmic preservative.
FORMULA

quantity
1 Sodium chloride 9g
2 Phenyl mercuric acetate 0.1g
PROCEDURE
Sodium chloride was dissolved in suitable quantity of purified water which was previously
boiled and cooled. Mix well. Added phenyl mercuric acetate, mixed well and final volume was
made up with remaining purified water.
109
CATEGORY:
Eye washing
STORAGE:
REPORT
110
SODIUM BICARONATE EYE LOTION B.P.C
AIM
To prepare and submit 10 ml of sodium bicarbonate lotion.
REQUIREMENTS
• Chlorbutol
• Purified water
PRINCIPLE
Eye lotions are sterile aqueous solutions intended for washing the eyes, with the help of eye bath
(eye cup) to remove any irritant or foreign body from the eye. Sodium bicarbonate acts as a
cleansing agent and was isotonic with lachrymal secretion. Chlorbutol acts as an ophthalmic
preservative.
FORMULA

quantity
1 Sodium bicarbonate 9g
2 Chlorbutol 0.4g
PROCEDURE
Sodium bicarbonate was dissolved in suitable quantity of purified water which was previously
boiled and cooled. Mix well. Add chlorbutol, mix well and final volume was made up with
remaining purified water.
111
CATEGORY:
Eye washing
STORAGE:
REPORT
112
SIMPLE EYE OINTMENT
AIM
To prepare and submit 10 g of simple eye ointment.
REQUIREMENTS
• Boric acid
• Benzalkonium chloride
• Yellow soft paraffin
PRINCIPLE
Eye ointments are sterile semisolid preparations are applied to the eyes. Boric acid acts as
antiseptic. Benzalkonium chloride acts as an ophthalmic preservative.
FORMULA

quantity
1 Boric acid 2g
2 Benzalkonium chloride 0.1g
3 Yellow soft paraffin q.s to 100g
PROCEDURE
Yellow soft paraffin was properly melted on a clean china dish and added suitable quantity of
boric acid and mixed well. Added benzalkonium chloride and mixed well to get suitable
quantity.
CATEGORY: Antiseptic
STORAGE: Store in a well closed container
REPORT
113
TRANSDERMAL PATCHES
114
TRNSDERMAL PATCHES
In transdermal permeation, the drug molecules can diffuse not only through the skin
layers but also through the openings of the hair follicles and the sweat gland regions. The stratum
corneum is a complex layer and is capable of binding some drug molecules. The steady state
transdermal flux of drugs through the skin can be mathematically represented by the following
equation.
Ps = Ds/Cs
Where,
Ds is the transdermal flux
Cs is the concentration difference across the skin barrier
Ps is the permeability coefficient.
Advantages of transdermal drug delivery systems:

❖ Transdermal drug delivery systems provide relatively steady and sustained drug
concentration in plasma in contrast to the conventional systems.
❖ The hepatic first pass metabolism is avoided.
❖ Variability due to factors such as pH, intestinal motility, food intake etc. which make vast
difference in the bio-availability of the drugs given through oral route are non-existent.
❖ A constant rate of absorption is possible in a vast variety of adverse patient population.
❖ Ease of administration and patient convenience.
❖ Drug input terminable by mere removal of the transdermal patches.
❖ Absence of side effects of drugs
115
Disadvantages of transdermal drug delivery systems:
❖ Can be used only for drugs which require very small plasma concentrations for action.
❖ Local irritations or allergic responses possible.
❖ One of the major problems faced in transdermal permeation of the drugs is the low
penetration rate of drugs. The stratum corneum is the rate determining barrier.
❖ Enzymes in the epidermis or derived from microorganisms present on the skin surface
may denature the drugs.
116
FORMULATION OF TRANSDERMAL PATCHES OF PARACETAMOL
AIM
To prepare transdermal patches of paracetamol.
PRINCIPLE
Passage of a drug through the skin and its subsequent entry into the systemic circulation
is basically a function of the drug compound and the skin conditions. Since the driving force for
the diffusion of the drug into the skin is its concentration, factors controlling concentration in
solution, such as its solubility coefficient, partition coefficient, molecular size, play an important
role in the diffusion rate. The ionized or the nonionized form is yet another important factor
affecting permeability of the drug. All transdermal drug delivery systems consist mainly of drug,
polymer matrix, enhancers, adhesives and other additives. The transdermal drug delivery systems
(TDDS) in use are fall in various groups like membrane modulated, matrix diffusion controlled
or micro sealed.
In membrane modulated systems the drug reservoir is covered on all sides but one which
consists of the rate controlling polymeric membrane. Rate release variations are possible by
change in the composition and thickness of the polymer membrane. In matrix diffusion control
systems, the drug reservoir is a polymer matrix containing dispersed drug molded into a disc of
preconceived surface area and thickness. The drug release is controlled by matrix reservoir
material through which the drug diffuses from the drug reservoir to the body tissues.
In microsealed systems the drug is dispersed in a silicon polymer in liquid micro-
components which serve as small drug reservoirs. Nitro glycerin has been marketed in such
systems under the trade name of nitro-disc.
117
FORMULA
Sl. no Ingredients Official Required

quantity quantity
1 Paracetamol 500mg
2 Ethyl cellulose 2.1g
3 Methanol 6.2ml
4 Dibutyl phthalate 4.1ml
5 Glycerin 3ml
PROCEDURE
Polymer was dissolved in vehicle by continuous agitation using a magnetic stirrer.
Paracetamol drug was then added and completely dissolved in polymeric solution with agitation.
Plasticizer was then added and mixed well. The mass was then transferred to an adhesive
membrane in a clean petri dish. The rate of evaporation was controlled by inverting a funnel over
the petri dish. After 24 hrs the dried film was taken, labeled and packed.
REPORT
118
FORMULATION OF TRANSDERMAL PATCHES OF NIFEDIPINE
AIM
To prepare transdermal patches of nifedipine.
PRINCIPLE
Passage of a drug through the skin and its subsequent entry into the systemic circulation
is basically a function of the drug compound and the skin conditions. Since the driving force for
the diffusion of the drug into the skin is its concentration, factors controlling concentration in
solution, such as its solubility coefficient, partition coefficient, molecular size, play an important
role in the diffusion rate. The ionized or the nonionized form is yet another important factor
affecting permeability of the drug. All transdermal drug delivery systems consist mainly of drug,
polymer matrix, enhancers, adhesives and other additives. The transdermal drug delivery systems
(TDDS) in use are fall in various groups like membrane modulated, matrix diffusion controlled
or micro sealed.
In membrane modulated systems the drug reservoir is covered on all sides but one which
consists of the rate controlling polymeric membrane. Rate release variations are possible by
change in the composition and thickness of the polymer membrane. In matrix diffusion control
systems, the drug reservoir is a polymer matrix containing dispersed drug molded into a disc of
preconceived surface area and thickness. The drug release is controlled by matrix reservoir
material through which the drug diffuses from the drug reservoir to the body tissues.
In microsealed systems the drug is dispersed in a silicon polymer in liquid micro-
components which serve as small drug reservoirs. Nitro glycerin has been marketed in such
systems under the trade name of nitro-disc.
119
FORMULA
Sl. Ingredients Official Required

no quantity quantity
1 Nifedipine 100mg
2 Ethyl cellulose 2.1g
3 Methanol 6.2ml
4 Dibutyl phthalate 4.1ml
5 Glycerin 3ml
PROCEDURE
Polymer was dissolved in vehicle by continuous agitation using a magnetic stirrer.
Nifedipine drug was then added and completely dissolved in polymeric solution with agitation.
Plasticizer was then added and mixed well. The mass was then transferred to an adhesive
membrane in a clean petri dish. The rate of evaporation was controlled by inverting a funnel over
the petri dish. After 24 hrs the dried film was taken, packed and labeled.
REPORT
120
MICROENCAPSULATION
121
MICROENCAPSULATION
Microencapsulation is a process of applying thin coatings reproducibly to small particles of

solids, droplets of liquids, or dispersions; thus forming microcapsules. A number of
microencapsulation processes are employed now a days but the one commonly used in pharmacy
is the phase separation or coacervation technique. The process consists of three steps. Formation
of three immiscible phases
❖ A liquid manufacturing phase
❖ A core material phase
❖ A coating material phase
Deposition of liquid polymer coating on the core material and rigidifying the coating to form
a microcapsule.This process is particularly advantageous in overcoming the problem of masking
the disagreeable taste of the bitter drugs. It is also used in prolonged release formulation.
REFERENCE
A text book of Professional pharmacy by N K Jain, pg no 347
122
FORMULATION OF ALGINATE BEADS OF DICLOFENAC SODIUM
AIM
To formulate alginate beads of diclofenac sodium
REQUIREMENTS
• Diclofenac Sodium
• Sodium alginate
• Calcium chloride
• Disposable syringe
• Mechanical stirrer
PRINCIPLE
For orally administered dosage forms extended action is activate by affecting the rate at which
the drug is released from the dosage form or by slowing the transit time of dosage form through
gastro intestinal tract. The rate of drug release from dosage form may be modified by
technologies like controlling drug interaction or between them or its pharmaceutical barriers like
specific biologic barrier, modified drug dissolution by controlling access or biological study to
the drug through the use of barrier coating.
PROCEDURE
Prepare 25 ml of 1% w/v of sodium alginate solution. Weigh 250 mg of diclofenac sodium and
dispersed in the above solution using a mechanical stirrer. The dispersion is took on a disposable
syringe and added drop wise into a beaker containing 50 ml of 2% calcium chloride solution
along with continuous stirring. The beads formed are then separated y filtration and dried.
REPORT
123
FORMULATION OF ALGINATE BEADS OF PARACETAMOL
AIM
To formulate alginate beads of paracetamol
REQUIREMENTS
• Paracetamol
• Sodium alginate
• Calcium chloride
• Disposable syringe
• Mechanical stirrer
PRINCIPLE
For orally administered dosage forms extended action is activate by affecting the rate at which
the drug is released from the dosage form or by slowing the transit time of dosage form through
gastro intestinal tract. The rate of drug release from dosage form may be modified by
technologies like controlling drug interaction or between them or its pharmaceutical barriers like
specific biologic barrier, modified drug dissolution by controlling access or biological study to
the drug through the use of barrier coating.
PROCEDURE
Prepare 25 ml of 1% w/v of sodium alginate solution. Weigh 250 mg of paracetamol and

dispersed in the above solution using a mechanical stirrer. The dispersion is took on a disposable
syringe and added drop wise into a beaker containing 50 ml of 2% calcium chloride solution
along with continuous stirring. The beads formed are then separated y filtration and dried.
REPORT
124
EVALUATION OF WATER FOR INJECTION
AIM
To evaluate the given sample of water for injection
PROCEDURE
Evaluation parameters
Acidity or alkalinity
To 10 ml of solution added 0.05 ml of methyl red solution and observe.
Chlorides
To 10 ml added 1ml of 2M nitric acid and added 0.2 ml of 0.1M silver nitrate and observe.
Sulphates
To 10 ml added 2M HCl and 0.1 ml barium chloride solution and observe.
Physical evaluation
Examine the given sample under suitable conditions.
REPORT
125

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PHARMACEUTICS

Formulative and Industrial Pharmacy

Formulative and Industrial Pharmacy is a wing of pharmacy deals with the

Qualities and accessories to be maintained by the student

• Weight of tablets may vary from 0.2 gm to 0.8 gm.

• Brocken don, an Englishman carries the credit of tablet fabrication in

• Compressed tablets offer a number of advantages to the patients as well as

• Easy to carry by patients.

• Marketed mainly in strip and blister packagings.

▪ An accurate amount of medicament even if very small can be incorporated.

▪ Less incompatibility problems than all other dosage forms.

▪ Since tablets are produced on a large scale cost of production is relatively

▪ Tablets are available as coated, sugar coated, film coated etc…

▪ Even lakhs of tablets can be prepared per day in a pharmaceutical industry.

▪ Discoloration, chipping, sticking, picking etc. are observed in certain tablets.

▪ Less preference for pediatrics and geriatrics.

▪ Water or fluid is required for swallowing tablet.

Sl.No Ingredients Formula for 1 Formula for 100

where h = height of the pile

Relationship between angle of repose and powder flow

Angle of repose Powder flow

Tapped density= weight of granule/ tapped

%compressibility = (St- So/St)×100

Where St= tapped bulk density

%loss on drying =weight before drying/weight after drying

4. Collected granules that are passed through Sieve no: 20

7. The granules are then taken for compression.

Determination of packed density, hausner’s ratio, carr’s index

• Tablet compression machine

• Hot air oven

SL.NO INGREDIENTS FORMULA FOR 1 FORMULA

Angle of repose Powder flow

Bulk density= weight of granules/bulk volume of granules

Tapped density= weight of granule/ tapped

%compressibility = (St- So/St)×100

Where St= tapped bulk density

%loss on drying =weight before drying/weight after drying

4. Collected granules that are passed through Sieve no: 20

7. The granules are then taken for compression.

Determination of packed density, hausner’s ratio, carr’s index

Sodium sulphate- active drug act as laxative

H3C6H5O7.H2O+3NaHCO3 – Na3C6H5O7 + 3H2O+ 3CO2

Relationship between angle of repose and powder flow

Angle of repose Powder flow

Bulk density= weight of granules/bulk volume of granules

Tapped density= weight of granule/ tapped

%compressibility = (St- So/St)×100

Where St= tapped bulk density

%loss on drying =weight before drying/weight after drying ×100

Determination of packed density, hausner’s ratio, carr’s index

• Starch paste (5%)

• Tablet compression machine

• Hot air oven

Relationship between angle of repose and powder flow

Bulk density= weight of granules/bulk volume of granules

Tapped density= weight of granule/ tapped

%compressibility = (St- So/St)×100

Where St= tapped bulk density

%loss on drying =weight before drying/weight after drying ×100

Wet granulation method

4. Collected granules that are passed through Sieve no: 20

7. The granules are then taken for compression.

Determination of packed density, hausner’s ratio, carr’s index