BPH 1073 DOSAGE FORM

DESIGN AND
DISPENSING II

SEMI-SOLID
PRODUCT :
OINTMENT

SITI AMIRAH HAKIMAH BINTI MOHD

FAIRUZ
BPH COHORT 7
2062181008
S.POONGUZHALI
PART 1 : COLLECTION OF PRODUCT DATA
01 BRAND NAME
 CNI FireSens Mentholated Rub

02 DESCRIPTION
 As the name itself suggests FireSens is a multi-usage and for all
seasons’ balm. Single product can compete in both cold & pain
balm segment which has a greatest added advantage. It’s not
single season product, it is useful in all the seasons since it’s a
multifunctional product.

 The main benefits would be it relieves from tensed shoulders,

stuffy nose, tightened thighs, arthritis, aching ankles, headaches,
sprains, backaches, strained muscles, foot cracks, stomach pain,
flu and cold, insect bites and so on.

03 LIST OF INACTIVE INGREDIENTS

Ingredients
1. Nutmeg Oil
2. Tree Tea Oil
3. Eucalyptus Oil
4. FSM Compound Oil
5. White Soft Paraffin

04 LIST OF ACTIVE INGREDIENTS

 Ingredients % w/w
1. Methyl Salicylate 22.0
2. Menthol Crystal 11.5
3. Camphor 5.0

05 DIRECTION OF USES / APPLICATION

 Gently apply to the affected area.
 Store at room temperature and in dry and cool place.
 Do not apply on open wounds or damaged skin.

06 PRODUCT WARNING
 Do not use FireSens on children under 3 years.
 For pregnant and nursing women, consult your health care
provider.
 Avoid contact with eyes, mucous membranes and broken skin.

07 MACNUFACTURING COMPANY
 CNI Enterprise (M) Sdn Bhd
 Q-Pack (M) Sdn Bhd

08 COUNTRY OF MACNUFACTURES
 Shah Alam, Selangor, Malaysia

09 DATE OF MACNUFACTURE AND DATE OF EXPIRATION

 MFG : 03/2019
 EXP : 03/2021

PART 2 : ANALYSIS
01 LIST OF INACTIVE INGREDIENTS WITH FUNCTION

Ingredients Functions
1. Nutmeg Oil Traditionally used for abdominal discomfort,
relieves headache, backache, relieves itchiness
due to skin bites and warms up muscles.
2. Tree Tea Oil Contain Terpene-4-ol which is main component
for antibacterial and antimicrobial. Relieves
itchiness due to skin bites and rashes.
3. Eucalyptus Oil Good for flu and cold, enhances blood circulation
and warmth, and treats minor cuts.
4. FSM Compound Oil Oil which helps to alleviate muscular pains and a
good antiseptic for wounds and other skin
problems.
5. White Soft Paraffin Helps in the spreadability of the balm.

02 LIST OF ACTIVE INGREDIENTS WITH FUNCTIONS

Ingredients % w/w Functions
1. Methyl 22.0 Analgesics ingredients used for temporary
Salicylate relief of muscle or joint pain caused by
strains, sprains, arthritis, bruising, or
backaches.
2. Menthol Crystal 11.5 Provides a cooling sensation when
applied to the skin and used to relieve
minor muscle or joint pain. Also, can be
used as a chest rub to soothe chest
congestion and relieve cough caused by
the flu or common cold.
3. Camphor 5.0 A mild pain reliever and it can
be used topically to relieve pain, irritation,
and itching.

03 TYPE OF BASE USED

  White soft paraffin (WSP)

04 DISCUSSION ON THE USE OF BASE

CNI FireSens Mentholated Rub is an ointment that are semisolid
preparations intended for topical application. They are used to provide
protective and emollient effects on the skin and carry medicaments for
treating certain topical ailments.

The base used for this ointment is white soft paraffin (WSP) which are
hydrocarbon bases that made of oleaginous materials. They provide
emollient and protective properties and remain in the skin for prolonged
periods. It is difficult to incorporate aqueous phases into hydrocarbon
bases. Removal of hydrocarbon bases from the skin is difficult due to
their oily nature. Other than that, oleaginous base does not absorb water
and occlusive which can form a film on skin so it increases skin
hydration by reducing the rate of loss of surface water.

White soft paraffin (WSP) is defined in “British Pharmacopoeia” as :

“Purified and wholly or nearly decolorized mixture of semi-solid
hydrocarbons, obtained from petroleum. It may contain suitable
antioxidant.” WSP is obtained by distillation of crude petroleum followed
by purification processes. The purified fraction contains saturated
hydrocarbons. White soft paraffin is available as a white color solid and
does not possess any specific odor or taste.

CNI FireSens Mentholated Rub is a hydrophobic topical ointment as it

contains 4 different oil which is nutmeg oil, tree tea oil, eucalyptus oil and
FSM compound oil and WSP drug incorporation potential is solid or oil
soluble only. The best base used in this ointment is white soft paraffin
(WSP) as it is insoluble in water. Other than that, WSP is an excellent
carrier material (base) for active dermatological ingredients as well as
acting as a barrier to the environment, providing moisturizing trapping,
oily characteristics preventing evaporation of water to the environment.

WSP congealing point is affected by the carbon chain length and

saturation of the hydrocarbon present in the paraffin fraction. These
factors help the blending process when white soft paraffin wax blends.
What makes WSP useful and special is that it can be a relatively stable
product and does not react with other active ingredients, such as the API
or other components.

In other words, WSP is nonreactive and compatible with a wide variety of

drugs and auxiliary agents. This is the best fit for the formulation is this
CNI FireSens Mentholated Rub. WSP also chemically and physically
stable under normal conditions of use and storage. The product warning
stated that it should avoid contact with broken skin, the best bases used
is WSP which is an oleaginous bases as it should not applied on broken
skin.

Next, not only is it important to control the molecular components of

white soft paraffin, but also the mixing process. When developing
formulations for ointments the ratio of drug to WSP and water should all
be considered as WSP is insoluble in water. It has been shown that
making a primary mixture of an ointment base and a second mixture with
the active pharmaceutical ingredient (API) component in an oil phase,
helping to prevent oxidation of the API and improving product stability.

WSP blends also have better solubility in lower molecular weight

solvents with medium dispersion force strength. For stiffer blends like
ointments, addition of oil can help to optimise the blend, creating a
model WSP that would be suitable for consumer end use (within quality
assurance parameters), the swelling and strengthening of the crystal
lattice allows greater qualities of the WSP. However further addition of oil
still found an overload and syneresis was visible and evident after long
period of storage.
Syneresis is the separation of liquid from the ointment caused by
contraction. Oleaginous bases like WSP also not water-washable so they
stay on the skin and keep incorporated medications in contact with the
skin (prolonged released) which increase the duration of contact of
medicaments with skin and parallel to the product functions.
05 CONCLUSION
Selection of an appropriate base for an ointment formulation is important
as it depends on the type of activity desired for topical absorption,
compatibility with other components, physicochemical and microbial
stability of the product, ease of manufacture, pourability and
spreadability of the formulation, duration of contact, chances of
hypersensitivity reactions, and ease of washing from the site of
application.

White soft paraffin is used as a functional ingredient of ointments and

also used as a stiffening ingredient in ointment bases. It is the best fit in
hydrophobic ointment other than absorption base, water-soluble base
and emulsion base as when you apply it to the skin it leaves a layer of
oil on the surface of the skin that prevents water evaporating from the
skin surface. It is a very greasy moisturiser and also water repellent
and helps protect the skin from irritants.
06 REFERENCES

Bentley, P. J. (2017). Investigation of the Functionality of White Soft

Paraffin with Regards to Ointments (Doctoral dissertation,

University of Leeds).

De Villiers, M. (2009). Ointment Bases. A Practical Guide to

Contemporary Pharmacy Practice, Edition, 3, 277-290.

Enterprise, A. (n.d.). CNI Firesens (Twin pack). Retrieved April 24, 2020,

from https://aavishkaarone.com/product/cni-firesens-twin-pack/

Liya, S. (2012, July 25). FIRE-SENS MENTHOLATED RUB. Retrieved

from http://syazacni.blogspot.com/2012/07/fire-sens-mentholated-

rub.html

Mahalingam, R., Li, X., & Jasti, B. R. (2010). Semisolid dosages:

ointments, creams, and gels. Pharmaceutical Sciences

Encyclopedia: Drug Discovery, Development, and Manufacturing,

1-46.

Mundschenk, D. D. (1996). U.S. Patent No. 5,512,278. Washington, DC:

U.S. Patent and Trademark Office.