SEMI-SOLID

PREPARATONS FOR
CUTANEOUS APPLICATION
Part 2

Exercise 26: UNGUENTUM EMULSIFICANS AQUOSUM

Exercise 27: CREAM FOR DRY SKIN WITH UREA
Exercise 28: SULPHUR OINTMENT
Exercise 29: CALCULATING THE HLB VALUE OF THE EMULSIFIER
OR THE REQUIRED HLB VALUE OF THE EMULSION SYSTEM
FOLLOWING INDIVIDUAL RECIPE

Exercise 26: UNGUENTUM EMULSIFICANS AQUOSUM

Hydrophilic ointment with water

Hydrophilic ointment
30 parts
Hydrophilic cream!
Water


70 parts

Melt hydrophilic ointment in a water bath at approx. 70C. Gradually add previously boiled
and cooled water adding small amounts at a Yme and mix well. ConYnue mixing the cream
unYl it has cooled down, making sure to replace the water which was evaporated.

UNGUENTUM EMULSIFICANS
Water emulsifying
Hydrophilic ointment
ointment (Ph. Eur.)!

Cetyl and stearyl alcohol, emulsifying (type A)
30 parts
Liquid paran



35 parts
White petrolatum


35 parts

If the method applied does not yield a well spreadable ointment, you can replace liquid
paran with white petrolatum as necessary up to 10%

Prepara3on procedure
Melt the ingredients in a water bath and sYr unYl the mixture has cooled down.

CETOSTEARYL ALCOHOL, EMULSIFYING (TYPE A)

lat. Alcohol cetylicus et stearylicus emulsicans A
INGREDIENTS:
min. 80% of cetostearol
min. 7% of sodium cetyl and stearyl sulphate

EMULSIFIER O/W

mixture of Na-cetylsulphate (min 40%) and Na-stearylsulphate

C16H33SO4Na

C18H37SO4Na

complex emulsier
a mixture of an W/O and O/W emulsifying agents
synergy, properYes of one prevail
forms a more coherent (rm) lm on the interfacial area as each
emulsier separately

DETERMINING THE TYPE OF AN EMULSION

DROP DILUTION TEST
ELECTRICAL CONDUCTIVITY TEST
COBALT PAPER

CoCl2 x 2 H2O
STAINING TEST

H2O

CoCl2 x 6 H2O

Exercise 27: CREAM FOR DRY SKIN WITH UREA

Cream base with cholesterol 35,0

Olive oil

20,0
Urea


5,0
Puried water

40,0

Prepare 1/5 of prescribed mass.

Dissolve the acYve ingredient in water in a beaker. Add cream base with cholesterol to
the container rst then olive oil and at the end water soluYon of urea. Mix with
Unguator at 1700 rpm for 90 seconds. During last 20 seconds use higher rpm and hold
the container at lowest posiYon to self clean the mixer.

CREAM BASE WITH CHOLESTEROL

Cholesterol

5,0
Lanolin

9,5
White petrolatum
85,5

Melt all the ingredient on water bath at approximately 60C and mix unYl cooled.

 CHOLESTEROL
cyclic sterol
emulsier W/O increases the absorpYon of acYve ingredients in the
skin
it forms a lipid barrier of the skin (together with ceramids and faky acids)
prevents water loss

UREA
works as a moisturizer (increases the hydraYon of the stratum corneum
due to the binding of water in its own crystal structure)

 UNGUATOR
device, which allows mixing of
the components in a closed
system
CONDITIONS: Yme & speed of
rotaYng

Exercise 28: SULFUR OINTMENT USP XXV

Sulphur ointment
Precipitated Sulphur
Mineral Oil

White Ointment

100 g
100 g
800 g
WHITE OINTMENT
50 g

950 g

White wax

White petrolatum

To make white ointment you need to melt white petrolatum in a suitable dish
(round-bokomed dish) in a water bath, add white petrolatum and heat unYl
the mixture has melted. Remove the dish from the bath and mix unYl the
mixture has cooled down. Prepare white ointment rst, and the ointment
with sulphur second.

 hydrophobic ointment suspension

acts as scabicide (precipitated sulphur)
homogenizaYon of the ointment made with a three-roll mill

more even distribuYon of the parYcles in the ointment

EXCIPIENTS
WHITE WAX (beewax, white; Cera Alba)
beeswax is obtained by melYng the honeycomb (bleaching)
waxes?
myricyl palmitate

SUB-CATEGORY: CREAMS
CREAMS
emulsion gels
mulYphase preparaYons (lipophilic and aqueous phase)
HYDROPHOBIC
ConYnuous phase: lipophilic
Inner phase: aqueous phase
EMULSIFIERS W/O
wool alcohols
sorbitan esters
monoglycerids

HYDROPHILIC
ConYnuous phase: aqueous phase
Inner phase: lipophilic

EMULSIFIERS O/W
sodium or trolamine soaps
sulphated faky alcohols
polysorbates (TWEEN)
polyoxyl faky acid and faky alcohol
esters

Exercise 29: CALCULATING THE HLB VALUE

HLB hidrophile lipophile balance

mass of the hydrophilic part of the molecule

HLB = ---------------------------------------------------------------- x 100 x 1/5

total mass of the molecule


relaYve proporYon of the lipo- and hydrophilic part of the molecule of a
surfactant
HLB value: 0 20
it applies only to non-ionogenic emulsiers
we can calculate it

The required HLB value (for emulsifying of the

oil phase)
some components of the lipophilic phase of the cream require a

specic HLB value required HLB value

if there are more lipophilic components, the required HLB value is

the sum of all required HLB values for each component, mulYplied by
its relaYve proporYon
the selecYon of the emulsiers in the cream depends on the
required HLB value the emulsiers can be combined

Calculate the required HLB value of the lipophilic phase of an

O/W emulsion:

Liquid paran
Cera Alba
Cetyl alcohol
Emulsiers
Glycerol
Puried Water

35
1
1
7
10
46

37

Required HLB value

lipophilic components

proporYon of the
component in the lipophilic
phase

Liquid paran 12 x 35/37

Cera Alba 10 x 35/37
Cetyl alcohol 15 x 35/37
Required HLB value:

fracYon

11,4
0,3
0,4
12,1

Required HLB value of the lipophilic phase in O/W emulsion is

12,1. How much of the each emulsier Span 80 (HLB=4,3) and
Tween 80 (HLB=15) is needed for the preparaYon of the cream?



4,3 x + 15 (1-x) = 12,1

x = 0,73


0,73 7 g = 5,1 g Span 80

7 g 5,1 g = 1,9 g Tween 80

TWEEN
type O/W
esters of sorbitan with faky acids and ethers of polyethylene

glycols (polysorbates)

Tween 60 = polysorbat 60 = polyoxyethylene

20 sorbitan monostearat e
R = C17H35
w + x + y + z = 20
HLB = (1045/1312) x 20 = 15,93

SPAN
esters of sorbitan with faky acids
typ W/O emulsier

Span 20 = sorbitan monolavrate R = C11H23

BRIJ
ethers of faky alcohols and PEG

R-CH2-O-CH2-(CH2-O-CH2)n-CH2-OH

Brij 30 = polyoxyethylen-4-lavryl ether R=C11H23; 4 (CH2-O-CH2)

units