5. Pharmaceutical Technology-III: (Marks-35) Preparation of water for injection, preparation of injection of (a) procaine and adrenaline (b) procaine benzylpenicillin with benzylpenicillin; studies on the of formulation problems of vitamins with minerals; formulation of prolonged acting dosage forms.

1. Laboratory Manual
Course: 410
Subject: Practical-Pharmaceutical Technology-III
Prepared By
Md. Imran Nur Manik
M.Pharm
Department of Pharmacy
University of Rajshahi
Rajshahi-6205, Bangladesh
Available at
Essential Pharma documents
www.pharmacydocs.blogspot.com

2. 1
Sl. No. Date Name of the experiment Page No.
01 15.02.12 Preparation of cold cream. 2 – 5
02 15.02.12 Preparation of vanishing cream. 6 – 8
03 15.02.12 Preparation of shaving cream. 9 – 12

3. 2
Experiment No. 01 Date: 15.02.12
Name of the experiment: Preparation of cold cream.
Introduction:
Cold cream is a perfect semisolid water in oil w/o type emulsion. In cold cream, the
main ingredient is oil. It is also referred to as beeswax-borax emulsion.
In cold cream, 1-4% water is dispersed at 96-99% of oil. When it is applied to skin, cream
is readily absorb and produces a feeling of coolness.
In winter season, water evaporates from the skin. So, skin becomes dry and rough. Cold
cream gives an oily protective covering over the skin and consequently water cannot
evaporate out.
Formula of cold cream:
Ingredients Theoretical content Weighed content
1. Beeswax 24.5 gm
2. Liquid paraffin 56 ml
3. Borax 0.5 gm
4. Glycerin 4.28 ml
5. Distilled water 14 ml
6. Methyl paraben 0.2 gm
7. Propyl paraben 0.02 gm
8. Perfume 0.5 ml
9. Tween-80 0.5 ml
Ideal characteristics of cold cream:
1. The pH of the cold cream must be optimum for maintaining the normal pH of the
skin. It should be 4.6–6.
2. Its consistency should be optimum, so that it can be put out easily from the container
and apply easily.
3. There should have no oily appearance of cream and should give cooling effect on skin
after application.
4. It must provide a waxy protective layer on skin to protect the water evaporation.
5. It should give faster emollient effect, so that very dry skin can swell up and become
soft within short time.
6. It should be easily spread on skin.
7. It should be free from gritty particles.
8. It should be nonirritant and nontoxic.
9. It should be attractive in appearance.
10. It should be physically and chemically stable throughout its shelf-life.
11. The additives should be compatible with each other.
Md.
Imran
Nur
Manik

4. 3
Function of ingredients:
1. Beeswax: Beeswax is an important factor in determining quality of the cream. It is the
basic raw material of natural origin. It consists of:
a. Approximately 71% esters of wax acid
b. Approximately 10.5–13.5% hydrocarbon
c. Approximately 13.5–14.5% free wax acid
d. 1–1.25% free higher alcohol
e. Cholesterol esters of fatty acid
Purpose of beeswax:
i. It does not develop rancidity.
ii. It has no irritant or sensitizing activity.
iii. It produces good odour in final product.
iv. It generally forms a soft emulsion.
2. Liquid paraffin: It is a hydrocarbon. It is oily in nature and constitutes the oil phase
of cold cream.
3. Borax Na2B4O7 . 10H2O: It is a salt that act as an emulsifying agent. It gives an
opaque or white appearance to the preparation and also used for its antiseptic property.
4. Glycerin: It is a hygroscopic substance. It acts as humectants and maintains water
content of the preparation. It provides a protective layer on the skin and also helps in
smoothing the skin.
5. Perfume: It is essential for cold cream. It should be mildly perfumed so that, it
imparts light perfume to the final product. Generally flower fragrances like rose, jasmine,
labendar are mainly used.
6. Water: It constitutes the water phase of cold cream. It must be distilled, free from
large amount of electrolytes such as Na+
, K+
, Ca2+
etc.
7. Other additives: These are used to increase the stability, quality and other properties
of cold cream. These are given below:
a. Antioxidant: It should be used because of the presence of oil phase. Oil phase is
very susceptible to oxidation by atmospheric oxygen, become rancid and produce
bad odour to the preparation. Some examples of antioxidant are BHT, BHA,
ascorbic acid, tocopherol etc. The usual range is 0.01–0.03%.
b. Preservative: It is used to prevent the bacterial contamination to the water phase
as well as the oily phase. It must be dissolved in both water and oil phase. Some
examples of preservative are methyl paraben, propyl paraben etc.
c. Colour: Generally no colour is used, because borax provides a very nice white
colour. The white colour is sufficient to make the preparation very attractive. If
any required, FDA colour should be used.
Md.
Imran
Nur
Manik

5. 4
Apparatus:
1. Beaker 5. Thermometer
2. Balance 6. Measuring cylinder
3. Water bath 7. Container
4. Glass rod 8. Heater
Procedure:
The following steps are involved in the preparation of cold cream:
1. Preparation of oil phase
2. Preparation of water phase
3. Addition of water phase to oil phase
4. Milling of cream
5. Filling, labeling and packaging of cream
1. Preparation of oil phase: At first all the required ingredients were dispensed for the
preparation. Beeswax and liquid paraffin were melted in a beaker at 70C and the oil phase
was prepared. Proper care was taken so that, temperature did not exceed 70C.
2. Preparation of water phase: Borax and glycerin were dissolved in water in another
beaker and the temperature was brought to 70C. The prepared solution was water phase.
3. Addition of water phase to oil phase: The water phase was then added to the oil
phase with continuous one direction stirring.
4. Milling of cream: All other ingredients were added at 70C except perfume and
stirring was continued. When the temperature reduced to 45C then perfume was added. The
methyl paraben should be dissolved in small amount of water before adding it.
5. Filling, labeling and packaging: Finally it was checked analytically. When the
temperature of the cold cream reduced to 40C, then it was filled in a suitable jar. The jar was
properly labeled and packaged in a suitable container or paper package.
Mechanism of emulsion formulation:
Borax is added as an emulsifying agent. The basic reaction involves in the manufacturing
of beeswax-borax cleansing cream is the hydrolysis of borax and subsequently reaction with
free acids present in beeswax to form the corresponding salt or soap. This soap emulsified the
liquid paraffin in water. Other components of beeswax are myricyl alcohol, myricyl palmitate
etc.
Md.
Imran
Nur
Manik

6. 5
Uses of cold cream:
i. Cold cream is used for skin care. Skin gradually losses water and oil content. As a
result it becomes rough and fails to retain normal features. To avoid these conditions, cold
cream is applied to the skin.
ii. Cold cream gives an oily protective layer in the skin.
iii. The oil content of cream gives polishing effect on the skin.
iv. It removes oil soluble impurities.
Labeling:
Homa
Cold cream Moisture control 100 gm
MRP:
Batch No.:
Mfg date:
Exp date:
Manufactured by: Pharmaceutical Lab. of RU.
Ingredients: Beeswax, Borax, Liquid
paraffin, Glycerin, Water, Methyl and
Propyl paraben, Perfume and Tween-80.
Precaution: Store in cool and dry place.
For external use only.
Direction to use: Use twice daily on
cleaned face for best results.
Market preparation:
1. Lakme 4. Pond’s
2. Garnier 5. Johnson  Johnson’s baby cream
3. Meril 6. Cute
Md.
Imran
Nur
Manik

7. 6
Experiment No. 02 Date: 15.02.12
Name of the experiment: Preparation of vanishing cream.
Introduction:
Vanishing cream is a perfect semisolid oil water o/w emulsion. It must be vanished after
use. Appearance is fairly light. It is well polished preparation with pearl like appearance. It is
softer than cold cream.
Ideal characteristics of vanishing cream:
1. It should be easily spread on the skin.
2. It should be vanished after application.
3. It should be physically and chemically stable.
4. Ingredients used must be compatible with each other.
5. It should not too alkaline and pH about 6 should be maintained properly.
6. It should not be too much greasy or oily.
7. It should not be too viscous.
8. It should be nontoxic and nonirritant.
9. It should not be too much dry before application.
10. It should be easy to wash out after application.
Formula of a vanishing cream:
Ingredients Theoretical content Weighed content
1. Stearic acid 25 gm
2. NaOH 0.5 gm
3. Glycerin 3 ml
4. Methyl paraben 0.25 gm
5. Propyl paraben 0.002 gm
6. Perfume 0.5 ml
7. Distilled water 70 ml
Function of ingredients:
1. Stearic acid: It is used to constitute the oil phase of vanishing cream. It is very
popular, because it provides sparkling appearance to the cream.
2. NaOH: NaOH forms the salt Na-stearate with stearic acid which acts as both
emulsifier and opacifier. It partially dissolved in water, which makes the product more stable.
All NaOH must be neutralized by reacting with stearic acid, otherwise excess NaOH will
cause skin irritation. Instead of NaOH, KOH can be used.
Md.
Imran
Nur
Manik

8. 7
3. Glycerin: It acts as humectants i.e. it hold water in the skin and also in the
preparation. In the formulation, it also helps to dissolve NaOH in solution.
4. Preservatives: As the vanishing cream is an o/w type emulsion, it is very much
susceptible to the microbial contamination. To prevent this, preservatives are used. Some
examples are methyl paraben, propyl paraben etc.
5. Water: It constitutes the water phase of the vanishing cream. It must be distilled, free
from large amount of electrolytes such as Na+
, K+
, Ca2+
etc.
6. Other additives: These are used to increase the stability, quality, attractiveness and
other properties of vanishing cream. These are given below:
a. Antioxidant: Though vanishing cream contains small amount of oil, but there is a
chance of oxidation of oil which may cause degradation of the formulation. To
prevent this oxidation, antioxidants are used. Some examples of antioxidant are
BHT, BHA, ascorbic acid, tocopherol etc. The usual range is 0.01–0.03%.
b. Colour: Generally no colour is used in the preparation of vanishing cream. If any
required, FDA colour should be used.
c. Perfume: It is must for vanishing cream. Generally aromatic water and perfumery
oil are used to get strong fragrance.
Apparatus:
1. Beaker 5. Thermometer
2. Balance 6. Measuring cylinder
3. Water bath 7. Container
4. Glass rod 8. Heater
Procedure:
The steps which were followed during the preparation of vanishing cream are given below:
1. At first, all the ingredients required for the preparation were dispensed properly.
2. Stearic acid was melted at 60–70C in a beaker, which constituted the oil phase of the
cream.
3. NaOH was dissolved in glycerin and water in another vessel and the temperature of
that solution was brought to 65C. This solution constituted the water phase.
4. Then oil phase was dispersed in water phase by continuous one-direction stirring and
maintained the same temperature.
5. At the same time, all other excipients except perfume were added with continuous
stirring. Finally perfume was added to the formulation at 40-42C.
6. When the temperature of the preparation reached to 30C, then it was filled in a
suitable jar and labeled.
Md.
Imran
Nur
Manik

9. 8
Mechanism of emulsion formulation:
The basic reaction involves in the manufacturing of vanishing cream is the reaction of the
stearic acid with NaOH to form the corresponding salt or soaps Na-stearate. These soaps
emulsify the water in stearic acid. Na-stearate acts both as an oil phase and emulsifier.
Uses of vanishing cream:
i. It supplies water to the skin, so it remains smooth and soft.
ii. The oil content of the cream gives a polishing effect to the skin.
iii. It removes some extent water soluble impurities.
iv. It is used for skin care.
v. It gives an emollient action on the skin.
Labeling:
Homa
Vanishing cream Oil control system 100 gm
MRP:
Batch No.:
Mfg date:
Exp date:
Manufactured by: Pharmaceutical Lab. of RU.
Ingredients: Stearic acid, NaOH,
Glycerin, Methyl and Propyl paraben,
Perfume and water.
Precaution: Store in cool and dry place.
For external use only.
Direction to use: Use twice daily on
cleaned face for best results.
Market preparation:
1. Lakme 4. Pond’s
2. Garnier 5. Fair  Lovely
3. Meril 6. Cute
Md.
Imran
Nur
Manik

10. 9
Experiment No. 03 Date: 15.02.12
Name of the experiment: Preparation of lather shaving cream.
Introduction:
Lather shaving cream is a cream which is used for smooth, easy and comfortable shave
and to keep the skin rich and refresh afterwards. Shaving with a razor without assistance of
cosmetic preparation is possible but certainly less convenient. In less favourable
circumstance, shaving cream can lead to discomfort irritation and actual physical damage of
the skin. These hazards can be minimized by the intelligence choice of shaving cream and
shaving instruments.
Ideal characteristics of lather shaving cream:
1. A small quantity must give sufficient lather.
2. It must produce stable foam on shaving.
3. It causes hair swelling and softening.
4. It must be free from skin irritation.
5. Must have no smarting or astringent effect on the skin.
6. Must remain soft in the tube and not go lumpy if overheated.
7. Its stability should be adequate at various temperatures with geographically different
areas.
8. It should be noncorrosive to razor blade and not cause dulling of razor blade.
9. Must be sufficiently tacky to adhere to both brush and face yet be easily washed of the
razor.
Formula of lather shaving cream:
Ingredients Theoretical content Weighed content
1. Stearic acid 35 gm
2. Coconut oil 10 ml
3. Glycerin 10 ml
4. Borax 0.6 gm
5. NaOH 2 gm
6. Perfume 0.5 ml
7. Water 36 ml
8. KOH 6.1 gm
9. Methyl paraben 0.18 gm
10. Propyl paraben 0.02 gm
Md.
Imran
Nur
Manik

11. 10
Function of each ingredients:
1. Stearic acid: In shaving cream, stearic acid acts as super fatting agent. It is used for
the following purposes:
a. To make the lather soften.
b. To increase the stability of foam.
c. As a lubricating agent on skin.
d. To neutralize any free alkali that might be present in the preparation.
e. To act as oil phase.
2. Coconut oil: In shaving cream, coconut oil serves as super fatting agent. It helps:
a. To make the cream softer.
b. To increase the stability of the foam.
c. It has lubricating effect on the skin.
3. Glycerin: It acts as humectants which often help to retain water in the formulation
and thus help to keep normal form i.e. the cream soft. Other functions are:
a. Improves wetting property of cream
b. Prevent too rapid drying of lather
c. Make the skin more elastic
d. Soften the beard
e. Facilitate the transit of the razor over the face
4. Borax Na2B4O7 . 10H2O: In lather shaving cream, minor quantity 0.1–1% has
been used as viscosity imparting agent.
5. NaOH: NaOH forms the salt Na-stearate with stearic acid. Na-stearate acts both as oil
phase and emulsifier.
6. Water: It is used as water phase.
7. Preservatives: Shaving cream is slightly alkaline. This alkalinity favours the growth
of microorganism. Due to stability consideration and economical view points, shaving creams
are not sterilized. So, preservatives are included to inhibit the microbial growth.
8. Perfumes: These are used to mask the unpleasant odour of the surfectants and super
fatting agent and to offer a pleasant sensation.
9. Viscosity imparting agent: It is essential for shaving cream to keep them correctly
consistent which must remain stable over a wide range of temperature.
10. Colour: It is not essential in shaving cream.
11. Antiseptic: Minor cuts may occur during shaving. To set remedy from every hazard,
antiseptic is added to the formulation.
12. Astringent: During shaving, bleeding may occur due to any cuts. So, astringents e.g.
alum are used which constricts the exposed capillary and help to stop bleeding.
Md.
Imran
Nur
Manik

12. 11
Apparatus:
1. Beaker
2. Balance
3. Water bath
4. Glass rod
5. Thermometer
6. Measuring cylinder
7. Container
8. Heater
Procedure:
The following steps are involved in the preparation of vanishing cream:
1. At first, all the ingredients required for the preparation were dispensed properly.
2. Stearic acid and coconut oil were heated together at 75–80C. This mixture is called
as oil phase.
3. Water, glycerin, NaOH and Borax as well as KOH were heated together to the same
temperature. It is called as water phase.
4. The water phase was added to the oil phase with slow agitation and continuous one-
way gentle stirring. The stirring was continued to 45-47C and perfume was added. After
that, the product was allowed to cool without further stirring.
5. When the temperature of the shaving cream reached to room temperature, then it was
filled in a suitable jar and labeled.
Mechanism of emulsion formulation:
The basic reaction involves in the manufacture of the shaving cream is the reaction of
stearic acid with NaOH to form the corresponding soaps i.e. Na-stearate. These soaps
emulsify the water in the preparation of the lather shaving cream.
Uses of lather shaving cream:
i. It removes the stiffness, roughness of the hair.
ii. It causes swelling and softening the hair.
iii. It removes oily layer from the hair secreted by sebaceous glands, thus shaving
becomes easy and smooth.
iv. It helps to hold the hair erect.
v. The foam produced provides a lubricating effect.
Md.
Imran
Nur
Manik

13. 12
Labeling:
Homa
Lather shaving cream 100 gm.
MRP:
Batch No.:
Mfg date:
Exp date:
Manufactured by: Pharmaceutical Lab. of RU.
Ingredients: Stearic acid, Coconut oil,
Glycerin, NaOH, KOH, Borax, Water,
Methyl and Propyl paraben and Perfume.
Precaution: Store in cool and dry place.
For external use only.
Direction to use: Use on wet and cleaned
face for best results.
Market preparation:
1. Gillete 3. Tibet
2. BiC 4. Kool
Md.
Imran
Nur
Manik