Faculty of Pharmacy, Nursing and Health Professions

Master in Industrial Pharmaceutical Technology

Lab Report

Experiment # 1

Pharmaceutical technology 2 Lab

Mayson Bali 1185273

Products: Hydrophilic Petrolatum USP

Vanishing Cream

Supervised by: Dr.moammal qurt

Hydrophilic Petrolatum USP

material Function Melting range solubility

Cholesterol an emulsifying agent at 147–150C˚ Soluble in alcohols,
concentrations of 0.3– Vegetable oils,
5.0% w/w Practically insoluble in
It imparts water- water
absorbing power to an
ointment and has
emollient activity
Stearyl alcohol Emollient; emulsifying 49–56C˚ Soluble in ethanol (95%),
agent; viscosity- ether, and oil; practically
increasing agent. At insoluble in water.
concentration up to 12%
w/w
White wax Controlled-release agent; 61–65C˚ Soluble in chloroform,
stabilizing agent; ether, fixed oils, volatile
stiffening agent. oils, and warm carbon
disulfide; sparingly
soluble in ethanol (95%);
practically insoluble in
water.
White petrolatum emollient-ointment base 38–60C˚ Practically insoluble in
acetone, ethanol, hot or
cold ethanol (95%),
glycerin, and water;
soluble in benzene,
carbon disulfide,
chloroform, ether,
hexane, and most fixed
and volatile oils.
Table 1. Materials properties.

Procedure and justifications:

1- Melt the stearyl alcohol and white wax together in a beaker

*The result was forming perfectly clear melted solution in a water bath at 70c˚.
*This might be related to the similarity in melting range between both materials.

2- Add the cholesterol and stir until completely dissolved. (Bulk A).
 * The outcome was poorly dissolved cholesterol clumps.

* The justification for these phenomena can be related to three causes:

 Melting range differences as the cholesterol needed much higher

heat in order to be dissolved properly.
 Bad or slow stirring: when we used magnetic stir bar led to better
dissolving results.
 The short time of heating or stirring: it needed longer period in
order to be dissolved properly.

3- Melt the white petrolatum in a mortar. (Bulk B).

4- Add Bulk A to bulk B and mix using mortar and pestle until the base begins to
congeal
5- When the base begins to congeal, add 50 ml water slowly while mixing until all the
water is absorbed.

*in this step we the absorption base became saturated after adding only 32ml of
water forming w/o emulation with very good consistency and thickness.

Parameters:

Water bath temperature: 70C˚.

Stirring (mixing time): 10 minutes.

Heating time: depending on the melting point.

Speed of mixing: manual, mix thoroughly

Emulsion Bases O/W Type

E.g. Vanishing Cream

 material Function Melting solubility
range
Stearic acid Emulsifying agent; 383˚C Freely soluble in
solubilizing agent; benzene, carbon
tablet and capsule tetrachloride,
lubricant. chloroform, and ether;
soluble in ethanol (95%),
hexane, and propylene
glycol; practically
insoluble in water
Potassium Alkalizing agent. To 360˚C; 380˚C Practically insoluble in
hydroxide adjust the pH of when Ether, soluble in Ethanol
solutions. It can also be anhydrous (95%), Glycerin and
used to react with weak Water
acids to form salts

Glycerin Antimicrobial 17.8˚C Soluble in water, Ethanol

preservative; cosolvent; (95%).
emollient; humectant; Insoluble in Oils,
plasticizer; solvent; Benzene, Chloroform
sweetening agent;
tonicity agent.
Methylparaben Antimicrobial 125–128˚C Insoluble in Mineral oil.
preservative Soluble in Ethanol,
Glycerin, Peanut oil,
Propylene glycol and
Water.
Propylparaben Antimicrobial 96.0–99.0˚C Freely soluble
preservative.
Purified water Vehicle and solvent 0C˚ Miscible with most polar
solvents.
Table 2. Materials properties.

Procedure:
1- Melt the stearic acid in a separate beaker (to make a solution of the alkalies, oil
phase)
We started with Solid with cracks form of the substance that transformed into Parts of
translucent after heating then became a colorless liquid in a water bath at 70c˚.

2- The remaining ingredients were dissolved in the water at 75 °C (aqueous phase)

 Potassium hydroxide first added to 76g of water
 Methylparaben, and Propylparaben were added to slightly heated glycerin
 Then mix it thoroughly with KOH and water.
 This solution was heated to 700C.

3- Discontinue heating. The aqueous solution is added to the oil phase with agitation.
Then the solution is poured into melted stearic acid with stirring at same temperature
for 10 mins until the saponification is completed.

4- Allow to cool, and stir until congealed.

Parameters:

Water bath temperature: 75C˚.

Stirring (mixing time): 10 minutes.

Heating time: depending on the melting point.

Speed of mixing: manual, mix thoroughly

Justifications:

1- Glycerin also acted as a humectant, which helps prevent the vanishing cream
from drying out while it sat on the shelf.

2- The selection of the alkali affects the consistency of the cream; potassium
hydroxide produced softer cream with a good consistency and sheen.

3- Saponification of stearic acid (the alkaline hydrolysis of the fatty acid esters) by

adding Potassium hydroxide is a process by which triglycerides are reacted with
potassium hydroxide to produce glycerol and a fatty acid salt, called "soap”.

4- Methylparaben and Propylparaben where combined to creates synergistic effect

as a broad-spectrum preservative blend with minimum concentrations and less
toxicity.

Lab question:
What is the effect of each of the following (glycerin, propylene glycol and water)
if added individually in excess quantity to the previous prepared vanishing
cream?

Glycerin: is a humectant, which helps prevent the vanishing cream from drying
out while it sat on the shelf, the excess amount made the cream more smooth, soft
and less viscous due to the decreased o/w phase volume fraction of the interfacial
layers.

Propylene glycol: is a carrier or inert medium used as a solvent (or diluent), the
excess amount made the cream more diluted, liquid like texture due to the
decreased o/w phase volume fraction of the interfacial layers.

Water: act as a vehicle and solvent; the excess amount of water increased the
firmness, hardness and thickness of the cream due to the increased water phase
volume fraction of the interfacial layers that reduced the resist to the coalescence
of water droplets.