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PRACTICAL : 23
(A)
Aim: To prepare and evaluate Ibuprofen gel.
Formula: Each 30 g gel contains 1.5 g Ibuprofen
Excipients q.s
Batch size: 50 g
Packaging: In metal or plastic collapsible tubes with screw caps.
Pack size: 30 g
Formulation:
Ingredients Quantity given (100 g)
Quantity taken (50 g)
Role of ingredients
Ibuprofen 5 g 2.5 g Active pharmaceutical ingredient
Alcohol 10 ml 5 ml VehiclePropylene glycol 10 ml 5 ml VehicleCarbopol 15 g 7.5 g Gelling agentIsopropyl myristate 1 ml 0.5 ml To make the
gel less stickyPreservatives q.s. q.s. PreservativeWater purified 5 g 2.5 g Vehicle
Method of preparation:
Solution of Ibuprofen in alcohol and propylene glycol was made. This solution was heated at 70-80 °C. Dissolve carbopol and isopropyl myristate in the above solution and
cool. Dissolve preservatives in water and add in the above gel.
Observation:
Particle size distribution:
RANGE MEAN(d) NO. OF PARTICLES(f)
f*d
0 1 2 3 4 5 6 7 80
5
10
15
20
25
frequency distribution curve
frequency distribution curve
mean size
frequency
Method of characterization:
1. Appearance2. Texture3. Odour4. Spreadability5. Film formation6. Irritation7. Water washability8. PH of the preparation9. Particle size distribution10.Type of emulsion
Comments:
Reference: Handbook of pharmaceutical manufacturing formulations; semisolid products; volume -4; Sarfaraz K.Niazi; page no: 180.
Observation parameters Inference
Appearance
Texture
Odour
Spreadability
Film formation
Irritation
Water washability
PH of the preparation
Mean particle size
Type of emulsion
(B)
Aim: To prepare and evaluate barrier cream.
Formula:
Batch size: 50 g
Packaging: In metal or plastic collapsible tubes with screw caps.
Pack size: 30 g
Formulation:
Ingredients Quantity given (100 g)
Quantity taken (50 g)
Role of ingredients
Hard paraffin 25 g 12.5 g Emulsifying wax
Soft paraffin 11.75 g 5.875 g Emulsifying wax
Liquid paraffin 3.5 ml 1.75 ml Emulsifying wax
Cetostearyl alcohol 5 ml 2.5 ml Emulsifying agentTriethanolamine 0.7 ml 0.35 ml Neutralizing agentStearic acid 1.8 g 0.9 g Emulsifying agentChlorocresol 0.2 ml 0.1 ml Vehicle
Purified water 100 ml 50 ml Vehicle
Method of preparation:
Cetostearyl alcohol, stearic acid and the three paraffins were melted together.
Triethanolamine was dissolved in a solution of chlorocresol.
Observation:
Particle size distribution:
RANGE MEAN(d) NO. OF PARTICLES(f)
f*d
0 1 2 3 4 5 6 7 802468
101214161820
frequency distribution curve
frequency distribution curve
Mean size
Frequency
Both solutions were maintained at about 70°C. Then oily constituents were added to the aqeous solution with constant
stirring until the emulsion was cold.
Method of characterization:
11.Appearance12.Texture13.Odour14.Spreadability15.Film formation16.Irritation17.Water washability18.PH of the preparation19.Particle size distribution20.Type of emulsion
Comments:
Reference: Cooper and Gunn’s dispensing for pharmaceutical students; edited by S.J.Carter; 12th edition; CBS publishers; page no: 157-158.
Observation parameters Inference
Appearance
Texture
Odour
Spreadability
Film formation
Irritation
Water washability
PH of the preparation
Mean particle size
Type of emulsion
