SHIRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCES

SHIRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCES,DEHRADUN M.PHARM PHARMACEUTICS I SEMESTER [PRACTICAL]

EXPERIMENT NO.

OBJECT/AIM: - TO PREPARE AND EVALUATE HYDROGEL THICKENED MICROEMULSION OF IBRUPROFEN FOR TOPICAL DRUG DELIVERY. REFERENCE:- M .C Gohel, S.A Nagori, Indian Jounral Of Pharmaceutical Education And Research 44(2), Apr- Jun 2010. REQUIREMENTS:LABORATORY APPARATUS:, beakers, measuring cylinder, pipette, magnetic stirrer, pH meter. CHEMICAL REQUIREMENT:ibuprofen (Drug), tween 80(surfactant) ethanol90%v/v (cosurfactant) carbopol 940(hydrogel thickening agent ) , camphor and menthol(solvents ,permeation enhancer) THEORY/PRINCIPLE:- . TRANSDERMAL DRUG DELIVERY SYSTEM The aim of formulation is to prepare hydrogel thickened microemulsion with good stability, powerful, permeation ability and suitable viscosity for the topical delivery of ibruprofen using

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eutectic mixture of camphor and methanol as oily phase, solvent for the ibruprofen, as permeation enhancers and to imparts cooling effect to the skin. Carbopol 940 was used as hydrogel thickening agent Transdermal drug delivery system offers number of advantages over conventional drug delivery systems however a major problem with transdermal drug delivery systems is skin behaves as natural barrier making it difficult for most drugs to be delivered into and through it. Microemulsions have evolved as a suitable mode of delivery of drugs because they have high low skin irritation, powerful permeation ability and high loading dose. Microemulsion is optically isotropic and thermodynamically stable liquid solution there are several permeation enhancement mechanisms of microemulsions such as increased concentration gradient and thermodynamic activity toward skin. Even though microemulsion offers several advantages it is difficult to stabilize them. Additionally low viscosity of micro emulsion restrains clinical application due to inconvenience in use. The problem of poor patient compliance and stability can be overcome by hydrogel thickened microemulsion using carragenan, carbopol, hydroxypropyl methyl cellulose, xanthan gum as hydrogel thickening agent. METHODOLOGY FORMULATION OF MICROEMULSION The hydrogel thickened ibuprofen microemulsion was formulated into the laboratory for transdermal application using Eutectic mixture of camphor and methanol as oily phase Carbpol 940 as hydrogel thickening agent

The components and their concentration ranges for formulation are as follows

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SHIRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCES

Batch code

Ibuprofen %w/w

Eutectic %w/w (camphor/menthol)

S/C %w/w (tween80/ethanol) 50 40 30

Water %w/w

F1 F2 F3

1 1 1

39 39 39

10 20 30

1. Ibruprofen 1% was dissolved in eutectic mixture consisting of equal quantities of camphor and methanol, the ibuprofen solution was then mixed with mixture of surfactant and co surfactant finally appropriate amount of water was added to ibruprofen solution mixture drop by drop to get microemulsion 2. Carbopol 940 was hydrated 4 hours before formulation in fixed amount of water then previously formulated microemulsion was gradually added with continuous stirring till clear viscous solution was obtained finally fixed amount of trietenolamine was added to get hydrogel thickened microemulsion

EVALUATION
The hydrogel thickened microemulsion was characterized for pH, spredability, skin irritation study, short term stability study

1.CHARACTERIZATION OF PH: pH characterization was done by using digital pH

meter

2.SKIN IRRITATION STUDY: irritation study of the placebo hydrogel thickened

microemulsion formulation was carried out onto three healthy adults human volunteers. The volunteers are asked to apply formulation onto the hand. And skin was observed for any signs of redness or irritation

3.SHORT TERM STABILITY STUDY: short term stability study of hydrogel thickened
microemulsion was carried out for one month at 252 and 75%Rh.

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4.DETERMINATION OF GLOBULE SIZE- The optical microscopy method using calibrated ocular and stage micrometer can be utilized for globule size determinations of both multiple emulsion droplets as well as droplets of internal dispersed phase. The mean globule size of the internal aqueous droplet and multiple oil droplet was determined. 5.AREA OF INTERFACES The average globule diameter determined can be used in the calculation of the total area of interface using the formula S = 6/d S = Total area of interface (sa, cm) d = Diameter of globules (cm) 6.MEASUREMENT OF DRUG RELEASE- The in vitro drug release from multiple emulsion was studied by invert test tube method using cellophane tubing. The emulsion was taken in the test tube in which one end of the test tube is closed via cellophane membrane, then test tube is immersed in 200ml of phosphate buffer saline (pH 7.4 at 371oc) . the dilution media was agitated with the help of magnetic stirrer at appropriate intervals 5 ml of sample was withdrawn and replaced with equal volume of fresh buffer solution. The drug concentration were analyzed by UV visible spectroscopy.

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OBSERVATIONS:

Determination of globule sizeTest Duration of stability (in days) pH Batch F1 Batch F2 Batch F3

Least countFor formulation 1 S.NO 1 2 3 4 5 6 7 Average size on No. of particles micrometer Calculated size

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For formulation 2 S.NO 1 2 3 4 5 6 7 Average size on No. of particles micrometer Calculated size

For formulation 3 S.NO 1 2 3 4 5 6 7 Average size on No. of particles micrometer Calculated size

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Area of Interfaces S = 6/d In vitro dissolution and release kinetics:

s.no 1 2 3 4 5 6 7 8 Time (min) absorbance I II concentration I II Drug release I II %cumu releas I II

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RESULTS AND DISCUSSIONS:

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