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Effect of Shellc and pH Concentration on Drug Release of Diclofenac Sodium from the Granules (Efek Kadar Selak dan pH terhadap Pelepasan Diklofenak Natrium dari Sediaan Granul)
The aims of this study were to find out formulas of granules made from complexes drugs-shellac resin that has constant release pattern. The influence of pH on the drugs release was also investigated. The drug-shellac resin complex was made by dispersing disclofenac sodium into alcoholic solution of shellac. Three different ratios of the drug-shellac resin (1:5; 1:3; 1:1) respectively were made. Thus mixtures then were dried in an oven at 40 degree C for three days, and than were granulated and shieved on 20 to 40 mesh. The sieved granules were studied on its drugs-release profile in the solution that had variation pH which made from phosphate buffer. The dissolution tester of USP XX model that had been modified was performed for getting drugs-release profile of three different formulas granules. Three variative of dissolution media at pH 5.8; 6.8 and 7.6 respectively were applied and the temperature was maintained at 37 degree C during operation time. The amount of drug released in medium was assayed spectrophotometrically. The extents of drug in medium (dissolution) was expressed as dissolution efficiency in 8 hours. The results showed that DE of three types of formulas had significantly different and the formula granules made from ratio of drug-shellac resin (1:5) had smallest value. The curve of the correlation of time and drugs release were mostly linier, and the coefficient correlation of regression curve of drug-shellac resin complex that had ratio 1:5 was highest. The increasing pH of dissolution media caused increasing drug release of each granules. The granule of drug-shellac resin having ratio 1:5 shown drug release profile more controlled pattern than the other formulas, therefore the former formula wound be as a pattern of drugs-resin complex for making a sustained release dosage from.
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