The Development of Para-Aminosalicylic Acid Sodium Multiple Units Controlled Release Dosage Forms
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Abstract
The objective of this study was to develop para-aminosalicylic acid sodium (PAS) multiple units controlled release dosage forms. PAS granules were prepared by wet granulation method. The characteristics of these granules were studied i.e. size and size distribution, friability and content uniformity. PAS granules were subcoated with HPMC E50 1, 3 and 5% loading (w/w) and then enteric coated with Eudragit® L 30D55 10, 20 and 30% loading (w/w) by using fluidized bed bottom spray coater. In vitro drug release studies of coated PAS granules were performed in 0.1 N HCl for 2 hours and replaced with phosphate buffer pH 6.8 for 1 hour. It was found that, formula 18-9 (3% HPMC + 30% Eudragit®) and 18-11 (5% HPMC + 20% Eudragit®) met the acceptance criteria of dissolution of delayed release dosage forms. Those are no individual unit dissolved more than 10% within 2 hrs in 0.1 N HCl and not less than 80% of labeled amount of drug is dissolved in phosphate buffer pH 6.8 within 45 minutes.
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