Development of para-amino salicylic acid minitablets for controlled release drug delivery
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Abstract
The aim of this experiment is to develop enteric coated para-amiosalicylic acid (PAS) in the form
of multiple unit dosage forms. The minitablets were prepared by wet granulation method. The characteristics of these small units were studied include hardness, friability, weight variation and content uniformity. Coteric®L 100 was used as a film former. Desired film properties were adjusted by addition of plasticizer and glidant . Pan coater with nozzle is used in this study. Coated minitablets were filled into capsule for PAS equivalent to 300 mg. The physical properties of enteric coated minitablets was evaluated. The drug release of minitablets were performed in 0.1 N HCl for the first 2 hours and replaced with phosphate buffer pH 6.8 for another 2 hours. The obtained core minitablets had average weight 0.050 g, standard deviation was 1.62, percentage of friability was 1.44 and percent labeled amout was 101.26. The enteric coated minitablets released 1.39% PAS in 0.1 N HCl and 81.10% in phosphate buffer pH 6.8 within 45 minutes. These properties are complied with the USP 29 regulation of which in 0.1 N HCl no individual value exceeds 10% and in phosphate buffer pH 6.8 dissolved not than 75% within 45 minutes.
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