Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF DELAYED RELEASE TABLETS OF ASPIRIN USP

Palanisamy. P,* R. Margret Chandira, B. Jaykar, A. Pasupathi, B. S. Venkateshwarlu

Abstract

The investigation is undertaken with an aim to formulat ion, development and evaluation of delayed release tablet of Aspirin. The Assay and Impurity drug were carried out by HPLC method. The drug powders were subjected to Preformulation studies. The Preformulation characteristics are within the Pharmacopeial specifications. The drugs and excipients compatibility were carried out by FT-IR studies and DSC. The spectra showed that there was no interaction between them. The drugs and excipients compatibility were carried out by HPLC method and by physical observation showed that there was no interaction between them. For Aspirin DR tablets direct granulat ion was method of choice. Optimizat ion was done and it was found that release profile was found to be best with disintegrant i.e. sodium starch glycolate. Enteric coating of Protectab HP-1 Sunset yellow Lake IPA coating 10%w/w was done on Aspirin tablets as to avoid any interaction gastric problems. Results found that release profile of batch no.AF4 matches with Innovator product . The Percentage cumulative drug release of batch. No. AF4 was found at 90 Minutes 104.21%. From results it can be inferred that release profile of Batch. No: AF4matches with that of innovator product, also f1&f2 (62) value are good enough to comply with the innovator‟s product INNOVATOR have reported similar kind of results for studies with Aspirin.

Keywords: Aspirin, Coronary artery disease, Acute coronary syndrome, Delayed release.