Abstract

A Sustained release formulations can be utilized to avoid repetitive dosing of drugs in a day and few drugs like Didanosine incompatible with gastric juice, to avoid overcome the incompatibility of drug, tablet is coated with the enteric coat. The objective of the present study is to develop competitive enteric sustained release tablets of Didanosine for a period of 12 hrs, by preparing wet granulation method using different polymers and study the effect of polymers on their release pattern. The drug – excipients compatibility was done at accelerated temperature 25°C/55% ± 5% and 30°C/60% ± 5% relative humidity. Based on preformualation studies different formulation batches of Didanosine were prepared using selected excipient. Granules were evaluated for tests loss on drying, bulk density, tapped density, compressibility index, Hausner ratio before ring punched as tablet. Tablets were tested for weight variation, thickness, hardness, friability and in vitro drug release as per official procedure. Change in dissolution parameter study made it suitable for minute physiological variables. From the above results and discussion it is concluded that formulation of sustained release tablet of Didanosine containing 20 % of Ethyl cellulose Std 100 P, diluents MCC and with binder Povidone i.e formulation batch F6 can be taken as an ideal or optimized formulation of Enteric coated sustained release tablets for 12 hour release as it fulfills all the requirements for sustained release tablet.

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