Abstract

FORMULATION AND EVALUATION OF MODIFIED RELEASE TRI-LAYERED TABLET USING A FIXED DOSE COMBINATION OF IBUPROFEN AND FAMOTIDINE

Abhishek Jain* and Geeta K. Patel

ABSTRACT

The aim of present investigation is to formulate the tri-layered tablet of a non-steroidal anti-inflammatory drug comprising Ibuprofen as an immediate release layer and Histamine blocker comprising Famotidine as a sustained release floating layer in a fixed dose combination along with an intermediate layer or barrier layer between the above two layer. Ibuprofen is indicated for treatment of pain management. It is a non-selective COX inhibitor. Famotidine is indicated for treatment of gastric ulcer by inhibition of gastric secretion. An attempt was made to prepare a tri-layered tablet as Famotidine and Ibuprofen are incompatible with each other. Famotidine in presence of Ibuprofen degrades in single unit dosage form. The pre compression parameters of the powder blends used for the preparation of immediate release layer and sustained layer were in acceptable range of pharmacopoeial specification with good flow and good compressibility. The in vitro release of Ibuprofen was rapid from tablet and showed highest drug release 98% within 30 Minutes and hence, formulation IT10 was selected for preparation of trilayer tablet. Famotidine was prepared as sustained release floating layer using HPMC K100M and using bicarbonate as a gas forming agent by wet granulation technique. The in vitro release was prolonged up to 12 hours released 96% drug, which was comprised of polymer HPMC K100M. Formulation FST5 prolonged the drug release up to 12 hours with highest drug content and hence, it was selected for preparation of trilayer tablet. Intermediate barrier layer was optimised using lactose monohydrate and microcrystalline cellulose as a diluents and Croscarmellose sodium as a disintegrant. The disintegration time of tablet into two halves for final formulation IFS6 is 41 Sec. and floating lag time of Famotidine layer in trilayer tablet is 86 Sec. Hence combination therapy with chemical incompatibility by incorporation inert intermediate layer will help to achieve a stable formulation and hence will help to overcome the chemical incompatibility.

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