Abstract

FORMULATION AND STABILIZATION OF ASPIRIN MINI-TABLETS WITH THE AID OF WEAK ACID AND MOISTURE PROTECTIVE COATING

Abstract

The main objective of the present study is to formulate a stable aspirin mini tablets with the aid of a weak acid in core tablet & coated with non aqueous moisture protective coating. Aspirin is highly unstable at alkaline environment & and prone to undergo degradation by hydrolysis. The preformulation study reveals, Aspirin is incompatible with alkali salts, and aspirin itself degrades at exposure condition of elevated temperature and humidity. Whereas, with weak acids, the stability of aspirin is comparatively better. Hence, a weak acid is selected in core tablet. To control the impact of humidity on degradation, a moisture protective layer is coated on core tablet with non aqueous solvent, using conventional coating pan. The coated mini tablets are encapsulated in a hard gelatin capsule shell. The filled capsules are evaluated for description, assay, dissolution, water by KF at initial and 3months accelerated condition (40 ± 2°C/75± 5%RH), and to conclude the quantity of weak acid & percentage of moisture protective coating required to stabilize the formulation. The formulation with 4mg & 6mg/unit of alginic acid/unit and 4% film coating are failed in stability. The formulation with 8mg/unit of alginic acid & 6% moisture protective coating was found to be stable, and the degradation was controlled.

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