FORMULATION DEVELOPMENT AND QUALITY PROFILING OF PARACETAMOL – IBUPROFEN COMBINATION TABLETS

Opportunity is envisaged by some astute pharmaceuticals manufacturers to increase product portfolio and widen the spectrum of treatment of pains to cover analgesia, pyrexia and inflammation using one product. In this research work, paracetamol – ibuprofen combination tablet was designed and formulated, developed and profiled to address this anticipation thus satisfying the requirement of one product fits 3 health challenges. As a consequence of adoption of wet granulation method, granules of acceptable quality profiles were developed and processed and subsequently culminated in production of tablets that met all required critical quality attributes as defined in quality target product profile. Characterization of both granules and tablets showed results that reassured that the requirements of fitness for purpose were met and will lead to product quality and patient safety on the long run. Indeed, content uniformity of active ingredients in each tablet was engendered by equally uniform tablet weight to the extent that relative standard deviation was only 1.29% for uniformity of weight, 1.74% for ibuprofen content and 0.28% for paracetamol content. Brittle/friable index of 9.2 is high enough to assure that the tablets will withstand both normal and abnormal stresses during handling throughout life cycle as time-release capability of the tablets was evident in the result of disintegration time.