Comparative Evaluation Test of Fresh & Expired Pharmaceutical Tablets
DOI:
https://doi.org/10.22270/ajprd.v14i5.1860Abstract
This study evaluates the physicochemical properties, including hardness, friability, weight variation, disintegration time, and dissolution profiles, of fresh and expired paracetamol and calcium carbonate-vitamin D3 tablets to determine the impact of shelf-life expiration on critical quality attributes and therapeutic efficacy in accordance with pharmacopeial standards such as USP and IP[1][2][3][4]. Such assessments are essential, as prior research indicates that expired tablets often exhibit increased hardness due to moisture loss or polymorphic changes, altered porosity leading to faster disintegration, and potential reductions in drug content uniformity, thereby compromising bioavailability and posing health risks [1,5,6]. By employing standardized tests like diametric compression for hardness and basket apparatus for dissolution, this investigation elucidates degradation patterns specific to these formulations, informing stability predictions and post-expiry usage guidelines [2,7].The objective of this study was to conduct a comprehensive assessment of the physicochemical stability and degradation kinetics of paracetamol and calcium carbonate with vitamin D3 in pharmaceutical tablet formulations, distinguishing between fresh and expired batches to elucidate the impact of shelf-life on drug product quality. The accurate estimation of drug shelf-life is critical for ensuring pharmaceutical quality, as decomposition or structural changes over time can lead to a loss of efficacy and potential health risks
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