Stability Studies of Solid Dosage Forms

Abstract

Pharmaceutical preparation mechanism is a continuous phenomenon. Hundreds of new solid formulations are developed every year. Thus, it is necessary to test and evaluate each solid dosage form for the accurate dispensing and safety of consumers. For this purpose, stability studies and chemical kinetic evaluation pattern must be observed to get the license for the delivery of new drug formulation. For the stability evaluation of solid dosage forms, ICH and WHO guidelines have to be followed, in which a series of tests is involved to prove the validity and rationality of solid dosage forms. Furthermore, the factors or issues related to stability are observed, and chemical kinetics of the solid dosage forms are monitored. The chemical kinetics involved in drug products from their preparation to storage cause chemical instability of drug formulation. This instability may be due to hydrolysis, photolysis, racemization, or other chemical reactions induced during preparation or storage. Thus, for this purpose, stability studies are applied to achieve the stable finished product. Degradation reactions constitute the reason of chemical instability. Thus, it is considered as the most important aspect during stability studies. Degradation processes affect the pre-formulation studies. If this process is not monitored, drugs stored in optimum conditions could be vigorously degraded. Thus, the stability testing is required to prevent any kind of unwanted effects and for the achievement of stable drug throughout its expected shelf life.