A Simple and Economical Approach/Concept to Evaluate Quality of Pharmaceutical Products Based on an Improved Dissolution Testing Methodology

摘要

Often the quality of drug products is evaluated based on chemical tests, commonly described in different pharmacopeiassuch as the USP. These tests includes: assay (potency), uniformity of dosage form and dissolution test. Presently,these tests are conducted separately with three procedures. Furthermore, dissolution tests are also conducted usingmultiple product-specific procedures. This makes the current practice of evaluation of the quality of pharmaceutical productscomplex and resource (human and financial) intensive. Recently a new improved dissolution methodology, based ona modified spindle known as crescent-shaped spindle, has been proposed. Using the proposed methodology, all these testsmay be conducted based on a single dissolution test procedure. Such an approach would, therefore, provide a simpler alternativeto the current practice with significant economical benefits. The attributes of the proposed approach which leadto the concept of product evaluation based on a single dissolution test procedure, are described here by testing a number ofdiltiazem products having different strengths and release characteristics.