Abstract:

Often the quality of drug products is evaluated based on chemical tests, commonly described in different pharmacopeias such 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 using multiple product-specific procedures. This makes the current practice of evaluation of the quality of pharmaceutical products complex and resource (human and financial) intensive. Recently a new improved dissolution methodology, based on a modified spindle known as crescent-shaped spindle, has been proposed. Using the proposed methodology, all these tests may be conducted based on a single dissolution test procedure. Such an approach would, therefore, provide a simpler alternative to the current practice with significant economical benefits. The attributes of the proposed approach which lead to the concept of product evaluation based on a single dissolution test procedure, are described here by testing a number of diltiazem products having different strengths and release characteristics.