Logic of Selecting Suitable Dissolution Parameters in New DrugFormulations Based on A BCS Approach

Since the biopharmaceutical quality of generic drug formulations depends on the quality ofthe reference products and also information about the in-vitro release performance of drugs underdifferent conditions is scarce in the literature, a dissolution study of four reference tablets wasperformed. each drug was representative of one class of the biopharmaceutical classificationsystem. the in-vitro release performance of propranolol-hcl, carbamazepine, ranitidine-hcl,and metronidazole was evaluated using a usp basket and paddle apparatus at different agitationrates (50, 75, and 100 rpm) with two doses of each drug. in all experiments, pharmacopeialdissolution media was used and the samples were taken with automatic equipment at specifictimes up to 60 min, except for propranolol-hcl, for which the samples were taken up to 30min. the dissolution profiles were compared by model-independent, model-dependent, andanova-based comparisons. the three methods of data comparison showed that low vs. highdoses were significantly different (p < 0.05), which may influence cases in which biowaivers ofpropranolol-hcl and ranitidine-hcl are requested. additionally, the results showed that despitedifferent hydrodynamic environments produced by the basket and paddle apparatus, under certainconditions, both types of equipment generated comparable in-vitro results. variables such as thedose, agitation rate, and type of dissolution apparatus are important factors to consider in designingdissolution tests for drug products. this information can be used to test a new dosage when thereis no pharmacopeial method available to perform a dissolution study. further researches on thein-vitro release performance of reference drug products are required.