Keywords
dissolution
similar
polymorphism
How to Cite
Abstract
Some active pharmaceutical ingredients (API) might present polymorphism at any stage of the industry production process. In caseit is not characterized and specified, a different polymorph might be erroneously used during the manufacturing procedure. Polymorphisms cause some variations in the physicochemical properties of APIs, especially in solubility. Therapeutic inefficacy was detected in some glyburide drug products, and the occurrence of polymorphs might be one of the possible reasons. This study analyzed five drug products and five APIs., The characteristic pharmaceutical equivalence tests were used for analyzing the drug products. The techniques employed to evaluate the APIs showed no differences in polymorphism, no significant changes in the physicochemical properties or in the intrinsic dissolution rate. However, the dissolution profiles of the drug products, mainly between two similar products A and B, showed significant differences in the f2 factor values, being 20 and 42, respectively, indicating that these values were related to the occurrence of different excipients, such as mannitol.
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