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BioMed Research International
Volume 2014, Article ID 929248, 9 pages
http://dx.doi.org/10.1155/2014/929248
Research Article

Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

1Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Palackeho 1/3, 612 42 Brno, Czech Republic
2Faculty of Chemistry, Brno University of Technology, Purkynova 464/118, 612 00 Brno, Czech Republic

Received 2 August 2014; Revised 25 August 2014; Accepted 27 August 2014; Published 15 September 2014

Academic Editor: Kin Tam

Copyright © 2014 Erika Bojnanska et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation.