Multivariate analysis in the development of bioequivalent tablets containing bicalutamide

Autor: Petr Sova, Pavel Farkaš, Roman Goněc, Aleš Franc, Petr Doležel
Rok vydání: 2020
Předmět:
Zdroj: Pharmaceutical development and technology. 26(1)
ISSN: 1097-9867
Popis: The pharmaceutical industry has to tackle the explosion of high amounts of poorly soluble APIs. This phenomenon leads to numerous sophisticated solutions. These include the use of multifactorial data analysis identifying correlations between the components and dosage form properties, laboratory and production process parameters with respect to the API liberation Example of such API is bicalutamide. Improved liberation is achieved by particle size reduction. Laboratory batches, with different PSD of API, were filled into gelatinous capsules and consequently granulated for tablet compression. Comparative dissolution profiles with Casodex 150 mg (Astra Zeneca) were performed. The component analysis was used for the statistical evaluation of
Databáze: OpenAIRE