Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

Juan G. Rosas, Marcel Blanco, Josep M. González, Manel Alcalá

Producció científica: Contribució a una revistaArticleRecercaAvaluat per experts

28 Cites (Scopus)

Resum

This work was conducted in the framework of a quality by design project involving the production of a pharmaceutical gel. Preliminary work included the identification of the quality target product profiles (QTPPs) from historical values for previously manufactured batches, as well as the critical quality attributes for the process (viscosity and pH), which were used to construct a D-optimal experimental design. The experimental design comprised 13 gel batches, three of which were replicates at the domain center intended to assess the reproducibility of the target process. The viscosity and pH models established exhibited very high linearity and negligible lack of fit (LOF). Thus, R2 was 0.996 for viscosity and 0.975 for pH, and LOF was 0.53 for the former parameter and 0.84 for the latter. The process proved reproducible at the domain center. Water content and temperature were the most influential factors for viscosity, and water content and acid neutralized fraction were the most influential factors for pH. A desirability function was used to find the best compromise to optimize the QTPPs. The body of information was used to identify and define the design space for the process. A model capable of combining the two response variables into a single one was constructed to facilitate monitoring of the process. © 2011 Wiley-Liss, Inc. and the American Pharmacists Association.
Idioma originalEnglish
Pàgines (de-a)4432-4441
RevistaJournal of Pharmaceutical Sciences
Volum100
Número10
DOIs
Estat de la publicacióPublicada - 1 de gen. 2011

Fingerprint

Navegar pels temes de recerca de 'Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space'. Junts formen un fingerprint únic.

Com citar-ho