RT Journal Article
T1 Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products
A1 Ruiz Picazo, Alejandro
A1 Colón Useche, Sarín Gabriela
A1 Perez Amorós, Blanca
A1 González Álvarez, Marta
A1 Molina Martínez, Irene Teresa
A1 González Álvarez, Isabel
A1 García Arieta, Alfredo
A1 Bermejo, Marival
AB Abstract: The purpose of this work is to explore the predictive ability of the biopharmaceutics classification system (BCS) biowaiver based on the dissolution methods for two pravastatin test products,where one of themshowedbioequivalence (BE)while the other test failed(non-bioequivalence, or NBE), and to explore the reasons for the BE failure. Experimental solubility and permeability data confirmed that pravastatin is a BCS class III compound. The permeability experiments confirmed that the NBE formulation significantly increased pravastatin permeability, and could explain its higher absorption rate and higher Cmax. This finding highlights the relevance of requiring similar excipients for BCS class III drugs. The BCS-based biowaiver dissolution tests at pH 1.2, 4.5, and 6.8, with the paddle apparatus at 50 rpm in 900 mL media, were not able to detect differences in pravastatin products, although the NBE formulation exhibited a more rapid dissolution at earlier sampling times.Dissolution tests conducted in 500 mL did not achieve complete dissolution, and both formulations were dissimilar because the amount dissolved at 15 min was less than 85%. The difference was less than 10% at pH 1.2 and 4.5, while at pH 6.8 f 2, results reflected the Cmax rank order.
PB MDPI
SN 1999-4923
YR 2019
FD 2019-12-09
LK https://hdl.handle.net/20.500.14352/6757
UL https://hdl.handle.net/20.500.14352/6757
LA eng
NO Ministerio de Ciencia e Innovación (MICINN)/FEDER
NO Universidad de Los Andes, Venezuela
DS Docta Complutense
RD 8 abr 2025