Please use this identifier to cite or link to this item:
Title: Evaluation of the losartan solubility in the biowaiver context by shake-flask method and intrinsic dissolution.
Authors: Souza, Janine Braga de
Souza, Jacqueline de
Castro, Lara Maria Lopes de
Savedra, Melissa Fabíola Siqueira
Savedra, Ranylson Marcello Leal
Issue Date: 2019
Citation: SOUZA, J. B. de et al. Evaluation of the losartan solubility in the biowaiver context by shake-flask method and intrinsic dissolution. Pharmaceutical Development and Technology, v. 24, n. 3, p. 1-33, 2019. Disponível em: <>. Acesso em: 25 fev. 2019.
Abstract: This study aimed at evaluating the shake-flask use as a universal method to evaluate drug solubility in a biowaiver context as proposed by FDA, EMA and ANVISA. The solubility of losartan was determined in three buffers using the shake-flask method, intrinsic dissolution (ID) and Quantum Chemistry. Moreover, the evaluation of a losartan dissolution profile from coated tablets was conducted. The losartan low solubility in pH 1.2 and high solubility in pH 6.8 were observed using the shake-flask method. However, the solubility results using ID demonstrated its high solubility in pH 1.2 and 6.8. It was not possible to find conclusive results regarding the solubility of the drug in pH 4.5. The studies conducted by Quantum Chemistry provide molecular and electronic data that helped understand the losartan solvation in different pH values. Our experimental results defined that losartan can be classified as a low-solubility drug. In addition, this work shows that shake-flask cannot be a universal method of solubility studies in biowaiver context. Individual analysis will be necessary. The intrinsic dissolution should be considered as a complementary method.
ISSN: 1097-9867
Appears in Collections:DEFAR - Artigos publicados em periódicos

Files in This Item:
File Description SizeFormat 
ARTIGO_EvaluationLosartanSolubility.pdf1,32 MBAdobe PDFView/Open    Request a copy

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.