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Development of a Discriminative Dissolution Method, Using In-Silico Tool for Hydrochlorothiazide and Valsartan Tablets.
Leon, Rosmery Merma; Issa, Michele Georges; Duque, Marcelo Dutra; Daniel, Josiane Souza Pereira; Ferraz, Humberto Gomes.
Afiliação
  • Leon RM; Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo 05508-080, SP, Brazil.
  • Issa MG; Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo 05508-080, SP, Brazil.
  • Duque MD; Department of Pharmaceutical Sciences, Institute of Environmental, Chemical and Pharmaceutical Sciences, Universidade Federal de São Paulo-UNIFESP, Rua São Nicolau, 210 Centro, Diadema 09913-030, SP, Brazil.
  • Daniel JSP; Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo 05508-080, SP, Brazil.
  • Ferraz HG; Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo 05508-080, SP, Brazil.
Pharmaceutics ; 15(6)2023 Jun 14.
Article em En | MEDLINE | ID: mdl-37376183
Hydrochlorothiazide (HTZ) and Valsartan (VAL) are poorly soluble drugs in BCS classes IV and II. This study aimed to develop a method to assess the dissolution profile of tablets containing HTZ (12.5 mg) and VAL (160 mg) as a fixed-dose combination, using in silico tools to evaluate products marketed in Brazil and Peru. Firstly, in vitro dissolution tests were performed using a fractional factorial design 33-1. Then, DDDPlus™ was used to carry out experimental design assays of a complete factorial design 33. Data from the first stage were used to obtain calibration constants for in silico simulations. The factors used in both designs were formulation, sinker use, and rotation speed. Finally, effects and factor interaction assessment was evaluated based on a statistical analysis of the dissolution efficiency (DE) obtained from simulations. Thus, the established final conditions of the dissolution method were 900 mL of phosphate buffer pH 6.8, 75 rpm of rotation speed, and sinker use to prevent formulation floating. The reference product stood out because of its higher DE than other formulations. It was concluded that the proposed method, in addition to ensuring total HTZ and VAL release from formulations, has adequate discriminative power.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharmaceutics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Suíça

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharmaceutics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Suíça