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Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets.
Carapeto, Gustavo Vaiano; Duque, Marcelo Dutra; Issa, Michele Georges; Ferraz, Humberto Gomes.
Afiliação
  • Carapeto GV; 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.
  • 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.
  • 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(5)2023 May 19.
Article em En | MEDLINE | ID: mdl-37242786
This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) to address the challenge of developing generic drug products by reducing the risk of product failure in pivotal bioequivalence studies. For this purpose, a PBBM was developed in GastroPlus® and combined with a Taguchi L9 design, to evaluate the impact of different drug products (Reference, Generic #1 and Generic #2) and dissolution test conditions on desvenlafaxine release. The influence of the superficial area/volume ratio (SA/V) of the tablets was observed, mainly for Generic #1, which presented higher SA/V than the others, and a high amount of drug dissolved under similar test conditions. The dissolution test conditions of 900 mL of 0.9% NaCl and paddle at 50 rpm with sinker showed to be biopredictive, as it was possible to demonstrate virtual bioequivalence for all products, despite their release-pattern differences, including Generic #3 as an external validation. This approach led to a rational development of a biopredictive dissolution method for desvenlafaxine ER tablets, providing knowledge that may help the process of drug product and dissolution method development.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Pharmaceutics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Brasil País de publicação: Suíça
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

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