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Biopharmaceutics classification system: importance and inclusion in biowaiver guidance BJPS
Arrunátegui,Lorena Barbosa; Silva-Barcellos,Neila Márcia; Bellavinha,Karime Rezende; Ev,Lisiane da Silveira; Souza,Jacqueline de.
Pharmacological therapy is essential in many diseases treatment and it is important that the medicine policy is intended to offering safe and effective treatment with affordable price to the population. One way to achieve this is through biowaiver, defined as the replacement of in vivo bioequivalence studies by in vitro studies. For biowaiver of new immediate release solid oral dosage forms, data such as intestinal permeability and solubility of the drug are required, as well as the product dissolution. The Biopharmaceutics Classification System (BCS) is a scientific scheme that divides drugs according to their solubility and permeability and has been used by various guides as a criterion for biowaiver. This paper evaluates biowaiver application,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Medicines/biowaiver; Biopharmaceutics Classification System; Drugs/solubility; Drugs/permeability; Drugs/dissolution; Drugs/legislation.
Ano: 2015 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502015000100143
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Equilibrium solubility study to determine fexofenadine hydrochloride BCS class and challenges in establishing conditions for dissolution profiles applied to suspension BJPS
Rosa,Lorena de Sousa; Marques-Marinho,Flávia Dias; Braga,Silmara Leôncio; Souza,Jacqueline de.
The aim of this work was to perform solubility studies for fexofenadine hydrochloride and establish dissolution conditions for this drug in oral suspension dosage form. The solubility study was executed through the shake-flask method, below 37 ºC±1 ºC, at 100 rpm stirring for 12 h in three buffer solutions: hydrochloric acid pH 2.0, acetate pH 4.5 and phosphate pH 6.8. The dissolution test was developed in vessels containing 900 mL of the same buffer, employing the paddle apparatus in speed of 25 and 50 rpm, below 37 ºC±0.5 ºC. The drug was classified as low solubility according to the Biopharmaceutics Classification System, since the dose/solubility ratio was higher than 250 mL in all media tested (326.55 mL in buffer pH 2.0; 2,456.33 mL in buffer pH 4.5...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Fexofenadine hydrochloride; HPLC method; Biopharmaceutics; Suspension; Dissolution profile.
Ano: 2020 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502020000100585
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