Optimization of Diltiazem hydrochloride osmotic formulation using QBD approach
Braz. J. Pharm. Sci. (Online)
;
58: e19779, 2022. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-1383968
ABSTRACT
Abstract Diltiazem hydrochloride (DLH) is a calcium channel blocker useful for the treatment of angina pectoris, arrhythmia, and hypertension. DLH having a short half-life needs frequent administration for successful treatment but this poses a problem of poor patient compliance. These requirements are served by elementary osmotic pump tablets (EOP) based controlled-release (CR) systems. Quality by design (QbD) approach assists in screening various factors with subsequent assessment of critical parameters that can have a major impact on the scalability of EOP. Tablets were formulated using wet granulation method followed by osmotic coating. Factorial design based QbD strategy aided in defining the risk assessment of influential variables such as hydrophilic polymers and osmotic coat component on the in-vitro release kinetics of the designed EOP tablets. These formulated EOP systems followed zero-order kinetics, a characteristic feature of EOPs. EOP tablets were formulated applying a systematic QbD statistical approach. The formulated DLH EOP systems with improved concentration-independent behavior helped to address the challenges of IR formulation. Application of QbD strategy in ascertaining the scalability of DLH EOP formulation would help pharmaceutical industries in the translation of EOP based drug delivery systems from R&D to market.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Comprimidos
/
Diltiazem
/
Sistemas de Liberação de Medicamentos
/
Gestão da Qualidade Total
/
Métodos
Tipo de estudo:
Fatores de risco
Idioma:
Inglês
Revista:
Braz. J. Pharm. Sci. (Online)
Assunto da revista:
Farmacologia
/
Teraputica
/
Toxicologia
Ano de publicação:
2022
Tipo de documento:
Artigo
País de afiliação:
Índia
Instituição/País de afiliação:
Bharati Vidyapeeth University/IN
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