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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.2011.tde-08072011-104933
Document
Author
Full name
Ana Lucia Nobusa
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2010
Supervisor
Committee
Ferraz, Humberto Gomes (President)
Andreazza, Itamar Francisco
Cavalcanti, Osvaldo Albuquerque
Title in Portuguese
Desenvolvimento e avaliação de minicomprimidos de indapamida de liberação prolongada
Keywords in Portuguese
Dissolução
Formas farmacêuticas multiparticuladas
Hipertensão
Indapamida
Liberação prolongada
Minicomprimidos
Abstract in Portuguese
A hipertensão arterial é a principal causa da incidência de doenças cardiovasculares no mundo. Os diuréticos anti-hipertensivos como a indapamida são muito utilizados para o tratamento da hipertensão arterial, sendo a formulação de liberação prolongada muito eficaz e bem tolerada para o uso em pacientes idosos. Sistemas multiparticulados de formas farmacêuticas sólidas orais de liberação prolongada apresentam uma série de vantagens tecnológicas e biofarmacotécnicas em relação aos sistemas monolíticos.Assim, o presente trabalho teve como objetivo desenvolver formas farmacêutica sólidas multiparticuladas de indapamida com controle de liberação através de sistema de revestimento utilizando polivinilacetato e sistema matricial de hipromelose. Para avaliação das diferentes formulações de minicomprimidos de indapamida de liberação prolongada, foram empregados os aparatos 1 (cesta) e 3 (Bio-Dis) para, deste modo, identificar aquelas cuja liberação do fármaco estivesse mais próxima do produto referência (Natrilix SR® 1,5mg). Ao final, foi realizada uma busca de patentes relacionadas ao sistema multiparticulado de liberação prolongada de indapamida, para avaliar a possibilidade de uma patente para a formulação proposta.
Title in English
Development and evaluation of indapamide controlled release minitablets
Keywords in English
Dissolution
Extended release
Hypertension
Indapamide
Mini-tablets
Multiparticulate dosage forms
Abstract in English
Hypertension is the main cause of cardiovascular disease around the world. Diuretic antihypertensives, such as indapamide, are widely used for treating hypertension, and, with regards to elderly patients, its extended release formulation is the most effective and well tolerated. Multiparticulate systems of solid oral dosage forms for extended release present a series of technological and biopharmaceutical benefits, when compared to monolithic systems. Thus, the purpose of this study was to develop a multiparticulate solid form of indapamide with controlled release by using a polyvinyl acetate coating system and a hypromelose matrix. For an evaluation of different formulations of indapamide extended release mini-tablets, a 1 (basket) and 3 (Bio-Dis) apparatus was used to identify those with a drug release rate closest to the reference product, Natrilix® SR 1.5mg. Finally, multiparticulate indapamide extended release patents were researched, in order to evaluate the possibility of obtaining a patent for the proposed formulation.
 
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ANA_LUCIA_NOBUSA.pdf (786.96 Kbytes)
Publishing Date
2011-08-26
 
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