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Doctoral Thesis
DOI
10.11606/T.9.2017.tde-02082017-143546
Document
Author
Full name
Newton Andreo Filho
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2006
Supervisor
Committee
Ferraz, Humberto Gomes (President)
Chacra, Nádia Araci Bou
Funck, Jose Aparicio Brittes
Serra, Cristina Helena dos Reis
Sonaglio, Diva
Title in Portuguese
Desenvolvimento e avaliação de formas farmacêuticas sólidas contendo didanosina
Keywords in Portuguese
AIDS
Antivirais (Avaliação; Desenvolvimento)
Cinética de dissolução
Comprimidos gastro-resistentes
Comprimidos tamponados mastigáveis
Didanosina
Dissolução
Formas farmacêuticas (Avaliação)
Pellets
Quimioterápicos (Avaliação)
Abstract in Portuguese
A Síndrome da Imunodeficiência Adquirida (AIDS) é uma doença de amplo espectro de manifestações, sendo razão de preocupação para qualquer autoridade sanitária. A terapêutica da AIDS é complexa sendo utilizados vários medicamentos, diversas vezes ao dia. Deste modo, objetivou-se o desenvolvimento de formas farmacêuticas sólidas como comprimidos tamponados mastigáveis (CTM), comprimidos com revestimento gastro-resistentes (CRGR) e pellets (PEL) para a veiculação de didanosina (ddl). Seis especialidades farmacêuticas na forma de CTM foram estudadas quanto ao perfil de dissolução, pH do meio e capacidade neutralizante ácida (CNA). Formulações teste de CTM foram propostas visando obter CNAs e perfis de dissolução adequados. Também foram testadas formulações de comprimidos e de pellets para posterior revestimento com filme gastro-resistente derivado do ácido metacrílico. Os ensaios de dissolução das amostras de CTM revelaram diferenças nas características de liberação do fármaco. Também foram observadas diferenças relacionadas a CNA. As formulações de CTM propostas apresentaram, na maioria dos casos, adequados perfis de dissolução e CNA. As formulações CRGR que receberam revestimento gastro-resistente apresentaram perfis de dissolução de ddl adequados, entretanto os comprimidos testados intumesceram em meio ácido, indicando descontinuidade do filme polimérico sobre os comprimidos. Testes para a produção de pellets veiculando ddl mostraram-se adequados quanto à morfologia e dissolução do fármaco, o mesmo sendo observado após o revestimento com filme gastro-resistente.
Title in English
Development and evaluation of solid dosage forms containing didanosine
Keywords in English
AIDS
Antivirals (Evaluation; Development)
Chemotherapeutics (Evaluation)
Chewable tablets
Didanosine
Dissolution
Dissolution kinetics
Gastro-resistant tablets
Pellets
Pharmaceutical forms (Evaluation)
Abstract in English
The Acquired Immune Deficiency Syndrome (AIDS) is a disease that manifests itself in a myriad of ways. Because of this, the condition has been subject of concern to all sanitary authorities. The treatment of AIDS is complex and many types of medicine are used, many times a day. The objective of the present study was to develop solid pharmaceutical dosage forms such as buffered chewable tablets (CTM), gastro-resistant coating tablets (CRGR) and pellets (PEL) for the loading of didanosine (ddl). Six pharmaceutical specialties in the form of CTM were studied so as to identify the profile of the dissolution, the pH of the environment, and the neutralizing acid capacity (CNA). The use of CTM tests formulations was proposed with the objective of obtaining adequate CNA and dissolution profiles. Different compositions of tablets and pellets were tested for a later addition of gastro-resistant film derived from the methacrylic acid. The experiments on the dissolution of the sample of CTM showed differences in the characteristic of the release of the substance. Differences related to the CNA were also observed. The formulations of the CTM proposed showed to have, in the most number of the cases, both adequate dissolution behavior and CNA. The formulations of the CRGR that had received the gastro-resistant coating showed adequate profile of ddl dissolution; the tested tablets, however, swelled in the acid environment, therefore indicating a lack of continuity of the polymeric film over the tablets. The tests for the production of pellets showed adequate results as to its morphology and dissolution of ddl. The same was observed after coating the pellets with gastro-resistant film.
 
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Publishing Date
2017-08-02
 
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