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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.1992.tde-02032015-113440
Document
Author
Full name
Maria Vitoria Lopes Badra Bentley
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 1992
Supervisor
Committee
Kedor, Erika Rosa Maria (President)
Fonseca, Maria Jose Vieira
Helou, Joao Haikal
Title in Portuguese
Influência de agentes antioxidantes na estabilidade do cloridrato de prometazina em preparações injetáveis
Keywords in Portuguese
Medicamento
Abstract in Portuguese
O cloridrato de prometazina constitui um potente antihistamínico, pertencente ao grupo das fenotiazinas, é comercializado sob várias formas farmacêuticas, isolado ou associado a outros fármacos. A decomposição oxidativa do cloridrato de prometazina é relativamente intensa em meio aquoso. No presente trabalho verificou-se a estabilidade do cloridrato de prometazina em preparações farmacêuticas injetáveis, contendo diferentes associações de agentes antioxidantes, aplicando-se como método de análise a espectrofotometria no ultravioleta. Pela cromatografia em camada delgada foi possível separar e identificar o produto de degradação, o sulfóxido de prometazina. Armazenaram-se as diferentes formulações foram armazenadas em estufas termostatizadas de 37°C, 50°C e 70°C por um período de 84 dias. Em intervalos de tempos pré-estabelecidos, analisaram-se as amostras quanto ao conteúdo de cloridrato de prometazina pela metodologia analítica proposta. Através dos resultados experimentais avaliou-se a cinética de decomposição do cloridrato de prometazina, e determinaram-se os prazos de validade (t90 a 25°C) para cada formulação. Selecionou-se o sistema antioxidante mais efetivo.
Title in English
Influência de agentes antioxidantes na estabilidade do cloridrato de prometazina em preparações injetáveis
Keywords in English
Drugs
Abstract in English
Promethazine hydrochloride constittites a strong antihistamine, that belongs to the phenothiazine group, commercialized under pharmaceutical dosage forms, being isolated or associated to other drugs. The oxiditive decomposition of promethazine hydrocloride is relatively intense in aqueous solution. In the present investigation, the stability of injectable promethazine hydrocloride, containning different associations of antioxidants, was evaluated. The spectrophotometric method was applied in the analyses. By means of thin layer chromatography was possible to separate and identify the sulphoxide of promethazine. Different formulations were stored in thermostatted incubators at 37°C, 50°C and 70°C for a period of 84 days, and assayed at apropriate intervals. Through the experimental results, the thermal decomposition kinetic of promethazine hydrocloride was evaluated, and the expiration date (t90 at 25°C) for each formulation was determined. The most effective antioxidant system was seleted.
 
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Publishing Date
2015-03-02
 
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