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Master's Dissertation
DOI
https://doi.org/10.11606/D.9.1994.tde-10072008-164932
Document
Author
Full name
Nádia Araci Bou Chacra
E-mail
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 1994
Supervisor
Committee
Sakuda, Telma Mary (President)
Fonseca, Maria José Vieira
Ohara, Mitsuko Taba
Title in Portuguese
Suspensão oftálmica de dexametasona e polimixina B: formulação e avaliação da eficácia antimicrobiana de conservantes
Keywords in Portuguese
Colírio
Conservantes
Dexametasona
Polimixinas
Abstract in Portuguese
Suspensões oftálmicas de dexametasona e polimixina B foram formuladas variando-se os conservantes e combinando 2 concentrações de polissorbato 20 e hidroxipropilmetilcelulose segundo o projeto fatorial 2n. A estabilidade das preparações foi avaliada através de parâmetros físicos, com ênfase na facilidade de rehomogeneização após período de repouso. Das 16 fórmulas foram selecionadas 8 para avaliação da eficácia antimicrobiana do sistema conservante pelo método de desafio, segundo B.P. 88, frente a Pseudomonas aeruginosa, Pseudomonas cepacia e Sthaphylococcus aureus. O ensaio foi precedido de validação da técnica segundo planejamento estatistico two way e split + plot. Os produtos contendo associação clorhexidina e álcool feniletílico atenderam às exigências do compêndio adotado, em oposição aos sistemas contendo cloreto de benzalcônio e EDTA, além de clorhexidina e EDTA, independente da concentração do tensoativo e agente suspensor.
Title in English
Ophthalmic suspension of dexametasone and polymyxin B: formulation and preservative antimicrobial efficacy
Keywords in English
Dexametasone
Ophthalmic
Polymyxin
Preservative
Abstract in English
Ophthalmic suspensions of dexametasone and polymyxin B were formulated varying the preservatives and combining two concentrations of polysorbate 20 and hydroxypropylmethylcellulose according to the factorial project 2n. The stability of the preparations were evaluated through physical parameters, with emphasis on the easing of the rehomogenization after a period of rest. 8 of the 16 formula were selected for an evaluation of the antimicrobial efectiveness of the preservative system through the challenge method, according to B.P. 88, against Pseudomonas aeruginosa, Pseudomonas cepacia and Sthaphylococcus aureus. The test was preceded by a validation of the technique according to statistical planning two way and split + splot. The products containing the association of chorhexidine and phenylethyl alcohol complied to the requirements of the adopted compendium, in opposition to the systems containing benzalkonium chloride and EDTA, besides clorhexidine and EDTA, not depending on the concentration of the surfactant and suspending agents.
 
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Publishing Date
2008-07-10
 
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