Desenvolvimento farmacotécnico e analítico de comprimidos revestidos de montelucaste: equivalência farmacêutica e bioequivalência
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Data
2011-03-18
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Universidade Federal de Goiás
Resumo
Montelukast is a potent reversible selective inhibitor of cysteinilleukotrien-
1 receptor, avoiding that these mediators promote the asthmatic
response. Its commercialization in Brazil, as a terminated product, is protected
by patent up to 2010. Once the active ingredient Montelukast is recent in the
pharmaceutical market and there is no methodology description in official
compendiums capable to assure the quality of new formulations, the objective
of this paper was the pharmaceutics of montelukast film coated tablets, the
development and the validation of analytical and bioanalytical methodologies
foreseeing the pharmaceutical equivalence and bioequivalence with the
reference medication of the market. With this purpose, some physicalchemical
parameters were characterized, assay and dissolution methodologies
were developed and validated per high performance liquid chromatography
with ultraviolet detection (HPLC-UV) for the quantification of montelukast
present in 10.0mg film coated tablets. The quantification of montelukast
sodium in human plasma was performed using Loratadine as internal standard
and high performance liquid chromatography attached to mass detector (HPLC
- MS / MS). The active ingredient was extracted from the human plasma using
precipitation extraction. The results found for the parameters of specificity,
linearity, accuracy, precision, quantification and detection limits and stability in
the methodologies validation confirm they were adequate for the objective
proposed. The analytical methodologies developed and validated were applied
in the pharmaceutics of the tablets for the determination of the formulation
similar to the market reference medication Singulair®. This formulation was
submitted to stability assays to assure its quality and to allow the performance
of pharmaceutical equivalence and bioequivalence with the purpose of
registering as a generic medication.
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ALVES, Carina Pimentel Itapema. Pharmaceutical and analytical development film coated
tablets of montelukast: pharmaceutical equivalence and
bioequivalence. 2011. 61 f. Tese (Doutorado em Ciencias da Saude) - Universidade Federal de Goiás, Goiânia, 2011.