Banca de DEFESA: MARCELO VITOR DE PAIVA AMORIM

Uma banca de DEFESA de DOUTORADO foi cadastrada pelo programa.
DISCENTE : MARCELO VITOR DE PAIVA AMORIM
DATA : 27/02/2018
HORA: 14:00
LOCAL: Sala do PPgDITM
TÍTULO:

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PALAVRAS-CHAVES:

Olanzapine; Near Infrared; HPLC; PAT; Control Charts; Karl Fischer.


PÁGINAS: 140
GRANDE ÁREA: Ciências da Saúde
ÁREA: Farmácia
RESUMO:

Olanzapine is a benzodiazepine which proved efficacy in the treatment of positive and
negative symptoms of schizophrenia, bipolar disorder and others psychoses. The
pharmaceutical industry and analytical laboratories have focus on quality, safety and efficacy
of their products, for this planning tools and monitoring are required in the production scale.
The concept of Process Analytical Technology introduces innovative approaches, as
improvement of process control and comprehension of carried out procedures to improve the
efficiency.
This study applies the near infrared spectroscopy to build the Process Analytical
technology in the production of Olanzapine coated tablets, since this technique has being
wide use, because it is not necessary to prepare the samples, the absence of residues
produced and the analysis are fast. Previously to implementation of Process Analytical
Technology some laboratory steps are required to evaluate if the technique are sensitive to
the objective. To prove the theory, alternative methods were developed to compare with their
references. In the Chapter 1 it was carried out the assay of the drug using high performance
liquid chromatography and near infrared associated to multivariate calibration techniques
(partial least square – PLS), after the spectra pre-treatment). The results obtained by the
near infrared were compared to the chromatography and as response: the assay by both
methods did not presented statistically significance difference. In the Chapter 2, the thesis
was focused at the construction of multivariate control charts, based on Net Analytical Signal
(NAS) to monitor the assay of the drug in laboratory and production samples using near
infrared spectroscopy. The control charts (NAS, interferers and residuals) were built and
they were promisor with high level of recognition (95 to 100%) of samples that were exactly
in or out of the specified range. Lastly, at the Chapter 3 the determination of water content by
near infrared associated to multivariate calibration, PLS, of Olanzapine and excipients
granulate mixtures in laboratory and production samples was analyzed and compared to the
reference method (Karl Fischer). The results, when NIR and Karl Fischer were compared,
presented no significant statistically difference, promoting the NIR associated to multivariate
calibration also works to analyze the water content into the coated olanzapine tablets.
The results showed that the multivariate calibration models constructed, using the
spectra obtained by the near infrared, were promisors, when compared to the reference
methods. Therefore, the alternative analytical tool (near infrared spectroscopy) can be
installed at production scale to monitor the drug quality at this matrix used.



MEMBROS DA BANCA:
Presidente - 1492900 - CICERO FLAVIO SOARES ARAGAO
Externo ao Programa - 2140814 - FERNANDO HENRIQUE ANDRADE NOGUEIRA
Externo ao Programa - 1714946 - KASSIO MICHELL GOMES DE LIMA
Externo à Instituição - LILIAN GRACE DA SILVA SOLON - UNIFAP
Externo à Instituição - LUIZ ALBERTO LIRA SOARES - UFPE
Externo à Instituição - MARCUS TULLIUS SCOTTI - UFPB
Notícia cadastrada em: 02/02/2018 15:53
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