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Souza J.A.L.,Federal University of Pernambuco | Albuquerque M.M.,Federal University of Pernambuco | Grangeiro S.,Federal University of Pernambuco | Pimentel M.F.,Federal University of Pernambuco | And 3 more authors.
Vibrational Spectroscopy | Year: 2012

Captopril disulphide (CD) is the major impurity upon captopril degradation. Besides a reduction of the active principle by degradation, the presence of a high amount of CD in a captopril tablet gives a metallic taste to the tablet, which reduces the therapeutic adhesion. Thus, it is important to quantify this impurity in captopril tablets. This work proposes a new methodology to determine this degradation product through near infrared spectroscopy (NIR) and chemometrics. To conduct this study, tablets of a recently manufactured batch were subjected to accelerated degradation using an environmental chamber to enlarge the range of CD in tablets. Tablets with their batch dates expired were also used. Near infrared (NIR) diffuse reflectance spectra of these tablets were recorded in the region between 14,000 and 3800 cm -1. The same tablets were also analysed using high performance liquid chromatography (HPLC). Partial least squares (PLS) models were constructed using different pre-processing techniques. The performances of the models were evaluated using an external validation set. In this step, a root mean square error of prediction (RMSEP) of 0.074 mg per tablet was obtained, using Savitzky-Golay 1st derivative spectra (15 points windows and 2nd order polynomial). The value of relative standard error (RSD) under repeat conditions was 12%, which is within the limits of the RSD required to determine traces or impurities (20%). The methodology was validated and can easily be used for routine analysis. © 2012 Elsevier B.V. Source

Lima A.C.B.,Laboratorio Farmaceutico Do Estado Of Pernambuco | Guerra D.M.,Programa de Residencia em Planejamento e Gestao de Servicos Farmaceuticos
Ciencia e Saude Coletiva | Year: 2011

This work evaluated wound dresses used in the Neurosurgery Department of Restauração Hospital: polyurethane, hydrogel and activated carbon wound dresses and hydrogel with alginate used for pressure ulcer care. This work aimed to identify a critical factor that increases demand and cost of wound dresses. The evaluation conducted at the Neurosurgery Department identified individuals at risk of pressure ulcer development. Sixty-two patients were evaluated and the prevalence of pressure ulcer was 22.6% according to the Braden scale. Comparative evaluation between patients that didn't receive preventive measures and others that received, showed that the average daily cost of hospitalization for the first group was 45% higher than the mean for the second group. The Wilcoxon-Mann-Withiney test compared the population at risk to develop pressure ulcer and population at low risk showing that the evaluation of Braden Scale scores between the groups presents statistically significant differences and confidence limits of 95%. Pressure ulcer is a key quality indicator in health services. It is possible to reduce costs and offer higher quality public health services by implementing a training program of nursing staff using a preventive measure protocol based on a test to evaluate risk as Braden Scale. Source

Grangeiro Junior S.,Federal University of Pernambuco | Grangeiro Junior S.,Laboratorio Farmaceutico Do Estado Of Pernambuco | de Moura Franca L.,Federal University of Pernambuco | Pimentel M.F.,Federal University of Pernambuco | And 5 more authors.
Microchemical Journal | Year: 2015

The production of solid drugs generally consists of several steps, which are monitored using quality control assays. In this work, rapid and non-destructive methods, which conform to the principles of the process analytical technology (PAT) framework, were developed for monitoring the production of fixed-dose combination tablets of zidovudine (AZT) and lamivudine (3TC). NIR spectroscopy was employed to determine the content of AZT and 3TC at three different steps of production: in the granulate material, in the core and in the manufactured tablet. NIR chemical images (NIR-CI) were used as a complementary study to evaluate the chemical distribution on the uncoated tablet surfaces, and its internal correlation structures. NIR methods for monitoring the moisture content in the granulate material and the hardness of the tablets before the coating step were also developed. A comparison between two multivariate calibration techniques: PLS and MLR was carried out. The models showed accurate results and prediction errors below those allowed by the regulatory agencies. Through the concentration maps associated with multivariate analysis, the internal chemical structure of API distribution and the excipient increased the understanding of the mixing process, allowing for further improvements. © 2014 Elsevier B.V. Source

Grangeiro Jr. S.,Federal University of Pernambuco | Albuquerque M.M.,Federal University of Pernambuco | Santana D.P.,Federal University of Pernambuco | Pimentel M.F.,Federal University of Pernambuco | And 2 more authors.
Quimica Nova | Year: 2011

The simultaneous determination of two or more active components in pharmaceutical preparations, without previous chemical separation, is a common analytical problem. Published works describe the determination of AZT and 3TC separately, as raw material or in different pharmaceutical preparations. In this work, a method using UV spectroscopy and multivariate calibration is described for the simultaneous measurement of 3TC and AZT in fixed dose combinations. The methodology was validated and applied to determine the AZT+3TC contents in tablets from five different manufacturers, as well as their dissolution profile. The results obtained employing the proposed methodology was similar to methods using first derivative technique and HPLC. Source

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