The aim of this study was the development and formulating of an eye contour serum containing hyaluronic acid (HA) and the assessment of stability tests performed for the cosmetic product, transfered into a glass cosmetic bottle with polipropylene (PP) pump and cap. Sample of cosmetic serum were stored using 20 mL glass bottles with PP (Polypropylene) pump and cap. The developed cosmetic formulation was monitored under accelerated stability studies, performed over a period of 30 days while maintaining the product at 4, 20 and 40�C. Quality control initial, and after initiating the accelerated stability test was performed for the developed cosmetic formulation.
A near infrared (NIR) method able to directly quantify the active content in pharmaceutical powder blends used for manufacturing meloxicam tablets, without any sample preparation, was developed and fully validated. To develop calibration models for the assay of meloxicam in powder blends for tableting, the NIR reflectance spectra of different meloxicam powder blends prepared according to a calibration protocol was analysed using different preprocessing methods by partial last-square regression (PLS) and principal component regression (PCR).The best calibration model was found when partial last-square regression (PLS) was used as regression algorithm in association with Smoothing-Savitsky as pre-processing spectrum method. The trueness, precision (repeatability and intermediate precision), accuracy, linearity and range of application of the developed NIR method were validated according to the International Conference of Harmonization (ICH) and Medicine European Agency (EMA) guidelines and found to be fit for its intended purpose.
Pharmaceutical controls are time-consuming and require extensive sample preparation. Process analytical technology (PAT) implementation in the pharmaceutical industry would reduce these time consuming operations. To perform this implementation, the use of analytical techniques capable of providing accurate results in a simple and rapid manner is necessary (1). Other advantages include little or no sample preparation (2, 3). Near infrared spectrophotometry (NIR) is a non-destructive and non-invasive technique that allows determination of chemical properties such as active pharmaceutical ingredient (API) or excipient content. The paper proposes a near infrared method able to directly and simultaneously quantify ascorbic acid and sodium ascorbate in powder blends for tableting and in vitamin C chewable tablets without any sample preparation. In the first step, calibration models for the quantification of ascorbic acid and sodium ascorbate in powder blends for tableting and subsequently in chewable vitamin C tablets (corresponding to 80-120 % active substance) were developed according to an experimental design with 2 variables and 5 levels. Then, using the best calibration models, the methods were fully validated in terms of recovery, precision and accuracy for both powder blends and vitamin C chewable tablets. NIR spectroscopy can be used to perform quantitative determinations of one, two or more compounds in complex matrices like, for instance, a pharmaceutical powder blend for tableting or tablets. A NIR assay method is usually not developed in the »traditional« way as UV spectrometry or HPLC assay methods (4). A major step to develop a NIR assay method is the calibration procedure for model development. Once calibration is developed and favourable predictions are expected, they must be validated to be accepted for routine use. For external validation, independent sets of samples are needed. There are several validation parameters that must be determined in order to be consistent with the recommendations of official guidelines: accuracy, precision (repeatability and intermediate precision), specificity, linearity and range of application (5, 6).Many papers report the determination of API content in powder blends or tablets by NIR methods (6, 7), but only a few are focused on the prediction of two or more APIs and/or excipients combined in powder blends or tablets (8, 9).The methods currently used to determine the amount of ascorbic acid and sodium ascorbate in tablets or powder blends for tableting are HPLC (10, 11) and titrimetry (12, 13), but they have the disadvantage of being rather time-consuming. Unlike the conventional methods, NIR-chemometric methods are faster and do not require prior preparation of the sample, so they can be a viable alternative for direct quantification of ascorbic acid and sodium ascorbate in powder blends for tableting and vitamin C tablets. The first objective of our research was to develop a NIR-chemometric method suitable for direct quantification of both APIs from powder blends f...
In Romania, antidiabetic medication is free, based on a program of the Ministry of Public Health: "Treatment of patients with diabetes mellitus". Since October 1, 2006, antidiabetic drugs have been delivered through open circuit pharmacies in contractual relationship with the National Health Insurance House, after four years of centralized delivery through hospital pharmacies. Objectives: This study aims to describe the influences of the diabetes treatment regarding patients' quality of life and their satisfaction. Methods: A cross-sectional descriptive study was performed in pharmacies. The study includes 477 patients with diabetes mellitus from Cluj County, Romania. The interviewing method was used on a questionnaire base. The participants included in the study admitted to participate in May-June, 2016. The questionnaire was systematically developed following comprehensive literature review and structured according to 3 main fields: 1) patient demographics; 2) diabetes patient treatment and 3) glycaemia control and patient satisfaction. Results: The research performed in two months showed that 78% of the respondents used oral antidiabetics for treatment, more than 19% of the inquired patients reached normal glycaemia values following antidiabetic treatment, and about 82% of patients were satisfied with the current system of acquisition of antidiabetic drugs. Conclusions: The treatment with antidiabetic drugs maintains a relatively good health status. Also, the life expectancy of diabetic patients has increased over the past period.
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