974 resultados para Pharmaceutical-industry
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Pós-graduação em Ciências da Motricidade - IBRC
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
A critical review of the properties of fusidic acid and the analytical methods for its determination
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Fusidic acid, an antibiotic produced from the Fusidium coccineum fungus, belongs to the class of steroids, but has no corticosteroid effects. It is indicated for the treatment of infections caused by methicillin-resistant Staphylococcus aureus strains. The aim of this study was to search for the properties of fusidic acid published so far in the literature, as well as the methods developed for its determination in biological samples and pharmaceutical formulations. From the findings, we can conclude that fusidic acid has been used for decades and is indicated for the treatment of serious infections caused by Gram-positive microorganisms to this day. Furthermore, it is a hypoallergenic agent, has low toxicity, shows low resistance, and has no cross-resistance with other clinically used antibiotics. The analytical method of high-performance liquid chromatography has been widely used, since it can reduce the cost and time of analysis, making it more viable for routine quality control in the pharmaceutical industry.
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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Pós-graduação em Agronomia (Horticultura) - FCA
Validation of analytical methodology for quantification of cefazolin sodium by liquid chromatography
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A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2 =0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy
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The pharmaceutical industry invests heavily in promoting their products, and studies suggest that these actions influence doctor’s prescribing. Therefore, this study aimed to analyze the opinions and attitudes of doctors when facing promotional activities of the laboratories. To this end, questionnaires were sent to doctors in Araraquara (SP) containing statements on the subject. Data analysis included study of the association by the chi-square. The results indicated that physicians relate to the propagandists (98%) by considering them useful (55%), but not as a main source update (86%). For 62% of them their prescriptions are not influenced by such relationships, while 24% disagree that doctors in general are influenced as well as new graduates (37%). The majority also disagrees that are influenced by amenities (86%) or free samples (70%) but only 38% believe their colleagues are not influenced by the samples. As for the ethics of these receipts, 57% considered to be appropriate when benefit patients, but only 32% while for personal use. The results show that doctors are vulnerable to the influences of marketing. Therefore, mechanisms and interventions are needed for prescribing drugs solely by criteria of effectiveness, safety, convenience and accessibility to the patient.
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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This paper describes the importance of an innovative analytical technique for drugs and pharmaceuticals quantification, using Fouriertransform infrared (FTIR) transmission spectroscopy. This method does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. The method involved absorbance measurements of the band corresponding to one of the chosen group in the molecule. Obviously, the method should be validated according to ICH guidelines, showing linearity, precision, accuracy and robustness, over a concentration range, using small amounts to prepare the analyte. The validated method is able to quantify drugs and pharmaceuticals and can be used as an environmentally friendly alternative for the routine analysis in pharmaceutical industry quality control.
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Antimicrobials have unquestionable importance in the control of many diseases; however the constant concern with evolution of resistant microorganisms is increasing. The ertapenem sodium is a β-lactam antibiotic of the carbapenem class, which it has a broader activity spectrum than most other β-lactam antimicrobials, and is more resistant to the enzyme β-lactamase, which is the main mechanism of resistance of many bacteria. The progress of microbial resistance to existing antibiotics is alarming. Thus we need to preserve antimicrobials that still have activity against these pathogens. In this context, the quality control has a key role to ensure the correct dosage, by contributing preventively to minimize the development of resistant microorganisms. Study of the physicochemical characteristics of the drug and the quantification of the content of active substance are of fundamental importance for the pharmaceutical industry to ensure the quality of the product sold. This work presents a literature survey of existing methods for ertapenem sodium quantification which was performed. Ertapenem sodium can be analyzed by many types of assays; however the HPLC is the most used method. This review will examine the published analytical methods reported for determination of ertapenem sodium, in biological fluids and formulations.
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Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.
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The Dipteryx alata is a tree specie with possibility of use in human and animal nutrition, and in the pharmaceutical industry. For reclamation of degraded areas, the revegetation has been an alternative, however, requires fertilizer addition. The objectives of this study were to evaluate the nutritional status and growth of Dipteryx alata seedlings, introduced in degraded soil under recovery process, with residues (organic and agroindustrial), compared to collected seedlings in preserved Cerrado, and evaluate the residues impact on soil chemical properties. In this work the degraded soil received the incorporation of residues, organic - RO (macrophytes) and agroindustrial - RA (ash derived from burning bagasse from sugarcane), with the following doses: 0, 16 and 32 t ha- 1 and 0, 15, 30 and 45 t ha-1 respectively. Within three months of incorporation of residues into the degraded soil, the D. alata seedlings were introduced in the experimental area, and 12 months later were evaluated for height, stem diameter, chlorophyll content and leaf contents of N, P, K, Ca, Mg, S, B, Cu, Fe, Mn and Zn. For purposes of comparison, the foliar concentration of those elements was determined in Dipteryx alata seedlings collected in preserved Cerrado area. Concomitant with the collect of leaves, at Cerrado and experimental area, soil was collected (0.0 - 0.20m deep) for evaluation of chemical parameters (P, OM, pH, K, Ca, Mg, H + Al, Al, Cu, Fe, Mn and Zn). Comparing the seedlings collected in the Cerrado with the seedlings from experimental area it is observed that the leaf concentration of N, P, K and Mg was higher in seedlings from preserved Cerrado in relation to those introduced in the experimental area. Fe, Mn and Zn, have lower foliar concentration in plants collected in the Cerrado, in the case of Mn the worst results occur in the absence of macrophytes indicating the importance of organic residue. The foliar concentration of Ca, S and Cu was similar in...
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The pharmaceutical industry was consolidated in Brazil in the 1930s, and since then has become increasingly competitive. Therefore the implementation of the Toyota Production System, which aims to lean production, has become common among companies in the segment. The main efficiency indicator currently used is the Overall Equipment Effectiveness (OEE). This paper intends to, using the fuzzy model DEA-BCC, analyze the efficiency of the production lines of a pharmaceutical company in the Paraíba Valley, compare the values obtained by the model with those calculated by the OEE, identify the most sensitive machines to variation in the data input and develop a ranking of effectiveness between the consumer machinery. After the development, it is shown that the accuracy of the relationship between the two methods is approximately 57% and the line considered the most effective by the Toyota Production System is not the same as the one found by this paper
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The pharmaceutical industry was consolidated in Brazil in the 1930s, and since then has become increasingly competitive. Therefore the implementation of the Toyota Production System, which aims to lean production, has become common among companies in the segment. The main efficiency indicator currently used is the Overall Equipment Effectiveness (OEE). This paper intends to, using the fuzzy model DEA-BCC, analyze the efficiency of the production lines of a pharmaceutical company in the Paraíba Valley, compare the values obtained by the model with those calculated by the OEE, identify the most sensitive machines to variation in the data input and develop a ranking of effectiveness between the consumer machinery. After the development, it is shown that the accuracy of the relationship between the two methods is approximately 57% and the line considered the most effective by the Toyota Production System is not the same as the one found by this paper