Desenvolvimento e validação de métodos analíticos para determinação do cloridrato de epinastina em comprimidos revestidos

O cloridrato de epinastina é um agente não sedativo, antagonista H1 da histamina, utilizado no tratamento da asma ou como anti-histamínico, comercializado no Brasil na forma farmacêutica comprimido revestido com o nome de Talerc ®. Embora, seja um medicamento amplamente comercializado não há referências relativas aos métodos de análise da forma farmacêutica. Este trabalho teve como objetivos o desenvolvimento e a validação de métodos analíticos para o controle de qualidade do cloridrato de epinastina nos comprimidos revestidos, bem como a realização de estudos preliminares de estabilidade térmica e de fotoestabilidade e determinação da cinética de reação do anti-histamínico em estudo.A análise qualitativa do cloridrato de epinastina foi realizada por ressonância magnética nuclear de próto n, determinação da faixa de fusão, espectrofotometria na região do infravermelho e do ultravioleta, cromatografia em camada delgada e por cromatografia a líquido de alta eficiência. Para análise quantitativa, foram validados os métodos por espectrofotometria na região do ultravioleta derivada de primeira ordem e por cromatografia a líquido de alta eficiência. A validação foi efetuada de acordo com as guias de validação disponíveis na literatura. No estudo preliminar de estabilidade térmica utilizou-se a forma farmacêutica submetida a temperatura de 80 °C por 10 dias. A fotoestabilidade foi realizada em câmara de luz ultravioleta de 254 nm por um período de 18 horas. Os métodos qualitativos foram úteis para identificação do cloridrato de epinastina. Os métodos quantitativos propostos foram validados de acordo com os parâmetros analíticos preconizados, podendo ser perfeitamente intercambiáveis. O estudo preliminar de estabilidade térmica não apresentou degradação da amostra nas condições de análise empregadas. O estudo de fotoestabilidade apresentou degradação intensa obedecendo uma cinética de reação de primeira ordem.

An analysis of the perceived service quality of hospitality industry in Rio de Janeiro through the SERVQUAL model: a multiple case study

Brazil is under political and financial crises where the end seems far away. Because of that, researchers argue that the hotel rooms offered by Rio de Janeiro, built to host the Olympic Games 2016, will be difficult to occupy after the event. It is then necessary for the hotels to understand how guests perceive the service quality in order to adapt to this new era. If guests’ perceptions meet or exceed their expectations, they will be satisfied and will probably return. Thus based on the SERVQUAL approach, this paper aims to study the impact of the service dimensions on the guests’ overall satisfaction at hotels of Rio de Janeiro. Two hotels were considered representative of the city in terms of service quality and customers’ profile. Interviews to the hotel managers were performed, and questionnaires to the guests were administered. Among the five SERVQUAL dimensions – Reliability, Tangibles, Responsiveness, Assurance, and Empathy – the Empathy dimension appears to be the only one that affects the guests’ overall satisfaction. The study could also identify that gender, country of residence, home country and family income have an impact on guests’ satisfaction. This study has no intention of generalization, but rather of refining the theory about services and the SERVQUAL model.

Instalações e recursos humanos

Afirma a importância do laboratório em usinas de açúcar e álcool devido ao fato do controle de qualidade em usinas ter as análises químicas como base. Menciona os altos custos para montar e manter um laboratório. Cita os cuidados a serem tomados ao instalar um laboratório em um prédio que não foi construído para isso e também ao planejar um novo laboratório. Como a confiabilidade do resultado final e o bom andamento das atividades do laboratório dependem da qualidade técnica e da capacidade de trabalho dos analistas e dos auxiliares técnicos do laboratório, indica a importância da identificação de amostras, tomadas de alíquotas, lavagem de vidrarias, preparo de soluções, uso de aparelhos e anotação de resultados.

Variabilidade de processos

Unidade 4

Análise da estabilidade genética de células-tronco mesenquimais humanas

Human multipotent mesenchymal stromal cells (MSCs), also known as mesenchymal stem cells, have become an important and attractive therapeutic tool since they are easily isolated and cultured, have in vitro expansion potential, substantial plasticity and secrete bioactive molecules that exert trophic effects. The human umbilical cord as a cell source for cell therapy will help to avoid several ethical, political, religious and technical issues. One of the main issues with SC lines from different sources, mainly those of embryonic origin, is the possibility of chromosomal alterations and genomic instability during in vitro expansion. Cells isolated from one umbilical cord exhibited a rare balanced paracentric inversion, likely a cytogenetic constitutional alteration, karyotype: 46,XY,inv(3)(p13p25~26). Important genes related to cancer predisposition and others involved in DNA repair are located in 3p25~26. Titanium is an excellent biomaterial for bone-implant integration; however, the use can result in the generation of particulate debris that can accumulate in the tissues adjacent to the prosthesis, in the local bone marrow, in the lymph nodes, liver and spleen. Subsequently may elicit important biological responses that aren´t well studied. In this work, we have studied the genetic stability of MSC isolated from the umbilical cord vein during in vitro expansion, after the cryopreservation, and under different concentrations and time of exposition to titanium microparticles. Cells were isolated, in vitro expanded, demonstrated capacity for osteogenic, adipogenic and chondrogenic differentiation and were evaluated using flow cytometry, so they met the minimum requirements for characterization as MSCs. The cells were expanded under different concentrations and time of exposition to titanium microparticles. The genetic stability of MSCs was assessed by cytogenetic analysis, fluorescence in situ hybridization (FISH) and analysis of micronucleus and other nuclear alterations (CBMN). The cells were able to internalize the titanium microparticles, but MSCs preserve their morphology, differentiation capacity and surface marker expression profiles. Furthermore, there was an increase in the genomic instability after long time of in vitro expansion, and this instability was greater when cells were exposed to high doses of titanium microparticles that induced oxidative stress. It is necessary always assess the risks/ benefits of using titanium in tissue therapy involving MSCs, considering the biosafety of the use of bone regeneration using titanium and MSCs. Even without using titanium, it is important that the therapeutic use of such cells is based on analyzes that ensure quality, security and cellular stability, with the standardization of quality control programs appropriate. In conclusion, it is suggested that cytogenetic analysis, FISH analysis and the micronucleus and other nuclear alterations are carried out in CTMH before implanting in a patient

Um sistema para a inferência de variáveis usando redes neurais artificiais

This work aims to obtain a low-cost virtual sensor to estimate the quality of LPG. For the acquisition of data from a distillation tower, software HYSYS ® was used to simulate chemical processes. These data will be used for training and validation of an Artificial Neural Network (ANN). This network will aim to estimate from available simulated variables such as temperature, pressure and discharge flow of a distillation tower, the mole fraction of pentane present in LPG. Thus, allowing a better control of product quality

Nanosistemas de penicilina G benzatina para tratamento profilático da febre reumática: estudo analítico

Investigations in the field of pharmaceutical analysis and quality control of medicines require analytical procedures with good perfomance characteristics. Calibration is one of the most important steps in chemical analysis, presenting direct relation to parameters such as linearity. This work consisted in the development of a new methodology to obtain calibration curves for drug analysis: the stationary cuvette one. It was compared to the currently used methodology, and possible sources of variation between them were evaluated. The results demonstrated that the proposed technique presented similar reproducibility compared to the traditional methodology. In addition to that, some advantages were observed, such as user-friendliness, cost-effectiveness, accuracy, precision and robustness. Therefore, the stationary cuvette methodology may be considered the best choice to obtain calibration curves for drug analyis by spectrophotometry

Otimização de solução extrativa e desenvolvimento tecnológico de produto seco por aspersão de Psidium guajava L.

The increasing in the consumption of plant medicine by parts of the population generated a bigger need for studies. Drug substitutions, changes and adulterations at the production techniques are common places at plant-originated drugs trade, leading governmental departments of drug control round the world to adopt many analytical practices to medicinal plants. However, agronomic and technological issues cause characteristics and chemical composition variation at the drug, problem to be solved by the subject researchers. The present work aims to obtain a spray dried extract from a extractive solution obtained from Psidium guajava L. leaves based in book references that stress the intermediate dosage forms advantages. It also tries to validate useful methodologies for the quality control for both raw material and its derivates. Using eight sets of the spray dried extract (with Eudragit®, Aerosil ® e Avicel PH101 ® as drying adjuvants), the study proposes analytical methods using techniques commonly performed to plant medicines and its intermediate forms. As results, a viable spray-dried extract was obtained from a standartized extract solution. Among the studied adjuvants, the combination Aerosil ® with Eudragit ® showed the drying outcome, rheology, humidity and tannin content values that best fitted the demands of the Brazilian Pharmacopaea

Avaliação in vitro da eficácia de produtos homeopáticos contendo momordica charantia através de bioensaios

Homeopathic medicines have been used for over two hundred years without the examination of their effects on in vivo and in vitro assays, due to the peculiarity of homeopathic preparations, the high dilution, which creates a challenge for the use of usual analytical techniques of quality control of medicine.Although there is scarcity of literature and variety of experiments, recently there have been some studies with few in vitro assays which have shown positive responses when evaluating the mechanism of action of homeopathic medicines which are able to act on a specific system.The present study aims to evaluate the efficacy of homeopathic products containing Momordica charantia through bioassays.Homeopathic products were tested by the MTT to assess cytotoxicity in RAW 264.7 (macrophage-like cells) and in tumor cells HeLa (human cervical adenocarcinoma cells), CHO K1 (Chinese hamster ovary cells), PANC-1 (human pancreas cancer cells) and PC-3 (human prostate cancer cells), dosage of inflammatory mediators NO, TNF-α and IL-6 released by RAW 264.7 cells, analysis of the death process and cell cycle changes of PC-3 by flow cytometry. The data demonstrate that homeopathic products of Momordica charantia did not show cytotoxicity to RAW 264.7, increased the production of inflammatory mediators by RAW 264.7 synergistically with LPS, showed cytotoxicity to PC-3 with change in its cell cycle inhibiting its proliferation, being the 30CH the most potent sample. Correlation studies were conducted in order to evaluate the possible in vitro applicable models to the quality control of homeopathic products with Momordica charantia. The data showed that the best applicable models in assessing the quality are the MTT to assess cytotoxicity in RAW 264.7 and PC-3 in 24 hours for Momordica charantia fruit products and dosage of NO production by RAW 264.7 with and without LPS

Testes bioquímicos para avaliação do vigor em sementes de Mimosa caesalpiniaefolia Benth

Mimosa caesalpiniaefolia Benth. is a forest species of the Mimosaceae family, recommended for recovery of degraded areas. The evaluation of vigor by biochemical tests have been an important tool in the control of seed quality programs, and the electrical conductivity and potassium leaching the most efficient in the verifying the physiological potential. The objective, therefore, to adjust the methodology of the electrical conductivity test for seeds of M. caesalpiniaefolia, for then compare the efficiency of this test with the potassium in the evaluation of seed vigor of different lots of seeds M. caesalpiniaefolia. To test the adequacy of the electrical conductivity were used different combinations of temperatures , 25 °C and 30 ºC, number of seeds , 25 and 50, periods of imbibition , 4 , 8 , 12 , 16 and 24 hours , and volumes deionized water, 50 mL and 75mL. For potassium leaching test, which was conducted from the results achieved by the methodology of the adequacy of the electrical conductivity test, to compare the efficiency of both tests , in the classification of seeds at different levels of vigor, and the period 4 hours also evaluated because the potassium leaching test can be more efficient in the shortest time . The best combination obtained in experiment of electrical conductivity is 25 seeds soaked in 50 mL deionized or distilled water for 8 hours at a temperature of 30 ° C. Data were subjected to analysis of variance, the means were compared with each other by F tests and Tukey at 5 % probability, and when necessary polynomial regression analysis was performed. The electrical conductivity test performed at period eight hour proved to be more efficient in the separation of seed lots M. caesalpiniaefolia at different levels of vigor compared to the potassium test

Obtenção de insumo farmacêutico a partir das folhas de Cissampelos sympodialis Eichl e seu efeito sobre mediadores inflamatórios relevantes para a asma

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Testes de vigor para avaliação de sementes de pepino

Dentro de um programa de controle de qualidade, a avaliação do vigor de sementes é fundamental e necessária para o sucesso da produção. O trabalho teve por objetivo comparar diferentes métodos para avaliação do potencial fisiológico de sementes de pepino. Para tanto, cinco lotes de sementes do híbrido Safira foram submetidos aos seguintes testes: germinação, primeira contagem de germinação, condutividade elétrica (4x50 sementes; 25ºC; 50 e 75mL; 12, 18 e 24h), germinação a baixa temperatura (4x50 sementes; 18ºC; contagens aos quatro e oito dias após a semeadura); envelhecimento acelerado tradicional (41ºC; 48, 72 e 96h) e com solução saturada de NaCl (41ºC; 72 e 96h). Pelos resultados obtidos, pode-se concluir que os testes de condutividade elétrica (50 e 75mL; 12, 18 e 24h) e de envelhecimento acelerado com o uso de solução salina (41ºC, por 72h), possibilitam a melhor identificação de lotes com diferentes níveis de qualidade fisiológica.

Metodologia alternativa para condução do teste de envelhecimento acelerado em sementes de milho

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)