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Pesquisa : E05.916.270 [Categoria DeCS]
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Id: biblio-1039034
Autor: Eissa, Mostafa Essam; Abid, Ahmedy Mahson.
Título: Application of statistical process control for spotting compliance to good pharmaceutical practice
Fonte: Braz. J. Pharm. Sci. (Online);54(2):e17499, 2018. graf.
Idioma: en.
Resumo: ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability and efficiency assessment but also for compliance with all appropriate pharmaceutical practices such as good manufacturing practice and good laboratory practice, known collectively as GXP. The current work aims to investigate two tablet inspection characteristics monitored during in-process control viz. tablet average weight and hardness. Both properties were assessed during the compression phase of the tablet and before the coating stage. Data gathering was performed by the Quality Assurance Team and processed by Commercial Statistical Software packages. Screening of collected results of 31 batches of an antibacterial tablet - based on Fluoroquinolone -showed that all the tested lots met the release specifications, although the process mean has been unstable which could be strongly evident in the variable control chart. Accordingly, the two inspected processes were not in the state of control and require strong actions to correct for the non-compliance to GXP. What is not controlled cannot be predicted in the future and thus the capability analysis would be of no value except to show the process capability retrospectively only. Setting the rules for the application of Statistical Process Control (SPC) should be mandated by Regulatory Agencies.
Descritores: Comprimidos com Revestimento Entérico/análise
Comprimidos com Revestimento Entérico/normas
Preparações Farmacêuticas/normas
Interpretação Estatística de Dados
-Fluoroquinolonas/normas
Composição de Medicamentos/métodos
Indústria Farmacêutica/classificação
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-951947
Autor: Rampelotto, Roberta Filipini; Lorenzoni, Vinicius Victor; Silva, Danielly da Costa; Moraes, Guilherme A. de; Serafin, Marissa Bolson; Tizotti, Maísa Kräulish; Coelho, Silvana; Zambiazi, Priscilla; Hörner, Manfredo; Hörner, Rosmari.
Título: Synergistic antibacterial effect of statins with the complex {[1-(4-bromophenyl)-3-phenyltriazene N 3 -oxide-κ 2 N 1,O 4 ](dimethylbenzylamine-κ 2 C 1, N 4 )palladium(II)}
Fonte: Braz. J. Pharm. Sci. (Online);54(2):e17369, 2018. tab, graf.
Idioma: en.
Projeto: CNPq.
Resumo: Abstract The treatment of infections caused by resistant microorganisms represents a big challenge in healthcare due to limited treatment options. For this reason, the discovery of new active substances which are able to perform innovative and selective actions is of great impact nowadays. Statins and triazenes (TZC) have consolidated as a promising class of compounds, characterized by the expressive biological activity, especially antimicrobial activities. The aim of this study was to assess the in vitro synergistic antibacterial effect of the association of statins and a new TZC complex {[1-(4-bromophenyl)-3-phenyltriazene N 3-oxide-κ 2 N 1,O 4](dimethylbenzylamine-κ 2 C 1,N 4)palladium(II)} (Pd(DMBA)LBr) against American Type Culture Collection (ATCC) strains and clinical isolates. The complex and the statins showed bacterial activity of all tested strains and clinical isolates, evidencing that TZC complexion with metals can be promising. Simvastatin showed synergy when associated to the complex (FICI≤0.5), being the minimum inhibitory concentration (MIC) of 16 µg mL-1 found in 6 samples. Thus, it is possible to infer that the association between Pd(DMBA)LBr and simvastatin consists of an alternative to increase the pontential of these compounds, since statins have low toxicity.
Descritores: Triazenos/efeitos adversos
Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos
-Sinvastatina
Composição de Medicamentos
Responsável: BR1.1 - BIREME


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Id: biblio-880743
Autor: Antonio, Raquel de Luna; Kozasa, Elisa Harumi; Rodrigues, Eliana.
Título: Tibetan medicinal formulas used to treat neuropsychiatric disorders
Fonte: Rev. bras. med. fam. comunidade;7(Suplemento 1):11-11, jun. 2012.
Idioma: en.
Resumo: Introduction: Men-Tsee-Khang in Dharamsala, India, formally known as the Tibetan Medical and Astrological Institute (TMAI), is dedicated to the teachings and practice of Tibetan medicine, which uses therapeutic agents in multi-ingredient formulas. Aim of the study: The aim of the present study was to identify formulas used at Men-Tsee-Khang for the treatment of neuropsychiatric disorders and to compare the Tibetan usage of particular ingredients with pharmacological data from the scientific database. Methods: Using ethnographic techniques and methods, five physicians were selected, and the interviews were conducted between July 2010 and February 2011. Results: A correlation was observed between central nervous system disorders and rLung, one of the three humors in Tibetan medicine, and 10 formulas used to treat the imbalance of this particular humor were identified. These formulas utilize 61 ingredients, including salts, animal products and plants. The 48 plant species identified in these formulas are traditionally used in Tibetan medicine and are deposited at the Men-Tsee-Khang Herbarium. Each formula treats several symptoms related to rLung imbalance, so the plants may have therapeutic uses distinct from those of the formulas in which they are included. Data from the scientific literature indicate that all of the formulas include ingredients with neuropsychiatric action and corroborate the therapeutic use of 75,6% of the plants. Conclusion: These findings indicate a level of congruence between the therapeutic uses of particular plant species in Tibetan and Western medicines.
Descritores: Medicina Tradicional Tibetana
Composição de Medicamentos
Neuropsiquiatria
Doenças do Sistema Nervoso
Responsável: BR408.1 - Biblioteca da Faculdade de Medicina - BFM


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Id: lil-631792
Autor: Andrade, Beatriz; Gil, Ada Betty; Molina, Juan C; González, Aura; Fernández, Antonio; Cordero, Atílio; Rincón, Adriana.
Título: Estudio comparativo de estabilidad de tres formulaciones magistrales de Sildenafil bajo la forma de solución, obtenidas a partir de diferentes productos comerciales / Comparative study stability of the three master formulation of Sildenafil solution obtained from differents trademarks
Fonte: Rev. Inst. Nac. Hig;42(1):43-51, jun. 2011. tab.
Idioma: es.
Resumo: El Sildenafil es un fármaco de comprobada actividad terapéutica en la disfunción eréctil; se encuentra disponible bajo la forma farmacéutica de tabletas de administración oral. En la actualidad se está formulando magistralmente en forma de so lución oral a una concentración de 1mg/ml, para la hipertensión pulmonar (HP), por lo que se ha planteado realizar un estudio de la estabilidad en tres condiciones: ambientales (25±-2 ºC), de refrigeración (5±3 ºC) y exageradas de almacenamiento (40 ºC ± 2 ºC). Los parámetros evaluados fueron apariencia, limpidez, densidad, pH y contenido de sildenafil. El método analítico empleado fue cromatografía líquida de alta resolución (HPLC) de fase reversa. La apariencia, los valores de pH y densidad de las soluciones obtenidas se mostraron sin cambios significativos, en las diferentes muestras y condiciones de estudio. En cuanto a los resultados del contenido inicial de sildenafil se obtuvo aproximadamente el 75% en peso al formular la solución, partiendo del comprimido. Cabe señalar que se observó discrepancia en los valores de concentración del sildenafil obtenidos en los diferentes tiempos y condiciones; resultados éstos de esperarse por tratarse de una formulación magistral que parte de comprimidos de diferentes casas comerciales, por lo que este estudio permitió sugerir que la formulación magistral se reformule a la forma farmacéutica de suspensión, para garantizar el contenido de todo el principio activo en la misma.

Sildenafil is a drug with proven therapeutic activity in erectile dysfunction is available under the pharmaceutical form of tablets for oral administration. It is currently being de veloped skillfully in an oral solution at a concentration of 1mg/ml, for pulmonary hypertension (pH), as has been planned to perform a study of stability in three conditions: environmental (25 ± 2 ºC), refrigeration (5 ± 3 ºC) and exaggerated storage (40 °C ± 2 ºC). The parameters evaluated were appearance, clarity, density, pH and content of sildenafil. The analytical method used was high performance liquid chromatography (HPLC) reverse phase. The appearance, pH and density of the solutions were no significant changes in the different samples and study conditions. As for the results of the initial content of sildenafil was obtained about 75% by weight in for mulating the solution, based on the tablet. It should be noted that there was discrepancy in the values of concentration of sildenafil obtained at different times and conditions, results they expected because it is a masterly formulation of tablets of different business houses, so this study suggest that the wording allowed masterful be reformulated to the pharmaceutical form of suspension, to ensure the contents of the entire active.
Descritores: Soluções Farmacêuticas/classificação
Composição de Medicamentos
Citrato de Sildenafila/síntese química
Hipertensão Pulmonar/patologia
-Pediatria
Saúde Pública
Limites: Seres Humanos
Masculino
Feminino
Tipo de Publ: Estudo Comparativo
Responsável: VE9.1 - Biblioteca


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Id: biblio-974420
Autor: Reddy, Boi Basanta Kumar; Nagoji, Kambhayathughar Eswara Venkata; Sahoo, Satyanarayan.
Título: Preparation and in vitro & in vivo evaluation of cephalexin matrix tablets
Fonte: Braz. J. Pharm. Sci. (Online);54(3):e17277, 2018. tab, graf.
Idioma: en.
Resumo: The purpose of the study is to develop cephalexin controlled-release matrix tablets by using lower proportions of release retardant polymer and to establish their in vitro & in vivo correlation. Tablets were compressed by incorporating polymers in a matrix form along with drug which prolong the drug release. Twelve formulations were prepared by mixing ethyl cellulose (EC) and hydroxypropyl methylcellulose (HPMC) (three different viscosity grades) in various proportions. F-1 to F-4 formulations were prepared by incorporating drug, HPMC K4M and ethyl cellulose in 100 : 5 : 5, 100 : 10 : 5, 100 : 15 : 5 and 100 : 20 : 5; similarly, F-5 to F-8 were prepared with HPMC K15M; and F-9 to F-12 were prepared with HPMC K100M using a wet granulation process maintained same proportions, along with drug and EC. Tablets were evaluated for their pre-compression and post-compression characteristics and they were found to be in limits. From the dissolution testing, F-4 showed 100.34% medicament release in 12 h. In vivo studies were conducted on rabbit and pharmacokinetic parameters of the optimized formulation were evaluated using HPLC method. It was found that matrix tablets showed increased t1/2 and decreased Kel. The design signified that the drug release rate from tablets was influenced by the small proportion (around 7% of a tablet weight) of polymer mixture and it controlled 100% medicament release upto 12 h effectively with the low grade viscosity of HPMC combination, with good in vitro & in vivo correlation.
Descritores: Comprimidos/análise
Técnicas In Vitro/instrumentação
Cefalexina/análise
-Polímeros
Cromatografia Líquida de Alta Pressão/métodos
Preparações de Ação Retardada
Composição de Medicamentos
Responsável: BR1.1 - BIREME


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Id: biblio-951940
Autor: Coelho, Angélica Gomes; Lima Neto, José de Sousa; Moura, Arkellau Kenned Silva; Morais, Ilmara Cecilia Pinheiro da Silva; Cunha, Francisco Valmor Macedo; Melo-Neto, Bernardo; Medeiros, Maria das Graças Freire de; Vasconcelos, Eilika Andreia Feitosa; Arcanjo, Daniel Dias Rufino; Nunes, Lívio Cesar Cunha; Citó, Antônia Maria das Graças Lopes.
Título: Pharmaceutical development of tablets containing a spray-dried optimized extract from Lippia origanoides H. B. K.: influence of excipients and toxicological assessment
Fonte: Braz. J. Pharm. Sci. (Online);54(2):e17226, 2018. tab, graf.
Idioma: en.
Resumo: ABSTRACT Lippia origanoides is a honey shrub which has showed hypotensive potential assessed by in vivo studies. The aim of this work is the development of a pharmaceutical formulation composed by an optimized extract obtained from aerial parts of L. origanoides. The quantification of the naringenin marker in the dry extract and tablets developed was performed, as well as the assessment of the oral acute toxicity in rats. The hydroalcoholic extract of L. origanoides was spray-dried with the addition of colloidal silicon dioxide (Lo-HAE/CSD), and then applied in the preparation of eight different lots of tablets. The influence of the diluent (cellulose or babassu mesocarp), the presence of binder, and the percentage of lubricant, as well as organoleptic and physicochemical characteristics were screened. For the quantification of the marker content both in Lo-HAE/CSD and in the tablets, an analytical curve of the naringenin standard was fitted, and the samples were then analyzed in UFLC. The toxicological assessment was performed in female Wistar rats according to the Acute Toxic Class Method from OECD. The developed tablets produced meet acceptable macroscopic characteristics, and the presence of babassu as diluent provided improved physicochemical properties. The best content of Lo-HAE/CSD in the tablet (100.27%) was identified for the lot containing babassu, composed by 1.0% magnesium stearate, without PVP binder in its formulation. Moreover, Lo-HAE/CSD showed no signs of toxicity. Therefore, the babassu mesocarp powder is a promising pharmaceutical excipient for the development of herbal tablets containing the Lippia origanoides extract.
Descritores: Comprimidos/farmacologia
Lippia
Composição de Medicamentos/estatística & dados numéricos
-Extratos Vegetais
Verbenaceae/classificação
Limites: Animais
Feminino
Ratos
Responsável: BR1.1 - BIREME


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Id: biblio-951897
Autor: Pietra, Renata Celi Carvalho de Souza; Cruz, Rosana Carvalho; Melo, Carla Nunes; Rodrigues, Lívia Bomfim; Santos, Patrícia Campi; Bretz, Gabriel Pissolati Matos; Soares, Betânia Maria; Sousa, Gerdal Roberto de; Ferreira, Marcus Vinícius Lucas; Cisalpino, Patrícia Silva; Magalhães, Paula Prazeres; Farias, Luiz de Macêdo; Pinotti, Marcos.
Título: Evaluation of polymeric PLGA nanoparticles conjugated to curcumin for use in aPDT
Fonte: Braz. J. Pharm. Sci. (Online);53(2):e16043, 2017. graf.
Idioma: en.
Resumo: ABSTRACT Antimicrobial photodynamic therapy (aPDT) involves the association of a photosensitizing agent with a light source with the goal of causing apoptosis or microbial lysing. The use of compounds with natural active principles is gaining prominence throughout the world. Several studies from groups that are linked to the development of innovations in the pharmaceutical market have used natural dyes, such as curcumin, the efficacy of which has been demonstrated in aPDT trials. Difficulties related to physicochemical stability, solubility and cell penetration are some of the challenges associated with this field. The present work aimed to prepare, investigate the characteristics and improve the photodynamic activity of PLGA-based nanoparticles loaded with curcumin for use in aPDT therapy. Using the simple technique of emulsion during the evaporation of a solvent, the particles were built, characterized and tested against microorganisms with importance for medicine and dentistry. The results revealed that the particles were able to protect the curcumin against degradation and eliminate some microorganism species at nanomolar concentrations.
Descritores: Curcumina/análise
Nanopartículas/análise
-Fotoquimioterapia/efeitos adversos
Composição de Medicamentos
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889428
Autor: Issa, Michele Georges; Souza, Natalia Vieira de; Duque, Marcelo Dutra; Ferraz, Humberto Gomes.
Título: Physical characterization of multiparticulate systems
Fonte: Braz. J. Pharm. Sci. (Online);53(4):e00216, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT The search for new pharmaceutical dosage forms and different drug delivery systems already used in therapeutics is a global trend, serving as an opportunity to expand the portfolio for the pharmaceutical industry. In this context, multiparticulate systems, such as pellets, granules, and minitablets, represent an attractive alternative, given the range of possibilities they provide. Among the methods used in the production of these systems, we highlight the process of extrusion-spheronization for pellet manufacture, wet granulation and hot-melt extrusion for the obtention of granules, and direct compression for minitablets. Although highly versatile, depending on the technology chosen, many processes and formulation variables can influence the ensuing stages of manufacture, as well as the final product. Therefore, the characterization of these small units is of fundamental importance for achieving batch homogeneity and optimal product performance. Analyses, including particle size distribution, morphology, density, porosity, mechanical strength and disintegration, are example tests used in this characterization. The objective of this review was to address the most widely used tests for the physical evaluation of multiparticulate systems.
Descritores: Preparações Farmacêuticas
Análise Física/classificação
Composição de Medicamentos/estatística & dados numéricos
-Peneiramento
Sistemas de Liberação de Medicamentos
Formas de Dosagem
Habilidades para Realização de Testes/métodos
Tipo de Publ: Revisão
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889408
Autor: Lima, Monica Força; Cassella, Ricardo Jorgensen; Pacheco, Wagner Felippe.
Título: Spectrophotometric determination of rosuvastatin in pharmaceutical formulations using quinalizarin
Fonte: Braz. J. Pharm. Sci. (Online);53(3):e00075, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT This work presents the development of a methodology based on the formation of a charge transfer complex between quinalizarin and rosuvastatin, allowing for the spectrophotometric determination of rosuvastatin at 579 nm. The factors involved in the sensitivity of the technique were studied (nature and proportion of the solvent, reaction time, pH of aqueous phase and quinalizarin concentration). The proposed spectrophotometric procedures were validated with respect to linearity, ranges, precision, accuracy, detection and quantification limits. Calibration curves of the formed color products showed good linear relationships over the concentration range of 6-15 mg L-1. The proposed method has been successfully applied, which can be confirmed by interference test (comparison between the standard curves and addition of analyte), method precision (RSD 2.3% to 6 mg L-1), and by accuracy (statistically equivalent results between the proposed method and a chromatographic method of reference).
Descritores: Espectrofotometria/métodos
Composição de Medicamentos/estatística & dados numéricos
Rosuvastatina Cálcica/análise
-Cromatografia Líquida de Alta Pressão/estatística & dados numéricos
Metodologia
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-839478
Autor: Pinto, Isadora Cabral; Cerqueira-Coutinho, Cristal; Freitas, Zaida Maria Faria de; Santos, Elisabete Pereira dos; Carmo, Flávia Almada do; Ricci Junior, Eduardo.
Título: Development and validation of an analytical method using High Performance Liquid Chromatography (HPLC) to determine ethyl butylacetylaminopropionate in topical repellent formulations
Fonte: Braz. J. Pharm. Sci. (Online);53(2):e16033, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT Diseases caused by insects are frequent in poor countries, leading to epidemic scenarios in urban areas; e.g., Dengue, Zika and Chikungunya. For this reason, the development of a safe and efficient topical formulation is essential. Ethyl butylacetylaminopropionate (EB) is a mosquito repellent developed by Merck, which is used in products for adults, children and especially babies, due to its low allergenic potential. The aim of this work was to validate an analytical methodology to quantify EB in a new poloxamer-based formulation by high-performance liquid chromatography (HPLC). The quantification methodology was performed at 40 ºC using a Kromasil reverse-phase column (C18), with the dimensions of 250 x 4.6 mm. The mobile phase was acetonitrile:water (1:1) at a 1.0 mL/min flow-rate. The detector wavelength was set at 218 nm to detect EB. The methodology was considered validated since the results indicated linearity (R2>0.99), specificity, selectivity, precision and accuracy (active recovery between 98% and 102%). It also presented limits of detection and quantification of 0.255 µg/mL and 0.849 µg/mL, respectively. The present study demonstrated the EB vehiculated in poloxamer gel is promising as a new insect repellent formulation, since it could be quantified and quality control evaluated.
Descritores: Cromatografia Líquida de Alta Pressão/instrumentação
Estudos de Validação
Repelentes de Insetos/análise
-Composição de Medicamentos
Métodos Analíticos de Preparação de Amostras/estatística & dados numéricos
Tipo de Publ: Estudos de Validação
Responsável: BR1.1 - BIREME



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