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Search Results: 1 - 10 of 586797 matches for " María Aurora; Casti?eira Díaz "
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Desarrollo tecnológico y estudio de estabilidad del colirio de idoxiuridina 0,1 % Technological development and study of 0.1 % Idoxuridine (eyedrops)
Martha Botet García,Caridad Margarita García Pe?a,Mirtha Castieira Díaz,María Aurora Barrios
Revista Cubana de Farmacia , 2007,
Abstract: La idoxiuridina, que se asemeja a la timidina, inhibe la timidílico fosforilasa y las polimerasas específicas del ADN que son necesarias para la incorporación de la timidina en el ADN del virus. La idoxiuridina se incorpora en el ADN defectuoso que incapacita al virus, para infectar o destruir tejidos o para reproducirse. El objetivo del presente trabajo consistió en el desarrollo tecnológico de una formulación de idoxiuridina, para su administración por vía ocular, que cumple con todos los requisitos de calidad exigidos para el producto, como: características organolépticas, pH, valoración y esterilidad, con un tiempo de vida útil de 2 a os, a temperatura de 2 a 8 oC, y que mantuvo invariables sus características físicas, químicas y microbiológicas durante el estudio de estabilidad realizado mediante el estudio de estabilidad acelerado a 25 oC y vida de estante de 2 a 8 oC, por espacio de 6 meses y de 24 meses, respectivamente. Idoxyuridine just like the Thymidine, inhibits thymidyl-phophorylase and DNA-specific polymerases, needed for Thymidine incorporation in virus-DNA. Idoxyuridine, added to defective DNA, renders unfit virus to infect or destroys tissues or for its reproduction. Aim of present paper was achieve technological development of a Idoxyuridine-formulation administered by ocular route, which meet all quality criteria called for the product, e.g. organoleptic features, pH, assessment and sterility, a 2 years useful lifetime, temperature of 2-8 °C, and with its invariable physical, chemical and microbiologic features over stability study performed by means of accelerated stability study to 25 °C, and support-life of 2-8 °C during 6 months and 24 months, respectively.
Estabilidad del inyectable de fosfato de disopiramida (13 mg/mL)
Fernández Monagas,Sol Amalia; Gra Ríos,Gisela; Barrios álvarez,María Aurora; Castieira Díaz,Mirta;
Revista Cubana de Farmacia , 2003,
Abstract: among the drugs presently used to treat cardiovascular disorders, we may find disopyramide phosphate, a type i anti-arrhythmia agent which stabilizes the membrane potential at rest. one of the dosage forms is the injection, at a dose of 13 mg/ml for the basis, therefore, this paper makes an accelerated study of the stability and the analysis of the lifetime of 3 batches of this injectable form. under the test conditions, the drug turned out to be stable and its expiry date was set at 2 years.
Validación de los métodos analíticos empleados en el estudio del inyectable de fosfato de disopiramida (13 mg/mL)
Gra Ríos,Gisela; Fernández Monagas,Sol Amalia; Castieira Díaz,Mirta; Barrios álvarez,María Aurora;
Revista Cubana de Farmacia , 2003,
Abstract: the validation of an spectrophotometric method, which will be used in the quality control of injectable disopyramide phosphate (13 mg/ml), was made in which absorbance was estimated at 269 nm and the dissolvent used was a sulfuric methanol mix. also, the validation of a high performance liquid chromatography technique was carried out in which a lichrosorb rp-8 column, and a solution of monobasic sodium phosphate (0,05 mol/l) ph3: acetonitrile (73:27 v/v) as mobile phase were employed. both methods turned out to be linear, precise and accurate, within the range of concentrations already studied. also, this paper proved the specificity of high performance liquid chromatography technique.
Validación de los métodos analíticos empleados en el estudio del inyectable de fosfato de disopiramida (13 mg/mL)
Gisela Gra Ríos,Sol Amalia Fernández Monagas,Mirta Castieira Díaz,María Aurora Barrios álvarez
Revista Cubana de Farmacia , 2003,
Abstract: Se realizó la validación de un método espectrofotométrico para ser utilizado en el control de la calidad del inyectable fosfato de disopiramida (13 mg/mL), en la que se determinó la absorbancia a 269 nm, y se empleó como disolvente una mezcla de metanol-sulfúrico. También se realizó la validación de una técnica de cromatografía líquida de alta resolución, en la que se utilizó una columna de Lichrosorb RP-8 y como fase móvil una solución de fosfato de sodio monobásico (0,05 mol/L) pH 3:acetonitrilo (73:27 v/v). Ambos métodos resultaron ser lineales, precisos y exactos, en el rango de concentraciones estudiado. Para la técnica de cromatografía líquida de alta resolución se comprobó, además, su especificidad. The validation of an spectrophotometric method, which will be used in the quality control of injectable disopyramide phosphate (13 mg/mL), was made in which absorbance was estimated at 269 nm and the dissolvent used was a sulfuric methanol mix. Also, the validation of a high performance liquid chromatography technique was carried out in which a Lichrosorb RP-8 column, and a solution of monobasic sodium phosphate (0,05 mol/L) ph3: acetonitrile (73:27 v/v) as mobile phase were employed. Both methods turned out to be linear, precise and accurate, within the range of concentrations already studied. Also, this paper proved the specificity of high performance liquid chromatography technique.
Estabilidad del inyectable de fosfato de disopiramida (13 mg/mL)
Sol Amalia Fernández Monagas,Gisela Gra Ríos,María Aurora Barrios álvarez,Mirta Castieira Díaz
Revista Cubana de Farmacia , 2003,
Abstract: Entre los fármacos utilizados actualmente en el tratamiento de las afecciones cardiovasculares, se encuentran el fosfato de disopiramida, un agente antiarrítmico tipo I, estabilizante del potencial de membrana en reposo. Una de las formas farmacéuticas en que este se presenta es la de inyectable, con una dosificasión de 13 mg/mL para la base, por lo que en este trabajo se realizó el estudio acelerado de estabilidad y el estudio de vida útil de 3 lotes de este innyectable. En las condiciones ensayadas, el medicamento resultó estable, por lo que se propuso una fecha de vencimiento de 2 a os. Among the drugs presently used to treat cardiovascular disorders, we may find disopyramide phosphate, a type I anti-arrhythmia agent which stabilizes the membrane potential at rest. One of the dosage forms is the injection, at a dose of 13 mg/mL for the basis, therefore, this paper makes an accelerated study of the stability and the analysis of the lifetime of 3 batches of this injectable form. Under the test conditions, the drug turned out to be stable and its expiry date was set at 2 years.
Desarrollo tecnológico y estudio de estabilidad del colirio de idoxiuridina 0,1 %
Botet García,Martha; García Pe?a,Caridad Margarita; Castieira Díaz,Mirtha; Barrios,María Aurora; Rodríguez Delgado,Caridad; Martínez Espinosa,Vivian;
Revista Cubana de Farmacia , 2007,
Abstract: idoxyuridine just like the thymidine, inhibits thymidyl-phophorylase and dna-specific polymerases, needed for thymidine incorporation in virus-dna. idoxyuridine, added to defective dna, renders unfit virus to infect or destroys tissues or for its reproduction. aim of present paper was achieve technological development of a idoxyuridine-formulation administered by ocular route, which meet all quality criteria called for the product, e.g. organoleptic features, ph, assessment and sterility, a 2 years useful lifetime, temperature of 2-8 °c, and with its invariable physical, chemical and microbiologic features over stability study performed by means of accelerated stability study to 25 °c, and support-life of 2-8 °c during 6 months and 24 months, respectively.
Método analítico por cromatografía líquida de alta resolución para el ensayo de disolución de las tabletas de clonazepam 2 mg sin lactosa Analytical method by high resolution-liquid chromatography for assay of 2 mg Clonazepam tablets disolution without lactose
Caridad M. García Pe?a,Rafael Diego León,Mirta Castieira Díaz,Mirna Fernández Cervera
Revista Cubana de Farmacia , 2007,
Abstract: Se desarrolló y validó un método para evaluar la disolución de las tabletas de clonazepam 2 mg sin lactosa por cromatografía líquida de alta resolución, con detección ultravioleta a 254 nm. Se comprobó la condición de insaturación del clonazepam en el medio de disolución empleado y se evaluaron los parámetros de especificidad, linealidad y precisión, así como la influencia de la filtración y la estabilidad del principio activo. La curva de linealidad se realizó en el rango de 1,2 a 2,6 μg/mL con un coeficiente de correlación igual a 0,99418; la prueba estadística para el intercepto y la pendiente se consideró no significativa. En el estudio de estabilidad del principio activo en el medio de disolución se demostró que era estable en el medio por más del doble del tiempo de duración del ensayo de disolución. A valid method was developed to assess 2 mg Clonazepam tablets disolution without lactose by high-performance liquid chromatography by UV detection to 254 nm. Establishment of Clonazepam in dissolution medium was confirmed, and parameters of specificity, linearity, and accuracy were assessed, as well as influence of filtration and stability or active principle. Linearity curve was drawed in rank of 1, 2-2,6 mg/mL, with a correlation coefficient similar to 0,99418; statistical test wasn’t statistically significant for interceptor and slope. In study, it was possible to demonstrate that stability or active principle in dissolution was maintained in more than double of duration of dissolution assay.
Estudio de estabilidad de tabletas de clonazepam 2 mg sin lactosa Study on stability of Clonazepam tablets (2 mg) without lactose
Caridad M. García Pe?a,Rafael Diego León,Mirta Castieira Díaz,Mirna Fernández Cervera
Revista Cubana de Farmacia , 2007,
Abstract: Se desarrolló el estudio de estabilidad de las tabletas de clonazepam 2 mg sin lactosa y se determinó su fecha de vencimiento. Este estudio se realizó por los métodos de vida de estante y de estabilidad acelerada mediante cromatografía líquida de alta eficiencia, desarrollados y validados en el Centro de Investigación y Desarrollo de Medicamentos. El estudio de vida de estante se desarrolló por un periodo de 24 meses a temperatura ambiente; mientras que el estudio de estabilidad acelerada se efectuó sometiendo el producto a la influencia de la luz, la humedad y la temperatura; se realizó el análisis durante 3 meses, para los 2 primeros y durante 6 meses para el estudio de la temperatura. La formulación de clonazepam tabletas 2 mg sin lactosa cumplió con las especificaciones de calidad descritas en la farmacopea. Los resultados del estudio de estabilidad por vida de estante después de transcurridos los 24 meses indican que el producto mantiene los parámetros que determinan su calidad durante ese tiempo, y en los estudios acelerados no se observó degradación significativa del producto. Se establece 2 a os como fecha de vencimiento en las condiciones se aladas. Study of 2 mg Clonazepam tablets without lactose was performed, and due date was determined. This study was performed by support-life method and accelerated stability by high-performance liquid chromatography, developed and validated in Drugs Research and Development Center. Support-life study was developted during 24 months to a room-temperature; whereas accelerated stability study as performed with product undergoes light, humidity, and temperature. Analysis was carried out during 3 months for two above first, and during 6 months for temperature-study. Formulation of 2 mg tablets Clonazepam meets quality specifications described in Pharmacopeia. Results of stability study for support-life after 24 months, showed that product maintains parameters determining its quality during that period, and in accelerated studies there wasn’t a significant degradation of product. Two years are stablished as due date in above mentioned conditions.
Método analítico por cromatografía líquida de alta resolución para el ensayo de disolución de las tabletas de clonazepam 2 mg sin lactosa
García Pe?a,Caridad M.; León,Rafael Diego; Castieira Díaz,Mirta; Fernández Cervera,Mirna; Martínez Espinosa,Vivian;
Revista Cubana de Farmacia , 2007,
Abstract: a valid method was developed to assess 2 mg clonazepam tablets disolution without lactose by high-performance liquid chromatography by uv detection to 254 nm. establishment of clonazepam in dissolution medium was confirmed, and parameters of specificity, linearity, and accuracy were assessed, as well as influence of filtration and stability or active principle. linearity curve was drawed in rank of 1, 2-2,6 mg/ml, with a correlation coefficient similar to 0,99418; statistical test wasn’t statistically significant for interceptor and slope. in study, it was possible to demonstrate that stability or active principle in dissolution was maintained in more than double of duration of dissolution assay.
Estudio de estabilidad de tabletas de clonazepam 2 mg sin lactosa
García Pe?a,Caridad M.; Diego León,Rafael; Castieira Díaz,Mirta; Fernández Cervera,Mirna; Martínez Espinosa,Vivian;
Revista Cubana de Farmacia , 2007,
Abstract: study of 2 mg clonazepam tablets without lactose was performed, and due date was determined. this study was performed by support-life method and accelerated stability by high-performance liquid chromatography, developed and validated in drugs research and development center. support-life study was developted during 24 months to a room-temperature; whereas accelerated stability study as performed with product undergoes light, humidity, and temperature. analysis was carried out during 3 months for two above first, and during 6 months for temperature-study. formulation of 2 mg tablets clonazepam meets quality specifications described in pharmacopeia. results of stability study for support-life after 24 months, showed that product maintains parameters determining its quality during that period, and in accelerated studies there wasn’t a significant degradation of product. two years are stablished as due date in above mentioned conditions.
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