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Id: biblio-1008055
Autor: Fretes-de Aquino, Sonia Lorena; Coronel, Ma. Belén; Armoa, Evelyn; Fernández, Emile L; Vera, Rocio; Cho-Kim, Chang Kun; Benítez, Lourdes A; Villamayor, Melissa; Chena, Loren L; González, Andrea A; Sanabria, Lorena E.
Título: Evaluación de la Calidad vs precio de comprimidos de Metformina de 850mg de producción nacional e importados, comercializados en Paraguay utilizados para el control de diabetes / Quality vs. price evaluation of national and imported 850 mg metformin tablets marketed for the control of diabetes in Paraguay
Fonte: Mem. Inst. Invest. Cienc. Salud (Impr.);17(1):93-98, abr. 2019. tab, ilus.
Idioma: es.
Resumo: La metformina es un fármaco de primera elección, solo o combinado, en el tratamiento inicial de pacientes con diabetes tipo 2, cuya prevalencia a nivel nacional es de 8,0% en hombres y 8,3% en mujeres, con un gasto anual de 283 USD/persona. El estudio fue realizado con el objetivo de evaluar la calidad fisicoquímica y precio de comprimidos de 850 mg de metformina comercializados en nuestro país. Se analizaron medicamentos de producción nacional e importada, conteniendo 850 mg de metformina HCl, tomando como referencia la Farmacopea de los Estados Unidos (USP 38). Para evaluar la calidad de los productos se realizaron ensayos físicos químicos, además de los perfiles de disolución según el medio propuesto por la USP 38. Los resultados obtenidos se encontraron dentro de las especificaciones de valoración, entre 96% y 101% de metformina y los perfiles de disolución entre 70% y 90% de la cantidad declarada en 20 minutos, con una eficiencia de disolución (EF) entre 58% y 93%, mostrando que no existe diferencia estadísticamente significativa (p=0,41). La variación de precios encontrados fue entre 3,6 USD y 8,4 USD. Los productos analizados pueden ser intercambiables en cuanto a la calidad y los perfiles de disolución in vitro, siendo una herramienta para demostrar intercambiabilidad de productos farmacéuticos, buscando el precio más accesible en el mercado nacional y facilitando el tratamiento adecuado sobre todo para la población de escasos recursos manteniendo la calidad y eficacia del mismo(AU)
Descritores: Preço de Medicamento
Diabetes Mellitus Tipo 2/tratamento farmacológico
Avaliação de Medicamentos
Hipoglicemiantes/uso terapêutico
Metformina/uso terapêutico
-Paraguai
Comprimidos
Dissolução
Hipoglicemiantes/análise
Metformina/análise
Responsável: PY3.1 - Biblioteca


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Id: biblio-998224
Autor: Martín Casanova-Godoy, Luis Antonio; Castillo-Saavedra, Ericson Félix; Reynoso-Leyva, Elva Milagros; Ayala-Jara, Carmen Isolina.
Título: Estudio comparativo de perfiles de disolución de tabletas de prednisona 20 mg comercializados en Perú / Comparative study of dissolution profiles of prednisone 20 mg tablets marketed in Peru
Fonte: Mem. Inst. Invest. Cienc. Salud (Impr.);16(3):13-21, dic. 2018. tab, ilus.
Idioma: es.
Resumo: El estudio tuvo como finalidad comparar los perfiles de disolución de tabletas de prednisona 20 mg comercializados en Perú. Se realizó un estudio cuantitativo comparativo con diseño no experimental, que incluyó doce tabletas para cada formulación a evaluar (referente y multifuente), bajo condiciones similares de trabajo, en tres medios de disolución: buffer ácido clorhídrico pH 1,2; buffer acetato pH 4,5 y buffer fosfato pH 6,8. Los porcentajes temporales disueltos de prednisona fueron evaluados mediante el orden cinético cero, uno, Higuchi, raíz cúbica y Weibull para el modelo dependiente; mientras que el factor de similitud (f2), tiempo medio de disolución y eficiencia de disolución fueron utilizados para el modelo independiente. En el modelo dependiente, la liberación de prednisona; se ajustó a la cinética de función de Weibull; evaluada mediante el criterio de información de Akaike. En el modelo independiente, los valores de f2 en todos los medios de disolución cumplieron con el rango 50 - 100 establecida por la Food and Drug Adminstration, para indicar similitud in vitro entre los perfiles de disolución. Asimismo, se evidenció que no existe diferencia estadísticamente significativa entre las formulaciones, respecto al tiempo medio de disolución y la eficiencia de disolución. Las tabletas de prednisona 20 mg referente y multifuente comercializados en Perú son similares, con base en pruebas de perfiles de disolución in vitro(AU)

The purpose of the study was to compare the dissolution profiles of prednisone 20 mg tablets marketed in Peru. A comparative quantitative study with a non-experimental design was carried out, which included twelve tablets for each formulation to be evaluated (referent and multi-source), under similar work conditions in three dissolution media: hydrochloric acid buffer pH 1.2, acetate buffer pH 4.5 and phosphate buffer pH 6.8. The dissolved temporal percentages of prednisone were evaluated by zero kinetic order and first kinetic order, Higuchi, cubic root and Weibull models for the dependent model; while the similarity factor (f2), mean dissolution time and dissolution efficiency were used for the independent model. In the dependent model, the release of prednisone was adjusted to the Weibull function kinetics, evaluated using the Akaike information criterion. In the independent model, the values of f2 in all the dissolution media fulfilled the range 50 - 100 established by the Food and Drug Administration, to indicate in vitro similarity between the dissolution profiles. Likewise, it was evidenced that there is no statistically significant difference between the formulations with respect to the mean dissolution time and the dissolution efficiency. The reference and multi-source prednisone 20 mg tablets marketed in Peru are similar based on in vitro dissolution profiles tests(AU)
Descritores: Prednisona/farmacocinética
Liberação Controlada de Fármacos
Glucocorticoides/farmacocinética
-Peru
Comprimidos
Técnicas In Vitro
Dissolução
Tipo de Publ: Estudo Comparativo
Responsável: PY3.1 - Biblioteca


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Araújo, Magali Benjamim de
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Id: biblio-1039059
Autor: Ângelo, Marilene Lopes; Ruela, André Luís Morais; Ferreira, Anna Clara Marques; Ramos, Marcus Vinicus de Faria; Montanari, Cristina Martiniano; Silva, Lucélia Magalhães da; Araújo, Magali Benjamim de.
Título: Evaluating the discriminatory power of a dissolution assay for rosuvastatin calcium capsules: Solid-state properties and dissolution media
Fonte: Braz. J. Pharm. Sci. (Online);55:e17520, 2019. tab, graf.
Idioma: en.
Projeto: Fundação de Amparo à Pesquisa do Estado de Minas Gerais.
Resumo: We propose to evaluate the dissolution properties of rosuvastatin calcium (ROSC) capsules in different media to characterize the discriminatory power of the assay method. Dissolution assays were performed in media with different pH, and including the surfactant sodium dodecyl sulfate (SDS). Several immediate-release formulations were manufactured using the commercial raw material characterized as amorphous solid. The hydrophobic adjutant magnesium stearate was employed in some formulations due to its negative effect in the wettability and dissolution efficacy of solid dosages. These formulations showed the lower dissolution efficacy values in media without surfactant; however, when SDS was added to the medium, the dissolution efficacy increased, and the discriminatory power was lost. In spite of micellar solubilization does not increase the ROSC solubility, it modifies the discriminatory power of the assay method, increasing the wettability of the powder mixtures. The crystalline form M of ROSC was recrystallized in our laboratory, and it showed lower solubility in water than amorphous solid. However, its dissolution properties were not influenced by SDS. These results are important to develop dissolution assays for other hydrophilic drugs with increased water solubility, once that dissolution media with surfactants increase the wettability of the formulations, leading to an overrated dissolution rate.
Descritores: Cápsulas/análise
Dissolução/análise
Rosuvastatina Cálcica/análise
-Solubilidade
Cromatografia Líquida de Alta Pressão/instrumentação
Formas de Dosagem
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-1001579
Autor: Shaheen, Nabeela; Zaman, Shahiq uz.
Título: Development of fast dissolving tablets of flurbiprofen by sublimation method and its in vitro evaluation
Fonte: Braz. J. Pharm. Sci. (Online);54(4):e17061, 2018. tab, graf.
Idioma: en.
Resumo: Flurbiprofen belongs to Biopharmaceutical Classification System (BCS) class II drugs which are poorly soluble in water. The objective of present research work was to prepare fast dissolving tablets of Flurbiprofen using varying concentrations of three different sublimating agents to improve the dissolution rate. Seven formulations were prepared containing different concentrations of camphor, ammonium bicarbonate and thymol as sublimating agent along with primogel as a superdisintegrant. Tablets were manufactured by direct compression method. The prepared tablets were evaluated for pre-compression and post-compression parameters result, For all formulations result was within official limits. FTIR studies revealed that there were no interactions between the drug and the excipients used. From in vitro drug release studies it was concluded that the formulations F6 and F7 containing 10% and 15% of thymol showed fast drug release of 100.00% and 100.84% respectively in 30 minutes. Formulations containing camphor (F2 & F3) and ammonium bicarbonate (F4 & F5) as sublimating agents showed a drug release of less than 80%, while the control formulation F1 having no sublimating agent showed 49.14% of drug release in 30 minutes. Thus thymol can successfully be used to formulate fast dissolving tablets of flurbiprofen by sublimation method with much better dissolution profile
Descritores: Comprimidos/farmacologia
Técnicas In Vitro
Flurbiprofeno/análise
Dissolução/análise
-Liberação Controlada de Fármacos
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-1001567
Autor: Sankari, Thaeer; Al-Hariri, Sahar.
Título: Preparation and characterization of cefuroxime axetil solid dispersions using poloxamer 188
Fonte: Braz. J. Pharm. Sci. (Online);54(4):e17644, 2018. tab, graf.
Idioma: en.
Resumo: The main objective of the present work was to enhance the solubility and dissolution rate of poorly water-soluble drug cefuroxime axetil (CA) by formulating it into solid dispersions (SDs) with water soluble carrier poloxamer 188. Different methods were employed to prepare the dispersion, such as: Solvent method (SM), Kneading method (KM), Melt evaporation method (MEM) and Physical mixture (PM) in different drug: carrier ratios 1:1, 1:2 and 1:3 (cefuroxime axetil: poloxamer 188). The physical mixture(s) and solid dispersion(s) were characterized for drug carrier interaction, drug content, solubility, dissolution rate, differential scanning calorimetry (DSC) and FT-IR study. The dissolution rate of the prepared solid dispersion systems was determined in phosphate buffer (pH 6.8) for 1 h. The solubility of drug from different systems was also determined in water. All SD formulations were found to have a higher dissolution rate comparatively to pure CA. The dissolution rate was enhanced in the following order SM > MEM > KM. The enhancement of dissolution rate may be caused by increase wettability, dispersibillity reduction in particle size or the formation of CA ß crystalline. The FT-IR study probability revealed that there was no chemical interaction between drug and poloxamer 188
Descritores: Solubilidade
Cefuroxima/agonistas
Dissolução/análise
-Poloxâmero/administração & dosagem
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889424
Autor: Toehwé, Leonardo Henrique; Prado, Livia Deris; Rocha, Helvécio Vinícius Antunes.
Título: Prednisone raw material characterization and formulation development
Fonte: Braz. J. Pharm. Sci. (Online);53(4):e00088, 2017. tab, graf, ilus.
Idioma: en.
Resumo: ABSTRACT Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API) prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.
Descritores: Prednisona/administração & dosagem
Estabilidade de Medicamentos
Dissolução/análise
-Preparações Farmacêuticas/normas
Propriedades Físicas e Químicas
Dosagem
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889421
Autor: Bonfilio, Rudy; Souza, Marília Cristina Oliveira; Leal, Jockastta Silva; Viana, Olímpia Maria Martins Santos; Doriguetto, Antônio Carlos; Araújo, Magali Benjamin de.
Título: Solubility and dissolution studies of tibolone polymorphs
Fonte: Braz. J. Pharm. Sci. (Online);53(4):e00233, 2017. tab, graf, ilus.
Idioma: en.
Projeto: FAPEMIG; . FINEP; . CAPES; . CNPq.
Resumo: ABSTRACT Different solid forms of an active pharmaceutical ingredient can have distinct chemical and physical characteristics. In this work, we studied the solubility and dissolution properties of the described tibolone polymorphic forms (I and II). Both forms were successively recrystallized and characterized by powder X-ray diffraction and attenuated total reflection infrared spectroscopy. Equilibrium solubility and dissolution profiles were performed for both forms. Solubility studies demonstrated that form II is statistically more soluble in water, 0.01 mol L-1 HCl and pH 4.5 acetate buffer. The solubility of forms I and II were explained in terms of crystal packing. Dissolution tests of tablets showed a lower release of polymorphic form II than form I from tablets. The results showed an impact of polymorphism on the quality of tibolone tablets and suggest that tibolone forms I and II can show distinct interactions with pharmaceutical excipients used in tablets. Therefore, only form I is acceptable for the preparation of tablet forms. Based on our results, we propose the quality control on tibolone raw materials using X-ray diffraction analysis and attenuated total reflection infrared spectroscopy.
Descritores: Solubilidade/efeitos dos fármacos
Dissolução/análise
-Análise Espectral
Comprimidos/normas
Difração de Raios X/métodos
Preparações Farmacêuticas/normas
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889412
Autor: Daravath, Bhaskar; Naveen, Chella; Vemula, Sateesh Kumar; Tadikonda, Rama Rao.
Título: Solubility and dissolution enhancement of flurbiprofen by solid dispersion using hydrophilic carriers
Fonte: Braz. J. Pharm. Sci. (Online);53(4):e00010, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT The intent of the current work is to study the effect of polyethylene glycol 8000 and polyethylene glycol 10000 as hydrophilic carriers on dissolution behaviour of flurbiprofen. In the present study, solvent evaporation method was used to prepare flurbiprofen solid dispersions and evaluated for physico-chemical properties, drug-carrier compatibility studies and dissolution behaviour of drug. Solubility studies showed more solubility in higher pH values and formulations SD4 and SD8 were selected to prepare the fast dissolving tablets. FTIR and DSC study showed no interaction and drug was dispersed molecularly in hydrophilic carrier. XRD studies revealed that there was change in the crystallinity of the drug. The results of In vitro studies showed SD8 formulation confer significant improvement (p<0.05) in drug release, Q20 was 99.08±1.35% compared to conventional and marketed tablets (47.31±0.74% and 56.86±1.91%). The mean dissolution time (MDT) was reduced to 8.79 min compared to conventional and marketed tablets (25.76 and 22.22 min.) indicating faster drug release. The DE (% dissolution efficiency) was increased by 2.5 folds (61.63%) compared to conventional tablets (23.71%). From the results, it is evident that polyethylene glycol solid dispersions in less carrier ratio may enhance the solubility and there by improve the dissolution rate of flurbiprofen.
Descritores: Solubilidade
Flurbiprofeno/análise
Dissolução
-Comprimidos/classificação
Preparações Farmacêuticas
Tipo de Publ: Técnicas In Vitro
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-889391
Autor: Romero, Daniel Cancelli; Lourenço, Felipe Rebello.
Título: Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations
Fonte: Braz. J. Pharm. Sci. (Online);53(3):e00163, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT Analytical results are widely used to assess batch-by-batch conformity, pharmaceutical equivalence, as well as in the development of drug products. Despite this, few papers describing the measurement uncertainty estimation associated with these results were found in the literature. Here, we described a simple procedure used for estimating measurement uncertainty associated with the dissolution test of acetaminophen tablets. A fractionate factorial design was used to define a mathematical model that explains the amount of acetaminophen dissolved (%) as a function of time of dissolution (from 20 to 40 minutes), volume of dissolution media (from 800 to 1000 mL), pH of dissolution media (from 2.0 to 6.8), and rotation speed (from 40 to 60 rpm). Using Monte Carlo simulations, we estimated measurement uncertainty for dissolution test of acetaminophen tablets (95.2 ± 1.0%), with a 95% confidence level. Rotation speed was the most important source of uncertainty, contributing about 96.2% of overall uncertainty. Finally, it is important to note that the uncertainty calculated in this paper reflects the expected uncertainty to the dissolution test, and does not consider variations in the content of acetaminophen.
Descritores: Comprimidos/análise
Método de Monte Carlo
Acetaminofen/análise
-Técnicas, Medidas, Equipamentos de Medição
Dissolução/métodos
Responsável: BR40.1 - DBD - Divisão de Biblioteca e Documentacão do Conjunto das Químicas


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Id: biblio-839479
Autor: Rubim, Alexandre Machado; Rubenick, Jaqueline Bandeira; Maurer, Marcela; Laporta, Luciane Varini; Rolim, Clarice Madalena Bueno.
Título: Inclusion complex of amiodarone hydrochloride with cyclodextrins: preparation, characterization and dissolution rate evaluation
Fonte: Braz. J. Pharm. Sci. (Online);53(2):e16083, 2017. tab, graf.
Idioma: en.
Resumo: ABSTRACT This study aimed to improve the water solubility of amiodarone hydrochloride (AMH) via inclusion complexes with β-cyclodextrin, methyl-β-cyclodextrin and 2-hydroxypropyl-β-cyclodextrin. Inclusion complexes were developed by physical mixture, coevaporation, spray-drying and freeze-drying. Solid state analysis was performed using X-ray powder diffraction, differential scanning calorimetry and scanning electronic microscopy. Thermodynamic studies demonstrate that the inclusion complexes of drug into different cyclodextrins were an exothermic process that occurred spontaneously. Water solubility and drug dissolution rates were significantly increased after the formation of inclusion complexes with the cyclodextrins evaluated in relation to the physical mixture and pure drug. The present study provides useful information for the potential application of complexation with amiodarone HCl. This may be a good strategy for the development of solid pharmaceutical dosage forms.
Descritores: Ciclodextrinas/farmacologia
/análise
EXERCISE TEST0/análise
Dissolução/análise
Amiodarona/farmacologia
-Solubilidade
Responsável: BR1.1 - BIREME



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