Blanca Elena Ortega Markman

Assessment of the quality of simvastatin capsules from compounding pharmacies

OBJETIVO: Validar metodologia por cromatografia liquida de alta eficiencia para determinacion del tenor de sinvastatina en capsulas manipuladas. METODOS: Fueron evaluadas 18 muestras de capsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los analisis se basaron en la Farmacopeia Brasilena y en el metodo de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificacion, y cuantificacion en capsulas manipuladas. RESULTADOS: El peso promedio de las capsulas variaron de 70 a 316 mg; cuatro muestras presentaron variacion de peso en desacuerdo con la especificacion. El tenor de sinvastatina en las capsulas estaba de acuerdo con la especificacion en 11 muestras; en seis, ese tenor vario entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinacion del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvios-patrones relativos mayores que 6%; tres farmacias atendian la especificacion del ensayo. En el ensayo de disolucion, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demas presentaron resultados inconclusitos. CONCLUSIONES: El metodo utilizado mostro buena adecuacion para aplicacion en control de calidad, revelando la falta de calidad de capsulas de sinvastatina producidas por algunas farmacias de manipulacion.OBJECTIVE To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais

OBJETIVO: Validar metodologia por cromatografia liquida de alta eficiencia para determinacion del tenor de sinvastatina en capsulas manipuladas. METODOS: Fueron evaluadas 18 muestras de capsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los analisis se basaron en la Farmacopeia Brasilena y en el metodo de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificacion, y cuantificacion en capsulas manipuladas. RESULTADOS: El peso promedio de las capsulas variaron de 70 a 316 mg; cuatro muestras presentaron variacion de peso en desacuerdo con la especificacion. El tenor de sinvastatina en las capsulas estaba de acuerdo con la especificacion en 11 muestras; en seis, ese tenor vario entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinacion del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvios-patrones relativos mayores que 6%; tres farmacias atendian la especificacion del ensayo. En el ensayo de disolucion, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demas presentaron resultados inconclusitos. CONCLUSIONES: El metodo utilizado mostro buena adecuacion para aplicacion en control de calidad, revelando la falta de calidad de capsulas de sinvastatina producidas por algunas farmacias de manipulacion.OBJECTIVE To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

Physicochemical quality evaluation of amoxicillin capsules produced in compounding pharmacies at Diadema, São Paulo, Brazil

Article history: Received on: 27/08/2015 Revised on: 15/09/2015 Accepted on: 03/10/2015 Available online: 27/12/2015 The evaluation of the physicochemical quality of amoxicillin (500 mg) capsules produced in Compounding Pharmacies at Diadema SP Brazil, was performed by comparing these capsules with reference, generic and similar drugs, through the dissolution, assay, average weight, water content analysis, all according to the pharmacopeial methodology. The compounded drug samples were acquired on 8 different Compounding Pharmacies of Diadema (M1, M2, M3, M4, M5, M6, M7, M8), and five (reference, generic and similar) drug samples (R, G1, G2, S1, S2) produced by distinct pharmaceutical industries were obtained from different Drugstores also at the same area. The samples were evaluated using the methodology proposed by the American and Brazilian Pharmacopoeia. All samples were approved in the dissolution and water content assay. Only samples R and S1 were approved assay of dose. Samples M3, M4 and S1 were disapproved in the average weight assay. The non-fulfillment of the Brazilian Good Manufacturing Practices recommended procedures for industries and compounding pharmacies show the need for improvements in the overall drug quality control manufacturing process of finished products in consonance with the actual health legislation, guaranteeing access to safe, effective medicines, control of bacterial resistance and rational use of antibiotics.

Evaluación de la calidad de cápsulas de sinvastatina de farmacias magistrales

OBJETIVO: Validar metodologia por cromatografia liquida de alta eficiencia para determinacion del tenor de sinvastatina en capsulas manipuladas. METODOS: Fueron evaluadas 18 muestras de capsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los analisis se basaron en la Farmacopeia Brasilena y en el metodo de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificacion, y cuantificacion en capsulas manipuladas. RESULTADOS: El peso promedio de las capsulas variaron de 70 a 316 mg; cuatro muestras presentaron variacion de peso en desacuerdo con la especificacion. El tenor de sinvastatina en las capsulas estaba de acuerdo con la especificacion en 11 muestras; en seis, ese tenor vario entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinacion del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvios-patrones relativos mayores que 6%; tres farmacias atendian la especificacion del ensayo. En el ensayo de disolucion, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demas presentaron resultados inconclusitos. CONCLUSIONES: El metodo utilizado mostro buena adecuacion para aplicacion en control de calidad, revelando la falta de calidad de capsulas de sinvastatina producidas por algunas farmacias de manipulacion.OBJECTIVE To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fictitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identification and quantification tests on compounded capsules. RESULTS The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specification. The simvastatin content in the capsules was within the specification in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specification in this test. In the dissolution test, eight samples presented unsatisfactory results in the first stage of the test, while the remainder presented inconclusive results. CONCLUSIONS The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

Elementos histológicos característicos de Cecropia pachystachya Trécul (embaúba)

Anatomical characteristics of the leaf and the barks of the stem of the species Cecropia pachystachya Trecul are described aiming to identify this species when it is employed for therapeutic purposes. Epidermal annexs and cellular inclusions allow the diagnosis of the species from its leaves. Peculiarities of the fibers, petrea cells and vases allow the recognizing of the barks of the stem of Cecropia pachystachya Trecul.