Assessment of the quality of simvastatin capsules from compounding pharmacies

dc.creatorMarkman, BEO
dc.creatorRosa, PCP
dc.creatorKoschtschak, MRW
dc.date2010
dc.dateDEC
dc.date2014-11-16T23:47:08Z
dc.date2015-11-26T16:32:30Z
dc.date2014-11-16T23:47:08Z
dc.date2015-11-26T16:32:30Z
dc.date.accessioned2018-03-28T23:13:56Z
dc.date.available2018-03-28T23:13:56Z
dc.identifierRevista De Saude Publica. Revista De Saude Publica, v. 44, n. 6, n. 1055, n. 1062, 2010.
dc.identifier0034-8910
dc.identifierWOS:000286481800010
dc.identifier10.1590/S0034-89102010000600010
dc.identifierhttp://www.repositorio.unicamp.br/jspui/handle/REPOSIP/55015
dc.identifierhttp://www.repositorio.unicamp.br/handle/REPOSIP/55015
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/55015
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1270535
dc.descriptionOBJECTIVE: 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 Sao Paulo, Guarulhos, Sao 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.
dc.description44
dc.description6
dc.description1055
dc.description1062
dc.languagept
dc.publisherRevista De Saude Publica
dc.publisherSao Paulo
dc.publisherBrasil
dc.relationRevista De Saude Publica
dc.relationRev. Saude Publica
dc.rightsaberto
dc.sourceWeb of Science
dc.subjectSimvastatin, standards
dc.subjectCapsules, chemistry
dc.subjectDrug Compounding
dc.subjectChemistry, Pharmaceutical
dc.subjectDrug Quality
dc.subjectHmg-coa Reductase
dc.subjectHypercholesterolemic Patients
dc.subjectPharmaceutical Formulations
dc.subjectLiquid-chromatography
dc.subjectAtorvastatin
dc.subjectTherapy
dc.subjectSerum
dc.titleAssessment of the quality of simvastatin capsules from compounding pharmacies
dc.typeArtículos de revistas


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