Determination of carbamazepine in pharmaceutical formulations
| العنوان: | Determination of carbamazepine in pharmaceutical formulations |
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| المؤلفون: | Gerlane Coelho Bernardo Guerra, Aurigena Antunes de Araújo, Luiz Alberto Lira Soares, Ana Isabel Maia de Oliveira, Lílian Grace da Silva Solon |
| المصدر: | Repositório Institucional da UFRN Universidade Federal do Rio Grande do Norte (UFRN) instacron:UFRN Brazilian Journal of Pharmaceutical Sciences, Vol 46, Iss 3, Pp 509-513 (2010) Brazilian Journal of Pharmaceutical Sciences, Volume: 46, Issue: 3, Pages: 509-513, Published: SEP 2010 Brazilian Journal of Pharmaceutical Sciences; Vol. 46 No. 3 (2010); 509-513 Brazilian Journal of Pharmaceutical Sciences; Vol. 46 Núm. 3 (2010); 509-513 Brazilian Journal of Pharmaceutical Sciences; v. 46 n. 3 (2010); 509-513 Brazilian Journal of Pharmaceutical Sciences Universidade de São Paulo (USP) instacron:USP |
| بيانات النشر: | Universidade de São Paulo, USP, 2010. |
| سنة النشر: | 2010 |
| مصطلحات موضوعية: | Medicines^i1^squality cont, Medicines/quality control, Medicamentos^i2^scontrole de qualid, lcsh:RS1-441, Friability, law.invention, Toxicology, Medicamento genérico, Medicines, lcsh:Pharmacy and materia medica, law, medicine, Generic medicines, General Pharmacology, Toxicology and Pharmaceutics, Medicamentos similares, Traditional medicine, business.industry, Medicamentos^i2^sformulação magist, Medicines^i1^smagistral formulat, Carbamazepine, Similar medicines, Medicines/magistral formulation, Compounding, Capital city, Medicamentos, Pharmacopoeia, business, Carbamazepina, medicine.drug |
| الوصف: | The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time.O objetivo desse trabalho foi avaliar a qualidade de cinco formulações de carbamazepina na dosagem de 200,00 mg: medicamento referência Tegretol® (Novartis), medicamento genérico (indústria nacional), medicamento similar (indústria nacional) e cápsulas do mesmo medicamento obtidas de duas farmácias de manipulação da cidade do Natal, RN. Os ensaios realizados foram: peso médio, diâmetro, espessura, teor, dissolução, desintegração, dureza, friabilidade e umidade. Foi observado que nenhuma das amostras analisadas apresentou friabilidade superior ao limite máximo determinado pela Farmacopéia Americana (1,5%). O medicamento genérico, apesar de apresentar dureza superior em relação ao medicamento de referência, desintegrou em menor tempo, o que pode estar relacionado à crospovidona presente na formulação. As amostras analisadas atenderam às especificações da Farmacopéia Brasileira no que diz respeito à dissolução. Em geral, os resultados das amostras A, B, C, D e E foram considerados satisfatórios uma vez que atenderam as especificações farmacopéicas. Embora a apresentação similar não tenha atendido ao padrão USP no que diz respeito à dureza, esse dado não se mostrou significativo, uma vez que o tempo de desintegração foi satisfatório. |
| وصف الملف: | text/html; application/pdf |
| اللغة: | Portuguese |
| تدمد: | 2175-9790 1984-8250 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6aab7f7d07e7b3810c34fd2e62ae0caaTest https://repositorio.ufrn.br/jspui/handle/123456789/25361Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....6aab7f7d07e7b3810c34fd2e62ae0caa |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 21759790 19848250 |
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