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Previous issue date: 2010-02-26 / Compounded medicines have been reported by the ANVISA due to decreased of the therapeutic response or toxicity of these formulations. The aim of this work was to investigate the physicochemical quality control among naproxen sodium oral
suspensions 25 mg/mL obtained from six compounding pharmacies (A, B, C, D, E and F) and the manufactured suspension (R). In the quality control test, the tests of pH,
content, homogeneity, volume and physical and organoleptic characteristics were performed according to the Brazilian Pharmacopoeia. The analytical method for determination of naproxen in suspensions was validate. This method showed
excellent precision, accuracy, linearity and specificity. In the content test the suspensions B, C and E showed lower value and the F suspension showed a high value of the content. The products C and E were disapproved in the description of the
physical and organoleptic characteristics test. In the pH test, three suspensions were outside specifications (C, E and F). Only the products R, A and D showed satisfactory results in these tests and therefore they were approved for relative bioavailability test. The R, A and D suspensions were orally administered to Wistar rats and the blood samples were taken at time intervals of 10, 20, 40, 60 min, 3, 4, 6, 24 and 48 h. The
plasma samples were immediately stored at 80 ?C until analysis of HPLC. The bioanalytical method validation showed specificity, linearity (R2 0.9987), precision, accuracy, good recovery and stability. The chromatographic conditions were: flow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile : sodium phosphate buffer pH 4.0 (50:50, v/v) at 280 nm, using a C18 column. The confidence interval of 90% for the Cmax and AUCt ratio was within the range of 80 - 125% proposed by the FDA. Only one suspension, obtained from the compounding pharmacy D, was considered bioequivalent to the rate of absorption under the conditions proposed by this study. Thus, the results indicate the need for strict supervision from the relevant authorities to ensure the patient safety and the quality of compounded drugs by pharmacies / Os medicamentos vendidos nas farm?cias de manipula??o t?m sido notificados pela ANVISA quanto ? resposta terap?utica reduzida ou por toxicidade. Disto e visando avaliar a qualidade dos produtos magistrais o presente trabalho objetivou realizar
ensaios de controle de qualidade e biodisponibilidade relativa em suspens?es de naproxeno s?dico na concentra??o de 25 mg/mL, obtidas de seis farm?cias de manipula??o na cidade do Natal (A, B, C, D, E e F) e de uma suspens?o de refer?ncia (R). No controle de qualidade f?sico-qu?mico foram realizados ensaios para determina??o do teor, pH, homogeneidade, volume e caracter?sticas organol?pticas. O m?todo utilizado no doseamento mostrou precis?o, exatid?o, linearidade e especificidade. As formula??es obtidas nas farm?cias B, C e E apresentaram um teor abaixo das especifica??es, enquanto que a formula??o F apresentou um teor acima do recomendado pela Farmacop?ia Americana. Em rela??o ao pH as suspens?es C,
E e F apresentaram resultados fora das especifica??es farmacop?icas. Desta forma, apenas as suspens?es R, A e D foram selecionadas para o ensaio de biodisponibilidade relativa. As suspens?es R, A e D foram administradas oralmente em ratos Wistar e o sangue foi coletado em intervalos de 10, 20, 40 e 60 min, 3, 4, 6, 24 e 48 h. O plasma obtido foi ent?o armazenado em freezer a 80 ?C para posterior an?lise em CLAE. O m?todo utilizado apresentou especificidade, linearidade (R2 =
0,9987), precis?o, exatid?o, adequada recupera??o e estabilidade. As condi??es cromatogr?ficas utilizadas na metodologia foram: fluxo 1,2 mL/min, a fase m?vel constituiu tamp?o fosfato de s?dio monob?sico 0,01 M pH 4,0 e acetonitrila (50:50, v/v), coluna C18 e comprimento de onda em 280 nm. O ?ndice de confian?a de 90% para as raz?es de Cmax e ASCt se encontrou dentro do intervalo de 80 125% proposto pelo FDA apenas para a suspens?o obtida da farm?cia de manipula??o D, sendo, portanto considerada bioequivalente para a taxa de absor??o nas condi??es propostas por este estudo. Assim, os resultados obtidos indicam a necessidade de
uma maior fiscaliza??o pelos ?rg?os competentes de forma a garantir a seguran?a do paciente e qualidade do medicamento produzido pela farm?cia de manipula??o
| Identifer | oai:union.ndltd.org:IBICT/oai:repositorio.ufrn.br:123456789/13452 |
| Date | 26 February 2010 |
| Creators | Solon, Lilian Grace da Silva |
| Contributors | CPF:88258033468, Guerra, Gerlane Coelho Bernardo, CPF:37963953415, http://lattes.cnpq.br/5677318431530876, Barichelo, Jos? M?rio, CPF:48450154049, http://lattes.cnpq.br/8192385731123737, Soares, Lu?z Alberto Lira |
| Publisher | Universidade Federal do Rio Grande do Norte, Programa de P?s-Gradua??o em Ci?ncias Farmac?uticas, UFRN, BR, Bioan?lises e Medicamentos |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Format | application/pdf |
| Source | reponame:Repositório Institucional da UFRN, instname:Universidade Federal do Rio Grande do Norte, instacron:UFRN |
| Rights | info:eu-repo/semantics/openAccess |
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