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Previous issue date: 2015-03-27 / Objective: to evaluate the stability of PLGA 50:50 formulations incorporated with recombinant human growth hormone (rhGH) under different storage time and temperatures. Material and Methods: a total of 27 macrospheres of PLGA + rhGH were prepared using 7.5g of PLGA and 1,33mg of rhGH. Twenty-four of the 27 samples were equally divided into 4 groups (I, II, III and IV), according to the storage time, and two subgroups (A and F), according to the storage temperature prior to degradation. The remaining 3 samples were degraded immediately after its preparation (group 0). The concentration of rhGH released from the matrices was measured by UV-visible spectrophotometry absorption analysis. A calibration curve defined rhGH concentration values based on the final absorbance values. All colected data were submitted to descriptive and analytical statistical analysis with a confidence interval of 95% (p <0.05). Results: in general, the samples stored for different periods of time followed similar rhGH release rate of the samples belonged to group 0, with peaks of major and minor release rates and showing an important release until the 14th day of degradation, but no statistically significant differences between the study groups. Although higher absorbance values were constantly found for the matrices in subgroup F, the pattern of rhGH release was similar and no statistically significant difference was evident between the subgroups compared. The pH analysis revealed a lower pH for the matrices stored refrigerated, with no statistical difference. Conclusion: PLGA + rhGH formulations are stable. Until the 28th day, storage time and temperature do not affect the stability of the formulation. / Objetivo: avaliar a estabilidade das formula??es de PLGA 50:50 incorporadas com horm?nio de crescimento recombinante humano (rhGH) sob diferentes per?odos e temperaturas de armazenamento. Materiais e m?todos: um total 27 matrizes de PLGA + rhGH foram confeccionadas utilizando 7,5g de PLGA e e 1,33mg de rhGH. Vinte e quatro das 27 matrizes foram divididas igualmente em 4 grupos (I, II, III e IV), de acordo com o tempo de armazenamento, e em 2 subgrupos (A e F), de acordo com a temperatura de armazenamento previamente ? sua degrada??o. As 3 matrizes restantes foram degradas imediatamente ap?s sua confec??o (grupo 0). A concentra??o de rhGH liberado das matrizes foi mensurada em dias determinados atrav?s da an?lise de espectrofotometria de absor??o UV-vis?vel do sobrenadante removido do tubos de ensaio onde as matrizes foram degradadas. Uma curva de calibra??o definiu os valores de concentra??o de rhGH baseado nos valores finais de absorb?ncia. Os dados obtidos foram submetidos ? an?lises estat?sticas descritivas e anal?ticas com intervalo de confian?a de 95% (p<0,05). Resultados: em geral, as matrizes armazenadas por diferentes per?odos de tempo seguiram o mesmo padr?o de libera??o de rhGH das matrizes do grupo 0, com picos de maior e menor libera??o entre os dias avaliados e demonstrando uma libera??o expressiva at? o 14o dia de degrada??o, mas sem diferen?as estatisticamente significativas entre grupos do estudo. Apesar de constantemente haver maiores valores de absorb?ncia para as matrizes do subgrupo F, o padr?o de libera??o de rhGH foi similar para os dois subgrupos, e n?o houve diferen?a estatisticamente significante entre os dois subgrupos comparados. A an?lise de pH revelou menor pH para as matrizes armazenadas em ambiente refrigerado, sem diferen?a estat?stica. Conclus?o: as formula??es de PLGA incorporadas com rhGH s?o est?veis. At? 28 dias, o tempo e a temperatura de armazenamento n?o influenciam na estabilidade da formula??o.
| Identifer | oai:union.ndltd.org:IBICT/oai:tede2.pucrs.br:tede/6008 |
| Date | 27 March 2015 |
| Creators | Antonini, Fernando |
| Contributors | Pagnoncelli, Rog?rio Miranda |
| Publisher | Pontif?cia Universidade Cat?lica do Rio Grande do Sul, Programa de P?s-Gradua??o em Odontologia, PUCRS, Brasil, Faculdade de Odontologia |
| 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:Biblioteca Digital de Teses e Dissertações da PUC_RS, instname:Pontifícia Universidade Católica do Rio Grande do Sul, instacron:PUC_RS |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | -8096554818733665164, 600, 600, 600, 4673435736271820140, -2070498469879244349 |
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