Avaliação da estabilidade do rhGH incorporado a matrizes de PLGA : análise in vitro comparativa entre diferentes temperaturas e diferentes períodos de armazenamento das matrizes

Abstract

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.