部分水解的聚乙烯醇用于融合的药物配制方法:评价合适的增塑剂

本研究评估了几种药物增塑剂对融合的药物制剂制剂方法中使用的部分水解聚(乙烯醇)(PVA)的热物理和物理化学性质的影响。

Specifically, the effect of mannitol (MAN), sorbitol (SOR), sucrose (SUC), anhydrous citric acid (CA), triethyl citrate (TEC) and low-molecular weight polyethylene glycol (PEG400) on PVA’s melting properties, physical state and thermal degradation was evaluated via differential scanning calorimetry (DSC), powder X-ray diffractometry (pXRD) and thermo-gravimetric analysis (TGA).

Results showed that the use of MAN, SOR, SUC and PEG400 led to the reduction of PVA’s melting onset temperature, while MAN, SUC, CA and SOR were amorphously dispersed within PVA’s matrix, and the addition of SUC and CA resulted in significant reduction of PVA’s crystallinity. TGA results showed the formation of thermally highly unstable PVA mixtures in the cases of CA and TEC (degradation started from ∼150 oC and ∼125 oC, respectively), while significant molecular interactions were identified by FTIR in the cases of PVA-MAN, PVA-SOR and PVA-SUC.

热级偏振显微镜(HSM)显示PVA的熔体混溶性仅与人和索尔,而熔体流量指数(MFI)测量表明,使用人,SOR和PEG400的使用导致PVA的熔体流动性能显着提高。最后,MD模拟与实验观察密切一致,表明它们可以被认为是这种系统理论建模的有希望的工具。继续在部分水解的聚乙烯醇中用于融合的药物制剂方法

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