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Physicochemical Characterization of Poly(ethylene glycol) Plasticized Poly(methyl vinyl ether-co-maleic acid) Films

机译:聚乙二醇增塑聚甲基乙烯基醚-马来酸薄膜的理化特性

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摘要

The influence of the poly(ethylene glycol) (PEG) plasticizer content and molecular weight on the physicochemical properties of films cast from aqueous blends of poly(methyl vinyl ether-co-maleic acid) (PMVE/ MA) was investigated with tensile mechanical testing, thermal analysis, and attenuated total reflectance/Fourier transform infrared spectroscopy. Unplasticized films and those containing high copolymer contents were very difficult to handle and proved difficult to test. PEG with a molecular weight of 200 Da was the most efficient plasticizer. However, films cast from aqueous blends containing 10% (w/w) PMVE/MA and either PEG 1000 or PEG 10,000 when the copolymer/plasticizer ratio was 4 : 3 and those cast from aqueous blends containing 15% (w/w) PMVE/ MA and either PEG 1000 or PEG 10,000 when the copolymer/ plasticizer ratio was 2 : 1 possessed mechanical properties most closely mimicking those of a formulation we have used clinically in photodynamic therapy. Importantly, we found previously that films cast from aqueous blends containing 10% (w/w) PMVE/MA performed rather poorly in the clinical setting, where uptake of moisture from patients’ skin led to reversion of the formulation to a thick gel. Consequently, we are now investigating films cast from aqueous blends containing 15% (w/w) PMVE/MA and either PEG 1000 or PEG 10,000, where the copolymer/plasticizer ratio is 2 : 1, as possible Food and Drug Administration approved replacements for our current formulation, which must currently be used only on a named patient basis as its plasticizer, tripropylene glycol methyl ether, is not currently available in pharmaceutical grade.
机译:通过拉伸机械试验研究了聚(乙二醇)(PEG)增塑剂含量和分子量对由聚(甲基乙烯基醚-马来酸)(PMVE / MA)的水性共混物流延的薄膜的理化性能的影响。 ,热分析和衰减全反射/傅立叶变换红外光谱。未增塑的薄膜和含有高共聚物含量的薄膜非常难以处理,而且难以测试。分子量为200 Da的PEG是最有效的增塑剂。但是,当共聚物/增塑剂比例为4:3时,由含10%(w / w)PMVE / MA和PEG 1000或PEG 10,000的水性共混物铸成的薄膜和由含15%(w / w)PMVE的水共混物铸成的薄膜当共聚物/增塑剂之比为2:1时,MA / MA和PEG 1000或PEG 10,000的机械性能最接近于我们在光动力疗法中临床使用的配方。重要的是,我们先前发现,由含有10%(w / w)PMVE / MA的水性共混物制成的薄膜在临床环境中表现较差,因为从患者皮肤中吸收水分会导致制剂回复为浓稠凝胶。因此,我们现在正在研究由含有15%(w / w)PMVE / MA和PEG 1000或PEG 10,000的水性共混物铸成的薄膜,其中共聚物/增塑剂的比例为2:1,美国食品药品监督管理局批准了这种替代品。我们目前的配方,由于其增塑剂三丙二醇甲醚,目前只能在指定的患者基础上使用,目前尚无法用于药物级。

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