DISCAFF, Università degli Studi del Piemonte Orientale, Largo Donegani 2, 28100 Novara, Italy.
J Pharm Sci. 2010 Apr;99(4):2070-9. doi: 10.1002/jps.21949.
This article proposes thermogravimetric analysis (TGA) as a useful method to investigate the hydration behaviour of hydrophilic matrix tablets containing hydroxypropylmethylcellulose (HPMC), sodium carboxymethylcellulose (NaCMC) or a mixture of these two polymers and four drugs with different solubility. The hydration behaviour of matrix systems was studied as a function of the formulation composition and of the dissolution medium pH. TGA results suggest that the hydration of matrices containing HPMC is pH-independent and not affected by the characteristics of the loaded drug; this confirms HPMC as a good polymer to formulate controlled drug delivery systems. On the other hand, the performances of NaCMC matrix tablets are significantly affected by the medium pH and the hydration and swelling of this ionic polymer is influenced by the loaded drug. For systems containing the two polymers, HPMC plays a dominant role in the hydration/dissolution process at acidic pH, while at near neutral pH both the cellulose derivatives exert a significant influence on the hydration performance of systems. The results of this work show that TGA is able to give quantitative highlights on the hydration behaviour of polymeric materials; thus this technique could be a helpful tool to support conventional hydration/swelling/dissolution studies.
本文提出热重分析(TGA)是一种有用的方法,可用于研究含有羟丙基甲基纤维素(HPMC)、羧甲基纤维素钠(NaCMC)或这两种聚合物混合物的亲水性基质片剂的水合行为,以及四种具有不同溶解度的药物。研究了基质系统的水合行为,作为配方组成和溶解介质 pH 的函数。TGA 结果表明,含有 HPMC 的基质的水合作用与 pH 无关,也不受负载药物特性的影响;这证实了 HPMC 是一种用于配制控制药物释放系统的良好聚合物。另一方面,NaCMC 基质片剂的性能受介质 pH 的显著影响,并且这种离子聚合物的水合和溶胀受负载药物的影响。对于含有两种聚合物的系统,HPMC 在酸性 pH 下的水合/溶解过程中起主导作用,而在接近中性 pH 时,两种纤维素衍生物都对系统的水合性能产生显著影响。这项工作的结果表明,TGA 能够定量突出聚合物材料的水合行为;因此,该技术可以成为支持传统水合/溶胀/溶解研究的有用工具。