Takeuchi Yoshiko, Hayakawa Fumika, Takeuchi Hirofumi
Laboratory of Advanced Pharmaceutical Process Engineering, Gifu Pharmaceutical University, 5-6-1 Mitahora-Higashi, Gifu 502-8585, Japan.
Pharmaceutics. 2025 Jan 10;17(1):84. doi: 10.3390/pharmaceutics17010084.
: Orally disintegrating film (ODF) is prepared using water-soluble polymers as film-forming agents. To improve mechanical and disintegration properties, some polymers need to be blended with others. This study aimed to investigate the utility of hydroxypropyl cellulose (HPC) and hydroxypropyl methyl cellulose (HPMC) as blend film-forming components for ODFs. : Placebo ODFs were prepared using polymer mixtures with blend ratios ranging from 20% to 80% HPC with HPMC. Mechanical properties, including tensile strength, elastic modulus, elongation at break, and folding endurance, as well as disintegration times, were evaluated. Additionally, blend films incorporating donepezil hydrochloride (DH) as a model active pharmaceutical ingredient (API) were prepared and assessed to determine their mechanical properties and disintegration behavior. : Blend films were successfully formed using HPMC/HPC solutions. The 40/60 and 20/80 HPMC/HPC blends exhibited the lowest mechanical strength and elongation, whereas blends containing more than 40% HPC demonstrated shorter disintegration times. Films with DH were successfully formed, though the addition of DH reduced tensile strength and elongation. The decline in mechanical properties was mitigated in HPMC/HPC blend films. Our results, including DSC and FTIR results, led us to conclude that the HPMC/HPC blend films were micro-immiscible, but they were macro-miscible when the amount of the minor component was sufficiently small. : HPMC/HPC blends in appropriate ratios are effective as film-forming polymers for ODFs. The addition of DH impacts the mechanical properties, but the decline is less pronounced when using HPMC/HPC blends.
口腔崩解膜（ODF）是使用水溶性聚合物作为成膜剂制备的。为了改善机械性能和崩解性能，一些聚合物需要与其他聚合物混合。本研究旨在探讨羟丙基纤维素（HPC）和羟丙基甲基纤维素（HPMC）作为ODF混合成膜成分的效用。：使用HPC与HPMC混合比例为20%至80%的聚合物混合物制备安慰剂ODF。评估了包括拉伸强度、弹性模量、断裂伸长率和耐折性在内的机械性能以及崩解时间。此外，制备并评估了含有盐酸多奈哌齐（DH）作为模型活性药物成分（API）的混合膜，以确定其机械性能和崩解行为。：使用HPMC/HPC溶液成功形成了混合膜。40/60和20/80的HPMC/HPC混合物表现出最低的机械强度和伸长率，而含有超过40%HPC的混合物崩解时间较短。含有DH的膜成功形成，尽管添加DH降低了拉伸强度和伸长率。在HPMC/HPC混合膜中，机械性能的下降得到缓解。我们的结果，包括DSC和FTIR结果，使我们得出结论，HPMC/HPC混合膜是微不相溶的，但当次要成分的量足够小时，它们是宏观相溶的。：适当比例的HPMC/HPC混合物作为ODF的成膜聚合物是有效的。添加DH会影响机械性能，但使用HPMC/HPC混合物时下降不太明显。
