Krka, d.d., Novo mesto, Šmarješka cesta, Slovenia.
Pharm Dev Technol. 2013 Mar-Apr;18(2):343-7. doi: 10.3109/10837450.2011.609991. Epub 2011 Sep 14.
The importance of functionality-related characteristics (FRC) of hydroxypropyl methylcellulose (HPMC) described in the pharmacopeia monograph can be evaluated only for selected formulation or technological process. The aim of our work was to investigate the influence of apparent viscosity as one of the FRC for two batches of the same HPMC grade on the release properties of diclofenac sodium from HPMC matrix tablets. Our results show that two batches of HPMC differ in viscosity significantly and as a consequence, the significant differences were observed in the release profiles as well. HPMC-B sample has higher viscosity and therefore higher average molecular weight, thus the erosion and drug release were slower compared to HPMC-A sample with lower apparent viscosity. It can be concluded that batch-to-batch viscosity variation of the same HPMC grade can lead to the different release profiles; therefore the specification limits of some FRC should be postulated during the development of each individual formulation. However, the viscosity interval as FRC can not be generalized, because it is different for different tablet compositions.
羟丙甲纤维素（HPMC）在药典专论中描述的功能相关特性（FRC）的重要性只能针对特定的制剂或工艺过程进行评估。我们的工作旨在研究作为 FRC 之一的表观粘度对两种相同 HPMC 级别的 Diclofenac Sodium 从 HPMC 基质片中释放性能的影响。结果表明，两个批次的 HPMC 在粘度上存在显著差异，因此在释放曲线中也观察到了显著差异。HPMC-B 样品具有更高的粘度和更高的平均分子量，因此与具有较低表观粘度的 HPMC-A 样品相比，侵蚀和药物释放更慢。可以得出结论，同一 HPMC 级别的批次间粘度变化会导致不同的释放曲线；因此，在开发每个单独的制剂时，应规定某些 FRC 的规格限制。然而，FRC 的粘度区间不能被普遍化，因为它因不同的片剂组成而不同。
