Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 20 North Pine Street, Baltimore, MD, 21201, United States.
College of Pharmacy, the University of Texas at Austin, 2409 University Avenue, PHR 4.214, Austin, TX, 78712, United States.
J Pharm Sci. 2021 Jul;110(7):2789-2799. doi: 10.1016/j.xphs.2021.03.008. Epub 2021 Mar 16.
Poly (ethylene oxide) (PEO) has been widely used in abuse-deterrent formulations (ADFs) to increase tablet hardness. Previous studies have shown that formulation variables such as processing conditions and particle size of PEO can affect ADF performance in drug extraction efficiency. This work aims to understand the effect of PEO grades and sources on the compaction characteristics of model ADFs. PEOs from Dow Chemical and Sumitomo Chemical with different molecular weights were examined using a Styl'One compaction simulator at slow, medium, and fast tableting speeds. Particle-size distribution, thermal behavior, tabletability, compressibility using the Heckel model, compactibility, and elastic recovery were determined and compared between the neat PEOs and model ADFs. Multivariate linear regression was performed to understand the effect of compression conditions and PEO grades and sources. Our results show that neat PEOs with high molecular weight exhibit high tabletability. The source of neat PEOs contributes to the difference in tabletability, out-die compressibility, compactibility, and elastic recovery. However, the influence of the PEO source on tabletability and compactibility decreases after adding the model drug. In our model ADFs, tablets using PEOs with high molecular weight have high crushing strength, and tablets using PEOs from Dow Chemical display low elastic recovery.
聚环氧乙烷（PEO）已广泛应用于防滥用制剂（ADF）中，以提高片剂的硬度。先前的研究表明，制剂变量，如 PEO 的加工条件和粒径，会影响药物提取效率的 ADF 性能。本工作旨在研究 PEO 牌号和来源对模型 ADF 压缩特性的影响。使用 Styl'One 压片机在慢速、中速和快速压片速度下，考察了陶氏化学和住友化学的不同分子量的 PEO。对纯 PEO 和模型 ADF 之间的粒径分布、热行为、可压性、Hackel 模型压缩性、可压缩性和弹性回复进行了测定和比较。采用多元线性回归来理解压缩条件和 PEO 牌号和来源的影响。结果表明，高分子量的纯 PEO 表现出高的可压性。纯 PEO 的来源对可压性、出模压缩性、可压缩性和弹性回复有影响。然而，在加入模型药物后，PEO 来源对可压性和可压缩性的影响降低。在我们的模型 ADF 中，使用高分子量 PEO 的片剂具有较高的破碎强度，而使用陶氏化学 PEO 的片剂显示出较低的弹性回复。
