Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA.
Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA.
Int J Pharm. 2024 Apr 10;654:123981. doi: 10.1016/j.ijpharm.2024.123981. Epub 2024 Mar 7.
A precompression pressure optimization strategy using in-die elastic recovery was developed to effectively address tablet lamination caused by air entrapment. This strategy involves exacerbating the air entrapment issue using high tableting speeds and main compaction pressures and collecting in-die elastic recovery data as a function of precompression pressure. The optimized precompression pressure, which corresponds to the minimum elastic recovery, is most effective at eliminating air from the powder bed prior to the main compression. When the optimized precompression pressure was employed, intact tablets of a model blend prone to lamination due to air entrapment could be produced over a wide range of high main compaction pressures, while tablets without precompression laminated immediately after ejection at equivalent main compaction pressures. This optimization strategy is effective for addressing lamination issues due to air entrapment using precompression. An advantage of this strategy is that intact tablets are not required to identify an optimized precompression pressure since elastic recovery measurements occur in-die.
采用模内弹性回复的预压缩压力优化策略，可有效解决因空气夹带导致的片剂分层问题。该策略通过使用高压片速度和主压压力来加剧空气夹带问题，并收集模内弹性回复数据作为预压缩压力的函数。在主压缩前从粉末床中去除空气的最佳预压缩压力对应于最小弹性回复。当使用优化的预压缩压力时，即使在高主压压力范围内，也可以生产出不易分层的模型混合物的完整片剂，而没有预压缩的片剂在等效主压压力下立即弹出后就会分层。这种优化策略可有效解决因空气夹带导致的分层问题。该策略的一个优点是，由于弹性回复测量是在模内进行的，因此无需使用完整的片剂来确定最佳的预压缩压力。
