Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, Minnesota, 55455, USA.
Pharm Res. 2019 Jul 29;36(10):139. doi: 10.1007/s11095-019-2675-7.
To identify the minimum interfacial bonding strength (IBS) required for bilayer tablets to sustain the stresses experienced during manufacturing, transportation, and handling.
Bilayer tablets of a number of formulations with systematically varied IBS were prepared on a materials testing macine. Five bilayer tablets with the same IBS were repeatedly dropped at a fixed height in a friabilator and integrity of the interface was periodically examined. The number of tablets free from observable defects at the interface was plotted as a function of the number of drops. The IBS for all five tablets to remain intact after 1000 drops was taken as the minimum IBS for a given formulation.
The minimum IBS depends on both layer composition and tablet size. For bilayer tablets made with more brittle materials or a larger size, a higher minimum IBS is required to pass the survival test. The incorporation of HPMC leads to a lower minimum IBS. An IBS of 0.26 MPa is sufficient for all bilayer tablet formulations and sizes to pass the survival test in this work.
A minimum IBS of 0.26 MPa is recommended as a tentative criterion for bilayer tablets of most materials to avoid quality issues arising from inadequate IBS.
确定双层片剂在制造、运输和处理过程中所需的最小界面结合强度（IBS），以承受所经历的应力。
在材料试验机上制备了一系列具有系统变化 IBS 的双层片剂。将具有相同 IBS 的五个双层片剂在固定高度的脆碎度仪中重复跌落，并定期检查界面的完整性。以界面无可见缺陷的片剂数量为函数绘制了片剂数量。在 1000 次跌落后仍保持完整的所有五个片剂的 IBS 被视为给定配方的最小 IBS。
最小 IBS 取决于层组成和片剂尺寸。对于使用更脆材料或更大尺寸的双层片剂，需要更高的最小 IBS 才能通过生存试验。HPMC 的加入会导致更低的最小 IBS。在这项工作中，0.26 MPa 的 IBS 足以使所有双层片剂配方和尺寸通过生存试验。
建议将 0.26 MPa 的最小 IBS 作为大多数材料双层片剂的暂定标准，以避免由于 IBS 不足而导致的质量问题。
