Air entrapment during tablet compression – Diagnosis, impact on tableting performance, and mitigation strategies

Air entrapment during tablet compression – Diagnosis, impact on tableting performance, and mitigation strategies
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片剂压缩过程中的空气滞留 — 诊断、对压片性能的影响以及缓解策略

DOI:
10.1016/j.ijpharm.2022.121514
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发表时间:
2022
影响因子:
5.8
通讯作者:
Sun, Changquan Calvin
Sun, Changquan Calvin
中科院分区:
医学2区
文献类型:
--
作者:
Vreeman, Gerrit;Sun, Changquan Calvin

文献摘要

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通过比较塞来昔布粉末在主压片前进行和不进行预压片时的模内弹性恢复曲线,诊断了粉末压片过程中的空气截留,这是一种在减压和弹出时可能导致片剂缺陷的现象。在没有预压缩的情况下,塞来昔布压块的弹性恢复率从150 MPa的主压实压力下的0.4%显著增加到200 MPa及以上时的0.14%。当采用预压缩步骤时,消除了弹性恢复的大幅增加。通过预压缩对粉末进行脱气导致更高的片剂强度,伴随着更低的片剂孔隙率。因此,预压缩是减轻片剂生产中空气滞留有害影响的有效策略。我们还发现,虽然夹带的空气引起显着更高的弹性恢复,它不影响来自模内Heckel分析的塑性参数。
Air entrapment during powder compression, a phenomenon that can cause tablet defects upon decompression and ejection, was diagnosed for celecoxib powder by comparing its in-die elastic recovery profiles with and without precompression prior to the main compression. Without precompression, the elastic recovery of celecoxib compacts significantly increased from ∼4% at a main compaction pressure of 150 MPa to ∼14% at and above 200 MPa. The large increase in elastic recovery is eliminated when a precompression step is employed. The deaeration of powder by precompression resulted in higher tablet strength, accompanied by lower tablet porosity. Thus, precompression is an effective strategy to mitigate the deleterious effects of air entrapment in tablet manufacturing. We also found that, although entrapped air caused significantly higher elastic recovery, it does not affect the plasticity parameter derived from an in-die Heckel analysis.