Dwell time on tableting: dwell time according to force versus geometric dwell time.

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmaceutical Development and Technology Pub Date : 2024-09-01 Epub Date: 2024-08-01 DOI:10.1080/10837450.2024.2384446

Valentyn Mohylyuk

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Abstract

Dwell time is an important parameter responsible for the material deformation and the mechanical and biopharmaceutical properties of the tablet. Thus, it is widely used for scale-up purposes. The geometric dwell time (GDT) can be assumed based on the shape of the punch head and the diameter and speed of the turret. This research is aimed to compare compaction simulator-recorded dwell time according to force (DTF) and the GDT calculated for the simulated rotary tablet press using the microcrystalline cellulose and calcium phosphate mixtures (CEOLUS™ UF-711 and DI-CAFOS^® A60) in different proportions. Tablets were prepared, and DTF was analyzed with a compaction simulator (STYL'One Nano and Alix software) upon simulating a small rotary press at 70 rpm and a compression pressure of 10-50 kN (100-500 MPa). While GDT comprised of 14.4 ms, DTF was compression force and formulation dependent. The differences between the DTF values of the formulations decreased as the compression force increased, which was most pronounced at compression forces of 10 and 15 kN.

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台模的停留时间：根据力计算的停留时间与几何停留时间。

停留时间是影响片剂材料变形、机械和生物制药性能的一个重要参数。因此，它被广泛用于放大生产。几何停留时间（GDT）可以根据冲头的形状、炮塔的直径和速度来假设。本研究旨在比较压实模拟器记录的受力停留时间（DTF）和使用不同比例的微晶纤维素和磷酸钙混合物（CEOLUSTM UF-711 和 DI-CAFOS® A60）模拟旋转压片机计算的 GDT。制备片剂后，使用压实模拟器（STYL'One Nano 和 Alix 软件）在 70 转/分的转速和 10-50 千牛（100-500 兆帕）的压缩压力下模拟小型旋转压机，对 DTF 进行分析。GDT 为 14.4 毫秒，而 DTF 则取决于压缩力和配方。随着压缩力的增加，各配方的 DTF 值之间的差异也在减小，这在压缩力为 10 和 15 kN 时最为明显。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Development and Technology 医学-药学

CiteScore

5.90

自引率

2.90%

发文量

审稿时长

1 months

期刊介绍： Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.