冲头涂层表面特性对压片过程中粘连的影响

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pharmaceutical Development and Technology Pub Date : 2024-11-01 Epub Date: 2024-10-12 DOI:10.1080/10837450.2024.2413147
Komlan Koumbogle, François Gitzhofer, Nicolas Abatzoglou
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引用次数: 0

摘要

本研究评估了在 Manesty® F3 单工位压片机上进行微晶纤维素 (MCC) 压片过程中,未涂层钢、氮化铬 (CrN)、氮化锆 (ZrN)、氮化钛 (TiN) 和 Ultracoat 冲压涂层的粘附倾向。表面特性包括表面粗糙度、表面自由能(SFE)及其成分、用 X 射线光电子能谱仪测量的表面极性官能团和氧化物的原子百分比,用于表征表面粘附倾向。表面分析表明,所有测试冲头的表面粗糙度相似。研究发现路易斯碱 SFE 成分(LB-comp)控制着测试表面的酸碱相互作用,受粘附影响的冲头表面的路易斯碱 SFE 成分值较高。LB-comp 值较高的表面更容易与压缩过程中从粉末床蒸发的水分子发生强烈的酸碱相互作用。因此,这些表面会吸附水,并通过毛细管附着力产生粘性。在压片过程中粘附在 MCC 上的表面极性官能团(PFG)和氧化物的总原子百分比也很高,这表明冲头表面的亲水分子有利于粘附。
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Influence of punch coating surface properties on sticking during the tableting process.

Introduction: The present study evaluates the sticking propensity of Uncoated steel, and chromium nitride (CrN), zirconium nitride (ZrN), titanium nitride (TiN) and Ultracoat punch coatings during the tableting process of microcrystalline cellulose (MCC) conducted on a Manesty® F3 single station tableting press.

Methods: Surface properties including surface roughness, surface free energy (SFE) and its components, the atomic percentage of surface polar functional groups and oxides measured with X-ray photoelectron spectroscopy were used to characterize the surface propensity to sticking.

Results: After five hours of tablet pressing, MCC powder particles were found to adhere to the TiN coated and the uncoated steel punches. Surface analysis show that surface roughness of all the tested punches was similar. The Lewis base SFE component (LB-comp) was found to govern the acid-base interactions of the tested surfaces, and its value was higher for punch surfaces affected by sticking. The surfaces exhibiting higher LB-comp are more prone to strong acid-base interactions with water molecules that evaporate from the powder bed during compression. Therefore, these surfaces adsorbed water and allow sticking through capillary adhesion force.

Conclusion: The total atomic percentage of the surface polar functional groups (PFG) and oxides was also high for the surfaces that stick to MCC during tableting, suggesting that hydrophilic molecules on the punch surface favor sticking.

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来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
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.
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