Temperature effects on ribbon characteristics in soft gelatin capsule manufacture

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Fabian Polyak, Sonia Pugliese, Constantin Reinelt, Gabriele Reich
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Abstract

In the manufacture of soft gelatin capsules using a rotary-die encapsulation machine, the formation of ribbons at the cooling drums and their subsequent mechanical performance are key attributes for a smooth machinability. In this paper we present the results of a comprehensive investigation of the intricate impact of the cooling drum temperature in the range between 5 and 25 °C on the mechanical and the microstructural properties of a highly concentrated gelatin formulation (40% w/w) typically used in soft capsule manufacture.

The study demonstrates that the temperature at the cooling drums strongly affects the gelation kinetics, the gel elasticity and the tensile strength of the ribbons. The temperature correlates linearly with the storage modulus G′ under low shear deformation, i.e. the lower the temperature of the gel, the higher the gel elasticity. A reverse linear relationship was found for the temperature-dependent ultimate tensile strength (UTS) of the gelatin ribbons, i.e. a higher drum temperature leads to a higher UTS. This inverse effect of the ageing temperature on G′ and UTS can be explained by temperature-induced microstructural differences within the gel network, as indicated by FTIR spectroscopy and Differential Scanning Calorimetry (DSC) measurements. Lower ageing temperatures result in a higher number of triple helical junction zones with fewer and/or weaker hydrogen bonds, which translate into a higher gel elasticity under low shear deformation, but a lower resilience of the ribbons against rupture in tensile testing. At higher temperatures, fewer but longer and/or more thermostable triple helical links in the gel network enhance the stability of the ribbons against tensile stress.

In summary, the results clearly reveal that a detailed understanding of the complex relationship between the drum temperature, the gel network structure and the mechanical properties of gelatin ribbons is essential for process optimization.

Abstract Image

温度对软胶囊生产中胶条特性的影响
在使用旋转模头封装机制造软明胶胶囊的过程中,冷却鼓上形成的条带及其随后的机械性能是保证顺利加工的关键因素。本文介绍了一项全面研究的结果,即冷却鼓温度在 5 至 25 °C 之间对软胶囊生产中常用的高浓度明胶配方(40% w/w)的机械性能和微观结构性能的复杂影响。研究表明,冷却鼓的温度对凝胶化动力学、凝胶弹性和条带的拉伸强度有很大影响。温度与低剪切变形下的储存模量 G' 成线性关系,即凝胶温度越低,凝胶弹性越高。明胶带的极限拉伸强度(UTS)与温度呈反向线性关系,即转鼓温度越高,极限拉伸强度越高。傅里叶变换红外光谱法和差示扫描量热法(DSC)测量结果表明,凝胶网络中由温度引起的微观结构差异可以解释老化温度对 G' 和 UTS 的反向影响。较低的老化温度会导致三重螺旋交界区的数量增加,氢键减少和/或变弱,从而在低剪切形变下产生较高的凝胶弹性,但在拉伸测试中,带状材料的抗断裂弹性较低。在较高温度下,凝胶网络中数量较少但长度较长和/或热稳定性较高的三重螺旋连接可增强带材对拉伸应力的稳定性。总之,研究结果清楚地表明,详细了解转鼓温度、凝胶网络结构和明胶带机械性能之间的复杂关系对于优化工艺至关重要。
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来源期刊
CiteScore
8.80
自引率
4.10%
发文量
211
审稿时长
36 days
期刊介绍: The European Journal of Pharmaceutics and Biopharmaceutics provides a medium for the publication of novel, innovative and hypothesis-driven research from the areas of Pharmaceutics and Biopharmaceutics. Topics covered include for example: Design and development of drug delivery systems for pharmaceuticals and biopharmaceuticals (small molecules, proteins, nucleic acids) Aspects of manufacturing process design Biomedical aspects of drug product design Strategies and formulations for controlled drug transport across biological barriers Physicochemical aspects of drug product development Novel excipients for drug product design Drug delivery and controlled release systems for systemic and local applications Nanomaterials for therapeutic and diagnostic purposes Advanced therapy medicinal products Medical devices supporting a distinct pharmacological effect.
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