结冷胶和黄原胶与商用车辆作为口服混悬液中药物增稠剂的比较研究

IF 4.4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Pauline Claraz , Luc Fillaudeau , Chloé Jadoul , Thomas Storme , Coralie Guillemot , Mélanie White-Koning , Florent Puisset , Cécile Arellano
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引用次数: 0

摘要

药物口服混悬液是用于吞咽困难患者的主要形式。复合这些形式是具有挑战性的,因为它们在热力学上不稳定,但必须保持物理稳定。现成的载体,如Inorpha®或Orablend®存在,但这些都不是最佳的,和物理稳定性可以提高使用增稠剂或悬浮剂。高酰基结冷胶是一种欧洲食品添加剂(E418),也用于药物制剂,作为胶凝剂,稳定剂或增稠剂,但从不作为悬浮剂。本研究旨在研究和表征高酰基结冷胶作为悬浮剂的性能,并将其与现成的载体和另一种悬浮剂黄原胶进行比较。用厄贝沙坦作为模型不溶性药物,研究了载体的流变行为、沉降和再悬浮。分别在室温和室温条件下进行了90 d的粘度稳定性研究。我们发现,高酰基结冷胶载体在药物混悬液中提供了最佳的粘度和稳定性结果,因为它在时间上表现出稳定的均匀性和粘度,无论储存温度如何,并且在90天后与吞咽困难患者的安全给药兼容。高酰基结冷胶是一种较好的悬浮剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A comparative study of gellan gum and xanthan gum versus commercial vehicles as pharmaceutical thickening agents in oral suspensions

A comparative study of gellan gum and xanthan gum versus commercial vehicles as pharmaceutical thickening agents in oral suspensions
Pharmaceutical oral suspensions are the main form used for patients with dysphagia. Compounding these forms is challenging because they are thermodynamically unstable but must remain physically stable. Ready-to-use vehicles such as Inorpha® or Orablend® exist but these are not optimal, and physical stability can be improved using a thickening or suspending agent. High-acyl gellan gum is a European food additive (E418), also used in pharmaceutical preparations, as a gelling agent, stabilizer or thickener but never as a suspending agent. This study aimed to investigate and characterize the properties of high-acyl gellan gum as a suspending agent and to compare it with ready-to-use vehicles and with another suspending agent, xanthan gum. Rheological behaviour, sedimentation and resuspension of vehicles were studied with and without irbesartan used as a model insoluble drug. Viscosity stability was studied for 90 days at room temperature and controlled temperature. We show that the high-acyl gellan gum vehicle offers the best viscosity and stability results for use in pharmaceutical suspensions because it exhibits stable homogeneity and viscosity in time, regardless of storage temperature, and is compatible with safe administration in dysphagic patients after 90 days. High-acyl gellan gum appears to be a good suspending agent for pharmaceutical suspensions.
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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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