乳基外用制剂的稳定性评价:动态机械热分析(DMTA)试验作为常规冻融试验的快速流变替代方法的宝贵潜力

Q4 Pharmacology, Toxicology and Pharmaceutics
Nebojša Cekić, Sanela Savić, Snežana Savić
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引用次数: 0

摘要

乳基外用制剂的稳定性评估可以通过实时监测和/或加速方法来实现,从相关的稳定性相关的物理化学参数中得出预测。为了确保局部产品在储存、运输和应用过程中的坚固性和耐久性,需要进行彻底的稳定性测试。然而,由于乳液类型及其预期用途的多样性,没有通用的标准测试,因此配方商/制造商有责任定制适当的评估。值得注意的是,局部乳剂,特别是化妆品变体,通常表现出令人印象深刻的稳定性和延长的保质期。然而,在工业环境中,评估它们的稳定性和决策仍然具有挑战性和耗时。这强调了对替代测试方案的需求,以加快稳定性评估和准确预测乳化基产品的稳定性。本文综合文献资料,丰富了实践见解,探讨了乳状液稳定性和预防失稳的核心机制。讨论了稳定性评估的各种方法,揭示了测试过程中检查的方法和参数。特别关注动态机械热分析(DMTA)方法作为传统冻融试验的一种快速、基于流变学的替代方法,强调其在加速乳基外用制剂稳定性评估方面的实用性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability evaluation of emulsion-based topical preparations: A valuable potential of dynamicmechanical thermoanalysis (DMTA) test as a rapid rheological alternative to conventional freezethaw test
The assessment of stability in emulsion-based topical preparations can be approached through real-time monitoring and/or accelerated methods, drawing predictions from pertinent stability-related physicochemical parameters. Ensuring the robustness and durability of topical products during storage, transport, and application necessitates thorough stability testing. However, due to the diversity of emulsion types and their intended use, there is no universal standard test, placing the liability on formulators/manufacturer to tailor appropriate assessments. Notably, topical emulsions, particularly cosmetic variants, often exhibit impressive stability with extended shelf lives. Nonetheless, evaluating their stability and decision-making remain challenging and time-consuming in industrial contexts. This underscores the demand for alternative testing protocols that expedite stability assessments and predict emulsion-based product stability accurately. This article comprehensively surveys literature, enriched with practical insights, exploring core mechanisms behind emulsion stability and prevention of instability. The discussion encompasses diverse approaches to stability assessment, revealing methodologies and parameters under examination during testing. Particular focus is placed on the dynamic-mechanical thermoanalysis (DMTA) method explored as a rapid, rheologically-based alternative to the conventional freeze-thaw test, emphasizing its usefulness for expediting the stability evaluation of emulsion-based topical preparations.
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来源期刊
Arhiv za Farmaciju
Arhiv za Farmaciju Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
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发文量
19
审稿时长
12 weeks
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