在生物药品中探索聚山梨酸盐替代品的制药工业调查结果:波洛沙姆和其他表面活性剂。

IF 3.8 3区 医学 Q2 CHEMISTRY, MEDICINAL
Seema Thakral , Christine Levesque , Kellye Cung , Lin Li , Ryan E Mould , Ehab Moussa , Jason Pinkstaff , George Crotts , Manceva Slobodanka , Yogita Krishnamachari
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引用次数: 0

摘要

聚山梨酯(特别是PS20和PS80)是生物药品中最常用的表面活性剂,因为它们具有良好的稳定性和公认的肠外给药安全性。由于对聚山梨酯组成的可变性和稳定性的关注,人们也在探索替代表面活性剂来稳定生物制剂。poloxam188被认定为潜在的表面活性剂,poloxam188已经是23种获批生物药品的组成部分。然而,整个行业对生物制剂替代表面活性剂使用的立场和理解并没有在文献中清楚地反映出来。IQ Consortium进行了一项保密调查,以了解(i)行业对不同生物模式使用poloxamers的经验;(ii)与聚山梨酸酯相比,在生物制品中使用poloxomer的优势和障碍/考虑因素(iii)行业对使用聚山梨酸酯/ poloxomer以外的新型表面活性剂和使用多种表面活性剂的意见。本报告综合了来自14家IQ联盟成员公司的调查反馈和相关讨论。在不久的将来,配方师工具包中聚山梨酯替代品的可用性将是有益的,报告为该工具包提供了相关信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A pharmaceutical industry survey results on exploring polysorbate alternatives in biological drug products: poloxamer and other surfactants
Polysorbates (specifically PS20 and PS80) are the most popular surfactants used in biological drug products because of their excellent stabilizing properties and well-recognized safety profile for parenteral administration. Due to concerns regarding compositional variability and stability of polysorbates, alternative surfactants are also being explored to stabilize biologics. Poloxamers are identified as potential surfactants and poloxamer 188 is already a constituent of 23 approved biological drug products. However, industry-wide position and understanding on use of alternative surfactants for biologics is not clearly reflected in literature. A confidential survey was conducted by IQ Consortium to understand (i) industry’s experience on the use of poloxamers for different biological modalities, (ii) the advantages and barriers/considerations associated with the use of poloxamers in biological products in comparison with polysorbates (iii) industry’s opinion on use of novel surfactants beyond polysorbates/poloxamer and use of multiple surfactants. The present report consolidates survey responses from 14 IQ Consortium member companies and the associated discussion. The availability of polysorbate alternatives in the formulator’s tool kit would be beneficial in the near future, and the report provides relevant information for this tool kit.
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来源期刊
CiteScore
7.30
自引率
13.20%
发文量
367
审稿时长
33 days
期刊介绍: The Journal of Pharmaceutical Sciences will publish original research papers, original research notes, invited topical reviews (including Minireviews), and editorial commentary and news. The area of focus shall be concepts in basic pharmaceutical science and such topics as chemical processing of pharmaceuticals, including crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pharmacodynamics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, protein-peptide chemistry and biotechnology specifically as these relate to pharmaceutical technology, and targeted drug delivery.
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