Seema Thakral , Christine Levesque , Kellye Cung , Lin Li , Ryan E Mould , Ehab Moussa , Jason Pinkstaff , George Crotts , Manceva Slobodanka , Yogita Krishnamachari
{"title":"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。","authors":"Seema Thakral , Christine Levesque , Kellye Cung , Lin Li , Ryan E Mould , Ehab Moussa , Jason Pinkstaff , George Crotts , Manceva Slobodanka , Yogita Krishnamachari","doi":"10.1016/j.xphs.2025.103917","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":"114 9","pages":"Article 103917"},"PeriodicalIF":3.8000,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A pharmaceutical industry survey results on exploring polysorbate alternatives in biological drug products: poloxamer and other surfactants\",\"authors\":\"Seema Thakral , Christine Levesque , Kellye Cung , Lin Li , Ryan E Mould , Ehab Moussa , Jason Pinkstaff , George Crotts , Manceva Slobodanka , Yogita Krishnamachari\",\"doi\":\"10.1016/j.xphs.2025.103917\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>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.</div></div>\",\"PeriodicalId\":16741,\"journal\":{\"name\":\"Journal of pharmaceutical sciences\",\"volume\":\"114 9\",\"pages\":\"Article 103917\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2025-07-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of pharmaceutical sciences\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0022354925003697\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of pharmaceutical sciences","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0022354925003697","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
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.
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.