{"title":"在配制药物时需要考虑到扩大规模。","authors":"","doi":"10.1016/j.jconrel.2024.07.016","DOIUrl":null,"url":null,"abstract":"<div><p>Formulation scale-up remains a major hurdle in drug development in part because preliminary formulation research efforts rarely consider the challenges of scaling up production for commercialization. This Perspective outlines considerations around scalability that can be incorporated into formulation design work in order to increase the chances of successful translation. Both technical (unit operations, excipient selection, scaling principles) and non-technical (funding, publications, and personnel) considerations are discussed, with a focus on lab-scale work by academic researchers.</p></div>","PeriodicalId":15450,"journal":{"name":"Journal of Controlled Release","volume":null,"pages":null},"PeriodicalIF":10.5000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0168365924004474/pdfft?md5=210332156889d394156ef0e6dd1d706d&pid=1-s2.0-S0168365924004474-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Drugs need to be formulated with scale-up in mind\",\"authors\":\"\",\"doi\":\"10.1016/j.jconrel.2024.07.016\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>Formulation scale-up remains a major hurdle in drug development in part because preliminary formulation research efforts rarely consider the challenges of scaling up production for commercialization. This Perspective outlines considerations around scalability that can be incorporated into formulation design work in order to increase the chances of successful translation. Both technical (unit operations, excipient selection, scaling principles) and non-technical (funding, publications, and personnel) considerations are discussed, with a focus on lab-scale work by academic researchers.</p></div>\",\"PeriodicalId\":15450,\"journal\":{\"name\":\"Journal of Controlled Release\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":10.5000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0168365924004474/pdfft?md5=210332156889d394156ef0e6dd1d706d&pid=1-s2.0-S0168365924004474-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Controlled Release\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0168365924004474\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Controlled Release","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0168365924004474","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
Formulation scale-up remains a major hurdle in drug development in part because preliminary formulation research efforts rarely consider the challenges of scaling up production for commercialization. This Perspective outlines considerations around scalability that can be incorporated into formulation design work in order to increase the chances of successful translation. Both technical (unit operations, excipient selection, scaling principles) and non-technical (funding, publications, and personnel) considerations are discussed, with a focus on lab-scale work by academic researchers.
期刊介绍：
The Journal of Controlled Release (JCR) proudly serves as the Official Journal of the Controlled Release Society and the Japan Society of Drug Delivery System.
Dedicated to the broad field of delivery science and technology, JCR publishes high-quality research articles covering drug delivery systems and all facets of formulations. This includes the physicochemical and biological properties of drugs, design and characterization of dosage forms, release mechanisms, in vivo testing, and formulation research and development across pharmaceutical, diagnostic, agricultural, environmental, cosmetic, and food industries.
Priority is given to manuscripts that contribute to the fundamental understanding of principles or demonstrate the advantages of novel technologies in terms of safety and efficacy over current clinical standards. JCR strives to be a leading platform for advancements in delivery science and technology.
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