| 书目名称 | Pharmaceutical Suspensions | | 副标题 | From Formulation Dev | | 编辑 | Alok K. Kulshreshtha,Onkar N.‘Singh,G. Michael Wal | | 视频video | | | 概述 | Written by experienced experts in applicable field from academia/industry/regulatory agencies, volume will systematically discuss the development of stable pharmaceutical suspensions | | 图书封面 |  | | 描述 | The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in ac | | 出版日期 | Book 2010 | | 关键词 | Formulation; Kulshreshtha; Singh; Suspentions; Wall; clinical trial; development; drug; kinetics; manufacturi | | 版次 | 1 | | doi | https://doi.org/10.1007/978-1-4419-1087-5 | | isbn_softcover | 978-1-4899-8417-3 | | isbn_ebook | 978-1-4419-1087-5 | | copyright | Springer-Verlag New York 2010 |
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发表于 2025-3-21 16:55:30
