captisol产品代理
captisol产品代理
FDA 批准的 Captisol-enabled® 药物由包括 Amgen、Pfizer、Merck & Co.、Melinta Therapeutics、Acrotech Biopharma L.L.C 在内的合作伙伴销售。和百特国际。 Ligand 还与全球许多其他制药公司签订了许可和供应协议 (LSA)，提供 Captisol-enabled® 候选产品。研究的给药途径包括肠胃外、口服、眼部、鼻部、局部、口服和吸入。
Captisol 的监管接受得到了广泛的安全性研究的支持，这些研究证明了它们出色的系统安全性。 1999 年，V 型药物主文件 (DMF) 提交给 FDA。该监管安全数据包包括 80 多卷，随着时间的推移不断更新，现在支持在肠胃外制剂中使用 Captisol 环糊精以及支持其他递送途径。此外，美国还有用于化学、制造和控制 (CMC) 的 V 类美国 DMF，中国和日本也建立了 DMF。多个 FDA 部门和前美国监管机构已经评估了数据包，并允许在临床试验中使用 Captisol 环糊精。
Captisol 已发表在科学文章中，并被领先的制药和生物技术公司用于多项正在进行的临床试验，被认为是一种有价值且至关重要的递送技术，其使用可能意味着开发计划的成功或失败。
Captisol® is a patented cyclodextrin for use in drug development and formulation.
FDA-approved, Captisol-enabled® medications are marketed by partners including Amgen, Pfizer, Merck & Co., Melinta Therapeutics, Acrotech Biopharma L.L.C. and Baxter International. Ligand also has License and Supply Agreements (LSAs) in place with a number of other pharmaceutical companies worldwide with Captisol-enabled® product candidates. Routes of administration investigated include parenteral, oral, ophthalmic, nasal, topical, oral, and inhalation.
The regulatory acceptance of Captisol is supported by extensive safety studies demonstrating their excellent systemic safety profile. In 1999, a Type V Drug Master File (DMF) was filed with the FDA. This regulatory safety data package, which includes greater than 80 volumes, has been updated over time and now supports the use of Captisol cyclodextrins in parenteral formulations as well as support for other routes of delivery. In addition, there is a Type V US DMF for Chemistry, Manufacturing and Controls (CMC) and DMFs have also been established in China and Japan. Multiple FDA divisions and ex-US regulatory agencies have evaluated the data package and permitted the use of Captisol cyclodextrins in clinical trials.
Published in scientific articles and utilized in a number of ongoing clinical trials by leading pharmaceutical and biotech companies, Captisol is recognized as a valuable and vital delivery technology whose use could mean the success or failure of a development program.
