The leading sulfobutylether beta-cyclodextrin (SBECD)
Captisol is a derivatized beta cyclodextrin used in 15 FDA-approved products to date, including VEKLURY® (remdesivir) and KYPROLIS® (carfilzomib) to help solubilize & stabilize difficult to deliver molecules. Made by CyDex Pharmaceuticals (a Ligand Company), Captisol is the leading pharmaceutical-grade sulfobutylether betacyclodextrin (SBECD), with an excellent record of safety and consistency. Captisol has been clinically used in therapeutics across many routes of administration, including parenteral, oral, subcutaneous, ophthalmic, nasal, inhalation, and dermal.
TRUSTED FOR OVER 20 YEARS
With over twenty years of approved Captisol-enabled drug products, there is significant regulatory experience with Captisol in regulatory agencies worldwide. In the United States there are two types of Drug Master Files (DMFs) with the FDA: Type IV including CMC information and Type V including regulatory safety information that supports all routes of delivery. Many FDA divisions and other regulatory bodies have evaluated the data package and approved the use of Captisol in more than 500 clinical trials.
QUALITY AND MANUFACTURING
Captisol is produced under cGMP controls at two validated sites in Loures, Portugal and Cork, Ireland. Captisol is manufactured under a patented all aqueous process. This process results in ultra-low endotoxin, ultra-low bioburden, and low chloride product. Each lot must meet strict analytical specifications before released. There is more than 20 years of history in manufacturing reproducible, high-quality batches of Captisol. While most excipients adhere to the minimum standards of USP and IPEC, Captisol exceeds those guidelines.
FORMULATION DEVELOPMENT & REGULATORY SERVICES
The CyDex Team has over 150 years of experience in drug development, from preclinical through Phase IV (postcommercial) clinical studies. While some partners prefer to keep development internal, we also assist clients in numerous development projects (EVOMELA®, NEXTERONE®, and SESQUIENT™ are three Captisol-enabled drug products the CyDex team has successfully developed). Our team has extensive, hands-on preclinical, CMC, clinical, orphan, ANDA, 505(b)(2), biowaiver, and NDA submission experience. In addition to Captisol material, we can perform formulation studies, advise on safety studies, guide regulatory strategies, and develop manufacturing processes, providing these services to big pharma, small biotech, academic groups, and non-profits.