A solution for poor solubility, extended release, depot formulation and abuse deterrence
Eastman BioSustane™ SAIB NF is a novel, non-polymeric excipient derived from sucrose, a biobased material. Highly hydrophobic, it has multiple potential applications. BioSustane can be used as:
- A carrier for amorphous solid dispersion for poorly water-soluble drugs
- A sustained-release excipient compatible with both water-soluble and poorly water-soluble drugs
- An abuse-deterrent excipient when formulating active pharmaceutical ingredients (APIs) that are subject to abuse
- A depot* former, as shown in some U.S. FDA drug approved formulations
In addition, the mucoadhesive property of BioSustane is hypothesized to enhance the bioavailability of the APIs.
Regulatory status
BioSustane SAIB NF is manufactured in a dedicated facility in accordance with Current Good Manufacturing Practices (CGMP) as provided for by the International Pharmaceutical Excipient Council. It has a published United States Pharmacopeia National Formulary (USP–NF) monograph and is considered Generally Regarded As Safe (GRAS) by the U.S. FDA.
Drug master file 19694 is on file with the FDA.
Marketed products
BioSustane is currently marketed in several formulations, including:
-
Posimir*— bupivacaine drug approved by the FDA
- Methydur Sustained Release Capsules — a drug formulation for the treatment of attention-deficit/hyperactivity disorder (ADHD), approved for marketing in Taiwan
-
SucroMate*— an FDA-approved animal health product