Eastman BioSustane™ SAIB NF is a novel, non-polymeric excipient derived from biobased material: sucrose. 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 APIs that are subject to abuse
- A novel depot former for injectable drugs,1 as shown in some U.S. Food and Drug Administration (FDA) approved drug formulations
In addition, the mucoadhesive property of BioSustane is hypothesized to enhance the bioavailability of the APIs.
1Eastman does not market an injectable grade of BioSustane. Customer is responsible for ensuring BioSustane meets injectable grade.
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 GRAS (Generally Regarded As Safe) by the FDA.
Drug master file 19694 is on file with the U.S. FDA.
Marketed products
BioSustane is currently marketed in several formulations, including:
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Posimir®—an injectable 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
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SucroMate™—an FDA-approved animal health product