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Eastman BioSustane™ SAIB NF

A solution for poor solubility, extended release, depot formulation and abuse deterrence

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Formulate with confidence

Eastman BioSustane™ SAIB NF is a novel, nonpolymeric excipient derived from sucrose, a biobased material. Highly hydrophobic, it has multiple potential applications.

BioSustane 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

BioSustane applications

BioSustane applications

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Amorphous solid dispersion

Dissolve APIs with poor water solubility and enable development of novel formulations. 

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Sustained release 

Use as a matrix former for sustained release of hydrophobic and hydrophilic APIs. 

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Abuse deterrence

Provide resistance to tampering such as crushing and dissolving in liquids.

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BioSustane applications

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Depot* former 

BioSustane functions as a depot former, enabling long-acting dosage forms.

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Other applications

BioSustane shows potential in many other pharmaceutical applications.

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*Eastman Chemical Company does not manufacture or market an injectable grade of BioSustane SAIB NF excipient. It is the responsibility of our customers to determine that their use of our product(s) is safe, lawful and technically suitable in their intended applications.

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An in-depth look at BioSustane

Understand how to dispense and handle BioSustane in laboratory conditions and in bulk quantities.

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