The New Excipient BioSustane – The Interview with Eastman
Recently, we did a small interview with Rajendran (Raj) Arunagiri, Global Segment Market Manager from Eastman. The main topic was Eastman’s new excipient BioSustane™ SAIB NF and we asked Raj some key questions to learn more about the new excipient, BioSustane™ from Eastman.
Pharma Excipients: Please tell us why the industry should care about the new excipient BioSustane™ from Eastman?
As you know, a new excipient does not happen often. So, formulators are generally excited when they hear of a “new” tool to add to their toolbox. Importantly, while BioSustane™ is multi-functional, it addresses one of the important problems facing the drug development pipeline: poorly soluble APIs. I have interacted with hundreds of formulators across the world. When I ask them what their key challenges in product development are, “poor solubility” is always in top three challenges and in many cases it’s the #1 challenge. So BioSustane™ being a potential solution to address poor solubility should be of interest to the industry. I must also share that BioSustane™ can also be used to formulate extended release and abuse deterrent dosage forms.
Pharma Excipients: While “new” is good, aren’t there concerns on (lack) precedence of use?
I would like to highlight that BioSustane™ is already in an FDA approved drug called Posimir®. There is also an animal health drug that is approved for marketing in the US and an ADHD drug approved for marketing in Taiwan. So, BioSustane™ while a new excipient the recent approvals by regulators should give confidence to the formulators. Also, the base chemistry behind BioSustane™ is well understood and considered to be generally safe.
Pharma Excipients: Is it in FDA’s IID?
Not yet. My understanding is that FDA needs a certain number of drugs to be approved before adding the excipient to IID. We are not there yet but with the market engagements we have we should get there.
“…BioSustane™ is already in an FDA approved drug called Posimir®.”
Pharma Excipients: How do we learn more about BioSustane™?
There are three ways. First you can visit the BioSustane™ page to learn more and request samples. Second, you can watch this technical presentation from my colleague Dr. Walter Thompson. And third, you can simply email us at [email protected] for questions/discussions/sample request.
Pharma Excipients: Thanks a lot for the answer, Raj! Thanks for this great interview.