Eastman

Excipients are crucial for drug delivery, but often overlooked for innovation. To address this challenge, the FDA recently launched a voluntary pilot program called PRIME. In this section we are pleased to feature Rajendran (Raj) Arunagiri, from Eastman, who led the development and launch of a new excipient called BioSustane^™.

Excipients are inactive ingredients that are essential for drug formulation and product viability. Although they do not cause any therapeutic effect, they can range from simple flavorings to sophisticated coating agents that impart sustained release of medication. Excipients that have a more complex functionality are usually referred to as "functional" excipients.

The development of BioSustane^™ is a significant breakthrough for the industry as it is a new multi-functional excipient that allows for the formulation of poorly water-soluble APIs, a widespread challenge in the industry.

We are pleased to introduce Raj Arunagiri, who played a crucial role in developing BioSustane^™, a solution to a critical challenge faced by formulators. His contribution to the development of BioSustane^™ is an extraordinary accomplishment, and we are excited to interview him.

Raj Arunagiri has co-authored publications on the use of BioSustane^™ for poorly soluble APIs and is a named inventor on the patent that uses BioSustane^™ for formulating poorly water-soluble APIs. His expertise is well recognized within the industry and earned him recognition as an invited speaker at several pharma conferences for the drug delivery track.

We thank Raj Arunagiri and his team at Eastman for this significant contribution to advancing drug delivery technologies.

We are excited to talk about the new excipient from BioSustane.

Interviewer: Firstly, congratulations on the launch. It’s an impressive feat.

• Please tell us a little about you.

Thanks for inviting me for this interview. I am Raj Arunagiri, Global Segment Market Manager for the Care Pharma business at Eastman. I am responsible for the pharma segments growth. One of my primary roles is to innovate and launch new excipients at Eastman. 

• Please tell us a little about Eastman.

Eastman is more than a century old company, headquartered in Kingsport TN.

We are about $10B in revenue and approximately 14,000 employees worldwide. We have several businesses in Eastman including my pharma business. We are one of the earliest entrants into the excipients area and I believe the first ever DMF with FDA was filed by Eastman in 1950. In pharma, we make functional excipients that are used in several critical drugs including hypertension indication. Our products enable zero-order release and modified release dosage form. Our new excipient BioSustane^™ enables the formulation of poorly water-soluble APIs.

• What would be your elevator pitch for BioSustane?

It is a multi-functional excipient that could be used to formulate poorly soluble APIs, extended release, and abuse deterrent formulations. BioSustane^™ SAIB NF, is made from sucrose as a starting material.

• What value does BioSustane bring to the drug delivery area?

Let me build on my response to the previous question. It’s a multi-functional excipient. One tool that lets formulators do multiple things. Importantly, BioSustane addresses one of the biggest problems with drug delivery: poor solubility of APIs. I have travelled across the globe to talk to formulators. I can confidently say that one of the biggest problems that faces the formulators today is “poor solubility” of the API. Industry is taking several routes to address poor solubility and BioSustane has opened a new route. Particularly, BioSustane does not need hot melt extrusion or spray drying. Traditional wet granulation will do it. So BioSustane^™ being a potential solution to address “poor solubility” should be and is of significant interest to the industry. As you know, new excipient does not happen often. So, formulators are generally excited when they hear of a “new” tool to add to their toolbox. BioSustane^™ is multi-functional, can also be used to formulate extended release and abuse deterrent dosage forms.

• Are there any drugs containing BioSustane approved by the regulators?

Yes, a few across the globe. 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 established and understood and there is a lot of safety data for the oral route.

• How do we learn more about BioSustane^™?

There are three ways. One you can visit this BioSustane^™ page to learn more and request samples. Two, you can watch this technical presentation. And three, you can simply email us at pharmacare@eastman.com for questions/discussions/sample request.

We thank Raj Arunagiri for his insights.