Eastman, a global specialty ingredient maker is pleased to share that the formulation scientists now have a new tool in their toolbox to formulate poorly water-soluble APIs. The excipient is called BioSustane™ SAIB NF. The company is excited to bring the news to the industry since we are aware that poor solubility of API is a major roadblock and a new excipient solution to formulate poorly water-soluble API is a significant development for the industry.
Rajendran (Raj) Arunagiri, responsible for the excipient product development at Eastman, led the development and launch of BioSustane™. Raj is an expert in drug delivery trends, pharma value chain trends, author of literature on excipients, and expert speaker in many drug delivery conferences. Let us get some firsthand information from Raj Arunagiri through a quick interview to highlight BioSustane™ value to the pharmaceutical market.
·Please tell our readers what difference will the new excipient BioSustane make to drug delivery?
Firstly, it’s a new excipient and so formulation scientists have a new way of solving problems. Precisely, formulators can formulate poorly soluble APIs through wet granulation and without having the need to spray dry or holt melt extrude. Spray drying and hot melt extrusion are comparatively complex manufacturing techniques. BioSustane™ is unique in how it solves the poor solubility problem.
·What can you tell us about safety of the excipient?
Well, the base chemistry for BioSustane™ is well understood and Eastman has several toxicity studies and data on it. Our BioSustane is NF complaint and made under cGMP conditions in the United States. On top of that, FDA has recently approved a formulation containing BioSustane.
·How can the formulators get their hands on the new excipient?
The best way to learn more is to visit us at eastman.com/pharma and use the “Contact us” option. We would glad to have a deeper technical conversation and provide samples. The readers may also reach out to us via email at pharmacare@eastman.com