AIR Option 1: Technology Translation Development of a Prototype Solubility Enhancing Formulation for Improved drug Delivery using novel Cellulose Derivatives.

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This PFI: AIR Technology Translation project focuses on translating our recent discovery of pharmaceutical crystallization inhibitors based on novel cellulose omega-carboxyalkanoates to improve the delivery of poorly water soluble drugs by formulating amorphous solid dispersions with enhanced processing and drug delivery characteristics. The translated novel polymeric materials have the following unique features: tailored amphiphilicity and high degree of substitution with carboxylic acid groups that provides exemplary crystallization inhibition of supersaturated solutions of hydrophobic drugs when compared to the leading competing polymer, hydroxypropyl methylcellulose acetate succinate, used in the formulation of amorphous solid dispersions in this market space. The project accomplishes this goal by synthesis of novel derivatives of cellulose designed to interact with poorly water soluble drugs which will be used in prototype amorphous solid dispersions formulations which are expected to lead to elevated concentrations of the drug and ultimately improved delivery of the therapeutic agent to the patient. Demonstration of the successful production of prototype formulations using common processing techniques will lead to partnerships and licensing agreements with specialty chemical and pharmaceutical companies. The potential economic impact is expected to be improved efficiency of the drug development process in the next decade, which will contribute to the U.S. competitiveness in the area of drug development. The societal impact, long term, will be the availability of new and improved medicines that might otherwise have never been made available to the public because of their poor aqueous solubility.