SoluMatrix

Reducing drug particle size to enhance drug dissolution

iCeutica’s proprietary SoluMatrix™ reformulation platform is a scaleable manufacturing process that can produce nano-sized drug particles which are 10 to 200 times smaller than conventional drug particles. The particles are generated using the patented SoluMatrix™ dry milling methodology, which both grinds the drug particles into a superfine powder and protects those nano-particles from subsequent agglomeration (or clumping together into big particles). Our unique technology makes it easier to formulate compounds into tablets and capsules as well as for other oral, intranasal and pulmonary delivery forms.

The SoluMatrix™ technology has been scaled up to commercial scale and commercial validation of the process is included in an NDA filing to be made in the coming months for one of our pain and inflammation products licensed to Iroko Pharmaceuticals. iCeutica can produce small or large scale clinical trial material utilizing the SoluMatrix™ technology.

Benefits

Benefits of SoluMatrix™ reformulation

It is estimated that approximately 10% of currently marketed drugs and at least 40% of drugs in development have limitations due to poor water solubility. By reducing drug particle size using SoluMatrix™, the objective is to achieve a vast improvement in the dissolution properties of the relevant drugs, without changing the chemical structures of the relevant drug molecules themselves. With improved dissolution, the SoluMatrix™-reformulated drugs are expected to have a number of significant benefits, including:

• reducing the amount of drug required to achieve a therapeutic effect;

• speeding up the drug’s therapeutic effect;

• removing the inter and intra patient variability of bioavailability of oral products;

• making alternative delivery routes (inhalable, intranasal, parenteral) possible; and/or

• reducing dosage size (and thereby improving patient convenience and compliance).