Nov 18 2008
PharmaForm, a pharmaceutical product development, manufacturing and analytical testing services company, today announced the launch of its new Evaporative Precipitation into Aqueous Solution (EPAS) drug delivery technology at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, November 16 through 20, 2008, Georgia World Congress Center, Atlanta, Georgia. PharmaForm will showcase the EPAS technology at booth #2813.
EPAS is a particle engineering technology that produces nanostructured particles with properties of high surface areas, rapid dissolution, improved physical stability, and exceptional bioavailability when compared to conventional formulation technologies. It is designed to transform poorly water-soluble drugs into stable nanoparticles, without physical milling or grinding procedures.
EPAS is applicable to a wide range of hydrophobic molecules and can be applied to a variety of dosage forms, including solid oral, liquid, pulmonary and transdermal. Companies can utilize EPAS to improve the bioavailability of poorly soluble new chemical entities (NCEs) or to improve upon existing formulations to extend patent life and product life cycle.
"The benefits of improved patient compliance and clinical profiles, reduced dose variability, and a readily scalable process provide companies with a patentable drug delivery technology for their development pipeline," said Michael Crowley, Ph.D. vice president of business development at PharmaForm. "EPAS is a powerful strategy for companies to capitalize on the full potential of their highly effective yet poorly soluble compounds."
The EPAS platform is fast, continuous, and scalable using conventional equipment which can be directly incorporated into an uninterrupted manufacturing process. The EPAS process eliminates concerns of particle contamination and reduces the degree of crystallinity compared to milling techniques. The process produces highly stable crystalline drug particles with low levels of residual solvents using GRAS approved excipients.
"Compared to physical methods of micronization, such as wet-milling, EPAS engineered particles demonstrate a very narrow particle size range, do not agglomerate and exhibit improved flow," said Jason Vaughn, Ph.D., vice president of operations at PharmaForm. "The added benefit of eliminating the concern for particle contamination observed with milling techniques facilitates high yield and efficient system validation, ensuring a smoother path towards clinical and commercial manufacturing."