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Posted: November 17, 2008
PharmaForm Introduces Nanoparticle Engineering Technology for Drug Delivery
(Nanowerk News) 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."
For further information on PharmaForm's EPAS technology or drug development services, visit booth #2813 at AAPS, Georgia World Congress Center, Atlanta, GA, USA or visit www.pharmaform.com, e-mail or call (512) 834-0449. [email protected]
EPAS particle engineering technology uses evaporative precipitation to generate nanostructured drug particles exhibiting rapid dissolution rates and enhanced bioavailability. The process involves dissolving the active in non-aqueous solvent followed by precipitation into an aqueous solution. The rapid expansion and atomization of the solvent in the water phase causes the formation of drug particles ranging in size from nanometer scale to micron scale, which are then stabilized using GRAS excipients. The evaporated solvent is recovered, and the stabilized particles isolated from the aqueous phase by standard techniques.
Since 1996, PharmaForm has built an international reputation for delivering novel and innovative solutions to challenging problems in pharmaceutical product development, manufacturing, and analytical services. We have formulation expertise in oral, nasal, pulmonary, dermal, mucosal and vaginal delivery. Our scientific staff has considerable experience in drug delivery including time-release formulations, solubility enhancement and hot-melt extrusion techniques. PharmaForm's state-of-the-art facility is registered with the FDA and the DEA and is cGMP/GLP compliant.