Formatech, Inc. has announced the issuance of U.S. patent 7,659,310, entitled “Methods of Enhancing Solubility of Agents” which covers novel formulation methods to enhance the solubility of certain hydrophobic compounds.
The patented nanoparticle technology effectively solubilizes pharmaceutical compounds in fatty acids and/or fatty alcohols. The formulation achieves aqueous form after dilution with equimolar of protonating agent, thereby keeping the drug in the micelle of the fatty acid salt. Furthermore, the technology addresses many excipient related safety issues, results in significantly higher maximum tolerated doses, provides a better PK profile and delivers drug formulations compatible with parenteral, oral, pulmonary and topical administration.
“This nanoparticle technology is ideal for application to commercially successful drugs that call for a safer, more effective drug product formulation, including: Lapachone, Digoxin, N-Acetylsalicylic Acid, Taxotere®, Taxol®, Diprivan® and Cyclosporin. Our first candidate under development at Formatech using this patented neunanotechnology is docetaxel,” said Indu Isaacs, Ph.D., CEO, Formatech, Inc. “The formulation technology is also applicable to many novel hydrophobic pharmaceutical compounds and new chemical entities,” she added.
Formatech is currently developing a novel docetaxel formulation using this patented neuNanoParticle™ technology which has demonstrated significantly higher maximum tolerated doses due to less toxicity, better PK profile, and best efficacy against human colon, melanoma, ovarian, and prostrate tumor xenografts in nude mice. Formatech is interested in strategic partnering opportunities for the further development of docetaxel.
Formatech, founded in 1993, is a contract development and manufacturing organization based in Andover, Massachusetts. The company provides unique solutions to product development and manufacturing challenges, including: preformulation/formulation development of all common dosage forms, such as lyophilized dosage forms; cell culture/fermentation process development and purification/downstream process optimization. Their aseptic manufacturing facility produces liquid and lyophilized dosage units for clinical supplies or small-scale commercial products. Manufacturing support services include compounding/formulation, diafiltration/concentration (UF/DF), release testing, and full ICH Guideline Stability Programs.