SAN DIEGO — (BUSINESS WIRE) — LATITUDE Pharmaceuticals, Inc. (LPI), a San Diego-based drug formulation developer, reported today that it is entering its fifth year of formulating a wide variety of poorly soluble/insoluble drug compounds using its proprietary intravenous (IV) nanoemulsion technology. To date, dozens of insoluble drug compounds have been formulated successfully with this approach and two (docetaxel and vinorelbine) are currently at the NDA-filing stage.
LPI's unique nanoemulsions incorporate FDA-approved oils and lipids in a proprietary, non-liposomal and manufacturing-friendly process to produce low cost, stable, filter-sterilizable and lyophilizable drug-carrying formulations.
LPI's easy-to-administer nanoemulsions are free of toxic solubilizers such as Cremophor®, polysorbate 80, DMSO, or other organic solvents that can cause adverse reactions. Their improved safety has been proven in human studies, which also showed the vein-irritation from phlebitis-inducing drugs could be eliminated.
LPI's nanoemulsions have been successfully engineered to match the pharmacokinetic profiles of marketed drugs, enabling a rapid 505(b)(2) regulatory pathway. They can also lower the neurotoxicity of cytotoxic drugs and selectively deliver drugs to certain organs.
“Our nanoemulsion platform is a proven safer and more practical approach to formulating insoluble drugs. We are receiving substantial interest in this technology because of its success in formulating even the most insoluble new chemical entities and approved drugs,” noted Andrew X. Chen, Ph.D., President of LPI and the inventor of LPI's nanoemulsion technology. “Drug developers can now capture the value of promising drugs that otherwise would be abandoned because of poor solubility or compromised with a less safe formulation.”
This advantageous technology is part of LPI's formulation development repertoire and is covered by a suite of pending patents. Like LPI's other technologies, the nanoemulsions are designed to add value to novel compounds and reformulated, off-patent drugs by providing additional intellectual property protection and other value-adding enhancements.
About LATITUDE Pharmaceuticals, Inc.
LPI is a leading contract research boutique that provides innovative, leading-edge drug formulation services to the biotech and pharmaceutical industries. The company is recognized for its success in formulating difficult-to-solubilize drugs and for developing inventive approaches and intellectual property for its clients. Since its founding in 2003, LPI has completed over 160 client projects and developed a reputation for creativity, reliability, rapid turnaround, and client satisfaction and success.