RespireRx Pharmaceuticals Inc. (OTCQB:RSPI) in association with Jeffrey King managing attorney at Patent Networks Law Group, has filed a provisional patent application describing novel lipid-based formulation technology that may be used to improve the solubility and bioavailability of poorly soluble drugs, particularly cannabinoids.
Low aqueous solubility is a major problem encountered during the formulation development of drug molecules, with an estimated 70% of current drug research pipelines containing such molecules. Because of its recent use in the formulation of mRNA vaccines for COVID-19, LFT has become a focus for formulation research efforts.
ResolutionRx, the company’s business unit focused on pharmaceutical cannabinoids, has been developing dronabinol that acts upon the nervous system’s endogenous cannabinoid receptors. Dronabinol was approved in 1985 by the FDA as Marinol for the treatment of AIDS-related anorexia and later for the treatment of chemotherapy-induced nausea and vomiting.
Using the commercial form of dronabinol, the company has successfully completed two Phase 2 clinical trials demonstrating significant reductions in the major symptoms of obstructive sleep apnea. However, based on these results and those from pharmacokinetic studies, it has been concluded that expansion of dronabinol’s use into OSA and other therapeutic indications will require new, improved formulations.
As it is commercially sold, dronabinol suffers from poor and highly variable absorption, low blood levels resulting from rapid and extensive first-pass liver metabolism, as well as a relatively brief half-life requiring high doses in order to achieve sustained, therapeutic blood levels for 4 hours or longer.
In order to circumvent these problems, the company has created a number of lipid nanoparticle formulations of dronabinol. Pending additional financing, the company plans to test these formulations in animal and human pharmacokinetic and pharmacodynamic studies.
The company noted that the development of a novel, proprietary formulation of dronabinol would not require significantly longer time to market entry compared to what would be required if it was to use the currently available soft gel capsule technology.
Photo: Courtesy of Benzinga
