At present, several methods are employed to improve the solubility of insoluble drug ingredients, ranging from micronization to complexation with carrier agents like polysorbate 80 and polyethoxylated castor oils such as BASF’s Cremophor EL.
While carrier agents are generally effective, some have been associated with hypersensitivity reactions and, perversely, a reduction in active pharmaceutical ingredient (API) bioavailability when administered at high dosages.
Massachusetts-based Formatech’s method, which recently received US patent protection, differs in that it enhances solubility by forming fatty acid or fatty alcohol micelles in the presence of the compound, directly contacting them with fatty acid salts.
The company claims that this solvent and detergent-free approach completely eliminates the potential for allergic and adverse site reactions, and can therefore be used to improve the stability of a wide range of drug formulations.
Company CEO Indu Isaacs told in-Pharmatechnologist.com that: “Recognizing an unmet need, Formatech [had] focused its energy on effectively solubilising and delivering water insoluble drugs with little or no adverse side effects historically associated with the traditional noxious formulation components.”
Dr Isaacs added that: “In addition to addressing significant excipient related safety issues, the technology also delivers drug formulations that are compatible with parenteral, oral, pulmonary and topical routes of administration.”
Formatech cited products like the anticancer agent paclitaxel, the sedative propofol and the immunosuppressant cyclosporin as being among the most suitable for the application of its technology.
Technology licensed to neuMiRx spin-out
Formatech has established a spin-out company, neuMiRx, which holds exclusive rights to the technology. Dr Isaacs explained that: “neuMirRx's business strategy is to develop and commercialize the products developed using this technology as Qualiceuticals.”
Isaacs commented that the company will also seek to out-license the proprietary technology and in-license new drug candidates. She added that: “Formatech will provide the production capacity for manufacturing of these products for partners licensing this technology from neuMirRx.
“The utility of this technology is ubiquitous hence its market potential is extremely wide. At present, we have targeted several potential markets for this technology,” added Isaacs.
She went on to say that, while the technology is unique the market for solubility technologies is highly competitive, citing companies like Abraxsis and Sonus as examples of firms with established solubility enhancement methods.