Marinus has created proprietary technologies that are critical for the cost effective and commercially viable ganaxolone dosages. The technologies are briefly described below:
Ganaxolone is a high dose water insoluble compound. Drugs of this type have presented significant formulation challenges with exposures keyed to the amounts of both food and drug given to an individual. Historically, many approaches to minimizing the effect of food on ganaxolone exposure identified small particle (nanoparticulate) formulations as the best option.
Marinus has discovered that addition of a class of small molecules used in drug formulations initiates a complex of ganaxolone nanoparticles that is more stable and appears to provide higher exposure in the fasted state as compared to previous ganaxolone formulations. The small molecule complexing agents have not been identified in the past to provide stabilization benefits to nanoparticles, and this discovery resulted in the recent issuance of U.S. patent # 7,858,609 & 8,022,054 which covers use of these complexed ganaxolone nanoparticles in solid and liquid dose formulations.
Marinus has filed a patent application (WO/2011/019821 and 20110040112) for the manufacture of ganaxolone drug substance. This application identified a novel organometallic methylating agent which is significantly more efficient and cost effective for the manufacture of ganaxolone drug substance.
The ganaxolone synthesis patent has been granted and will issue in 2013.
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