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Method for the stabilisation of the natural Nitric Oxide

[Category : - CHEMISTRY- HEALTH]
[Viewed 124 times]

Patent WO 2009/090439 enhances further the stability of the natural Nitric Oxide (NO)-donor S-nitrosoglutathione (GSNO) compositions described in Patent WO 2009/050527 (which relates to pharmaceutical compositions comprising GSNO and polysaccharide-type polymers, which are capable to stabilise the otherwise highly labile GSNO) by adjusting the pH to selected alkaline values; it has been granted in Europe, USA, Canada, China, Japan, and South Korea and is valid until 2029. Patent Abstract: The invention relates to pharmaceutical compositions having alkaline pH comprising GSNO as active ingredient together with usual additives, optionally with one or more polysaccharide-type polymer(s). Another subject of the invention is a method for stabilizing a solution or non-solid composition containing GSNO wherein the pH of the solution or composition is adjusted to an alkaline value. The innovative step of the technology's patent is in the enhanced stability of the NO-donor GSNO (otherwise highly labile), an endogenous compound that is a natural NO donor when it is decomposed, in a specific pH range. This invention coupled with the Company's data/know-how on an optimised method of administration for a stable (hydrogel) formulation developed to release NO over variable periods of time, are the key assets to unlocking a technology platform with a proprietary formulation which harnesses the well-known therapeutic properties of Nitric Oxide. NO is acknowledged as one of the most important mediators of intra- and extracellular processes, and has been demonstrated to have an important therapeutic impact on a wide range of diseases due to its well-documented vasodilatory, anti-inflammatory, and anti-microbial effects. However, harnessing the therapeutic potential of NO remains a challenge; its short biological lifespan, instability during storage, and the potential toxicity associated with NO excess are among the principal factors that have delayed the translation of the molecule’s therapeutic potential to beside. These challenges are addressed by the proprietary formulation that this patent relates to, capable of a stable topical release of NO. Many of the conditions that this formulation can treat do not have an effective Standard of Care. Although there are numerous patent applications describing the local delivery of NO generated by an NO-donor, only one technology has successfully advanced the derived products to a significant degree and is currently in Phase III clinical studies. However, it is likely that the local tolerability of SynDermix's formulation may be superior that of this existing technology in development, since the components of the SynDermix technology are all natural. rn

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