Also, since psilocybin potency diminishes upon exposure to water and UV light, our novel carriers and encapsulation process utilize both anhydrous carrier liquids and UVA&B resistant gelatins for our precisely dosed Soft gel capsules.
As legalized medicinal use of psilocin, psilocybin and other naturally derived tryptamines is a new frontier, this leaves open a great deal of opportunity to seize the market on new FDA approved formulations.
In addition to novel formulation development, there is also the opportunity for IP development for the mechanized manufacturing of these new medicines that incorporate our Licensed delivery systems and mechanisms.
The Company’s extraction process development includes large scale extraction, isolation and purification of psilocybin and other active tryptamines from various sources of refined biomass material consisting of both grown fungi and enzymatic de novo crude. Since psilocybin and psilocin are susceptible to rapid degradation when exposed to heat, water and oxygen, we had to develop a viable and cost-effective method of extraction in anaerobic and anhydrous conditions.
The process for synthesizing materials such as psilocybin has been around for many years. In fact, our team members were involved with developing many of the routes steps and the streamlining of the synthesis process.
The reason that no one has come forward with a viable method of extracting active tryptamines from biomass material like mushrooms or mycelium is because it is not an easy process to streamline and the yields have been poor.
Nirvana has acquired an exclusive license to the extraction and distillation technology for the Psychedelics market. The Company has purchased its first PureAI machine that will be in the Vancouver Lab facility. The Pure AI is a high vacuum fractional distillation system that should allow us to achieve separations of non-tryptamine compounds at a lower temperature than conventional fractional distillation systems.
The pure AI system will be used exclusively to isolate secondary and tertiary compounds that will be used for further research and study and to formulate new medicines. It is this level of research that will separate our work from companies that are simply trying to reach the finish line of API grade extraction of biomass and biomaterial. These isolated compounds will be studied in formulations clinically and our products formulated with these compounds will set us apart in the market.
The Pure AI produces compounds that are pure in nature since the technology has the ability of separating pristine compounds from complex mixtures due to incorporating the use of vapor temperature within a static multiple theoretical plate system.
As only a single compound or component boils at a specific temperature under a high vacuum system, the machine uses this law of physics to separate out pure compounds by both molecular weight and the law of entropy and thermodynamics.
Dr. Gaur and Dr. Barse of the International Centre for Genetic Engineering and Biotechnology of New Delhi, India has been contracted will undertake a research project on a novel process developed by the Company’s CSO to assess the ability to produce psilocybin materials at scale.
The project is focussing on strain engineering to achieve a cost- competitive large-scale fermentative production of psilocybin with a purity of >98% in kilogram batch quantities for use as an API”
For the next stage we are developing a means of adapting this extraction method for large scale pharmaceutical GMP production of clinical grade psilocybin.
The Company has acquired an exclusive license to a proprietary extraction technology that will support these developments.
The company has secured a location in Vancouver to conduct research that is suitable for this development. The company has received a Section 56 Exemption (research license) from Health Canada. The team has extensive experience planning and building similar facilities.
The facility will be built out to a level 9 Security standard, the 2,500 square foot lab space will facilitate all foreseeable activities as well allowing for scaling and expansion. These activities will include research of novel compounds, extraction and purification methods. The Company has applied to Health Canada for Dealer’s License that will allow for movement of materials between licensees.
