Optimizing extraction methods
The cannabis plant is highly complex with over 500 elements. From a pharmaceutical industry perspective, it is an amorphous Active Pharmaceutical Ingredient (API) for which there are challenges to chemically and biologically profile the active ingredients. There can also be huge variability in batches from one harvest to another. Many growers have developed standardized cultivation methods to reduce these variabilities but that is only the beginning. If you approach this from a pharmaceutical manufacturing perspective, you must somehow bring the variability into tolerance ranges aligned with the pharmaceutical industry.
This process starts with the extraction method and Scientus has developed a proprietary method for extraction and activation of API from natural cannabis plant materials. The result is an intermediary resin that can be used in a range of dosing forms. We use proprietary methods to qualify the resin as an API-like material, profiling phytochemicals and phytocannabinoids. Our methods provide the chemical and biological QC appropriate for pharmaceutical grade product lines.
In general, existing extraction methods in this industry do not adequately activate the API, nor do they compensate for large batch-to-batch variability inherent in natural plant materials. Scientus has solved these challenges on both fronts.
The next step in the process is to focus on producing different dosing forms. There are questions we must ask. For example, do we want to have quick absorption and quick onset for treatment for acute pain? Or do we want a formulation that offers sustained release for treatment of chronic pain.
Our Scientus researchers are working through all these challenges to develop a range of dosing forms and biochemical profiles for treatment of many disease indications such as neuropathic and other pain conditions, epilepsy, PTSD, and others.
In numerous studies, cannabinoids have been proven to be relatively safe. In drug research terms, it is difficult to demonstrate a lethal dose. There are however several other potential adverse effects that require further study, but the drug is generally considered to have a good safety and tolerance profile.
Our approach to clinical research is the following: before we can focus resources on specific clinical trials to demonstrate statistical validity of the efficacy of a cannabinoid profile to treat neuropathic pain, we can contribute value to the debate by providing substantive data on dosing response, pharmacokinetics, and on chemistry and formulation.
With this in mind, our first clinical trials are designed to examine the bioavailability and distribution of different cannabinoid profiles, dose responses, and adverse effects.
Collaborations are an integral part of our strategy at Scientus. We welcome the opportunity to partner with companies whose expertise in relevant therapeutic areas can help us develop and commercialize medicines for the patients who need them most. We are also open to speaking with potential investors to assist our growth and potential.
Scientus supports groups like the ICRS (International Cannabinoid Research Society) – a great community of scientists worldwide dedicated to studying the plant and its potential. As they advance the science, we are actively seeking collaborations in that community.
Our larger vision is that we want Scientus to be a genuine hub for research and development. The different spokes are comprised of international cannabinoid researchers, the physician and healthcare community, traditional pharma and biotech companies. Our role would be to maintain strong networks drawing from all these different specialities.