SOMNUS VITM Supplement for sleep and wellness Unscheduled and non-psychoactive, CANNABINOL represents a major market opportunity as a sedative as well as a potential treatment for insomnia, anxiety and symptoms of opioid withdrawal. We have developed a process to produce Cannabinol from Tetrahydrocannabinol. This provides a steady source of material to formulate into nutritional supplement products and clinical trials supplies. Our plan is to pursue FDA approval for SOMNUS VI as a sedative and potentially for other indications.
SOMNUS VI A Two phase approach to market development Phase 1 Market SOMNUS VI nationally as a nutritional supplement with testimonial claims for insomnia treatment, building a strong brand awareness and social following. Develop relationships in opioid-dependency treatment communities. Maintain message discipline during nutraceutical product release phase. Develop relationships with elder care facilities to introduce SOMNUS VI as an alternative for sleep aid medications. Phase 2 FDA Approval achieved for at least 1 indication. Direct medical marketing with label claims. Clinical trials to study Cannabidiol (CBD) products co-formulated with CBN. Develop extended release dosage forms and patches
SOMNIS VI 5, 10 and 25 mg formula Dosage is formulated with bioavailability enhancers and pharmacokinetic boosters. Production economics are favorable with up to 200,000 doses per kilogram for the lowest strength. Packaging for the nutraceutical and geriatric wellness markets will allow immediate market access but health claims will be limited to sleep support. Hard shell capsules in blister packs as initial configuration. Soft-gels and oral nano-emulsions as additional forms.
Investigational New Drug Application (IND) to New Drug Approval (NDA) PHASE 2 Our method for making Cannabinol will be combined with modern separation techniques to product CBN Isolate which will meet FDA requirements for purity as a candidate drug. GMP labs will be used to produce clinical trials supplies for FDA registered clinical trials in areas of Insomnia, Anxiety and Opioid Withdrawal. Clinical data collected on CBN will be used to inform a regulatory strategy aimed at gaining FDA approval for Somnus VI (Cannabinol) and possible combination with other cannabinoids (e.g. CBD and THC)
CBN Development and processing CBN is developed from the decomposition of THC and occurs naturally when Cannabis is exposed to air, heat and UV light or allowed to age. Acceleration and control of this process is conducted in laboratory conditions using concentrated THC distillate as the starting material. Advanced decomposition methods convert THC to CBN, whereby after reflux and distillation the CBN evolves as a concentrate of high purity ready for formulation and placement into hard or soft shell capsules. Starting material comes from licensed sources in the form of final distillate or bulk cannabis oil. Quality acceptance and process yield targets are produced via ISO Certified laboratory testing. Accurate measurement, testing and adherence to defined protocols are the benchmark for success in the production of CBN. The laboratory process and production environment must meet regulatory standards for nutritional supplements [phase one] (CFR 21 Part 111) and eventually of finished pharmaceuticals (Part 210 & 211) for [phase two].
Science supports the process The starting material (SM) is a distilled concentrate containing THC that will be converted to CBN. CBN is generated by controlled decomposition that is managed with temperature and vacuum in a reflux condition. The In-Process Material containing the CBN target is then final distilled producing a high concentration CBN distillate as a Finished Active. Finished Active is tested for CBN and THC potency and then formulated with bioavailability enhancers and pharmacokinetic boosters. The resultant formulation is a stable CBN concentrate with enhanced bio-availability specifically designed for oral dosing in capsule form
Commercial production capsule filling system Once quality tested, the CBN Finished Active is an oil of medium viscosity ready to be filled into hard or softshell capsules. Finished formulated and encapsulated doses are placed into blister packs with a foil backing. Packaging and blister labeling presents branding, dose, and warning information. The process for filling capsules can be completed by hand, however for commercial applications a liquid capsule filling machine is the solution for rapid, accurate and consistent production. Filling rates for hard shell capsules vary from 1000 to 100,000 units per hour depending on the system selected. Cost for these systems range from $30,000 to $150,000 respectively.
Blister packaging system A controlled environment is required for nutritional supplement and pharmaceutical production of SOMNUS VI. Packaging of finished dosage forms must meet standards for food and pharmaceutical manufacturing operations. Validation of CIP (Clean in Place) protocols will be established for all unit operations. Proper GMP documentation will be followed. Variants of this process: Manual capsule insertion and automatic sealing/manual boxing Automatic capsule insertion and automatic sealing/manual boxing. Automatic capsule insertion and automatic sealing/ automatic boxing with a cartoner The pace of the blister pack system will be selected to meet the capsule production line. Costs range from $12,000 to $95,000 for systems that meet the production output expected in the facility.
Revenue potential based on production value 1 KG of 70% THC Distillate (Starting Material) [estimated cost: $7500] Target of 80% CBN conversion for In-Process CBN: 700 gms Starting Material x.80 efficiency = 560 gms In- Process CBN 560 gms In-Process CBN refined via distillation to 93% purity = 520 gms Finished CBN Therefore: 1000 g Starting Material yields 520 gms CBN at 93% concentration. 520 gms Finished CBN = 520,000 mg x 93 % potency yielding 483,600 mg CBN 5 mg /dose yields 96,720 capsules Wholesale price per dose estimated at $2.00 to $2.40 each Value of 520 grams of concentrated CBN @ 5 mg dosage = $193,440 to $232,128
High value compound The value of this product is supported by multiple factors: 1. the compound potency allows for 5 mg/capsules to be an effective dose to achieve 6 hours of virtually uninterrupted sleep. 2. the processing for CBN can be integrated into an accredited manufacturing facility in a vertical fashion without major reinvestment to support the project. 3. Starting Material cost compared to Finished Product value supports the entire project consideration, as such; the finished product cost factor is estimated at.039 cents per dose; the formula used is the Dose Value Multiplier (DVM). The DVM can be expanded to include both fixed and variable costs associated with the project. 4. Viable market positions welcome a product that enhances the sleep cycle 5. Expedited recovery of expense for plant assets required to package the product is supported by the DVM. The dose value multiplier serves as the basis for project viability. To help bring into perspective the value of the Finished Product, using gram value comparison X DVM the product carries a value of $372.00 per gram.
Sleep Aid Market Segment 2017-2025 Drugs are widely used as sleep aids across the globe. The drug segment stood at around US$ 38.0 M in 2017 and is estimated to reach value of more than US$ 5.7 Bn by the end of the year of assessment (2025). The over-the-counter (OTC) sleep aids segment of the United States insomnia pharmacological treatment market is expected to grow at the highest CAGR during the forecast period. Reasons attributing to the growth of this market include easier availability, low prices, and publicity regarding the side effects of the prescription sleep aids has also steered the patients towards OTC sleep aid. Sleep aid is a billion dollar business Developing a sleep aid that has superior performance, nonnarcotic effects, no hangover and is derived from a natural compound has big value.