Pivot has acquired worldwide rights for four proprietary drug delivery technologies for the delivery and commercialization of cannabinoid, cannabidiol and tetrahydrocannabinol-based products
TRANSDERMAL NANOTECHNOLOGY FOR CANNABINOIDS
1% CBD Nano-Particulate Cream – Ready for Commercialization
- Patent applied lipid-based Nano Dispersion technology for topical cannabinoids using FDA approved materials
- Developed in Israel and animal tested for its transdermal properties
- Ability to specifically formulate various cannabinoids to control and prolong their release while maintaining steady therapeutic concentrations
- Can formulate to achieve transdermal formulations with high cannabinoids concentration
- Formulations do not cause a change to skin morphology
- Cannabinoids delivery through the skin avoiding sensitivity to the digestive system or pain from injection
- No observed adverse reaction
MICELLE ORAL DRUG DELIVERY TECHNOLOGY FOR CANNABINOIDS
1% CBD > 99% Pure – Ready for Commercialization
Solmic Solubilisation Technology Platform:
Pivot has acquired worldwide rights from Solmic GmbH (a privately / held German company) for the development and commercialization of “Solmic Solubilisation Technology Platform” for defined cannabinoids or cannabinoid-containing extracts. The formulation technology provides significantly higher bioavailability and stability compared to alternative oil-based formulations. This technology strongly enhances the uptake of water insoluble ingredients by keeping lipid soluble compounds trapped in micelles and thus increase significantly the uptake of these molecules from the intestine.
Solmic’s technology allows active ingredients to become water soluble without changing their composition and nature. Solubilized substances that are packed in micelles are protected from degradation from light, stomach acid, and from enzymes released in the intestinal tract. In addition, micelles can mask unpleasant smells and tastes. The micellisation process results in a stable, homogenous and transparent mixture, thereby significantly increasing uptake from the gut into the blood system of fat soluble ingredients, resulting in greater bioavailability.
TOPICAL DELIVERY TECHNOLOGY FOR CANNABINOIDS
1% CBD BiPhasix Cream – Ready for Commercialization
BiPhasix™ can entrap & transport drugs & biologics products through human skin to achieve therapeutic benefit in a wide range of indications and can carry active pharmaceutical ingredients in the range of ~300 Da to ~100 kDa
Pivot’s Proprietary BiPhasix™ can serve as an alternative dosage form to injectables by providing less invasive routes of administration such as dermal, nasal, vaginal and rectal
BiPhasix™ cannabinoids formulations have demonstrated excellent stability in accelerated and long-term stability tests.
Solvent-Free No Animal Products
Formulated with biocompatible materials. Neither organic solvents nor ingredients of animal origin are used in their manufacture. All materials are FDA approved
Clinical supplies and commercial batches have been prepared using conventional manufacturing equipment. Specialized equipment and extensive capital investment are not required
BiPHASIX™ PATENTED TOPICAL DRUG DELIVERY TECHNOLOGY
Patented BiPhasix is a dermal delivery system for macromolecules that:
- Has shown to be safe in pharmaceutical testing in human subjects
- Flexible and able to deliver both lipophilic and hydrophilic molecules
- Vesicles are composed of phospholipid bilayers (formed from pro-liposomal gel) which entraps an oil-in-water (o/w) submicron emulsion
- Hydrophilic APIs are incorporated into the aqueous phase of the o/w emulsion whereas lipophilic APIs can be incorporated into the oil phase of the submicron emulsion.
- BiPhasix products cause transient change in polymorphic state of stratum corneum (sc) lipids thereby changing the fluidity and permeability of the sc membrane
- BiPhasix vesicles interact with lipids in the sc and form aqueous penetration channels which serve as conduits for hydrophilic molecules
- It is believed that delivery of the BiPhasix vesicles is achieved by the uptake of the vesicles and encapsulated drug into the skin or mucosa via the lipid rich channels
- Followed by release of drug from the vesicles in a formulation-controlled manner
- The result may be either a rapid cutaneous transit time, to produce primarily transdermal delivery of the drug; or depot formation within the skin, with slow release for primarily dermal delivery of the drug
- Hypothetical diagram (above) showing penetration of the BiPhasix vesicles into the skin
RTIC “Ready To Infuse Cannabis”
TECHNOLOGY FOR TRANFORMATION
OF CANNABIS OIL TO POWDER
CAPSULES, STICK PACKS, BULK POWDER, BEVERAGES, BAKED GOODS
Our ecologically friendly process starts with high grade cannabis leaves and flowers. Using CO2 supercritical extracting methods as a cleaner, safer, and purer way to extract the essential oils, the final product consists of 95% pure cannabinoids. Finally, we infuse these purified oils into multiple GMO free substrates to allow homogenized blending into almost any food or beverage ingredient. Triple lab tested for consistency and consumer satisfaction.
RTIC infused substrates are a breakthrough in the science of edible cannabis, enabling maximum absorption of THC or CBD. RTIC’s proprietary technology allows the tested purified essential oils of the cannabis plant to be powderized, allowing it to be effectively blended with either dry or liquid ingredients.
The properties of RTIC infused substrates allow THC & CBD and other beneficial cannabinoids to reach the bloodstream faster than with traditional edibles, with onset as fast as 10-15 minutes. Scientists who study cannabis call this bioavailability, a term for the amount of substance that can be absorbed and utilized by our bodies after ingestion. Normally, the enzymes and acids in our stomach and liver destroy or filter out cannabinoid compounds before they have an opportunity to be absorbed. RTIC infused substrates increase in bioavailability which makes lower doses much more effective, allowing for less overall consumption.
All of RTIC Labs processes and SOPs follow HACCP Certification procedures & Orange County California Health Department requirements.
NASAL AND PULMONARY BREATH-PROPELLED,
MULTI-DIRECTIONAL DRUG DELIVERY SYSTEMS™
RTIC Cannabis Powder Combined with the TriVair™ Delivery System
The TriVair™ Nasal device uses the body’s natural breath to propel a medication deep into the nasal cavity to targeted sites, bypassing the Blood Brain Barrier, providing the potential to better treat central nervous system diseases such as migraines, epilepsy, insomnia, and post-operative pain, the latter of which is often remedied by opioids.
The TriVair™ Pulmonary device enables specific dosing to the pulmonary airways, thereby targeting the lungs. Such targeting can be highly relevant in the treatment of respiratory diseases and in the prevention and treatment of respiratory infections.
Pivot will combine its patented RTIC™ cannabis powder technology with the TriVair™ delivery system to provide a rapid onset effect for patients and consumers in markets where regulations permit.
- Large access to vascular beds
- Large surface area in nasal mucosa
- Drugs are absorbed directly into the bloodstream thus bypassing GI metabolism: avoiding GI side effects
- Provides a way to bypass BBB and deliver drugs directly to CNS
- Faster onset of action – ideal for acute conditions (migraine, epilepsy, seizures, pain, etc.)
- Less systemic side effects
- Presence of lymphatic tissue in nasal mucosa suggests potential of nasal vaccine delivery