Pivot has acquired worldwide rights for a patent pending topical transdermal drug delivery technology platform, or BiPhasix™, which we will use for the delivery and commercialization of cannabinoid, cannabidiol and tetrahydrocannabinol-based products.

BIPHASIX™ CBD TECHNOLOGY

Technology Overview

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


Alternative Routes

Pivot’s Proprietary BiPhasix™ can serve as an alternative dosage form to injectables by providing less invasive routes of administration such as dermal, transdermal, nasal, vaginal and rectal.

Controlled Release

BiPhasix™ can be formulated to effect varying degrees of tissue penetration and rate of release at the target site, in accordance with a desired clinical goal.

 Bioavailability Studies

Studies have shown that BiPhasix™ can significantly enhance the bioavailability of many drugs, leading to improved clinical outcomes.

Stability

BiPhasix™ has demonstrated excellent stability with most therapeutic agents tested, and in particular, proteins - which are characteristically unstable in traditional vehicles. Vulnerable drugs can be shielded from degradation in BiPhasix™, thereby enhancing their clinical usefulness and commercial viability. Compatible with most plastics and other container-closure systems

Solvent Free No Animal Products

Formulated with biocompatible materials. Neither organic solvents nor ingredients of animal origin are used in their manufacture.

Manufacturing Feasibility

Clinical supplies and commercial batches can be prepared using conventional manufacturing equipment and container closure systems. Specialized equipment and extensive capital investment are not required.

Patented

Provides market exclusivity for new drugs and the ability to introduce patented line extensions to a product portfolio

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.

EXCLUSIVE


- 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 (right panel) showing penetration of the BiPhasix vesicles into the skin