Cannabinoid-containing complex mixtures for the treatment of mast cell-associated or basophil-mediated inflammatory disorders

Inventors

Small-Howard, Andrea • Turner, Helen

Assignees

GBS Global Biopharma Inc

Abstract

Provided herein are cannabinoid-containing complex mixtures suitable for use as active pharmaceutical ingredients. The complex mixtures are comprised of the major cannabinoid, cannabidiol, a first minor cannabinoid, which is cannabigerol, at least a first selected terpene, and optionally a second minor cannabinoid. Also provided are methods of making the complex mixtures, pharmaceutical compositions comprising the complex mixture, and methods of using the pharmaceutical compositions for the treatment of mast cell-related immune disorders, including allergy and atopy (allergic asthma, eczema, rhinitis), mast cell activation syndrome (MCAS), physical and chemical urticarias, idiopathic urticaria, Crohn's disease, inflammatory bowel disorder, dermatitis and contact dermatitis, arthritis and rheumatoid arthritis, canine mastocytosis, and allergy and inflammation in cattle, swine, etc. The methods of the present invention further relate to the treatment of various basophil-mediated immune disorders.

Core Innovation

The document describes cannabinoid-containing complex mixtures as active pharmaceutical ingredients for mast cell- or basophil-mediated inflammatory disorders. In particular, it discloses treating Mast Cell Activation syndrome by administering a pharmaceutical composition comprising cannabidiol (CBD) together with specific minor cannabinoids and specific terpenes, in the presence of a pharmaceutically acceptable carrier or diluent, and the composition is substantially free of delta-9 tetrahydrocannabinol (THC), stated as being free of delta-9 THC.

The disclosed compositions are defined in terms of a major component and selected minor groups, including major cannabidiol (CBD) with minor cannabinoids such as cannabigerol (CBG), cannabichromene (CBC), and cannabidivarin (CBDV), and selected terpenes such as limonene and linalool. The document further describes compound-selection concepts using major/minor/terpene groupings and sub-mixtures, including ENT sub-mixtures (ENT1-ENT12), and provides formulation ranges and routes of administration.

Mechanistically and functionally, the document focuses on targeted mediator readouts associated with mast cell activation, including mast cell degranulation via FcεRI and histamine release, and de novo lipid mediator release via LTC4. It reports that certain CBD plus ENT complex mixtures significantly inhibit FcεRI-induced degranulation and LTC4 release, including effects described as synergistic or greater-than-additive compared to predicted sums from individual components, and highlights CBG as supporting synergy with CBD and terpenes.

Claims Coverage

The partial content provides one independent claim directed to treating Mast Cell Activation syndrome, with dependent claims refining subject and administration parameters by limiting routes of administration, adding dose constraints, and specifying the dosing schedule options and subject type. The main inventive features across the independent claim are the specific cannabinoid/terpene composition and the explicit delta-9 THC-free condition.

Across the independent claim, coverage centers on treating Mast Cell Activation syndrome using a CBD-based pharmaceutical composition that includes specific minor cannabinoids (CBG, CBC, CBDV) and specific terpenes (limonene and linalool), formulated with a pharmaceutically acceptable carrier or diluent, with the composition being free of delta-9 THC. Dependent claims further narrow coverage by specifying human subjects and by refining administration routes, dosing frequency, and CBD per-dose maximum constraints as described in the partial claim set.

Stated Advantages

Documented Applications