Synergistic combinations of atorvastatin and cannabidiol (CBD)
Inventors
Sherwood, Mathew • Smeeding, James
Assignees
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Publication Number
US-12115137-B2
Publication Date
2024-10-15
Expiration Date
Abstract
The invention relates to pharmaceutical compositions comprising a statin and a cannabinoid, and their use for the treatment of hypercholesterolemia and atherosclerosis. It has been found that compositions combining a statin and a cannabinoid are improved over existing statin formulations. The compositions of the invention for example allow for a lower effective dose of statin and a reduction of the adverse effects seen with statins taken alone. Dosing ranges and formulations suitable for oral, buccal, and sublingual administration are disclosed. Various specific cannabinoids such as cannabidiol and synthetic cannabidiols selected for their anti-inflammatory, antioxidant, and anti-atherosclerotic effect are shown to be particularly advantageous.
Core Innovation
The invention relates to pharmaceutical compositions and methods using a statin, including atorvastatin, in combination with a cannabinoid, particularly cannabidiol (CBD), for treating patients with lipid disorders. The compositions are formulated for oral or mucosal administration and are intended for once daily dosing. The compositions include less than or equal to 40 mg atorvastatin and between about 100 mg and 500 mg cannabidiol (CBD).
The stated problem is the treatment of hypercholesterolemia and atherosclerosis using statins while addressing statin-associated adverse effects, including myopathy and related conditions. The document describes that combining atorvastatin with cannabidiol (CBD) is intended to provide beneficial lipid disorder treatment while mitigating risks associated with statin exposure. The approach also includes cannabinoid embodiments described as non-psychoactive/THC-free, including biologically sourced or synthetic cannabidiol.
The invention further centers on improved oral or mucosal bioavailability and the use of shared CYP enzyme metabolism/inhibition. The document references CYP3A4, CYP2C19, and CYP2C9, describing CYP inhibition and CYP substrate overlap as a basis for improved bioavailability. The combination concept is tied to formulation and administration via oral, buccal, or sublingual routes consistent with mucosal administration.
Claims Coverage
The independent claims are clm-00001 and clm-00012, covering a once daily pharmaceutical composition and a once daily treatment method with the same quantitative composition constraints. Across the independent claims, the key inventive features involve combining ≤40 mg atorvastatin with about 100–500 mg cannabidiol (CBD) and formulating for oral or mucosal administration.
Once daily oral or mucosal atorvastatin–CBD composition for a lipid disorder
A pharmaceutical composition for once daily dosing, useful in treating a patient with a lipid disorder, comprising less than or equal to 40 mg of atorvastatin and between about 100 mg and 500 mg of cannabidiol (CBD), wherein the pharmaceutical composition is formulated for oral or mucosal administration.
Once daily oral or mucosal atorvastatin–CBD method for treating a medical condition
A method of treating a medical condition in a patient in need of such treatment, comprising administering to the patient a pharmaceutical composition for once daily dosing, comprising less than or equal to 40 mg of atorvastatin and between about 100 mg and 500 mg of cannabidiol (CBD), wherein the pharmaceutical composition is formulated for oral or mucosal administration.
Overall, the independent claim set focuses on once daily administration of an oral or mucosal pharmaceutical composition that combines limited-dose atorvastatin (≤40 mg) with cannabidiol (about 100–500 mg). Dependent claims refine the atorvastatin upper limits and the CBD ranges, and also specify particular medical conditions such as hypercholesterolemia and atherosclerosis.
Stated Advantages
Synergistic effect enabling lower effective statin doses.
Reduction of statin-associated adverse effects, including statin-associated myopathy.
Improved oral/buccal/sublingual bioavailability.
Documented Applications
Treating patients with lipid disorders using a once daily pharmaceutical composition comprising atorvastatin and cannabidiol (CBD) formulated for oral or mucosal administration.
Treating hypercholesterolemia using the atorvastatin–CBD oral or mucosal composition.
Treating atherosclerosis using the atorvastatin–CBD oral or mucosal composition.
Treating medical conditions selected from dysregulation of cholesterol metabolism, myositis, rhabdomyolysis, or statin-associated myopathy.
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