Stable composition for inhalation therapy comprising delta-9-tetrahydrocannabinol and semiaqueous solvent therefor
AssigneeUnimed Pharmaceuticals, LLC
InventorsMahendra G. Dedhiya, Julia J. Economou, Andrea M. McPhillips, Beverley A. Wynne
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Abstract
A formulation of delta-9-tetrahydrocannabinol in a semi-aqueous solvent, such as 35:10:55 alcohol:water:propylene glycol (v/v), produces a stable clear solution near the solubility point of the drug. Because delta-9-tetrahydrocannabinol has poor affinity for the formulation, it is able to partition out and transport across cell membranes to reach the bloodstream quickly. This has been demonstrated by the comparative tmax values achieved in single dose intravenous and 14 day multiple dose inhalation studies conducted in dogs and rats.
Claims20
A stable, aerosolizable composition, the composition consisting essentially of a therapeutically effective amount of delta-9-tetrahydrocannabinol in a pharmaceutically-acceptable semiaqueous solvent comprising volumetric ratios of about 10-70 parts of ethanol, about 10-30 parts of water and about 30-80 parts of propylene glycol having a combined total of 100, provided that:
- (i) upon aerosolization the composition has a mean mass median aerodynamic diameter in the range from about 1 up to about 10 μM;
- (ii) the ratio of the ethanol, water and propylene glycol produces a stable clear solution near the solubility point of the delta-9-tetrahydrocannabinol such that upon administration to the lung, the partitioning of the delta-9-tetrahydrocannabinol from the solvent is enhanced so as to reach the bloodstream;
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- (iii) the composition is pharmaceutically suitable for rapid bronchial delivery to the lung of a subject.
A stable, aerosolizable composition, the composition consisting essentially of a therapeutically effective amount of delta-9-tetrahydrocannabinol in a pharmaceutically-acceptable semiaqueous solvent comprising volumetric ratios of about 10-70 parts of ethanol, about 10-30 parts of water and about 30-80 parts of a glycol selected from the group consisting of polypropylene glycol and polyethylene glycol having a combined total of 100, provided that:
- (i) upon aerosolization the composition has a mean mass median aerodynamic diameter in the range from about 1 up to about 10 μM;
- (ii) the ratio of the ethanol, water and propylene glycol produces a stable clear solution near the solubility point of the delta-9-tetrahydrocannabinol such that upon administration to the lung, the partitioning of the delta-9-tetrahydrocannabinol from the solvent is enhanced so as to reach the bloodstream;
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- (iii) the composition is pharmaceutically suitable for rapid bronchial delivery to a lung of a subject.
Dependencies are inferred from the claim text.