Oral cannabinnoid liquid formulations and methods of treatment
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Abstract
A room temperature stable aqueous cannabinoid formulation is disclosed. In preferred embodiments, the cannabinoid formulation comprises dronabinol in a mixture of buffer solution, and organic cosolvents such as ethanol, propylene glycol and polyethylene glycol.
91 Citations
180 Claims
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1-159. -159. (canceled)
- 160. An oral liquid pharmaceutical formulation comprising an effective amount of dronabinol and at least one pharmaceutically acceptable excipient, the formulation providing a mean Cmax of dronabinol of from about 0.143 to about 0.493 ng/ml, based on a 2.5 mg dose of dronabinol administered to a population of human subjects.
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178. A method of treating nausea and vomiting associated with cancer chemotherapy comprising administering to a patient in need thereof an oral dronabinol syrup formulation comprising an effective amount of dronabinol and at least one pharmaceutically acceptable excipient, the formulation providing a median Tmax of about 1.5 to about 2 hours when orally administered to humans.
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179. The method of claim 179 wherein the formulation provides a mean Cmax when administered to a population of human subjects selected from the group consisting of about 0.318 ng/ml+/−
- 0.175 based on a 2.5 mg dronabinol dose, about 1.04 ng/ml+/−
0.52 based on a 5 mg dronabinol dose, 3.09 ng/ml+/−
1.46 based on a 10 mg dronabinol dose, and combinations thereof
- 0.175 based on a 2.5 mg dronabinol dose, about 1.04 ng/ml+/−
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180. A method of manufacturing an oral dronabinol syrup formulation comprising an effective amount of dronabinol and at least one pharmaceutically acceptable excipient comprising:
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admixing dronabinol, phosphate buffer and absolute alcohol; the formulation providing a median Tmax of about 1.5 to about 2 hours when a dose is administered orally to humans, said phosphate buffer having a pH of about 7.
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Specification