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Last Updated: January 26, 2022

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Claims for Patent: 10,265,293


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Summary for Patent: 10,265,293
Title:Oral cannabinoid formulations
Abstract: Oral cannabinoid formulations, including an aqueous-based oral dronabinol solution, that are stable at room or refrigerated temperatures and may possess improved in vivo absorption profiles with faster onset and lower inter-subject variability.
Inventor(s): Goskonda; Venkat R. (Phoenix, AZ), Chavan; Ashok (Chandler, AZ), Kokate; Amit (Englewood, NJ), Gill; Howard (Scottsdale, AZ)
Assignee: INSYS DEVELOPMENT COMPANY, INC. (Chandler, AZ)
Application Number:15/132,896
Patent Claims: 1. A stable oral pharmaceutical solution comprising: (a) dronabinol at a concentration of about 0.54%; (b) alcohol at a concentration of about 15-65%; (c) a co-solvent consisting of propylene glycol, polyethylene glycol, or a mixture thereof at a concentration of about 17.5%; (d) an antioxidant; and (e) water in a concentration of less than 31.9%.

2. The stable oral pharmaceutical solution of claim 1 wherein a 4.25 mg dose of dronabinol provides a pharmacokinetic profile of a subject in a fasted condition of C.sub.max of 1.95.+-.1.28 (ng/mL), AUC (0-t) of 3.53.+-.1.87 (h*ng/mL), AUC (0-inf) of 3.84.+-.1.80 (h*ng/mL) or a T.sub.max of 0.50-4.00 (h).

3. The stable oral pharmaceutical solution of claim 1 wherein a 5 mg dose of dronabinol provides a pharmacokinetic profile of a subject in a fasted condition of C.sub.max of 2.4.+-.1.30 (ng/mL), AUC (0-t) of 4.23.+-.1.97 (h*ng/mL), AUC (0-inf) of 4.48.+-.1.94 (h*ng/mL) or a T.sub.max of 0.25-4.00 (h).

4. The stable oral pharmaceutical solution of claim 1 wherein a 4.25 mg dose of dronabinol provides a subject in a fasted condition with a time to first measurable concentration of 0.15.+-.0.07 (h).

5. The solution of claim 1, wherein the solution is suitable for delivery to a gastrointestinal tract or a mucosa of an oral cavity.

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