Oral cannabinoid formulations
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.
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 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 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 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 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.