MARINOL®
(dronabinol)
Capsules
CIII
Rx only
DESCRIPTION
Dronabinol is a cannabinoid designated chemically as (6 aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6 H -dibenzo[ b,d ]pyran-1-ol. Dronabinol has the following empirical and structural formulas:
Dronabinol, the active ingredient in MARINOL® (dronabinol) Capsules, is synthetic delta-9-tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol is also a naturally occurring component of Cannabis sativa L. (Marijuana).
Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.
Capsules for oral administration: MARINOL Capsules is supplied as round, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.
|
