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The objectives of this study were 1 to assess the safety tolerability and pharmacokinetics of ascending doses of 9-tetrahydrocannabinol-hemisuccinate THC-HS after rectal administration as suppositories in male volunteers and 2 to compare the pharmacokinetics of oral administration of 9-tetrahydrocannabinol 9-THC with an equivalent amount of 9-THC delivered as THC-HS via the suppository formulation In support of the pharmacokinetic evaluations an analytical method was developed and validated for the determination of 9-THC and for its major circulating metabolites 11-hydroxy- 9-tetrahydrocannabinol 11-OH-THC and 11-nor- 9-tetrahydrocannabinol-9-carboxylic acid THC-COOH in human plasma 9-THC 11-OH-THC and THC-COOH were extracted from plasma using solid phase extraction and analyzed by liquid chromatography-tandem mass spectrometry The limits of detection and quantitation for all 3 analytes were 0 25 and 0 5 ng mL respectively The method was validated over the range of 0 5 25 ng mL This method was used to quantify 9-THC and any THC-HS as 9-THC due to the inclusion of a hydrolysis step as part of the extraction procedure Therefore 9-THC measured was the total THC free 9-THC plus 9-THC derived from THC-HS The assay was reproducible for the measurement of all 3 analytes with a variability of 7 2 13 7 and 8 3 respectively at the 1 ng mL level The method was then used to assess the pharmacokinetics of 9-THC and metabolites from the suppository dosage form in doses equivalent to 1 25 2 5 5 10 and 20 mg 9-THC per suppository as THC-HS Systemic exposure to 9-THC administered as THC-HS suppository increased broadly dose proportionally Systemic exposure and Cmax obs estimates for 11-OH-THC and THC-COOH generally increased subproportionally The pharmacokinetic profiles of 9-THC and metabolites were also compared after oral administration of 10 mg 9-THC as dronabinol capsules and after administration of 10 mg equivalents of 9-THC as THC-HS in suppository form Total systemic exposure to 9-THC was considerably higher following rectal administration of THC-HS than after oral administration The 9-THC area under the plasma concentration versus time curve AUC 0 for THC-HS was 2 44-fold higher 90 confidence interval 1 78 3 35 than for the capsule administration

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Pharmacokinetics and Tolerability of Δ9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for...

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