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Abstract

A direct compression formulation suitable for preparing buccal and/or sublingual and dosage forms incorporates a combination of a non-ionic polymeric solubility enhancer, a mucoadhesive polymer, a filler, a disintegrant, and a pharmaceutically active agent. Cannabinoid-cyclodextrin complexes exhibiting an improved property selected from improved stability, higher product yield and improved product uniformity may be obtained by complexing the cannabinoid with the cyclodextrin in a liquid medium containing an antioxidant. To enhance stability, product yield and/or product uniformity, complexing may be done while the liquid medium is in contact with an atmosphere having a very low oxygen content. The resulting complexes may be combined with decomplexing agents and/or dispersed in a matrix material comprised of a hydrogel-forming polymer to provide enhanced absorption of the cannabinoid through oral mucosa and reduced ingestion of the cannabinoid as compared with known commercially available cannabinoid-containing oral dosage forms.

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First Claim