Fabrication of Orally Fast-Disintegrating Wafer Tablets Containing Cannabis Extract Using Freeze-Drying Method

Abstract

Introduction: The development of a novel dosage form for cannabis extract is necessary to improve drug delivery and to also enhance patient convenience. Methods: Orally fast disintegrating wafer tablets containing cannabis extract, which were prepared using the freeze drying technique, were developed in this work. The formulation consisted of several key components: cannabis extract as the active compound, Tween® 80 as a surfactant and solubilizer, gelatin and mannitol as structural components, sucralose as a sweetening agent, and sodium methylparaben and sodium propylparaben as preservatives. Results: The optimized formulation consists of the following ingredients: 5% cannabis extract, 1.25% Tween® 80, 5% gelatin, 88.34% mannitol, 0.2% sucralose, 0.19% sodium methylparaben, and 0.02% sodium propylparaben. The resulting wafer tablets exhibited the following characteristics: a porous structure, an average weight of approximately 200 mg, minimal weight variation (less than 1.4%), slightly acidic pH (pH 5.12), disintegration within 10 s, low moisture content (less than 3%), a Δ9-tetrahydrocannabinol content of approximately 2.8 mg, and a cannabidiol content of approximately 0.9 mg. Additionally, the wafer tablets rapidly dissolved in simulated saliva fluid containing sodium lauryl sulfate. Conclusion: This work succeeded in the fabrication of orally disintegrating wafer tablets containing cannabis extract with desired properties.