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

Abstract

<b><i>Introduction:</i></b> The development of a novel dosage form for cannabis extract is necessary to improve drug delivery and also enhance patient convenience. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> This work succeeded in the fabrication of orally fast-disintegrating wafer tablets containing cannabis extract with desired properties.