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.

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Materials

Isolated Δ9-THC (purity 98.9%) and CBD (purity 97.4%) were obtained from the Medicinal Cannabis Research Institute, College of Pharmacy, Rangsit University. Tween®80 was purchased from P.C. Drug Center Co. Ltd., Bangkok, Thailand. Gelatin (246 Bloom) and mannitol were purchased from Union Chemical 1986 Co. Ltd., Bangkok, Thailand. Sucralose was purchased from ChemipanCorporation Co. Ltd., Bangkok, Thailand. Sodium methylparaben and sodium propylparaben were purchased from Namsiang Co. Ltd., Bangkok, Thailand. The other chemicals and solvents used in this study wereAR or HPLC grades.

Monton C, Kulvanich P, Chankana N, Suksaeree J, Songsak T, Fabrication of Orally Fast Disintegrating Wafer Tablets Containing Cannabis, Extract Using Freeze Drying Method, ISSN: (Print), eISSN: 2504-3889 (Online), Med Cannabis Cannabinoids , DOI: 10.1159/000537926, Published online: February 20, 2024, https://karger.com/MCA

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