Development of Mouthwash Product Prototype Containing Cannabis Root Extract: Stability and Acute Toxicity Assessment
Keywords:
cannabis root extract, mouthwashes, acute toxicity, product development, stability testAbstract
Cannabis sativa subsp. indica has been used for various purposes, especially for medical use. In the past, cannabis root has been used as an ingredient in mouthwash recipes to treat periodontitis. Objectives: This study aimed to develop prototype mouthwash formulations containing cannabis root extract and to evaluate their physical stability and acute toxicity. Materials and Method: the formulation extract, including four ingredients in equal proportions; Cannabis sativa, Smilax corbularia, Smilax Glabra and Syzygium aromaticum were extracted by decoction (water extract) and followed by freeze-drying. Mouthwash formulations with various extract concentrations were prepared. Physical stability; appearance, sedimentation, color, pH, and viscosity were evaluated after exposure to accelerated conditions (Heating-Cooling Cycles) and during storage at 30 °C for 3 months, compared to freshly prepared samples (Day 0). Acute toxicity was evaluated using the brine shrimp lethality assay (Artemia salina). Data were analyzed using descriptive statistic.
Results:Nine formulations of mouthwash products containing cannabis root extract were developed. Among these, Formulations 2, 5, and 8, with extract concentrations of 0.5, 1.0, and 1.5 mg/mL, respectively, were selected as suitable candidates for stability studies. The freshly prepared samples and those stored under real-time storage conditions at 30 °C for 3 months exhibited similar physical characteristics, including clear appearance with yellow, light brown, no sedimentation. pH ranged from 6.15 to 6.80, and viscosity ranged from 4.95 to 5.35 cP. Under accelerated storage conditions (heating–cooling cycles), reductions in both pH and viscosity were observed. Acute toxicity tests revealed low toxicity against brine shrimp, with LC₅₀ values between 501.12 and 820.24 µg/mL. Conclusion: The three selected mouthwash formulations containing cannabis root extract demonstrated good stability upon preparation and after storage at 30 °C for 3 months.
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