Formulation Development and Evaluation of Herbal Hard Candy Lozenges for Reducing Tobacco Withdrawal Symptoms and Promoting Healing of Tobacco-related Oral Lesions

Abstract Introduction: Despite the well-known health hazards linked with smoking and tobacco use, the availability of treatment options to aid in tobacco cessation is limited. Cravings for nicotine are among the most prevalent withdrawal symptoms of tobacco addiction. Oral lesions are another frequent problem associated with tobacco use. There aren’t many choices for treating these lesions, even if giving up tobacco usage is the greatest way to prevent them. These lesions may be treated with prescription drugs, such as topical creams and mouthwashes. The present study aimed at developing and evaluating polyherbal hard candy lozenges that could aid in tobacco cessation and promote healing of tobacco-related oral lesions. Materials and Methods: Preformulation ultraviolet (UV) analysis and antioxidant assays were performed to determine the optimal ratio for the combination of extracts. Guava leaf, Tulsi, Turmeric, and Oat extracts were used to prepare the hard candy lozenges using the heating and congealing technique. The lozenges were tested for organoleptic properties, thickness, diameter, variation in weight, friability, hardness, drug content, and in vitro dissolution. Results: The UV analysis showed the presence of flavonoids and their derivatives in all four herbal extracts. The antioxidant assay revealed the highest scavenging activity for the combination of extracts comprising 2 parts of Guava, 4 parts of Tulsi and Turmeric, and 3 parts of Oats extract. The herbal hard candy lozenges had a smooth texture, pleasant taste, and dimensions of 20.41 ± 0.18 mm in diameter and 9.53 ± 0.30 mm in thickness. The hardness of the lozenges was 30.98 ± 1.13 kg/cm 2 , and the uniform extract content was 97.7%. Lozenges had an average oral dissolving time of 10 ± 2 min. In vitro , the dissolution of hard candy lozenges was tested in a pH 6.8 phosphate buffer, with 97.7% of the medication released within 30 min. Conclusion: Herbs with good medicinal properties can be used in the form of lozenges to have both systemic and local effects. The use of herbal lozenges can be an alternative to Nicotine lozenges, which can aid in both smoking and smokeless tobacco cessation.