Formulation and Invitro Anti-Inflammatory Activity of Polyherbal Oral Gummies

Abstract

Background: Herbal gummies represent an emerging chewable oral dosage form that combines the therapeutic value of medicinal plants with improved palatability and patient acceptance. Clove (Syzygium aromaticum) and cardamom (Elettaria cardamomum) are traditionally used spices reported to possess anti-inflammatory activity, but their combined use in a single polyherbal gummy formulation has been little explored. Objective: This study aimed to formulate polyherbal oral gummies containing clove and cardamom extracts and to evaluate their physicochemical properties and in vitro anti-inflammatory activity. Methods: Authenticated clove and cardamom were extracted by cold maceration in ethanol and screened for phytoconstituents. Three gummy formulations (F1–F3) were prepared by the moulding method using gelatin as the base and evaluated for weight variation, pH, moisture content, thickness, physical appearance, stability and disintegration time. Anti-inflammatory activity of the aqueous extracts was assessed by the albumin denaturation inhibition assay over a concentration range of 100–500 µg/mL, using diclofenac sodium as the standard. Results: Phytochemical screening revealed alkaloids, flavonoids, tannins, saponins and terpenoids in clove extract, and alkaloids, terpenoids, tannins, glycosides and carbohydrates in cardamom extract. The optimized formulation (F2) showed an average weight of 4.696 g (deviation within ±7.5%), pH 4.05, moisture content 16.17% w/w, average thickness 4.89 mm, disintegration time 9.83 min, and physical stability over four weeks. Both extracts produced concentration-dependent inhibition of protein denaturation, reaching 82.16 ± 1.62% (clove) and 79.24 ± 1.30% (cardamom) at 500 µg/mL, compared with 89.24 ± 2.80% for diclofenac sodium. The estimated IC50 values were 151.9 µg/mL for clove and 168.3 µg/mL for cardamom. Conclusion: Syzygium aromaticum and Elettaria cardamomum can be successfully formulated into a stable, palatable polyherbal gummy with demonstrable in vitro anti-inflammatory activity, supporting their potential as a natural adjunct for managing mild inflammatory conditions, particularly of the oral cavity, pending further in vivo validation.