Abstract

FORMULATION AND EVALUATION OF HERBAL GUMMIES CONTAINING CYPERUS ROTUNDUS WITH SEDATIVE AND ANXIOLYTIC ACTIVITY

Dongare Vishakha Vishwanath*, Bhujabal Shreya Ravindra, Fulsundar Akshay, Dr. Ramteke Kuldeep, Dr. Datkhile Sachin

Abstract

Cyperus rotundus L. (family Cyperaceae), widely recognized as nut grass or nagarmotha, is a medicinally important plant characterized by a rich repertoire of bioactive phytochemicals. Notable among these are sesquiterpenoids (α-cyperone, β- selinene) and flavonoids (quercetin, kaempferol), which collectively endow the plant with substantial antioxidant, antiinflammatory, and antimicrobial properties. The current investigation was designed to develop and characterize sugarfree gummy dosage forms incorporating a standardized rhizome extract of C. rotundus as an innovative strategy for the delivery of phytoconstituents in a patient-compliant, palatable format suitable for individuals with diabetes and healthconscious consumers. Three gummy formulations (F1, F2, and F3) were prepared by varying gelatin concentrations as the primary gelling agent, with sorbitol and mannitol employed as sugar substitutes. Each formulation underwent physicochemical evaluation covering weight variation, thickness, hardness, gumminess, and moisture content. Phytochemical standardization was carried out through estimation of Total Phenolic Content (TPC) and Total Flavonoid Content (TFC), and antioxidant potential was quantified via the DPPH (2,2- diphenyl-1-picrylhydrazyl) free radical scavenging assay. Stability assessments were performed according to ICH Q1A(R2) guidelines under accelerated conditions (40°C ± 2°C / 75% RH ± 5% RH) across a three- month duration. Among the three formulations, F2 demonstrated the most favorable textural profile, exhibiting acceptable hardness, optimal gumminess, and the highest DPPH radical scavenging activity (IC₅₀ = X μg/mL). Satisfactory TPC and TFC values confirmed effective retention of bioactive constituents within the gummy matrix. Stability assessments indicated that all three formulations maintained their phytochemical potency and physical attributes without meaningful degradation during the study period. These findings establish that standardized C. rotundus extract can be successfully incorporated into sugar-free gummy matrices that function as stable and acceptable herbal nutraceutical delivery systems. The developed formulations are expected to improve patient adherence and broaden the therapeutic applications of C. rotundus phytochemicals within modern pharmaceutical dosage frameworks.

Keywords: Cyperus rotundus, Sugar-free gummies, Sesquiterpenoids, Flavonoids, DPPH assay, TPC, TFC, ICH stability, Nutraceuticals.