FORMULATION AND EVALUATION OF NARINGENIN-LOADED SPANLASTICS TOPICAL GEL FOR THE TREATMENT OF ACNE VULGARIS

Abstract

Background: Acne vulgaris is a prevalent chronic inflammatory dermatological disorder, marked by the impedance of hair follicles and sebaceous glands.

Aim: The current research aimed to develop, optimize and characterize a Naringenin-loaded spanlastic topical gel formulation for the effective treatment of acne vulgaris.

Materials and Methods: Spanlastics, an elastic nanovesicles composed of Span 60 and Tween 80, were formulated using the ethanol injection method. The formulated spanlastics were optimized by 2³ Factorial design using Design of Experiments Software. The selected independent variables include: concentration of Span 60 (X₁), Tween 80 (X₂) and Sonication time (X₃). The dependent variables includes: Particle size (Y₁), % Encapsulation efficiency (Y₂) and Zeta potential (Y₃). The optimized spanlastics formulation was incorporated into a gel base. The prepared gel was evaluated for various characterization studies such as pH, viscosity and drug content. Morphological characterization was performed using transmission electron microscopy (TEM). In vitro drug release studies were performed to assess the release kinetics. Stability studies were carried out in accordance to ICH guidelines at accelerated storage conditions for three months.

Results and Discussion: The optimized spanlastics formulation showed a particle size of 157.7 nm, with a zeta potential of -32.4 mV and an entrapment efficacy of 89.4 %. The TEM analysis confirmed the presence of uniformly distributed spherical vesicles. The gel formulations exhibited pH values in the range of 6.9 to 7.3, with a viscosity ranging from 2884 to 5987 cps and drug content of 78 – 85 %. The in vitro release was within the range of 72.49 to 95.36 %. The results of minimum inhibitory concentration of naringenin against P. acnes was 0.8 µg/ml, indicating its potential as an effective antibacterial agent at this concentration.

Conclusion: In conclusion, naringenin-loaded spanlastics gel demonstrated an improved skin permeation, sustained release and notable antimicrobial activity, suggesting its potential as an effective topical treatment for acne vulgaris.