Formulation and Evaluation of Topical Emulgel of Clascoterone

One common chronic inflammatory skin disorder in young adults is acne vulgaris. According to the Global Burden of Disease (GBD) study, it affects about 85% of people aged 12–25 years, with nearly four out of five adolescents experiencing it at some point. Acne involves the pilosebaceous units and appears as inflammatory or non-inflammatory lesions.

This study introduces emulgel based topical drug delivery system, providing uniform &

improved patient compliance.

2. MATERIALS AND METHODS

• Isoproyl myristate, Tween 80, PEG 400, Carbopol-940.
• A 3² factorial design was applied to optimize formulation variables.

RESULTS AND DISCUSSION

• 1. Evaluation of Optimized Batch (F5):
• These values confirm suitability for Topical delivery.

3.2 In-vitro Drug Release:

• 3. Statistical Analysis (ANOVA):
• Y₁ Model p-value = 0.0053 (< 0.05) → significant
• Y₂ Model p-value = 0.0010 (< 0.05) → significant
• Confirms model validity and optimization process.
  4. Stability Study:

• % Drug Release = 94.72 → 93.48
• No significant change

CONCLUSION

• The developed topical emulgel of Clascoterone showed excellent homogeneity,good consistency, skin compatible, viscosity, spreadability, extrudability, drug content, swelling index, % drug release, particle size & zeta potential.
• The formulation offers promising alternative to conventional cream.

REFERENCES

1. Raina N, Rani R, Thakur VK, Gupta M, “New insights in topical drug delivery for skin disorders from a nanotechnological perspective.” ACS Omega. 2023, 8(19), 19145-19167.
2. Waghmare ND, Hiwe KA, Bakal RL, Hatwar PR, Khansole NG, Saware US, “Emulgel: A Novel Topical Drug Delivery System.” Asian J Pharm Res Dev. 2025, 13(2), 82-91.
3. Jeong WY, Kwon M, Choi HE, Kim KS, “Recent advances in transdermal drug delivery systems: a review.” Biomater Res. 2021, 25:24.
4. Devi A, Yadav R, Bhateja P, Piplani M, “A systematic review on emulgel.” Int J Pharm Sci Res. 2025, 16(8), 2211-2227.
5. Lynn DD, Umari T, Dunnick CA, Dellavalle RP, “The epidemiology of acne vulgaris in late adolescence.” Adolesc Health Med Ther. 2016, 7, 13-25.
6. Lavagnino MA, Leger MC, “Interventions to increase adherence to acne treatment.” J Drugs Dermatol. 2016, 15(12), 1508-1512.
7. Kraus AL, Belsito DV, “Severity of acne vulgaris: comparison of two assessment methods.” J Am Acad Dermatol. 2007, 56(1), 101-105. 
8. Bhat YJ, Latief I, Hassan I, “Update on etiopathogenesis and treatment of acne.” Indian J Dermatol Venereol Leprol. 2017, 83(2), 135-148. 
9. Fox L, Csongradi C, Aucamp M, du Plessis J, Gerber M, “Treatment modalities for acne.” Molecules. 2016, 21(8), 1063. 
10. Dhawas V, Dhabarde D, Patil S, “Emulgel: A comprehensive review for novel topical drug delivery system.” Int J Recent Sci Res. 2020, 11(4C), 38134-38138.
11. Vishwakarma G, Panwar AS, “Emulgel emergent systems: at a glance for topical drug delivery.” Asian J Pharm Clin Res. 2022, 15(3), 8-14.
12. Kumbhar PR, Desai H, Desai VM, Priya S, Rana V, Singhvi G, “Versatility of emulgel in topical drug delivery: transforming its expedition from bench to bedside.” Expert Opin Drug Deliv. 2024, 21(12), 1-19.
13. Devi A, Yadav R, Bhateja P, Piplani M, “A systematic review on emulgel.” Int J Pharm Sci Res. 2025, 16(8), 2211-27.
14. Bhatti M.H.T, sohail S, et al., “Formulation, Development and Characterization of Ibuprofen Microemulgel for Arthritis.” Journal of Contemporary Pharmacy. 2022, 6(2), 57-64.
15. Sakarkar S, Jagdale S, Dargude S, Chabukswar A, Urooj S, Bilal A, Mengash HA, “Optimization of Anthralin Microemulgel Targeted Delivery for Psoriasis and Acne.” Molecules. 2025, 30(12), 2629.