Formulation, Optimization and In-Vitro Assessment of a Montelukast Sodium-Loaded Proniosomal Gel for Sustained Drug Delivery in Asthma Management

Lalchand Devhare¹*, Anitha K N², Kazi Sarfaraz Masoodali³, Anita.A⁴, Shobha A. Ubgade⁵, Krishnakant B Bhelkar⁶, Tufail Dana⁷

¹*Nagpur College of Pharmacy, Wanadongri, Hingna Road, Nagpur, Maharashtra, India 441110
²Government College of Pharmacy, No 2, P Kalinga Rao Road, Subbaiah Circle, Karnataka, Bangalore 560027
³Fabtech College of Pharmacy, Sangola, Miraj-Pandharpur Road, Sangola Dist Solapur
⁴Dayananda Sagar University, Devarakagalahalli , Harohalli, Kanakapura Road 5602112
^5,6Gurunanak College of Pharmacy, Nari, Near Dixit Nagar, Kamptee Road, Nagpur
⁷Swami Vivekanand Sansthas Institute of Pharmacy, Mungase, Malegaon

Received: 18^th Aug, 2025; Revised: 26^th Sep 2025; Accepted: 14^th Nov, 2025; Available Online: 30^th Nov, 2025

ABSTRACT

Montelukast Sodium is widely used for the management of asthma,but its low bioavailability due to the first-pass effect limits its therapeutic efficacy. A novel proniosomal gel-based delivery system can enhance EE, improve stability, and provide sustained drug discharge over an extended period.This study aims to formulate and assess a Montelukast Sodium proniosomal gel using different non-ionic surfactants, penetration enhancers, and gelling agents to optimize drug encapsulation, stability, and controlled drug discharge.Montelukast Sodium proniosomal gel was made using the coacervation phase separation approach. Varioussurfactants (Span 20/60/80, Tween 20/80), cholesterol (to control drug leakage), soya lecithin (as a penetration enhancer), and carbopol (as a gelling agent) were incorporated. The formulations were assessed for Fourier-transform infrared compatibility studies, vesicle size analysis, scanning electron microscopy (SEM), drug entrapment efficiency (EE), drug content, rheological behavior, in vitro drug discharge, and stability as per ICH Q1C guidelines.The study confirmed that Montelukast Sodium was successfully entrapped in all nine formulations. The type of surfactant and cholesterol content significantly influenced drug discharge and EE. FTIR analysis indicated no drug-excipient interactions, and SEM studies revealed uniform, spherical vesicles. The vesicle size of the optimized formulation (F2) ranged from 3.33±0.12 to 5.83±0.21 µm, with an EE of 54.46±0.50% and a drug discharge of 90.81±0.031%. The discharge kinetics followed a zero-order model and fitted the Higuchi equation, suggesting Super-Case II transport diffusion. Stability studies demonstrated that the formulation remained stable for 90 days, with the highest drug retention observed at 4°C.The optimized proniosomal gel formulation (F2) exhibited enhanced drug entrapment, prolonged drug discharge, and improved stability, making it a promising alternative for sustained delivery of Montelukast Sodium in asthma management...

Keywords: Montelukast Sodium, Proniosomal gel, Entrapment efficiency, Diffusion studies.

How to cite this article: Devhare L, N AK,Masoodali KS, A A,Ubgade SA,Bhelkar KB,Dana T, Formulation, Optimization, And In-Vitro Assessment of a Montelukast Sodium-Loaded Proniosomal Gel for Sustained Drug Delivery in Asthma Management. Int J Drug Deliv Technol. 2025;15(4): 1814-1825, DOI: 10.25258/ijddt.15.4.34