International Journal of Drug Delivery Technology
Volume 15, Issue 3

Design and Development of Nanoparticulate Dosage Form of Ivacaftor for Treatment of Cystic Fibrosis

Bhavesh Mali1, Kandukuri Sushma1*, Himanshu Patel1, Nidhi Raichura2

1Department of Pharmaceutics, Parul University, Vadodara, Gujarat-391760, India

2Department of Pharmaceutical Chemistry, Parul University, Vadodara, Gujarat-391760, India 

Received: 21st Jun, 2025; Revised: 1st Aug, 2025; Accepted: 14th Aug, 2025; Available Online: 25th Sep, 2025

ABSTRACT

Objective: This study aimed to develop Ivacaftor-loaded Poly(lactic-co-glycolic acid) (PLGA) nanoparticles to enhance drug solubility, pulmonary delivery, and therapeutic efficacy in CF patients.

Methods: PLGA was used to prepare Ivacaftor nanoparticles by the single-emulsion solvent evaporation method, using polyvinyl alcohol (PVA) as a stabilizer and a solvent system of ethanol and dichloromethane. Optimization of the formulation was carried out by changing the polymer-to-drug ratios, surfactant concentration, homogenization speed and time of sonication. The characterization of the produced nanoparticles, including particle size, polydispersity index, encapsulation efficiency, kinetics of drug release, and stability, was assessed.

Results: The optimized formulation achieved high encapsulation efficiency alongside a narrow size distribution and mean particle size that was tailored for pulmonary administration. In vitro drug release studies showed sustained release of the drug, exhibiting zero-order kinetics. Stability studies confirmed the physical and chemical stability of the nanoparticles over the duration of the storage period.

Conclusion: The PLGA nanoparticulate system containing Ivacaftor, developed in this study, holds potential for targeted pulmonary delivery in cystic fibrosis therapies. The system is designed to improve solubility and enable controlled drug release, thereby increasing bioavailability, reducing systemic exposure, and improving patient adherence through less frequent dosing. Further investigations, both in vivo and clinical, are needed to establish its therapeutic promise.

Keywords: nanoparticulate system, Ivacaftor, Cystic Fibrosis, PLGA

How to cite this article: Bhavesh Mali, Kandukuri Sushma, Himanshu Patel, Nidhi Raichura. Design and Development of Nanoparticulate Dosage Form of Ivacaftor for Treatment of Cystic Fibrosis. International Journal of Drug Delivery Technology. 2025;15(3):1119-29. doi: 10.25258/ijddt.15.3.30

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