A comprehensive study on formulation and optimization of ivacaftor oral granules and determination of drug release by using USP-IV apparatus

Divyanshu Nagar*, Harshit Gautam

University Institute of Pharmaceutical Education & Research, University of Kota, Kota, Rajasthan, India

Refer this article

Divyanshu Nagar, Harshit Gautam, 2026. A comprehensive study on formulation and optimization of ivacaftor oral granules and determination of drug release by using USP-IV apparatus. Journal of medical pharmaceutical and allied sciences, V 15, I 4, Pages 49 – 54. Doi: https://doi.org/10.55522/jmpas.V15I4.7112.

ABSTRACT

Ivacaftor is a first-in-class CFTR potentiator which has transformed the treatment of cystic fibrosis by targeting the underlying molecular defect rather than treating the symptoms alone. However, it is classified as a BCS Class II drug with poor aqueous solubility, which greatly limits its clinical utility. This review is directed toward the formulation challenges of ivacaftor, discusses the advanced solubility enhancement approaches such as solid dispersion techniques and discusses the application of USP Apparatus IV (flow-through cell) for biorelevant dissolution testing. The convergence of pediatric patient needs, regulatory requirements for generic formulations, and advances in technology provides a compelling reason to develop optimized oral granule formulations. This review provides a summary of the current literature concerning the physicochemical properties of ivacaftor, formulation strategies and dissolution methodology with special emphasis on the benefits offered by the USP-IV apparatus over conventional dissolution methods for poorly soluble drugs.

Keywords:

Ivacaftor, Cystic fibrosis, Oral granules, USP-IV apparatus, Solid dispersion, Dissolution test, BCS class II, Solubility enhancement.

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