MUMBAI, India, Feb. 13 -- Intellectual Property India has published a patent application (202521074652 A) filed by Parul University; Dr. Meenakshi Patel; Ankit Mishra; and Mitali Upadhyay, Vadodara, Gujarat, on Aug. 6, 2025, for 'pharmaceutical formulation of finerenone with improved solubility.'
Inventor(s) include Dr. Meenakshi Patel; Ankit Mishra; and Mitali Upadhyay.
The application for the patent was published on Feb. 13, under issue no. 07/2026.
According to the abstract released by the Intellectual Property India: "The present invention relates to a novel nanosuspension formulation of Finerenone, a BCS Class II drug, designed to overcome its inherent solubility and hence bioavailability limitations. The formulation is developed using a solvent-antisolvent precipitation technique, followed by high-speed homogenization and lyophilization. Polyvinylpyrrolidone K30 (PVP K30) serves as the stabilizer, sodium lauryl sulfate (SLS) as the surfactant, and trehalose as a cryoprotectant. A Quality by Design (QbD) approach was employed to optimize the formulation using Design of Experiments (DoE). The resulting nanosuspension exhibited significantly reduced particle size (~260 nm), low PDI ( 0.3), and enhanced zeta potential for stability. In vitro and ex vivo studies demonstrated a marked improvement in dissolution rate and intestinal permeability compared to the pure drug, achieving nearly complete drug release (98.13 %) and superior permeation (96.82 %). Characterization by FT-IR, DSC, XRD, SEM, and GC confirmed the physicochemical stability, amorphization, and absence of residual solvent. This nanosuspension formulation offers a promising and scalable strategy for improving the therapeutic efficacy and patient compliance in the treatment of chronic kidney disease."
Disclaimer: Curated by HT Syndication.
