Author(s):
Dhruvi Mehta, Riddhi Trivedi, Drashty Kakkad
Email(s):
dhruvimehta09@gmail.com , riddhi.trivedi@sal.edu.in , drashtykakkad@gmail.com
DOI:
10.52711/0974-360X.2026.00537 
Address:
Dhruvi Mehta1, Riddhi Trivedi2, Drashty Kakkad3
1PhD Scholar, Gujarat Technological University, Ahmedabad, India.
2Principal, SAL College of Pharmacy, Gujarat Technological University, Ahmedabad, India.
3Gujarat Technological University, Ahmedabad, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
Hypercholesterolemia is a disease that is one of the main causes of ischemic heart disease and ischemic strokes. A widely prescribed fixed-dose combination (FDC) is Ezetimibe and Simvastatin, exhibit poor solubility, leading to suboptimal bioavailability. This work introduces a novel nanosuspension to enhance solubility and dissolution. After preliminary screenings, Poloxamer 188 as stabilizer and High Pressure Homogenization method were selected for further optimization. A 3² full factorial design was employed with surfactant and polymeric stabiliser concentrations as independent variables, optimizing for particle size, entrapment efficiency and dissolution rate. The optimized nanosuspension exhibited a uniform particle size of 104.33 nm with stable zeta potential, and substantially improved dissolution (84.67% and 84.20% in 60 min for Ezetimibe and Simvastatin, respectively) compared to a marketed FDC (30% and 69% in 60 min for Ezetimibe and Simvastatin, respectively). DSC, XRD, and TEM confirmed nanoparticle formation and stability. In vivo studies demonstrated a significant reduction in cholesterol and LDL levels in rats which underscores enhanced therapeutic performance. The formulated nanosuspension significantly enhanced the dissolution and therapeutic performance of Ezetimibe and Simvastatin, offering a promising nanotechnology-based approach for fixed-dose combination therapy in Hypercholesterolemia.
Cite this article:
Dhruvi Mehta, Riddhi Trivedi, Drashty Kakkad. Formulation, Optimization and Evaluation of a Nanosuspension for the Fixed‐Dose Combination of Antihyperlipidemic Drugs. Research Journal of Pharmacy and Technology. 2026;19(8):3809-6. doi: 10.52711/0974-360X.2026.00537
Cite(Electronic):
Dhruvi Mehta, Riddhi Trivedi, Drashty Kakkad. Formulation, Optimization and Evaluation of a Nanosuspension for the Fixed‐Dose Combination of Antihyperlipidemic Drugs. Research Journal of Pharmacy and Technology. 2026;19(8):3809-6. doi: 10.52711/0974-360X.2026.00537 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-8-54
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