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Related Experiment Video

Updated: Jan 17, 2026

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

Validated Stability-Indicating RP-HPLC Method for Nirmatrelvir in Self-Emulsifying Drug Delivery Systems: Formulation

Ravi Patel¹, Ritu Sharma¹, Dignesh Khunt¹

¹School of Pharmacy, Gujarat Technological University, Gandhinagar, India.

Archiv Der Pharmazie

|September 23, 2025

Summary

This summary is machine-generated.

This study developed a novel self-emulsifying drug delivery system (SEDDS) to improve oral delivery of Nirmatrelvir. The validated HPLC method ensures quality assessment of this antiviral agent in lipid-based formulations.

Keywords:

Nirmatrelvir characterization high‐performance liquid chromatography self‐emulsifying drug delivery system stability study

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Published on: May 30, 2025

Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Analytical Chemistry

Background:

Nirmatrelvir is a poorly water-soluble antiviral agent requiring enhanced oral delivery strategies.
Quality assessment of poorly soluble drugs in advanced formulations presents analytical challenges.

Purpose of the Study:

To develop and characterize a self-emulsifying drug delivery system (SEDDS) for improved oral delivery of Nirmatrelvir.
To establish and validate a stability-indicating HPLC method for the quality assessment of Nirmatrelvir in SEDDS.

Main Methods:

Formulation of Nirmatrelvir-loaded SEDDS using Labrafac MC 60, ethanol, and Transcutol HP.
Characterization of nanoemulsion properties including droplet size, polydispersity, and transmittance.
Development and validation of a reverse-phase HPLC method according to ICH guidelines.
Forced degradation studies (oxidative, thermal, photolytic, acidic, alkaline) and LC-TQ/MS analysis of degradants.

Main Results:

Optimized SEDDS yielded nanoemulsion with droplet size of 145.23 nm and high transmittance (98.97%).
The SEDDS formulation demonstrated a fivefold increase in Caco-2 cell permeability compared to the tablet.
The validated HPLC method exhibited excellent linearity (R²=0.9999), accuracy (98.6%-100.2%), and precision (%RSD<0.3%).
Nirmatrelvir showed good stability under oxidative, thermal, and photolytic conditions, with maximum degradation under alkaline stress.

Conclusions:

The developed SEDDS effectively enhances Nirmatrelvir's oral permeability and offers a viable delivery strategy.
The validated stability-indicating HPLC method provides a reliable tool for routine quality control of Nirmatrelvir in lipid-based formulations.
The study offers a comprehensive approach to formulation development and analytical method validation for poorly soluble drugs.