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Updated: May 20, 2026

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Solid self-nanoemulsifying cyclosporine A pellets prepared by fluid-bed coating: stability and bioavailability study.

Yang Lei¹, Jianping Qi, Sufang Nie

¹School of Pharmacy, Fudan University, Key Laboratory of Smart Drug Delivery, Ministry of Education and PLA, Shanghai 201203, P. R. China.

Journal of Biomedical Nanotechnology

|July 7, 2012

Summary

Solid cyclosporine A (CsA) self-nanoemulsifying drug delivery system (SNEDDS) pellets showed good stability but reduced oral bioavailability. Fluid-bed coating improved performance, suggesting potential for enhanced drug delivery systems.

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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

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Published on: August 9, 2022

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

Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Nanotechnology

Background:

Solid dosage forms of self-nanoemulsifying drug delivery systems (SNEDDS) offer advantages over liquid formulations.
Cyclosporine A (CsA) is an immunosuppressant drug with variable oral bioavailability.

Purpose of the Study:

To evaluate the stability and oral bioavailability of solid CsA SNEDDS pellets.
To assess the impact of PVP K30 coating and fluid-bed coating on SNEDDS pellet performance.

Main Methods:

Preparation and in vitro characterization of solid CsA SNEDDS pellets.
Stability testing under stress (high temperature, illumination) and accelerated conditions (40°C/75%).
In vivo oral bioavailability study comparing coated pellets, liquid SNEDDS, and Neoral® in rats.

Main Results:

Solid CsA SNEDDS pellets (coated and uncoated) exhibited significant moisture absorption.
Pellets maintained CsA content within acceptable limits during stability testing.
Coated pellets showed improved redispersibility compared to uncoated pellets.
Oral bioavailability of coated CsA SNEDDS pellets was comparable to Neoral® and superior to uncoated pellets.
Liquid CsA SNEDDS formulation was bioequivalent to Neoral®.

Conclusions:

Solid CsA SNEDDS pellets require protective coating to maintain performance.
Fluid-bed coating is a promising technique for preparing stable and effective SNEDDS pellets.
Particle size of the pellet core may influence oral bioavailability, necessitating further optimization.