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Dispersion of Nanomaterials in Aqueous Media: Towards Protocol Optimization

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A novel USP apparatus 4 based release testing method for dispersed systems.

Upkar Bhardwaj¹, Diane J Burgess

¹School of Pharmacy, University of Connecticut, 69 North Eagleville Rd., Unit 3092, Storrs, CT 06269, USA. upkar.bhardwaj@uconn.edu

International Journal of Pharmaceutics

|January 20, 2010

Summary

A new dialysis adapter for USP Apparatus 4 offers superior in vitro release testing for dispersed dosage forms. This method effectively differentiates various formulations and liposome types, providing reliable and sensitive release data.

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Area of Science:

Pharmaceutical Technology
Drug Delivery Systems
Analytical Chemistry

Background:

In vitro release testing is crucial for evaluating dispersed dosage forms.
Current methods like dialysis sacs have limitations in discriminating release profiles.
A need exists for a compendial apparatus for testing complex formulations.

Purpose of the Study:

To develop and validate a novel dialysis adapter for USP Apparatus 4.
To compare its performance against traditional dialysis sac methods.
To assess its ability to discriminate release from various dosage forms and liposome compositions.

Main Methods:

Development of a novel dialysis adapter for USP Apparatus 4.
Optimization of the USP Apparatus 4 method, assessing flow rate and sample volume.
Comparative study with dialysis sac and reverse dialysis sac methods using dexamethasone formulations (solution, suspension, liposomes).

Main Results:

The USP Apparatus 4 method was not limited by flow rate or sample volume (250-500µL).
It successfully discriminated between solution, suspension, and liposome formulations.
It distinguished release from extruded/non-extruded liposomes and different phospholipid compositions (DMPC, DPPC, DSPC), outperforming dialysis sac methods.

Conclusions:

The novel dialysis adapter for USP Apparatus 4 is a sensitive and robust tool for in vitro release testing.
It addresses limitations of existing methods for dispersed systems.
This adapter provides higher release values and lower data variation, enhancing reliability.