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Metastable polymorph of etoposide with higher dissolution rate.

J C Shah¹, J R Chen, D Chow

¹Department of Pharmaceutical Sciences, College of Pharmacy, Medical University of South Carolina, Charleston, USA.

Drug Development and Industrial Pharmacy

|February 24, 1999

Summary

Developing a new etoposide polymorph significantly improved its solubility and dissolution. This metastable etoposide form offers enhanced oral bioavailability for cancer treatment.

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Area of Science:

Pharmaceutical Sciences
Materials Science

Background:

Etoposide, a crucial anticancer drug, exhibits poor oral bioavailability.
This limitation stems from its low aqueous solubility, slow dissolution, and instability in acidic environments.

Purpose of the Study:

To enhance the aqueous solubility and dissolution rate of etoposide.
To achieve this by inducing polymorph formation.

Main Methods:

Etoposide was crystallized from various organic solvents to generate different polymorphs.
Physicochemical properties including crystal habit, thermal behavior (hot-stage microscopy, DSC), IR spectrum, solubility, and dissolution rates were analyzed.

Main Results:

A metastable polymorph of etoposide was successfully identified upon crystallization from isopropanol.

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This metastable form demonstrated a 1.9-fold increase in equilibrium solubility (221 µg/ml) and a 1.7-fold increase in intrinsic dissolution rate (16.3 µg/min/cm²) compared to etoposide powder at 25°C.

Conclusions:

Polymorph formation is an effective strategy to enhance the solubility and dissolution of etoposide.
The identified metastable polymorph holds potential for improving etoposide's oral bioavailability and therapeutic efficacy.