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Related Experiment Video

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Quantitative and Temporal Control of Oxygen Microenvironment at the Single Islet Level

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Published on: November 17, 2013

Extrudable core system: development of a single-layer osmotic controlled-release tablet.

Kenneth C Waterman¹, Bruce C MacDonald, Michael C Roy

¹Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. ken.waterman@pfizer.com

Journal of Controlled Release : Official Journal of the Controlled Release Society

|December 23, 2008

Summary

A novel extrudable core system (ECS) tablet offers controlled osmotic delivery for high-dose, poorly soluble drugs. This innovative dosage form effectively manages drug release rates, even with substantial API content.

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Area of Science:

Pharmaceutical Technology
Drug Delivery Systems
Materials Science

Background:

High doses of poorly soluble active pharmaceutical ingredients (APIs) present challenges for effective drug delivery.
Existing controlled-release formulations may struggle with high API loads and specific release profiles.

Purpose of the Study:

To develop and characterize a novel controlled-release tablet system for osmotic delivery of high-dose, low-solubility APIs.
To evaluate the drug release characteristics and performance of the new dosage form.

Main Methods:

Development of a single-core tablet with a semi-permeable coating and an extrudable core system (ECS).
Formulation included hydroxyethylcellulose for API entrainment and a sugar for osmotic pressure.
Characterization of the tablet's ability to deliver APIs osmotically.

Main Results:

The ECS tablet successfully achieved controlled osmotic delivery of APIs.
The system demonstrated consistent drug release over a range of delivery rates.
Effective delivery was achieved even with up to 50% API content (approx. 500 mg).

Conclusions:

The developed extrudable core system (ECS) tablet is a viable dosage form for osmotically delivering high doses of poorly soluble APIs.
This technology offers a promising approach for controlled drug release with high API loading.
The system provides flexibility in managing drug delivery rates for challenging APIs.