Description

When drugs that are taken orally (e.g., tablets and capsules) are absorbed into the blood stream, they are transported directly to the liver before circulating throughout the body. As a result, many drugs are metabolized in the liver before reaching the intended site in the body. Furthermore, several drugs are irritating to a patient and can also be degraded by the acidic environment in the stomach or by the enzymes and the microflora present in the gastrointestinal tract.

This invention embodies a transmucosal patch that is a bilayered, hot-melt extruded film that adheres to the mucosa in the mouth and slowly swells to release medication in a unidirectional path. The drug containing layer is applied to the gum and the cover layer prevents adhesion to the lip. Further, the film can also contain a therapeutic agent that can be sized and shaped to provide controlled delivery of the said agent through the skin or to the buccal mucosa of the mouth. Lastly, the films can be used for wound treatment as well.

Benefits

• Drugs absorbed in this manner do not undergo first-pass metabolism by the liver.
  
• Problems related to stability and irritation can be overcome.

Features

• The process to prepare the films is simple and rapid, and no water or solvents are used to extrude the drug delivery system.
  
• The extrusion process can be adapted to almost any therapeutic agent.
  
• All components are approved by the FDA for use in human and animal drug formulations.
  
• The process employs standard commercial equipment
  

Market Potential/Applications

Nearly all compounds would be potential candidates for this delivery system. This dosage form could be used for new chemical entities or for line extensions of existing products.

IP Status

U.S. Patent issued: 6,375,963

For further information please contact:

University of Texas,
Austin, USA
Website : www.otc.utexas.edu