Improved, Modulated Release from Biocompatible Polymers for Effective Drug/Agent Delivery (Case 1277)

Principal Investigator:


Edith Mathiowitz, PhD, Professor

Department of Bio Med Molecular Pharmacology, Physiology & Biotechnology           

Brown University

Providence, RI


Brief Description:


Sustained release formulations have been prepared to provide a relatively constant release of prophylactics, therapeutics and diagnostic agents to more effectively treat diseases/conditions that require a relatively constant level of drug or agent in vivo.  Formulations such as biodegradable microspheres or films have been developed for controlled delivery.  However, the in vivo release from these biodegradable polymers is often not uniform throughout the life of the delivery device.  Some polymers degrade substantially after a period of hydration – in the body –, thereby limiting their effective life.  As such, many attempts have been made with the goal to create a system that provides a higher level of initial therapeutic release with longer periods of fairly consistent release levels at the site of interest.  Other typical problems arise from molecular weight limitations for the drug/agent when combined with a polymer, and/or the inconvenience of removing non-degradable polymers after therapeutic release.  Hence, the invention below improves upon the current state-of-the-art by offering a wide range of biocompatible polymer compositions for consistent, reliable, modulated drug/agent release.

This novel invention is a method and device for improved sustained delivery and modulated release (hours, days or months) of therapeutics, diagnostic agents and/or prophylactics via biocompatible polymers.  Specifically, a biocompatible polymeric matrix, with a monovalent cation component dispersed throughout, is created that holds drugs/agents for transport and subsequent controlled release.  The monovalent cation modulates the release of the incorporated drug/agent from the polymeric matrix.  Most simply, the biocompatible polymer is dissolved in a solvent to form a polymer solution; then, the monovalent cation and one or more drugs/agents are dispersed separately within this polymer solution, after which, the solution is solidified to form the polymeric matrix with dispersed cation and agent.  Salient release characteristics of initial and subsequent agent release levels, the amount of agent released, and/or the extent of the release period can be modified by selecting the type and concentration of the monovalent cation component dispersed in the polymeric matrix.  The cation particle size can also be selected to modify the release characteristics.  Any biocompatible polymer (biodegradable, non-biodegradable, copolymers, or blends of such) can be used with this method, and the matrix can be formed into desired, optimal, symmetrical or asymmetrical shapes – microparticle, cylinder, thin film, pellet, etc.  Also, any number of drugs/agents (proteins, nucleic acids, small molecules), including radioisotopes, can be incorporated for release, and the agents can be in a variety of particle forms such as crystalline, non-crystalline, freeze dried, and lyophilized particles.  Administration can be by multiple routes such as via implantation or injection (intramuscular, intravenous, subcutaneous, etc.) direct mucosal membrane delivery – intranasal -, suppository, or
in situ delivery.

The primary market is in pharmaceuticals – medical device – drug delivery and/or diagnostic systems.  However, other potential markets may be relevant such as: agricultural or environmental; personal consumer products; scientific R&D research tools.  Primary applications are in the production of a controlled and sustained delivery and release device such as for drug delivery and/or controlled release of biological material and/or other agents for site-specific, targeted treatment in the body.  Additional applications associated with other markets include for use in the production of: environmental/agricultural monitoring or treatment devices, various consumer products, and/or for use in R&D laboratory experiments to further the study of nanotechnology, biomedical science, and chemical engineering, material sciences, among other fields.


US patent 6,531,154 is issued (03/11/2003) 

Patent Information:
For Information, Contact:
Margaret Shabashevich,
Manager of Operations
Office of Industry Engagement & Commercial Venturing
Brown University
Edith Mathiowitz
Christopher Thanos
Wendy Webber
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