Microparticle protection of therapeutic agents

Abstract

The present invention is directed to the use of microparticles to protect the pharmaceutical effectiveness of a pharmaceutically active agent. According to one embodiment, a pharmaceutically acceptable suspension is provided that comprises microparticles and a pharmaceutically active agent. This pharmaceutically acceptable suspension is then exposed to a component or condition that is incompatible with the pharmaceutically active agent, such that the microparticles provide a pharmaceutical effectiveness that is greater than it would have been in the absence of the microparticles. Preferably, the microparticles result in a pharmaceutical effectiveness of the pharmaceutically active agent that is at least 10% greater than the pharmaceutical effectiveness of the pharmaceutically active agent would have been in the absence of the microparticles. Polymer microparticles, such as polystyrene microparticles, are one preferred class of microparticles. The microparticles preferably range from 0.01 to 100 microns in largest dimension, more preferably 0.1 to 10 microns in largest dimension. The microparticles are preferably provided in an amount of 0.1 to 1 wt % within the suspension. Agents comprising polynucleotides, including cells, plasmids and viral vectors, are a preferred class of pharmaceutically active agent. Other embodiments on the invention are directed to pharmaceutically acceptable suspensions, medical devices for parenteral injection, and methods of treatment.

Description

STATEMENT OF RELATED APPLICATIONS [0001] This is a divisional application and claims the benefit of priority to co-pending U.S. patent application Ser. No. 09 / 845,080, filed Apr. 27, 2001, and entitled “Microparticle Protection of Therapeutic Agents, which is related to U.S. Ser. No. 09 / 429,178 filed Oct. 28, 1999, now U.S. Pat. No. 6,638,259. This application is also related to U.S. Ser. No. 09 / 503,586 filed Feb. 14, 2000, now U.S. Pat. No. 6,663,606. Each of these applications is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION [0002] This invention relates to the protection of therapeutic agents and more particularly to novel techniques and compositions for the protection of therapeutic agents using microparticles. BACKGROUND OF THE INVENTION [0003] As noted in related U.S. Ser. Nos. 09 / 429,178 and 09 / 503,586, devices having metallic and polymeric components are used extensively in the medical field. In many cases, such medical devices are used for delivery...

AI Technical Summary

Benefits of technology

[0013] Another advantage of the present invention is that a pharmaceutically active agent can be stored in a storage container or delivered from a medical device that contains materials that would otherwise result in a substantial reduction in the pharmaceutical effectiveness of the pharmaceutically active agent.

[0014] Another advantage of the present invention is that a pharmaceutically active agent can be stored under conditions that would otherwise result in a substantial reduction in the pharmaceutical effectiveness of the pharmaceutically active agent.

[0015] Yet another advantage of the present invention is that an agent (i.e., microparticles) can be provided to protect the efficacy of the pharmaceutically active agent, but need not be introduced into a patient at the time of administration.

[0016] These and other embodiments and advantages of the present invention will become readily apparent to those of ordinary skill in the art upon review of the detailed description and claims to follow.

Problems solved by technology

Conditions incompatible with the pharmaceutically active agent include freeze-thaw transformations.

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