Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
1998-08-18
2001-07-24
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S426000, C424S502000
Reexamination Certificate
active
06264991
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to methods and compositions for treating intracellular infections and to microsphere preparations used for such treatment.
2. Background Art
Diseases associated with intracellular infections often do not respond adequately to conventional drug treatment regimens, causing many patients to suffer relapses after being treated for such diseases. A wide array of drugs are used to treat diseases associated with intracellular infections. In addition, much research is devoted to identifying new drugs to treat such diseases. However, conventional drugs and drug treatments are often limited by toxicity which, for many drugs, is very close to the minimum inhibitory concentration of the drug, thus giving a very narrow window of drug efficacy. Treatment regimens also typically involve multiple doses, increasing the risk of treatment failure caused by patient noncompliance.
The present invention provides a unique regimen of compositions and methods for treating all intracellular infections, using any drug suited for the particular disease. The regimen of this invention targets drugs to infected cells, and is more successful treating intracellular infections than conventional regimens. The regimen of this invention reduces intracellular counts better than equivalent doses administered in conventional treatment regimens. The regimen of compositions and methods also requires fewer administrations, thus minimizing the risk of patient noncompliance.
SUMMARY OF THE INVENTION
In accordance with the purpose(s) of this invention, as embodied and broadly described herein, the invention, in one aspect, relates to a method of treating or preventing an intracellular infection in an animal in need of such treatment or prevention comprising administering to the animal a first effective amount of a first suitable drug contained in first biocompatible microspheres that have a diameter of from about 1 to about 10 microns, wherein the first microspheres release the first suitable drug upon administration at a first effective rate.
In another aspect the invention relates to a method of treating or preventing an intracellular infection in an animal in need of such treatment or prevention comprising administering to the animal a first effective amount of a first suitable drug contained in first biocompatible microspheres that have a diameter of less than or equal to 10 microns, wherein the first microspheres release the first suitable drug upon administration at a first effective rate.
In another embodiment the invention provides a composition for treating an intracellular infection in an animal comprising an effective amount of a suitable drug contained within biocompatible microspheres, wherein the microspheres have a diameter from about 1 to about 10 microns, and release the suitable drug upon administration at an effective rate.
In still another aspect the invention provides a kit for treating an intracellular infection in a patient comprising (a) an effective amount of a suitable drug contained within first biocompatible microspheres that release the suitable drug upon administration at a first effective rate, and (b) an effective amount of a suitable drug contained within second biocompatible microspheres that release the suitable drug upon administration at a second effective rate, wherein the first microspheres have a diameter from about 1 to about 10 microns, and the second microspheres have a diameter greater than about 10 microns, and wherein the drug may be the same or different for the first and second microspheres.
In another embodiment the invention provides a method for reducing the toxicity of a suitable drug used to treat intracellular infections comprising encapsulating a first effective amount of the suitable drug in first biocompatible microspheres that have a diameter of from about 1 to about 10 microns, and administering the microspheres to an animal, wherein the first microspheres release the suitable drug upon administration at a first effective rate.
In a still further embodiment the invention provides a method of making a drug formulation having reduced toxicity comprising encapsulating a first effective amount of the suitable drug in first biocompatible microspheres that have a diameter of from about 1 to about 10 microns.
Additional aspects and advantages of the invention will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
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Barrow Esther L.
Barrow William W.
Quenelle Debra C.
Staas Jay K.
Winchester Gary A.
Azpuru Carlos A.
Needle & Rosenberg P.C.
Southern Research Institute
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