Title:  Pharmaceutical delivery device and method of preparation therefor

United States Patent:  6,203,813

Appl. No.:  169042

The present invention provides an opiate antagonist implant which is an admixture of an opiate antagonist, in either acid or base form, and a pharmaceutically acceptable carrier. The admixture is uniformly compressed into a subcutaneously implantable pellet which is effective to release levels of the opiate antagonist over desired amounts of time when subcutaneously implanted in a patient to effectively inhibit the effects of a number of addictive drugs.

SUMMARY OF THE INVENTION

To overcome the deficiencies of the above-described drug delivery devices, in one aspect, the present invention provides a subcutaneously implantable opiate antagonist and when implanted in a patient the antagonist is effective as a self-sustaining delivery mechanism for its own dissolution and for delivery over a desired extended period of time to effectively block the effects of heroin and/or other opiates, thus eliminating the craving response of addicts, and preventing re-addiction. The inventive implant is also useful in blocking the positive reinforcement from a number of other addictive substances including cocaine, alcohol, and nicotine. The opiate implant of the invention is effective to maintain sufficiently high levels of an opiate antagonist in a detoxified patient for an extended period of time, preferably at least about seventy-five days and longer in order to prevent a former addict from relapsing and to greatly aid in the rehabilitation of opiate-addicted patents.

The implant, which comprises an admixture of an opiate antagonist, an anti-inflammatory agent and a pharmaceutically acceptable carrier, is manufactured by compressing the admixture, preferably uniformly, into a subcutaneously implantable pellet containing antagonist in concentrated form, wherein such compressed admixture is effective to deliver therapeutically effective levels of an opiate antagonist when subcutaneously implanted over an extended period of time in a patient, for example, up to seventy-five days and longer.

In another aspect of this invention, there are provided subcutaneously implantable implants comprising any of a number of pharmaceutically and/or biologically active substances and drugs, including, but not limited to, protein drugs such as insulin, drugs used to treat rheumatoid arthritis and other forms of arthritis, antibiotics, and antiviral substances including anti HIV vaccines, deworming and distemper drugs such as those administered to pets and/or livestock, and drugs used for treating urinary tract infections, cancer-control/antineoplastic agents, vitamins and nutraceuticals, and any other pharmaceutical/biologically active substances. In similar manner as their opiate antagonist-comprising counterparts, these inventive implants are effective to maintain the desired drug/substance levels for an extended period of time, up to and exceeding ninety days. These drug comprising implants are prepared from compressed admixtures comprising one or more drugs, an anti-inflammatory agent and a pharmaceutically acceptable carrier in the form of a subcutaneously implantable pellet.

Claim 1 of 40 Claims

What is claimed is:

1. An opiate antagonist subcutaneous implant comprising an admixture of an opiate antagonist, an steroidal anti-inflammatory agent and a pharmaceutically acceptable carrier.

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