United States Patent:  6,074,673

Appl. No.:  639101

The present invention is directed to an implantable, slow-release, self-absorbing, biologically compatible drug delivery system such as slow-release pharmaceutical compositions, including for example, slow-release, allergy desensitization compositions containing one or more allergens in combination with a biologically-compatible, self-absorbing matrix. The present system is useful for treating disorders including, for example, infections, deficiencies or allergies. The present invention is also directed to methods of treating a patient suffering from a disorder, as well as methods for desensitizing a patient to one or more allergens. The present invention also relates to a device for implanting the present composition in a patient.

SUMMARY OF THE INVENTION

The present invention is directed to a slow-release, self-absorbing, pharmaceutical composition containing one or more active agents in combination with a biologically-compatible, self-absorbing matrix. More particularly, the present invention is directed to a slow-release, self-absorbing allergy desensitization composition containing one or more allergens in combination with a biologically-compatible, self-absorbing matrix. An objective of the present invention is to remove any dosage error due to patient non-compliance as well as minimize the amount of time a patient needs to spend in a doctor's office. Traditionally, allergy desensitization injections have had to be administered to a patient weekly by a doctor. This causes a major inconvenience for most people with significant allergic symptoms such as allergic rhinitis (hay fever), seasonal allergic rhinitis due to, for example, pollens, and asthma due to allergens.

The present composition, methods and device allow such patients to receive the same active ingredients in a slow-release, self-absorbing form at intervals of from about two weeks to about two months preferably at intervals of about one month, depending on the rate of absorption of the matrix in the subcutaneous tissue of the patient, and the degree of sensitivity of the patient. Once initial desensitization is reached maintenance dosage units can be implanted at intervals of about two to six months, preferably at intervals of about four months and most preferably at intervals of about every six months. Since the present composition contains a self-absorbing matrix, no removal of the matrix is necessary after the complete absorption of the active agent by the patient. After the initial desensitization series, patients need only receive a maintenance amount of the present allergy desensitization composition at intervals of from approximately two to ten months, preferably every four to eight months, and most preferably every six months, again depending on the rate of absorption of the matrix in the patient and the degree of sensitivity of the patient to the allergen(s).

The degree of sensitivity of a patient is easily determined by a medical doctor based on the patients' clinical history and allergy test results, either allergy skin tests or allergy laboratory tests, such as a RAST test. The RAST test is a radioallergosorbent test by which allergen-specific IgE antibodies are detected in the serum of a patient (Allergy, Principles & Practice, Middleton, Reed, Ellis, Adkinson, Yunginger, 3rd Edition, page 409 (1988)). These tests are read in a certain scale, for example, skin tests from 0 to 4+. Based on test results, the initial dose is determined. Generally, desensitization is started at a concentration of 1:10,000 w/v, but if the patient is extremely sensitive either by clinical history and/or skin tests result of 4+, it may be appropriate to start at a concentration of 1:100,000. This is a clinical decision which is specific for each and can be readily made by one of ordinary skill in the art, i.e., a physician.

The present invention is directed to an implantable, slow-release, self-absorbing pharmaceutical composition containing one or more active agents in combination with a biologically-compatible, self-absorbing matrix.

The present invention is further directed to a slow-release, self-absorbing, allergy desensitization composition containing one or more allergens in combination with a biologically-compatible, self-absorbing matrix.

The present invention is also directed to a method of desensitizing from one or more allergens, a patient suffering from allergies caused by said one or more allergens by administering to the patient a slow-release, self-absorbing, allergy desensitization composition, the composition containing one or more allergens in combination with a biologically-compatible, self-absorbing matrix, in an amount effective to desensitize the patient to the allergens.

The present invention is directed to a method for desensitizing from one or more allergens, a patient suffering from allergies by subcutaneously implanting in the patient a slow-release, self-absorbing allergy desensitization composition, the composition containing one or more allergens in combination with a self-absorbing, biologically-compatible matrix, in an amount effective to desensitize said patient to said allergens.

The present invention is also directed to a method for desensitizing from one or more allergens, a patient suffering from allergies by serially implanting over time, at least one dosage unit of a slow-release, self-absorbing allergy desensitization composition, the composition containing one or more allergens in combination with a self-absorbing, biologically-compatible matrix, where each dosage unit of the series increases in concentration from the prior dosage unit.

The present invention is also directed to a method for desensitizing an allergy patient from one or more allergens by a series of one or more dosage units of the present slow-release, self-absorbing allergy desensitization composition over time serially subcutaneously implanting in the patient, where a first dosage unit has a lowest concentration and each subsequent dosage unit has a higher concentration than the previous dosage unit in the series and where each dosage unit is implanted in the patient prior to the complete absorption of the previous dosage unit.

The present invention is further directed to an implantation device for subcutaneously implanting the present slow-release, self-absorbing, pharmaceutical composition in a patient, comprising a hollow cylindrical member having an inlet and an outlet, a hollow stylet having a sharp needle-like end and a blunt end, the stylet being slidable disposed within the cylindrical member such that the needle-like end is in slidable connection with the outlet of the hollow cylindrical member, and the blunt end extends beyond the hollow cylindrical member at the inlet end; and a pair of wings connected to a set of prongs present on the inlet of the hollow cylindrical member, where the hollow cylindrical member defines a hollow cylindrical unit.

The present invention is directed to an allergy-desensitization kit for use in desensitizing an allergy patient to one or more allergens, containing a series of one or more vials, each vial containing a single dosage unit of the present slow-release, self-absorbing allergy desensitization composition at a particular concentration, where a first vial contains a dosage unit having a first lowest concentration, while subsequent vials each contain a single dosage unit having a serially higher concentration than the previous vial in the series; packaged together with a device for subcutaneously implanting the present allergy desensitization composition in a patient, where the composition comprises one or more allergens in combination with a slow-release, self-absorbing, biologically-compatible matrix.

The present invention is directed toward an allergy desensitization kit for desensitizing an allergy patient to one or more allergens, containing a series of sterile disposable subcutaneous implantation devices, each device being preloaded with a sterile single dosage unit of the present slow-release, self-absorbing allergy desensitization composition containing one or more allergens in combination with a self-absorbing, biologically-compatible matrix, where each dosage unit contained in a separate device, increases in concentration from a first device having a first lowest concentration.

The present invention is directed to an implantation device for subcutaneously implanting the present allergy desensitization composition in a single-use disposable, sterile implantation device, where the device has a surgical steel stylet, and a polymeric hollow cylindrical member and a surgical steel pair of wings.

The present invention also is directed to a multi-use, implantation device for subcutaneously implanting the present allergy desensitization composition in a patient, where the device is produced from surgical steel.

The present invention is directed to a single-use, disposable implantation device for subcutaneously implanting the present allergy desensitization composition in a patient, where the device is produced from a polymeric material.

Claim 1 of 12 Claims

1. A slow-release, self-absorbing pharmaceutical composition comprising one or more active agents in combination with a biologically-compatible, self-absorbing matrix material, said one or more active agents mixed homogeneously with said biologically-compatible, self-absorbing matrix material to form a biologically-compatible, self-absorbing dry solid matrix, said matrix being shaped to be one selected from the group consisting of a solid cylinder and a hollow sleeve, and otherwise suitably configured for subcutaneously implanting with an injecting device.

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