Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1993-03-24
2001-04-17
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S465000
Reexamination Certificate
active
06217905
ABSTRACT:
DESCRIPTION OF TECHNICAL FIELD
This invention pertains to a dosage form comprising at least one drug indicated for the management of abnormal posture, tremor and involuntary movement. More particularly, the invention concerns a dosage form that administers at least one therapeutically useful drug for treating Parkinson's disease.
DESCRIPTION OF BACKGROUND ART
In 1817, James Parkinson described Parkinson's disease as paralysis agitans. The most common symptoms for paralysis agitans are constant tremors in the hands and legs, body movements that become stiff, slow and weak with near paralysis, and sober-mask like facial expressions. Patients suffering with this disease have difficulty in maintaining an erect posture as they often have a stooped appearance, and they lean forward while walking with a shuffling gait.
The pathological cause of Parkinson's disease involves destruction of the nerve cells in the substantia nigra part of the brain, the part of the brain involved with muscle movements. The nerve cells of the substantia nigra use an in vivo chemical dopamine for transmitting signals between each other, and it is the absence of dopamine that leads to Parkinson's symptoms. Consequently, present medical treatment for Parkinson's disease comprises administering a drug that acts on the basal ganglia to exert a dopaminergic or an anticholinergic effect, or administering a drug that substantially lessens or blocks the body's monamine oxidase from metabolizing nerve cell dopamine. The medical history of Parkinson's disease is presented in
The Pharmacological Basis of Therapeutics
, by Goodman and Gilman, 7th Ed., Chap. 21, (1985), published by Macmillan Publishing Company, New York. The drugs administered by the prior art for treating Parkinson's disease are administered usually from a tablet or a capsule. These forms deliver a drug in a bulk, non-rate uncontrolled dumping dose that is subject also to the changing adverse environment of the gastrointestinal tract.
In the light of the above presentation, it will be appreciated by those versed in the drug dispensing art to which this invention pertains, that a pressing need exists for a dosage form that can administer a drug for treating Parkinson's disease at a controlled rate in a constant dose per unit time over a prolonged period of time. The need exists for an oral dosage form that can administer an anti-Parkinson's disease drug for its therapeutic dopaminergic, anti-cholinergic, or anti-monoamine oxidase effect substantially independent of the variable environment of the gastrointestinal effect. It will be appreciated further by those versed in the dispensing art, that such a novel and unique dosage form that can administer an anti-Parkinson's disease drug in a rate controlled dose over time, and simultaneously provide therapy in the brain, would represent an advancement and a valuable contribution to the art.
DISCLOSURE OF OBJECTS OF THE INVENTION
Accordingly, in view of the above presentation, it is an immediate object of this invention to provide a novel dosage form for delivering a drug for treating Parkinson's disease, and which dosage form substantially overcomes the deficiencies associated with the prior art.
Another object of the present invention is to provide a dosage form for administering at least one drug over a prolonged period of time for treating Parkinson's disease.
Another object of the present invention is to provide a pharmaceutically acceptable composition comprising a drug for treating Parkinson's disease, and which pharmaceutically acceptable composition can be delivered from a dosage form manufactured as a drug delivery device.
Another object of the present invention is to provide a pharmaceutically acceptable composition comprising a drug pair indicated for treating Parkinson's disease, and which pharmaceutically acceptable composition can be delivered from a dosage form manufactured as a drug delivery device.
Another object of the present invention is to provide a novel dosage form manufactured as an osmotic device that can administer an anti-Parkinson drug to a human receptor in need of anti-Parkinson therapy.
Another object of the present invention is to provide a novel and unique dosage form manufactured as an osmotic dosage form that can deliver an anti-Parkinson drug and concurrently substantially reduce and/or substantially eliminate the unwanted influences of the gastrointestinal environment of use and still provide controlled administration of the anti-Parkinson drug over time.
Another object of the present invention is to provide a dosage form adapted for oral administration of an anti-Parkinson drug, which dosage form comprises a first composition comprising an anti-Parkinson drug, and a second composition for the rate-controlled administration of the first composition comprising the anti-Parkinson drug.
Another object of the present invention is to provide a complete pharmaceutical regimen for the management of Parkinson's disease, which regimen comprises a composition comprising an anti-Parkinson drug that can be dispensed from a drug delivery device, the use of which requires intervention only for initiation and possibly for termination of the regimen.
Another object of the presented invention is to provide a carrier composition for an anti-Parkinson drug, wherein the ingredients forming the carrier composition and the anti-Parkinson drug are in close contact substantially-free of interaction.
Another object of the present invention is to provide a composition for delivering an anti-Parkinson drug, wherein the ingredients forming the composition are free from exerting an adverse or deteriorating effect of the anti-Parkinson drug.
Another object of the present invention is to provide a dosage form designed and manufactured as an osmotic device containing an anti-Parkinson drug that is delivered in a dose amount for producing the desired therapeutic effect, and which device delivers substantially a full complement of the drug thereby avoiding the need for drug overage for delivering the needed dose.
Another object of the invention is to provide a method for treating Parkinson's disease by orally administering an anti-Parkinson drug in a rate controlled dose per unit time to a warm-blooded animal in need of anti-Parkinson therapy.
Other objects, features and advantages of the invention will be more apparent to those versed in the dispensing arts from the following detailed specification, taken in conjunction with the drawings, and the accompanying claims.
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Ayer Atul Devdatt
Bhatti Gurdish K.
Carpenter Howard A.
Edgren David Emil
ALZA Corporation
Page Thurman K.
Stone Steven F.
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