Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-02-12
2001-05-01
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S489000, C514S772400
Reexamination Certificate
active
06224907
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to both novel and useful dosage forms comprising an antiasthma therapeutic. More particularly, the invention relates to dosage forms comprising leukotriene-receptor antagonists useful for antiasthma therapy. The invention concerns additionally therapeutic compositions comprising leukotriene-receptor antagonists, and the invention concerns a method for administering leukotriene-receptor antagonists to a patient in clinical need of antiasthma therapy.
BACKGROUND OF THE INVENTION
Medical history records asthma in the adolescent and in the adult is characterized by reversible airway obstruction, airway inflammation, and airway hyperactivity. Clinical manisfestations of asthma, such as wheezing and cough, are caused by airway obstruction, induced by reversible smooth-muscle constriction, edema and mucus secretion. Accepted medical evidence indicates asthma is an inflammatory disorder of the airways involving the production and activity of endogenous inflammatory mediators known as leukotrienes. The present treatment indicated for the management of this condition comprises the administration of a leukotriene-antagonist that produces a therapeutic benefit in the patient afflicted with asthma by inhibiting the action of leukotrienes at receptor sites on airway smooth muscles.
Leukotriene-antagonists are indicated by the medical and the pharmaceutical arts as anti-asthamatic agents for the treatment of asthma. The prior art treatment of asthma comprised administering orally a leukotriene-antagonist to a patient in need of repeated doses from once-to-four times a day. With this therapeutic profile, it is difficult to achieve continuous-prolonged therapy for the better management of asthma, as the program requires rigid compliance and it is cost ineffective.
The properties of the leukotriene-antagonists do not lend themselves to provide dosage form and drug formulations that can administer the leukotriene-antagonist at a controlled and known rate per unit time over an extended time to produce the intended therapy. For instance, the leukotriene-antagonists can be adversely affected by light, they can be insoluble in water, they can undergo a change in polymorphic form in the presence of water which results in decreased drug absorption, and they need protection from air. All of these are conditions that lead-away for sustained-release therapy in system.
It is self-evident from the above presentation a need exists for a delivery system selected from a dosage form and a drug formulation that can deliver the selected anti-asthmatic drug substantially protected from physical change and from the environment. The need exists to insure a complete dose of the anti-asthmatic drug is administered to a patient by the delivery system substantially independent of the changing environment of the gastrointestinal tract. Additionally, the need exists for a delivery system that can deliver a therapeutic dose of the selected anti-asthma drug for its intended effect and concurrently lessen the side-effects that can accompany the drug.
It will be appreciated by those in the dispensing art, that a need exists for a novel and unique sustained-release delivery system and for a method of administering an antiasthma drug in a rate-controlled dose over time. The need exists for a delivery system that can deliver a leukotriene-receptor antagonist from a sustained-release dosage form over twenty-four hours in a substantially constant dose per unit time for its beneficial therapeutic effect. Further, it will be acknowledged by those skilled in the dispensing art, that if such a novel and unique delivery system and method are made available that can administer the antiasthma drug in a sustained-release controlled dose over time, the delivery system and the method would represent an advancement and an unexpected contribution to the medical and pharmaceutical arts.
OBJECTS OF THE INVENTION
Accordingly, in view of the above presentation, it is an immediate object of this invention to provide a dosage form for delivering an anti-asthma drug from a delivery system in a sustained-release rate, which delivery system substantially overcomes the deficiencies and omissions associated with the prior art.
Another object of the present invention is to provide a dosage form for orally administering a leukotriene-receptor antagonist at a controlled-rate over an extended time indicated for treating asthma.
Another object of the invention is to make available a novel dosage form manufactured as a tablet that can administer a leukotriene-antagonist to a biological receptor to produce the desired antiasthma effect.
Another object of the invention is to provide a novel drug formulation that makes available controlled and sustained leukotriene-antagonist therapeutic activity to a patient in need of antiasthma therapy.
Another object of the present invention is to provide a dosage form manufactured as an osmotic dosage form that maintains a leukotriene antagonist in the dosage form protected from the environment including light and moisture until the leukotriene-antagonist is released from the dosage form and thereby substantially reducing and/or substantially eliminating the unwanted influences of the gastrointestinal environment of use and still provide controlled administration of the leukotriene-antagonist over a period of twenty-four hours.
Another object of the present invention is to make available a dosage form comprising a leukotriene-antagonist in an initial polymorphic form substantially-free of conversion to a different polymorphic form.
Another object of the present invention is to make available a dosage form comprising a leukotriene-antagonist in an amorphous form with a higher solubility and bioavailability protected by a formulation to substantially prevent its conversion to a crystalline form with decreased solubility.
Another object of the invention is to make available a dosage form adapted as a tablet that administers a leukotriene-antagonist at a controlled-rate over a sustained release time of twenty-four hours for its therapeutic benefit accompanied by a lessening of possible unwanted side-effects.
Another object of the present invention is to provide a dosage form that contains initially an amorphous leukotriene-antagonist protected by a light-resistant semipermeable polymeric wall from light and can be administered in a dose in a rate controlled by the dosage form.
Another object of the invention is to provide a dosage form adapted for oral administration of a leukotriene-antagonist in a single drug composition that operates with the dosage form for the controlled administration of the leukotriene-antagonist to a patient.
Another object of the invention is to provide a dosage form sized for oral administration comprising a leukotriene-antagonist in a first drug composition in contacting layered arrangement with a second force generating second push composition that operate in combination for the controlled administration of the leukotriene-antagonist to a patient.
Another object of the present invention is to provide a complete pharmaceutical leukotriene-antagonist regimen comprising a composition comprising a leukotriene-antagonist that can be dispensed from the composition, the use of which requires intervention only for initiation of the regimen.
Another object of the present invention is to provide a complete pharmaceutical leukotriene-antagonist regimen comprising a dosage form that dispenses the leukotriene-antagonist over time, the use of which requires intervention only for the initiation and possibly for termination of the therapeutic regimen.
Another object of the invention is to provide a method for treating asthma by orally administering a leukotriene-antagonist from a delivery device in a rate-controlled amount per unit time over twenty-four hours to a warm-blooded animal in need of antiasthma therapy.
Other objects, features and advantages of this invention will be more apparent to those versed in the delivery arts from the following detailed specificati
Ayer Atul Devdatt
Davar Nipun
Hwang Paul Minn
Pollock Brenda J.
Shivanand Padmaja
ALZA Corporation
Fubara Blessing
Page Thurman K.
Sabatine Paul L.
Simboli Paul B.
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