Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1994-01-11
2002-03-26
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C514S255030, C514S866000
Reexamination Certificate
active
06361795
ABSTRACT:
DISCLOSURE OF TECHNICAL FIELD
This invention pertains to dosage forms comprising the drug glipizide. The invention relates also to compositions comprising glipizide, and the invention concerns additionally a method for administering glipizide to a patient in need of glipizide therapy.
DISCLOSURE OF BACKGROUND OF THE INVENTION
A clinical need exists for a dosage form and for a method for delivering an oral blood-glucose lowering drug to a patient needing this therapy. Glipizide is an oral blood-glucose lowering drug and it is indicated for the control of hyperglycemia and its associated symptomatology in patients with non-insulin dependent diabetes mellitus. Glipizide is useful therapeutically as an oral hypoglycemic drug because it stimulates insulin secretion from the beta cells of pancreatic-islet tissue, it increases the concentration of insulin in the pancreatic vein, and because it exhibits extrapancreatic action such as the ability to increase the number of insulin receptors.
Glipizide is known chemically as N-[2-[4-[[[(cyclohexylamino) carbonyl]amino]sulfonyl]phenyl]ethyl]-5-methylpyrazinecarboxamide. Glipizide is a white, odorless powder with a pKa of 5.9, and it is insoluble in both water and alcohol. These physical and chemical properties of glipizide do not lend the drug to formulation into a dosage form, and these properties do not lead to a method, that in both instances that can administer glipizide at a controlled and known rate per unit time to produce the intended therapy. The properties of glipizide are disclosed in
Martindale The Extra Pharmacopoeia
, 29th Ed., p 390, (1989); and,
AHFS Drug Information
, pp 1741-45, (1989).
In the light of the above presentation, it will be appreciated by those versed in the medical and in this pharmaceutical dispensing art to which this invention pertains, that a pressing need exists for dosage forms that can deliver the valuable drug glipizide in a rate-controlled dose to a patient in clinical need of blood-glucose lowering therapy. The pressing need exists also for an oral dosage form and for a method of therapy that can deliver glipizide at a controlled rate in a substantially constant dose per unit time for its beneficial therapeutic effects, and remain substantially independent of the changing environment of the gastrointestinal tract. It will be appreciated further by those skilled in the dispensing art, that if such a novel and unique dosage form and method is made available that can administer glipizide in a rate-controlled dose over time, and simultaneously provide a method of blood-glucose lowering therapy, the dosage form and the accompanying method would represent an advancement and a valuable contribution to the medical 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 dosage form for delivering glipizide in a rate controlled amount, and which dosage form 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 glipizide in a rate-controlled dose for blood-glucose lowering therapy.
Another object of the invention is to provide a pharmaceutical dosage form that makes available controlled and sustained glipizide therapeutic activity to a patient in need of glipizide therapy.
Another object of the invention is to provide a novel dosage form manufactured as an osmotic, diffusional, bioerodible or ion-exchange device that can administer glipizide to a biological receptor site to produce the desired glipizide pharmacological effects.
Another object of the present invention is to provide a dosage form manufactured as an osmotic, diffusional, bioerodible, or ion-exchange dosage form that maintains glipizide in the dosage form until released from the dosage form, thereby substantially reducing and/or substantially eliminating the unwanted influences of the gastrointestinal environment of use and still provide controlled administration of glipizide over time.
Another object of the present invention is to provide a dosage form that can deliver the substantially aqueous insoluble drug glipizide at a controlled and beneficial known rate over time.
Another object of the present invention is to provide a dosage form adapted for the oral administration of glipizide and which dosage form comprise a first composition and a contacting second composition that operate in combination for the controlled administration of glipizide.
Another object of the present invention is to provide a complete pharmaceutical glipizide regimen comprising a composition comprising glipizide that can be dispensed from a drug delivery dosage form, the use of which requires intervention only for initiation and possibly for termination of the regimen.
Another object of the invention is to provide a method for treating hyperglycemia by orally administering glipizide in a rate-controlled dose per unit time to a warm-blooded animal in need of hyperglycemia therapy.
Another object of the invention is to provide a method that engages osmotic, diffusional, bioerodible, or ion-exchange delivery for administering glipizide in a therapeutic dose per unit time or an extended time to a human patient in need of glipizide therapy.
Other objects, features and advantages of this 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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Martindale,The Extra Pharmacopoeia, 29th Ed. (1989) p 390.
AHF Drug Information, (1989) pp 1741-1745.
J. Am. Phar. Assoc., Sci. Ed., vol. 48 (1959) pp 451-459.
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Remington'sPharmaceutical Sciences, 14th Ed., (1970) pp 1626-1678.
Ayer Atul Devolatt
Kuczynski Anthony L.
Wong Patrick S.-L.
Alza Corporation
Miller D. Byron
Neller Robert R.
Webman Edward J.
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