Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1999-11-05
2001-04-24
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S448000
Reexamination Certificate
active
06221384
ABSTRACT:
BACKGROUND OF THE INVENTION
Transdermal absorption dosage units have been developed for use with a variety of pharmaceutical products, including beta-blockers, estrogen replacements, and nitroglycerin. An example of a dosage unit has been disclosed in U.S. Pat. No. 4,666,441 granted to Andriola et al. As disclosed therein, a dermal or transdermal patch includes a compartmentalized layer containing at least one drug or drug formulation within a respective compartment. The walls separating adjoining compartments are burstable thus allowing the respective pharmaceuticals of each adjoining compartment to be mixed or worked together by the user prior to applying the patch. Typically, transdermal absorption dosage units comprise a number of layers including a removable backing layer, an adjoining layer including a dosage of a pharmaceutical, a biologically acceptable adhesive means and an impermeable coating. During treatment, a heath care professional selects the appropriate dosage from an array of prepackaged dosage units. Each dosage requires a different dosage unit selection. Hence, a medical professional may prescribe a particular dosage unit for a patient, but if the dosage is inadequate, either by providing too high or low a dosage for that particular individual, the patient must buy an additional supply of the new dosage. This can be costly and wasteful to the patient, as dosage units in the unsatisfactory dosage level are left unused. Further, this procedure is time consuming for both the medical professional and the patient, particularly in cases in which the dosage must be modified and monitored over time to achieve the optimal dosage result for a particular individual. In those instances, the medical professional must rewrite a prescription for the patient to refill each time a different dosage is to be tried.
SUMMARY OF THE INVENTION
In view of the above-noted concerns, and also to present a dosage unit that is not rupturable to permit mixing of pharmaceutical ingredients, the present invention teaches a novel dosage unit option for transdermal and dermal absorption dosage units. A conventional dosage unit comprises a removable backing layer that is impervious to the pharmaceutical product to be administered, an adjoining layer having dissolved or microdispersed pharmaceutical product therein, a biologically suitable adhesive means by which the dosage unit adheres to the skin of a patient receiving the dosage, and an impermeable coating. The present invention contemplates a series of perforations or alternately, scoring lines, with purpose to divide the dosage unit into a series of dose specific segments. Thus the dosage unit patch may be used in its entirety for the full dosage, or in the alternative, may be separated along perforate or scored lines to reduce the dosage received by a predetermined amount. For example, a dosage unit patch may allow administration of 0.1 mg of a pharmaceutical product, but, in accordance with the present invention, may come in the form of four perforately attached segments each having a dosage of 0.025 mg. In this example, a physician may then prescribe the full 0.1 mg dosage, or, if the patient is unable to tolerate the full dosage, may prescribe any fractional dosage obtainable by separating the appropriate fractional dose from the total dosage patch. Fractional doses unused after separation may be used at a later time, thus reducing waste.
This invention further contemplates a method of administering a controlled amount of a pharmaceutical to the skin of a patient by dermal or transdermal absorption. The method includes the steps of providing an absorption dosage unit having a removable backing layer which is substantially impervious to the pharmaceutical to be administered. The dosage unit further includes a biologically acceptable adhesive layer for securing the dosage unit to the patient, a membranous layer permeable to the pharmaceutical and containing a measured amount of the pharmaceutical, a protective coating layer which is substantially impervious to the pharmaceutical, and means for dividing and severing said segmented dosage unit. Further steps include manually severing a pre-selected number of segments from the dosage unit, removing the backing layer from the pre-selected number of segments to expose the adhesive layer and membranous layer of each of the pre-selected number of segments, adhesively attaching the exposed segmented membranous layer to the skin of a patient and allowing the segmented membranous layer to remain adhesively attached to the skin of a patient for a predetermined amount of time.
REFERENCES:
patent: 4666441 (1987-05-01), Andriola et al.
patent: 4883669 (1989-11-01), Chien et al.
patent: 4906169 (1990-03-01), Chien et al.
patent: 5046618 (1991-09-01), Wood
patent: 5145682 (1992-09-01), Chien et al.
patent: 5756117 (1998-05-01), D'Angelo et al.
patent: 0335231 (1989-10-01), None
patent: 0559411 (1993-09-01), None
patent: 2162422 (1986-02-01), None
patent: 2184019 (1987-06-01), None
Advertisement page: Esclim—estradiol transdermal system.
Fubara B.
Page Thurman K.
Ryan Kromholz & Manion S.C.
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