Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1999-07-22
2002-04-23
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S464000, C424S441000, C424S466000, C424S456000, C424S489000, C206S528000, C206S531000, C206S534000, C206S538000
Reexamination Certificate
active
06375956
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a disposable dispensing apparatus and method for providing nutritional and/or therapeutic agents to humans and other animals. In particular, the invention relates to a shelf-stable blister pack having a plurality of recesses designed to conveniently supply a dosing regimen requiring administration of storage-incompatible or unevenly dosed components.
2. Description of the Related Art
Physiological requirements vary from individual to individual and even within an individual during the course of a lifetime. Further, various conditions may effect physiological requirements. For example, pregnant, lactating and menopausal women may have enhanced needs for certain nutrients, therapeutic agents or treatments and reduced needs, or even tolerance, for other nutrients, therapeutic agents or treatments.
Meeting the specific physiological requirements of humans and other animals may require the use of a complex daily therapeutic regimen requiring administration of various biologically-active substances simultaneously or at different times during the day. Moreover, the complex daily therapeutic regimen may require simultaneous administration of biologically-active substances which may be storage-incompatible. Storage-incompatibility exists between two or more substances when the substances may not be formulated together in a single dosage unit or stored together in direct contact because the substances will interact in a negative manner. Storage-incompatibility also exists between two or more substances that cannot be formulated together in a single dosage unit because the sum total of the dosage amounts of the substances would result in a single dosage unit which is difficult to swallow or at least not optimal for swallowing. Storage-incompatibility also exists between two or more substances wherein at least one substance is a prescription substance and at least one substance is a non-prescription substance.
In addition the problem of simultaneous administration of storage-incompatible substances, complex daily therapeutic regimens also present the problem of poor patient compliance. In fact, according to medical literature, approximately 30% to 50% of all patients fail to comply with their physician's prescriptions. See Libow et al.,
The Core of Geriatric Medicine: A Guide for Student and Practitioners
, 107 (1981). Interviews conducted with 178 elderly outpatients revealed that 59% are making errors in their medications and about 25% of the group as a whole averaged as many as 2.3 potentially serious errors per patient. See Schwartz et al., “Medication Errors Made by Elderly, Chronically Ill Patients”,
American Journal of Public Health
, 52:2018-29 (1962).
Further, a study examining non-compliance in patients recently discharged from an acute care facility found that 50% of the patients deviated from the prescribed regime. See Parkin et al., “Deviation from Prescribed Drug Treatment After Discharge from Hospital”,
British Medical Journal
, 2:686 (1976). Moreover, there is evidence that medication errors are an important factor in producing illness. See Seidl et al., “Studies on the Epidemiology of Adverse Drug Reactions”,
The Bulletin of Hopkins Hospital
, 119:299-315,1966.
There are a broad range of factors which play a role in poor patient compliance, including complexity of regimen, poor patient motivation, lack of sufficient knowledge on the part of the patient, memory loss and other cognitive dysfunctions, as well as attenuation of the special senses.
Disposable pharmaceutical containers for dispensing medicaments which are used to improve patient compliance have been previously disclosed. One type of pharmaceutical dispensing package arranges medicaments separately within individual recesses upon a planar card, forming a blister package. An example of such a package can be found in Knudsen, U.S. Pat. No. 4,295,567, which discloses a pharmaceutical dispensing container which holds two dosage units which are symptomatic treatment for respiratory tract disorders. The first of these dosage units being indicated for day-time administration and therefore being non-sedating. The second of these dosage units being indicated for night-time administration and therefore being sedating. Means of indication include dosage units being in register with a time chart and a distinguishing visible feature of the dosage units.
Thompson et al., U.S. Pat. No. 5,358,118, describe a stepped-edge blister pack for containing and dispensing units of doses of medication such as capsules, tablets, caplets or fast-dissolving dosage forms. The invention is comprised of a base sheet and a substantially planar lidding sheet. The base sheet has a plurality of blister compartments and a plurality of steps along its edges, one step being adjacent to each blister compartment. The substantially planar lidding sheet is peelably sealed to the base sheet except at extended edge regions, thus forming edge peel tabs. These edge peel tabs coincide with the steps along the edge of the base sheet, thus providing a series of finger accesses and thereby easing the process of opening each blister compartment. The lidding sheet is scored with lines of weakening, so that each blister compartment is removable from the blister package.
Sowden, U.S. Pat. No. 5,325,968, describes a package for holding tablets, which provides for limited entry into the package that is designed to be child proof. The user must complete a number of sequential steps in order to access the dosage. First, the user grips a trapezoidal section of an access tab to expose a finger depression. Next, the user grips a cover overlying the depression, which further extends over the dosage. Finally, the user pulls back this cover to reveal the dosage form.
Urheim, U.S. Pat. No. 4,958,736, describes a package for oral contraceptive tablets. The package contains four rows of seven tablets per row. Three adjacent rows contain active contraceptive tablets, while he fourth row contains placebo tablets. A line of severability is provided between the row placebo tablets and an adjacent row of active tablets, thereby enabling dispensing 21-day and 28-day oral contraceptive formulations using a single package.
Roulin et al., U.S. Pat. No. 5,695,063, describe a blister pack for pharmaceuticals containing a base with a plurality of recesses which are surrounded by a shoulder. A lid foil is attached to the shoulders. Removable contents such as a tablet, capsules, or ampoules reside in each of the recesses and may be removed therefrom by pressing the recess in question and penetrating the lid foil or by removing the lid foil over the recess. The blister pack features a movable lid or a clamping element which covers at least one recess, and the clamping element is arranged in such a manner that it can be slid over the lid foil, and the clamping element closes off again at least one recess where the lid foil has been penetrated or peeled back, or close again at least one lid which on filling was left untitled and without a lid.
D'Amico et al., U.S. Pat. No. 5,788,974, describe a pharmaceutical dispensing container which holds multiple dosage units for aiding in the compliance in the eradication/treatment of
Helicobacter pylori
and subsequent/related gastric maladies on relation to said bacterial infection using a repetitive dosage regimen for a treatment period of sufficient duration to mitigate said bacterial infection formatted in such a way to gain ease of compliance resulting in improved outcome of treatment. Dosage units may be antibiotic, anti-microbial, or symptomatic relief agents in any combination.
Bartell et al., U.S. Pat. No. 4,889,236, describe a rigid, tripartite, credit card-style blister pack medication package, which is particularly useful for dispensing medications which must be taken on a calendar day schedule. The package is of discrete design and may be conveniently carried in a purse or billfold.
Roulin et al., U.S. Pat. No. 5,624,036, describe a blister p
Hermelin Marc S.
Kirschner Mitchell I.
Osinga Sjoerd
Drugtech Corporation
Nath Gary M.
Nath & Associates PLLC
Spear James M.
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