Special receptacle or package – For ampule – capsule – pellet – or granule – Compartmented
Reexamination Certificate
2003-01-02
2003-11-18
Bui, Luan K. (Department: 3728)
Special receptacle or package
For ampule, capsule, pellet, or granule
Compartmented
C206S232000, C206S534000
Reexamination Certificate
active
06648143
ABSTRACT:
CROSS-REFERENCE TO RELATED APPLICATIONS
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not applicable.
BACKGROUND OF THE INVENTION
Aspirin, or acetylsalicylic acid, is a common household drug that can be found in almost every medicine cabinet in the United States. Aspirin has been used for over one hundred years, having been developed by German chemist Felix Hoffmann in 1897. Most commonly thought of as an analgesic, or pain reliever, it is considered by practitioners and consumers to be an effective, cheap and relatively safe drug. In recent years, however, aspirin also has been discovered to be effective in the treatment of cardiovascular disease, particularly heart attacks. Cardiovascular disease is the leading cause of death in the United States and most developed countries. Generally, there will be 1,250,000 heart attacks every year in the United States with 500,000 of those attacks resulting in death. Therefore, aspirin's ability to prevent and treat persons suffering from cardiovascular disease cannot be overlooked or overvalued.
A heart attack, or myocardial infarction (MI), may be caused by the blockage of blood flow to the heart. Without an adequate supply of oxygen rich blood, affected areas of the heart muscle die, and the pumping action of the heart is either impaired or stops altogether. A diminution of flow of blood to the heart muscle may be caused by the build-up of atherosclerosis, or plaque. A tear in plaque inside a narrowed artery causing platelets to aggregate and form a clot, may cause an acute myocardial infarction. It is not fully understood how aspirin functions to prevent or treat such conditions, but modem theories are based on the work of British pharmacologist John Vane. His research focused on prostaglandins, which are hormone-like substances that influence the elasticity of blood vessels and direct the functioning of blood platelets. It is believed that aspirin blocks the production of prostaglandins, thus, preventing platelets from aggregating and a blood clot from forming.
While scientists continue to more fully understand how aspirin functions, its ability to treat serious cardiovascular conditions has been recognized by the Food and Drug Administration (FDA) since at least 1985. In that year, the FDA approved the use of aspirin to prevent heart attacks in patients who had either suffered a previous heart attack or suffered from unstable angina. This approval was based on studies indicating that use of aspirin lowered the risk of a second heart attack by 20%, and, for persons suffering from unstable angina, reduced the risk of heart attack by 51%. In 1996, a further proposal was made by the FDA to amend professional labeling rules to include acute MI as an indication for aspirin. That proposal was incorporated into a final rule adopted by the FDA in 1998, which became effective Oct. 25, 1999. Adoption of this change was supported by recent studies on aspirin in the treatment of acute MI that were submitted to and considered by the FDA. Specifically, the rule states that, “Aspirin is indicated to (1) Reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) reduce the risk of vascular mortality in patients with a suspected acute MI, (3) reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, and (4) reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris.”
In light of the FDA's recognition that aspirin can reduce the risk of death if taken at the first signs of a heart attack, it is advantageous for persons who are at risk for a heart attack to have aspirin on hand in the event of a suspected heart attack. This is particularly true for those persons who have a prior history of heart attacks or other cardiovascular disease. Because a heart attack may occur at any time, it would be particularly beneficial for persons to have a convenient carrier or container to store and carry aspirin with them wherever they go. Such a container must be of an appropriate size and shape to be comfortably carried when at home, travelling, exercising, or during any other everyday activity. The contents of the carrier also must be easily accessible, as time is of the essence in an emergency situation.
In addition to being portable and providing immediate access to medication, the carrier also must comply with governmental requirements for a container closure system for packaging a human drug. In this regard, the FDA has promulgated a number of regulations for the control of drug product containers and closures. For example, the current good manufacturing practice (CGMP) requirements for the control of drug product containers and closures are included in 21 C.F.R. Parts 210 and 211. These requirements include the FDA requirement for tamper-resistant closures as indicated in 21 C.F.R. §211.132. The United States Pharmacopeil Convention also has established requirements for containers. In general terms, these standards address a number of issues. For example, containers must protect the contents contained therein, and the materials from which the containers are formed must be compatible with the enclosed drugs. Additionally, the packaging materials must be safely constructed to prevent leakage of undesirable substances into the container. More specifically, with respect to containers for solid oral dosage forms, containers must prevent potential adverse affects of water vapor, which may affect the decomposition rate of the active drug substance or the dissolution rate of the dosage form. This is accomplished by providing a container with an intrinsically low rate of water vapor permutation and an effective seal. Also, the container must protect the drug from light and reactive gases. Depending on the type of drug housed within the container, there may be requirements for indicia on the container including a description of the enclosed drug, instructions regarding dosage, and indications for its use.
BRIEF SUMMARY OF THE INVENTION
The present invention is directed to a thin carrier for storing and transporting a medicament wafer. The carrier includes a lower housing having a cavity formed from a flat base and connected sidewalls that extend to a flange. A medicament wafer rests within the cavity and is enclosed by a cover that is removably attached to the flange.
The lower housing may be made of rigid plastic that protects the medicament, which may be aspirin or any other medicament in wafer form. In one embodiment of the invention, the cover may be planar being formed of a film, foil, laminate, or plastic. In another embodiment, the cover may be an upper housing formed of plastic which, as with the lower housing, has a cavity defined by a base and connected sidewalls that extend to a flange.
One aspect of the present is a method for enabling a person to carry a medicament during everyday activities which includes the step of providing a credit card-sized carrier housing a medicament wafer within a lower housing. The lower housing has a cavity defined by a base and sidewalls that extend to a flange. A cover, removably attached to the flange, encloses the wafer within the lower housing.
Another aspect of the invention is a portable kit that includes a credit card-sized carrier, which houses a medicament wafer, and a patient information card attached to or included within the carrier. An alert to indicate the presence of the carrier on the patient also may be included as part of the kit.
REFERENCES:
patent: 3954179 (1976-05-01), Warmath
patent: 5584388 (1996-12-01), Johnson
patent: 5950814 (1999-09-01), Lindberg et al.
patent: 6155409 (2000-12-01), Hettinger
Bui Luan K.
Infosight Corporation
Mueller and Smith LPA
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