Special receptacle or package – For body treatment article or material – Bandage – drape or dressing
Reexamination Certificate
2002-09-16
2004-09-28
Ackun, Jr., Jacob K. (Department: 3712)
Special receptacle or package
For body treatment article or material
Bandage, drape or dressing
C206S804000
Reexamination Certificate
active
06796429
ABSTRACT:
The present invention relates to packaging for transdermal/transmucosal drug delivery patches.
BACKGROUND OF THE INVENTION
Transdermal and transmucosal patches containing drugs such as estradiol, levonorgestrel, testosterone, scopolamine, nitroglycerin, nicotine, heparin, melatonin, diagnostic compounds, and other ingredients are conventionally required to be packaged in hermetically sealed, individual foil and/or plastic pouches. Such packaging is necessary in order to maintain sanitary conditions and to prevent degradation, contamination, and/or loss of sensitive ingredients by environmental exposure. In many cases, the material used for such packaging has to be sufficiently impervious to volatile active ingredients, e.g., nitroglycerin, and environmental factors, e.g., humidity, to allow the device to remain stable under extended storage conditions of up to several years.
A serious disadvantage of conventional packaging is that the user must tear open a separate pouch each time one of the transdermal or transmucosal patches is needed. Furthermore, it is desirable for many pharmaceutical products that the packaging material be difficult to open by children, so called “child-resistant” packaging. These conventional pouches may not be child-resistant, but can be difficult to open, particularly for the elderly and those with conditions that impair strength and/or manual dexterity, and especially if the packaging is made of tear resistant or hard to grasp materials. Even for those without any special difficulties, opening such pouches on a frequent basis over an extended period can be a substantial inconvenience. Moreover, individual packaging can be expensive and wasteful due to the excessive packaging material required and manufacturing cost for individual packaging.
It would be desirable to package transdermal and transmucosal drug-containing patches so as to be simple to open for adult patients, difficult for children to open, economical, sufficiently impervious to prevent loss of volatile components, and easy to manufacture.
SUMMARY OF THE INVENTION
The present invention provides a dispenser for conveniently dispensing multiple transdermal/transmucosal drug-containing patches from a single container. The dispenser has a separate inner cartridge having walls made of an impermeable material, wherein the inner cartridge is hermetically sealed during storage. A plurality of individual patches are contained within the inner cartridge, and the patches can be removed from the dispenser through at least one aperture. The dispenser further comprises a housing comprising a base and an exterior cover, wherein the housing is adapted to fully enclose the inner cartridge and is capable of forming an impermeable seal defining an outer chamber.
In one preferred embodiment, the aperture of the inner cartridge is sealed with a foil seal, such that the inner cartridge is hermetically sealed during storage. The seal is then opened, broken, or otherwise removed in order to allow the enclosed transdermal patches to be removed from the inner cartridge during use. The inner cartridge is enclosed by a housing having a base and an exterior cover.
Preferably, the aperture has a secondary seal, such as a plastic film with a slit in the middle, or overlapping plastic films, which allows the patches to be removed, but otherwise minimizes air transfer into the inner cartridge and serves as a barrier for foreign debris.
In use, the inner cartridge is contained within the housing that contains other functional portions of the dispenser, such as a cover, buttons or other opening mechanisms, as well as defining the cosmetic appearance of the dispenser.
One benefit of this embodiment is the ability to improve stability, since the inner cartridge is the primary stability container closure during shelf life. The housing only has to maintain stability of the transdermal patch from the time that the inner cartridge seal is removed until the transdermal patches are exhausted from the dispenser. Separation of the inner cartridge and housing functions allows greater design flexibility for the housing, since cosmetic changes can be made to the housing with little or no impact on the pharmaceutical stability. Separation of the inner cartridge and housing functionality also provides the ability to make manufacturing processes more efficient and low cost, as well as providing for more convenient means of allowing the dispenser to be refillable.
In another aspect, the present invention provides a cartridge for use in a transdermal/transmucosal patch dispenser. The inner cartridge has walls made of an impermeable material, wherein the inner cartridge is hermetically sealed during storage. A plurality of individual patches is contained within the inner cartridge, and the patches can be removed from the cartridge through at least one aperture. The cartridge is adapted to be enclosed by a housing comprising a base and an exterior cover, wherein the housing is capable of forming an impermeable seal defining an outer chamber.
In yet another aspect, the present invention provides a dispenser for conveniently dispensing multiple transdermal/transmucosal drug-containing patches from a single container, wherein a child-resistant mechanism is incorporated into the dispenser. The dispenser has an inner cartridge defined by walls made of an impermeable material, wherein the inner cartridge is hermetically sealed during storage. A plurality of individual patches is contained within the inner cartridge, and the patches can be removed from the dispenser through at least one aperture. The dispenser further comprises an exterior cover adapted to enclose the aperture when the exterior cover is in a closed position.
The child-resistant mechanism can consist of a locking mechanism, a “lock-out” mechanism, an opening mechanism not readily apparent to children or not readily engaged by children, or any combination of the above. Locking mechanisms may include, for example, keypad or combination locks, keyed locks, or locks activated by biometric identification, such as through use of fingerprints. A “lock-out” mechanism may, for example, need to be activated by a magnetic or radio frequency identification signal before allowing the mechanism to open. Preferably, one or more triggering mechanisms, such as buttons, latches, levers, and the like, would have to be appropriately engaged before the dispenser could be opened for dispensing medicine. A “gravity switch” (i.e., a switch, latch, lock, or similar mechanism having gravity dependent operability related to physical orientation) could be employed, wherein engagement of the triggering mechanism allows the dispenser to open only if the dispenser is held in a particular, fixed orientation, such as parallel to the ground. Placing the dispenser in the proper alignment with relation to the ground, such that the gravity switch allows the dispenser to open, can be described as “engaging” the gravity switch.
In a particularly preferred embodiment, the dispenser is opened by activating a button while the dispenser is aligned such that a gravity switch is engaged.
In another particularly preferred embodiment, the dispenser is opened by simultaneously activating two (or more) buttons while the dispenser is aligned such that the gravity switch is engaged.
One benefit of this invention is to reduce the likelihood of a non-user being accidentally exposed to the active pharmaceutical ingredients in a transdermal/transmucosal patch. Additionally, embodiments with locking mechanisms can be used to deter abuse of the transdermal patches and “lock-out” mechanisms can be used to prevent patients from dosing with too many patches at one time. In a preferred embodiment, the dispenser has a lock-out mechanism and contains a controlled substance (e.g., a substance regulated in the United States by the Drug Enforcement agency), such as morphine, fentanyl, buprenorphine, or testosterone.
The transdermal/transmucosal patches are preferably arranged such that the removal of one patch thereby allows the next patch to be g
Cameron Brian D.
Chang Shu Kun
Chang Stacey H.
Ackun Jr. Jacob K.
Ringsred Ted
Sprague Robert
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