Special receptacle or package – For mixing
Reexamination Certificate
2002-12-18
2004-12-07
Bui, Luan K. (Department: 3728)
Special receptacle or package
For mixing
C206S528000
Reexamination Certificate
active
06827208
ABSTRACT:
FIELD OF THE INVENTION
The invention pertains to a packaging system for separately storing and dispensing together separate medication components. More specifically, the invention pertains to a pouch package which includes multiple compartments. The multiple compartments include multiple separate medication components, that are to be used together in a dose, but are kept separate prior to usage.
BACKGROUND OF THE INVENTION
Noncompliance with prescription medications has been identified as a major health care concern in the United States. At least one study has estimated that nearly 50 percent of all drugs are not taken as prescribed. As a result an estimated $100 billion is spent annually on lost productivity and unnecessary medical costs, such as doctor visits, hospitalizations, and nursing-home admissions. A further study has estimated that noncompliance with prescription medications causes 125,000 deaths, annually.
In some instances, patient noncompliance may be unintentional. Complex medication regimens can sometimes confuse even the most alert of patients. However when coupled with reduced memory capacity like that resulting from dementia, mental illness, or even less severe natural degradations in mental facilities due to aging, patient compliance becomes that much more difficult.
In other instances, patient noncompliance may be intentional. Pain, for example from arthritis, or other physical impairments, like difficulty swallowing, can sometimes deter patients from taking their medication as prescribed. Sometimes a patient's self comparison of the perceived side effects versus the perceived benefits of taking prescribed medication may lead to a patient's voluntary medication noncompliance.
In those instances where the side effects are real, the side effects can sometimes be treated and/or minimized by supplementing the original prescription with an additional medication directed to dealing with the side effects experienced. However, any additional medications being prescribed can only contribute to the complexity of the patient's prescription medication regimen. Depending on how complex the patient's prescription regimen already is, a doctor may be reluctant to prescribe additional medications, especially where compliance issues may already exist.
In some instances after being combined, medication components can be in a less stable form and/or can have special handling or storage requirements. For example it may be necessary to refrigerate the medication until shortly before being used. This can be problematic where refrigeration facilities are not conveniently available. This is especially problematic for school aged children who do not have access to a refrigerator at school, and who are prescribed a dose which is scheduled to be taken in the middle of the day. Many schools are reluctant to store and/or dispense the medications for various practical reasons. Consequently, a parent may need to leave work and retrieve the medication from refrigerated storage to administer the dose, even if the child was otherwise capable of properly administering their own medication.
In these instances storage as separate components prior to usage may mitigate some of the stability or special handling issues (i.e. refrigeration requirements). However, requiring preparation or mixing of multiple medication components shortly prior to usage is not free from its own set of concerns.
For example, in instances where prescribed medications are used in the form of a liquid dispersion, it may be impractical to expect a user to measure the proper amounts and to properly combine the separate medication components. The use of improper amounts of one or more components can adversely affect the strength of the medication or can result in a combination having a different synergistic effect.
Alternatively, it may be difficult for the user to know if the medication components have been properly mixed, thereby assuring proper uniformity of the combined components throughout the mixture. This may be of special concern where the medication is to be applied, topically, over a relatively wide area. Additionally, the medication may need to be administered during times of patient distress, which may also unduly complicate any required measuring and mixing.
Consequently, it would be beneficial to develop a packaging system by which multiple medications or medication components can be separately stored and dispensed together, and which reduces the burdens associated with taking the multiple medications or medication components as prescribed including simplifying the proper combination and administration of the multiple medication components.
Still further, it would similarly be beneficial to develop a packaging system, where the medication components are prevented from mixing until immediately prior to usage, and are kept substantially physically isolated from the environment outside of the package system prior to dispensing.
SUMMARY OF THE INVENTION
A package system is provided for separately storing and dispensing together separate medication components. The package system provides an outer containment pouch, which includes a surrounding pouch wall defining a pouch interior. Located within the outer containment pouch, at least partially, is a plurality of compartments. Each compartment includes a surrounding barrier material, which defines an enclosed internal storage space for receiving one of a plurality of different medication components.
The barrier material of each compartment has a weak point located on a portion of the barrier wall, that is present within the pouch interior of the outer containment pouch. When a sufficient compartment deforming force is applied to the plurality of compartments, the weak point will breach thereby releasing the medication components contained within the storage space into the pouch interior of the outer containment pouch.
In one aspect of the present invention the plurality of separate compartments are coupled to the outer containment pouch in at least a pair of disparate locations. The portions of the barrier material of the plurality of separate compartments located between the pair of locations are relatively taut, so as to resist further expansion in a lateral direction. The portion of the pouch wall of the outer containment pouch located between the pair of locations includes an amount of slack, which is capable of further expansion in a lateral direction.
In at least one instance the slack in the outer containment pouch is provided by a fold in the material. In at least a further instance, the surrounding pouch wall of the outer containment pouch is buckled, while the surrounding barrier material of the plurality of compartments is relatively taut.
In a further aspect, the interior storage space of the plurality of compartments is substantially fully expanded and substantially sealed, so that any decrease in the volume of the interior storage space will increase the internal pressure of the contents against the barrier material.
Numerous other advantages and features of the present invention will become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings.
REFERENCES:
patent: 4362241 (1982-12-01), Williams
patent: 4511533 (1985-04-01), Guadagno et al.
patent: 4608043 (1986-08-01), Larkin
patent: 5699902 (1997-12-01), Sperry et al.
patent: 5899325 (1999-05-01), Bertram et al.
patent: 5996782 (1999-12-01), Sperry et al.
Gupta Pramod
Taneja Rajneesh
Bui Luan K.
TAP Pharmaceutical Products Inc.
Yasger Paul D.
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