Patent Application
20190070071
The presently disclosed subject matter relates to imprinted medical packages and to methods of making and using the disclosed packages.
The illicit use of prescription drugs has become a major concern in the healthcare industry. Particularly, opiates, tranquilizers, stimulants, and sedatives are currently in widespread medical use and have been associated with a dramatic increase in use by drug addicts and recreational drug users. Prescription drugs are often obtained unlawfully through illegal internet shopping, prescription forgery, illegal prescriptions from physicians, and doctor shopping. As a result, the diversion of pain medications is one of the most severe healthcare problems, with the addictive nature of the drugs causing enormous challenges to users and their families. In addition to the immediate risk to the health of patients, the costs of providing health care to patients that become addicted to or otherwise abuse narcotics are, on average, approximately eight times greater than the costs of providing health care to non-abusers. Previous attempts to record and/or monitor the prescription, dispensing, and/or delivery of controlled substances and other prescription medications have proven to be inefficient and ineffective and fail to address widespread doctor-shopping practices that are common. It would therefore be beneficial to provide packaging that enables the tracking of individual prescription medication packages, including information such as dosage, prescribing physician, lot number, and the like.
In some embodiments, the presently disclosed subject matter is directed to a package comprising: a first panel constructed from a first packaging material; a second panel constructed from a second packaging material; wherein the first and second panels are sealed together to form a plurality of sealed edges, an interior, and an exterior; wherein the interior is configured to house a product; and wherein the exterior comprises a unique package identifier that identifies the product, product lot number, product manufacture date, prescribing physician, dosage, or combinations thereof. For example, in some embodiments, the identifier identifies the prescribing physician and the associated patient. In some embodiments, the identifier further identifies the product, associated product lot number, associated product manufacture date, product dosage, or combinations thereof.
In some embodiments, the product is a pharmaceutical product, a cosmetic, or a supplement. In some embodiments, the pharmaceutical product is a controlled pharmaceutical product, such as an opioid. In some embodiments, the product is a powder, liquid, gel, hydrogel, or combination thereof.
In some embodiments, the identifier is a 10-digit number. In some embodiments, the identifier is unique for the package.
In some embodiments, the package comprises at least one tear notch. In some embodiments, the tear notch is propagated in a direction parallel with the tear notch.
In some embodiments, the first packaging material, second packaging material, or both comprises a metal foil, wherein the metal foil is selected from aluminum, magnesium, stainless steel, titanium, zinc, nickel, tin, iron, copper, chromium, cobalt, silver, gold, manganese, nickel, alloys thereof, or combinations thereof.
In some embodiments, the first packaging material, second packaging material, or both comprises a polymeric material selected from polyvinyl chloride, polyvinylidene dichloride, polystyrene, ethylene vinyl alcohol, cyclic olefin copolymer, ethylene vinyl acetate, polyethylene, low density polyethylene, very low density polyethylene, polypropylene, polycarbonate, polyethylene terephthalate, polyester, polyamide, polymethylmethacrylate (PMMA), polyetheretherketone), nylon, polylactic acid, or combinations thereof.
In some embodiments, the first packaging material, second packaging material, or both comprises at least one foil layer adhered together with a paper layer, a polymeric layer, or both. In some embodiments, the first packaging material, second packaging material, or both comprises at least one paper layer adhered together with a foil layer, a polymeric layer, or both. In some embodiments, the first packaging material, second packaging material, or both comprises at least one polymeric layer adhered together with a paper layer, a foil layer, or both.
In some embodiments, the disclosed package is sterilizable.
In some embodiments, the disclosed package comprises a product.
In some embodiments, the presently disclosed subject matter is directed to a method of tracking a product, the method comprising packaging the product in a package. The package comprises a first panel constructed from a first packaging material; a second panel constructed from a second packaging material; wherein the first and second panels are sealed together to form a plurality of sealed edges, an interior, and an exterior; wherein the interior is configured to house a product; and wherein the exterior comprises a unique package identifier that identifies the product, product lot number, product manufacture date, prescribing physician, dosage, or combinations thereof; sealing the package to contain the product within the package interior; and tracking the product using the unique identifier.
The previous summary and the following detailed descriptions are to be read in view of the drawings, which illustrate some (but not all) embodiments of the presently disclosed subject matter.
The presently disclosed subject matter is introduced with sufficient details to provide an understanding of one or more particular embodiments of the broader inventive subject matters. The descriptions expound upon and exemplify features of those embodiments without limiting the inventive subject matters to the explicitly described embodiments and features. Considerations in view of these descriptions will likely give rise to additional and similar embodiments and features without departing from the scope of the presently disclosed subject matter.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently disclosed subject matter pertains. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, representative methods, devices, and materials are now described.
Following long-standing patent law convention, the terms “a”, “an”, and “the” refer to “one or more” when used in the subject specification, including the claims. Thus, for example, reference to “a package” can include a plurality of such packages, and so forth.
Unless otherwise indicated, all numbers expressing quantities of components, conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the instant specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.
As used herein, the term “about”, when referring to a value or to an amount of mass, weight, time, volume, concentration, and/or percentage can encompass variations of, in some embodiments +/−20%, in some embodiments +/−10%, in some embodiments +/−5%, in some embodiments +/−1%, in some embodiments +/−0.5%, and in some embodiments +/−0.1%, from the specified amount, as such variations are appropriate in the disclosed packages and methods.
The presently disclosed subject matter is generally directed to packages that are imprinted with a unique identifier to enable tracking and/or identification of the packages, as set forth in more detail herein below. The term “package” as used herein refers to materials configured around a product, and can include one or more bags, pouches, trays, containers, and the like. One example of the disclosed package is illustrated in
Package 5 can be constructed from any material known or used in the art, such as one or more of foil, polymeric materials, paper, or combinations thereof. For example, in some embodiments, package 5 can comprise one or more foil materials. The term “foil” as used herein refers to a thin, flexible film or sheet of metal and can include multilayer structures in which at least one layer of metal is adhered to additional layers of other materials. Any metallic material can be used to construct the disclosed foil packaging, such as (but not limited to) aluminium, magnesium, stainless steel, titanium, zinc, nickel, tin, iron, copper, chromium, cobalt, silver, gold, manganese, nickel, alloys thereof, and combinations thereof. In some embodiments, the foil can have a thickness of about 0.1 mil to about 10 mils (e.g., about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 mils).
The disclosed foil materials can be constructed using any method known or used in the art, such as refining, smelting, rolling, casting, and/or finishing.
In some embodiments, the disclosed package can be constructed from one or more polymeric materials. The term “polymeric” as used herein refers to products of polymerization reactions, and is inclusive of homopolymers, copolymers, terpolymers, and the like. Suitable polymeric materials can include (but are not limited to) polyvinyl chloride, polyvinylidene dichloride, polystyrene, ethylene vinyl alcohol, cyclic olefin copolymer, ethylene vinyl acetate, polyethylene, low density polyethylene, very low density polyethylene, polypropylene, polycarbonate, polyethylene terephthalate, polyester, polyamide, polymethylmethacrylate, polyetheretherketone, nylon, polylactic acid, and/or copolymers thereof. In some embodiments, the polymeric material can have a thickness of about 1-10 mils (e.g., about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, or 10 mils).
The disclosed polymeric materials can be constructed using any method known or use in the art. For example, the disclosed polymeric materials can be cast or blown through an annular or flat die, and can be fully coextruded. As used herein, the term “coextruded” refers to the process of extruding two or more materials through a single die with two or more orifices arranged so that the extrudates merge and weld together into a laminar structure before chilling and solidifying. The disclosed polymeric films can be constructed using rotary sealing machines, vertical form-fill and seal equipment, and the like.
In some embodiments, the disclosed package can be constructed from one or more paper materials. The term “paper” as used herein refers to any of the wide variety of known fibrous materials, such as cellulose, cardboard, kraft paper, coated papers, or any other pulp-based materials that are commercially available. In some embodiments, the paper materials can be coated, such as with wax, resin, paraffin, plastic, and the like. The disclosed paper can be of any desired thickness, such as about 1/64 inch to about 1/16 inch.
Thus, in some embodiments, package 5 can comprise at least one foil layer and at least one polymeric and/or paper layer. For example, the metal foil, paper, and/or polymeric film can be adhered together using a sealant layer and/or a tie layer. The term “sealant layer” as used herein refers to a layer, film, sheet, etc. that is capable of being attached to another material, forming a leak-proof seal. Representative sealant layers can include (but are not limited to) ethylene/alpha olefin copolymer, ethylene/vinyl acetate copolymer, ionomer resin, anhydride-modified ethylene/vinyl acetate copolymer, ethylene/acrylic or methacrylic acid copolymer, ethylene/ethylene acrylate copolymer, ethylene/acrylate or methacrylate copolymer, low density polyethylene, anhydride-modified ethylene/α-olefin copolymer, anhydride-modified polyolefin, or combinations thereof. The term “tie layer” as used herein refers to a layer of material that bonds two dissimilar materials and can include (but are not limited to) thermoplastic materials such as ethylene copolymers, polyurethanes, and the like.
In some embodiments, the materials used to construct package 5 can include one or more barrier layers to impart barrier properties to the package. The term “barrier layer” as used herein refers to a layer comprising materials that will control the oxygen and/or moisture permeability of the package. In some embodiments, the package materials can have an oxygen permeability or transmission rate of less than about 20 cm3/m2 for a 24-hour period at 1 atmosphere, 0% relative humidity and 23° C., measured in accordance with ASTM D-3985-81. In some embodiments, package 5 can have a moisture barrier transmission rate of about 0.5 g/100 in2/day or less, measured in accordance with ASTM E96B. Suitable oxygen and/or moisture barrier materials can include (but are not limited to) metal foils, ethylene/vinyl alcohol copolymer, polyvinyl chloride, polyvinylidene chloride, polyamide, polyester, polyacrylonitrile, copolymers of vinylidene chloride and vinyl chloride or alkyl acrylate, elastomer, or a blend thereof.
In some embodiments, the materials used to construct package 5 can include one or more abuse layers that serve to resist abrasion, puncture, and other potential causes of reduction in package integrity and package appearance quality. Suitable abuse materials can include (but are not limited to) nylon, metal foils, ethylene alpha/olefin copolymer, ionomer, ethylene/vinyl acetate, and combinations thereof. Optionally, the disclosed packaging materials can be irradiated to cause crosslinking of at least one polymeric layer to improve the abuse and/or puncture resistance and other physical characteristics. Crosslinking is the predominant reaction that occurs on irradiation of many polymers and results in the formation of carbon-carbon bonds between polymer chains. Crosslinking can be accomplished, for example, by irradiation using high energy electrons, gamma-rays, beta particles and the like. In some embodiments, the packaging materials can be irradiated at a level of from 2-12 MRads.
In some embodiments, the disclosed packaging materials have a thickness of about 10-100 μm, such as about 15-90, 20-80, 25-70, 30-60, or 35-50 μm. However, it should be appreciated that thinner or thicker materials can be used and are included within the scope of the presently disclosed subject matter.
In some embodiments, the disclosed package can be formed from one continuous portion of material sealed at one or more ends 15. Alternatively, the package can be constructed from two or more portions of material sealed together at one or more seams. The term “sealed” includes any and all means of closing the package, such as heat sealing via hot air and/or heated bar, ultrasonic sealing, adhesives, and the like.
As illustrated in
In some embodiments, the package is hermetically sealed. The term “hermetically sealed” refers to a package that is sealed in a manner such that liquids and/or gases located outside the package are prevented from entering the interior of the container, at least to some degree.
Package 5 can be constructed in any of a wide variety of shapes, such as square, rectangular, triangular, cylindrical, oval, tubular, pillowed, trapezoidal, circular, and abstract designs. For example, in some embodiments, container 5 can be shaped as an elongated cylinder, such as the straw-shaped design shown in
In some embodiments, package 5 can be of any desired stiffness required by the packaged contents. For example, in some embodiments, the package can be flexible or substantially flexible. The term “flexible” as used herein refers to the ability to bend relatively easily and/or the ability to withstand stress and strain without being damaged or broken with a modulus of less than about 50,000 PSI (ASTM D-882-81). However, in some embodiments package 5 can be rigid or substantially rigid. The term “rigid” as used herein refers to materials that have a high stiffness or modulus of elasticity. It should be appreciated that the level of flexibility of package 5 can be customized depending on the particular product to be packaged.
Optionally, package 5 can include one or more opening mechanism (such as tear notches) to facilitate opening of the package to gain access to the package contents. For example, as shown in
Any of a wide variety of products can be packaged within package 5. In some embodiments, product 25 can comprise a pharmaceutical product (such as a medication), a supplement, or a cosmetic. The term “medication” refers to any health-related product that is generally taken on a routine or as-needed basis, such as prescription medicine or other pharmaceutical products. The term “cosmetic” refers to substances that aid in the enhancement or protection of the appearance (e.g., color, texture, look, feel) or odor of the skin. The term “supplement” refers to refers to a composition comprising one or more vitamins, alkaloids, herbs, minerals, fatty acids, lipids, phospholipids, amino acids, herbs and/or other botanicals, enzymes, metabolites, or combinations thereof.
In some embodiments, the medication can be a controlled medication, such as those with a high potential for abuse. Examples of controlled medications include (but are not limited to) methadone, oxycodone, fentanyl, morphine, opium, codeine, hydrocodone, and the like. In some embodiments, the controlled medication can be an opioid. The controlled medication can include one or more substances selected from Schedule I, II, III/IIIN, IV, or V controlled substances as published in Title 21 C.F.R. sections 1308.11 through 1308.15, incorporated by reference herein.
It should be appreciated that product 25 is not limited and can include one or more powders, liquids, gels, hydrogels, and the like, as would be known to those of ordinary skill in the art. The products can be administered by any known method, such as parenteral or enteral (e.g., oral, gastric, subgastric) and thus can be formulated as pills, salves, creams, powders, ointments, capsules, injectable medications, drops, suppositories, etc.
In some embodiments, package 5 can be sterilizable. The term “sterilizable” as used herein refers to the ability of the package to be exposed to conditions to reduce the microorganism count to acceptable limits. Suitable sterilization techniques can include (but are not limited to) steam sterilization, ethylene oxide gas sterilization, formaldehyde sterilization, plasma sterilization, and/or ozone sterilization processes.
As set forth herein above, package 5 comprises identifier 30 that can be used to convey information about the package contents. In some embodiments, identifier 30 includes a plurality of numbers and/or letters imprinted or printed directly on the package materials. For example, in some embodiments, the identifier can comprise a unique 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20-digit combination of letters and/or numbers. It should be appreciated that more or less numbers/letters can be used. The identifier can be imprinted directly on one or more surfaces of the disclosed package. The term “imprinting” as used herein refers to stamping by application of pressure or through the use of a laser or to a significant depth inside the host material using machining or laser inscribing techniques as would be known in the art. Advantageously, identifier 30 can be embossed or imprinted on the package and cannot be easily altered. In some embodiments, identifier 30 can be indelible (e.g., cannot be removed).
Visual indicator 30 provides information such as one or more of the prescribing doctor, patient name/address/identifying information, identification of the pharmaceutical, lot number of the pharmaceutical, manufacturing date code, strength of the pharmaceutical, dosage of the pharmaceutical, manufacturer, expiration date, date the prescription was filled, date of previous prescriptions, and the like. Thus, each package 5 includes a unique identifier 30 that allows information about the package to be tracked. In some embodiments, some or all of the identifier is imprinted at the time the package is filled, since all the information may not be known prior to filling (e.g., prescribing doctor). The identifier can be “read” at the point of sale or at the point of dispensing in conjunction with an authentication process. A database can maintain a historical record of packages scanned for the purposes of allowing subsequent review. Such a record can be useful to verify that a package was dispensed, check for authenticity, and to flag any excessive or multiple prescription information (e.g., in situations where a patient has multiple prescriptions from multiple doctors). In some embodiments, the identifier can be scanned using commercially available scanners, saving time and increasing data accuracy. In this way, information can be tracked by regulatory agencies (FDA and/or DEA), doctors, pharmacists, and the like to prevent pharmacy hopping, track medical professionals that prescribe medications, and/or to monitor over prescribing by medical professionals.
As shown in
Advantageously, the disclosed packaging system therefore prevents or decreases over-prescription abuse, helps identify and verify patients and physician-prescribers, and tracks and monitors medication prescriptions. The disclosed system can also be used to identify physicians, pharmacists and others authorized to prescribe or dispense medications. When this is done, fraudulent prescriptions can be detected, and physicians, pharmacists, or others who may be obtaining drugs for unauthorized purposes can be identified, and their activities monitored. The technology further serves as a disincentive for practitioners that overprescribe prescription medications, such as opioids or other addictive medications. In this way, problems related with current pharmaceutical quality control can be decreased.
This application claims priority to U.S. Provisional Patent Application No. 62/555,168, filed Sep. 7, 2017, which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62555168 | Sep 2017 | US |
