FIELD OF THE INVENTION
The present invention provides packaging for unitary dosage items, such as capsules or tablets in a blister pack, where each sheet of the blister pack is individually wrapped in a paperboard sleeve to form an easily portable unit. Several of these portable units are packaged in a box for the consumer. Such packaging is particularly useful for oxygen- and light-sensitive dosage items, for example, omega-3-fatty acid, vitamin D, flax oil or conjugated linoleic acid nutritional supplements.
BACKGROUND OF THE INVENTION
Large bottles of pills, tablets and capsules are difficult to conveniently carry around with a person. This presents a problem, particularly when they need to take a unit dosage several times a day. Patient compliance is higher when it is easier for the person to take their dose of a medication. Pill boxes have existed for a very long time, for people to conveniently carry.
Reminder pill boxes are also known, such as a container with 7 compartments labeled with the days of the week, so a person can remember whether they took their dosage for the day. Other pill boxes have multiple compartments within each day so that a person can tell whether they took a given unit dosage for a certain time of day. The pills in pill boxes of the art are exposed to air and light as they are transferred from a reservoir bottle to the pill box, and they can contact each other, possibly breaking, while the pill box is shaken with the motion of transporting the pill box with a person.
Protective packaging for pills and tablets most commonly includes bottles where multiple pills and tablets are jumbled into a single bottle, often with cottony fill at the top and a lid. In some cases, the patient has difficulty opening a pill bottle, or difficulty in handling a large, cumbersome bottle. This type of packaging is somewhat limiting for breakable, fragile pills and capsules.
A single container holding several doses with one opening lid also leads to a shorter shelf life for oxygen-sensitive pills and capsules. In this case, oxygen-sensitive means that the ingredients of the pills or capsules are more rapidly degraded over time upon exposure to oxygen than non-oxygen-sensitive pills or capsules. Each time the bottle is opened to remove a single dose, the remainder of product is exposed to oxygen in advance of its own consumption, often multiple times.
Dosage-reminder packaging for tablets or capsules is known in the art. Several types of dosage-reminding packaging are blister packages with a certain arrangement of pills or capsules on the card, including some with labeling on the package for date or time for taking a particular pill or capsule. An example is the monthly package for birth control pills.
Blister packaging is known to protect oxygen-sensitive tablets or capsules. The entire enclosure for the tablet or capsule should be impermeable to oxygen. This typically includes both the formed film side (often shaped to receive the tablet or capsule) and the sealing membrane side (typically planar).
Some pills, tablets and capsules are fragile and can be physically damaged during storage and transport. For example, oral unit dosages of liquids are sometimes enclosed in a capsule. These liquid capsules may leak in storage if they get crushed. Pills or tablets may also be fragile or subject to damage by crushing or contact during transport and storage.
Blister packaging itself can provide some protection against crushing. A problem with some blister packaging, particularly press-release types, is that the packaged unit dosage may be released during storage or transport if the blister package is subject to some physical stress, such as folding or physical pressure.
Some medications or nutrients are sensitive to light. For example, the active ingredient can be degraded upon exposure to light of a certain wavelength. In the art, this problem is often minimized by using a dark-tinted bottle for medication or nutrient storage. In some cases, a protective coating that lets through less light is provided for the medication, on the unit dosage itself (e.g. opaque capsules).
The present invention provides an alternative solution to the problem of stability of unit-dose blister packaging, while also solving the problem of easy portability and protection of fragile, oxygen-sensitive or light-sensitive pills or capsules.
BRIEF SUMMARY OF THE INVENTION
The present invention contemplates a convenient package for unitary dosage items that permits relatively small amounts of fragile or sensitive nutrients or medication to be easily portable. The package is a typical blister package made up of a polymeric layer with indentations for a plurality of unitary dosage items that is sealed in with a substantially planar adhesive layer that seals off each indentation, resulting in a plurality of individual compartments, each containing a unitary dosage of the unitary dosage items. The blister package may provide protection of each unitary dosage item from exposure to oxygen prior to use by the consumer. The blister package slides into a paperboard sleeve for physical protection of the blister package and the items contained therein. The invention optionally contemplates that the paperboard sleeve can provide a light barrier for light sensitive unitary dosage items. The package according to the present invention includes the paperboard sleeve together with the blister package that encloses the unitary dosage items.
In some contemplated embodiments of a package for unitary dosage items according to the present invention, the package is particularly useful for the physical protection of fragile unitary dosage items. A contemplated fragile unitary dosage item is a gel cap containing a liquid nutritional supplement or a pharmaceutical active ingredient. One such contemplated unitary dosage item is a gel cap containing an edible oil and a nutritional supplement or a pharmaceutical active ingredient. Some of the contemplated nutritional supplements or pharmaceutical active ingredients include a polyunsaturated fatty acid compound having a carbon chain 16 carbons in length where at least one pair of double bonds in that chain are in a conjugated position, vitamin D, flax oil, the polyunsaturated fatty acid that is conjugated linoleic acid, the flax oil component that is omega-3 fatty acid.
In a contemplated embodiment, the blister package contains a convenient number of unitary dosage items to provide a reminder to the consumer as to whether a particular dose has been taken or when the next dose should be taken.
Also contemplated is the sale of a box containing a plurality of the described packages for unitary dosage items, where the width of the box is a multiple W of a side of the rectangle of the described protective sleeve and the length of the box is a multiple L of the other side of the protective sleeve and the depth of the box is a multiple D of the narrow opening of the sleeves that is basically the depth of the blister pack, so that the box able to hold at most a plurality of packages that is the multiple of W times L times D.
There are several advantages and benefits of the present invention:
It is an advantage of the present invention that an inner unit package of the present invention is easily personally portable.
It is a benefit of the present invention that an inner unit package of the present invention contains several unit dosages of the pill or capsules to last for a short period of time.
It is an advantage of present invention that the sleeve of the inner unit package provides a shield for light-sensitive pills or tablets to prolong their stability.
It is a benefit of the present invention that the outer package is of a convenient size and that it contains several easily portable inner unit packages.
It is an advantage of the present invention that the sleeve of the inner unit package provides protection against physical destruction (e.g. crushing or breakage) of the pills or tablets.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings forming part of the present disclosure:
FIG. 1 represents in FIG. 1A an elevated view of an inner blister pack of a shaped sheet with recesses shaped to receives the pills or capsules in dosage amounts, and an essentially planar sheet that seals the pills or capsules into the recesses. FIG. 1B shows the blister pack in position inside the sleeve.
FIG. 2 represents an inner sleeve formed out of a folded, single sheet of paperboard. FIG. 2A shows an overhead view of the single sheet that is folded and glued along edges 10 and 11 to form a paperboard sleeve, as shown in FIG. 2B from an elevated view.
FIG. 3 represents an outer box formed out of a folded, single sheet of paperboard. FIG. 3A shows an overhead view of the single sheet that is folded to form the outer box as shown in FIG. 3B from an elevated view.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides an alternative solution to packaging for a plurality of unitary dosage items that is convenient for a user to carry with them. Preferably, the easily portable package contains a number of unitary dosage items that will remind a user of which dosages have been administered. The present invention is particularly useful for unitary dosages of items whose stability or shelf life may be enhanced by decrease of exposure to degradative influences, such as light, oxygen or physical destruction.
The present invention contemplates a package for a plurality of unitary dosage items that is a blister package. The blister package is constructed using methods and materials known in the art. An example is shown in FIG. 1. According to the language used in the present description, such blister packages typically comprise a polymeric layer that is substantially a planar rectangle with a plurality of indentations of regular depth for storing said unitary dosage items. There is also a substantially planar rectangular sealing layer of about the same size as the polymeric layer. The sealing layer adheres to the planar regions of the polymeric layer, thereby sealing off each indentation. An example of a blister package (1) is shown in FIG. 1A; FIG. 1B shows the blister package inserted into the sleeve (5).
The present invention further contemplates a protective sleeve for the blister package, an example of which is shown in FIG. 2. The paperboard sleeve is constructed using methods and materials known in the art. In an example of convenient paperboard sleeve construction, a rectangular prismatic paperboard sleeve (5) is made up of a single sheet of substantially rectangular paperboard. The paperboard is folded four times (6, 7, 8, 9) with two opposing sides of the rectangle adhered together to form a sleeve that has substantially rectangular sides, two wide and two narrow in opposed pairs, with two substantially rectangular openings on opposite ends of the sleeve from each other. The two wide sides of the sleeve are slightly wider than the substantially planar rectangle of the blister pack and the two narrow sides of the sleeve are slightly wider than the indentation depth of the blister pack. The slightly larger size of the sleeve permits the paperboard sleeve to encompass the blister pack to form the package for the plurality of unitary dosage items, but it should not be so much larger that the package does not remain in the sleeve during transportation.
Sleeve construction. Contemplated sleeves may also be constructed in multiple parts rather than folded from a single sheet.
Sleeve material. Contemplated sleeves may also be constructed from cardstock or heavier cardboard, of various thicknesses, colors, weights, corrugation, or plastic. However, it should be noted that in embodiments for protecting from physical damage from shearing or crushing forces, stronger materials for sleeves are contemplated. In a contemplated embodiment, the paperboard sleeve is from 0.2 to 0.5 millimeters thick.
For embodiments for protecting from damage from light, opaque materials are contemplated. In a contemplated light protecting embodiment, sleeve construction material blocks 50 percent or more of the sun's ultraviolet rays, preferably more than 80 percent, and in a particularly preferred embodiment, a contemplated material blocks 100 percent of the sun's ultraviolet rays.
The unitary dosage items that would benefit from the contemplated packaging include liquids and solids including pastes and oils. Contemplated benefiting unitary dosage items include fragile items, such as capsules or tablets that may be crushed or burst. Contemplated benefiting unitary dosage items also include sensitive items, such as those sensitive to oxygen or light. Examples of such sensitive items include vitamin D, linoleic acid, particularly conjugated linoleic acid, flax oil or any of its long chain fatty acid oil components.
A particular problem addressed by the present invention is that many of the forms of vitamin D commercially available are not bioavailable to a body. This has led to a great deal of confusion in the art pertaining to vitamin D, as to whether vitamin D shows beneficial effects to humans, and how much should be administered to show those beneficial effects. Workers with the present inventors have found that only a fresh form of vitamin D, as a pasty oil, has proven itself to show beneficial effects.
Another particular problem addressed by the present invention is that the beneficial components of fatty acids have a short shelf life, going rancid or otherwise degrading rather quickly. Examples include omega-3 and omega-6 fatty acids, cod liver oil, fish oil, linoleic acid, conjugated linoleic acid, and flaxseed oil. The present invention permits the provision of a longer shelf life form of oils or their useful components, including fatty acids, by providing protection from light and oxygen; and also by permitting easy portability of unitary dosage amounts.
For example, it is common for flax seed users to store the seeds in the refrigerator or freezer to prolong the shelf life, and then to put the seeds only on already-cooked foods or raw foods, since the cooking process degrades the beneficial oil components. Gel caps of flaxseed oil are presently sold in large jars.
Contemplated unitary dosage items include pills or capsules (including gel caps and two-piece hard gel capsules) that includes a nutritional supplement or a pharmaceutical active ingredient; fragile items; items sensitive to oxygen; items sensitive to light; vitamin D; conjugated linoleic acid; omega-3 fatty acid; flax oil; cod liver oil, fish oil, and omega-6 fatty acid.
In an embodiment of the present invention, preferred fatty acids contained in a unitary dosage item include eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and alpha linolenic acid (ALA), typically from fish or marine sources, flax seed, krill or algae. In an embodiment, preferred fatty acid concentrations in mg of EPA:DHA per gram of oil include 250:450; 200:600; 500:200 and 400:200. Typical capsule sizes include 250 mg, 500 mg, 600 mg, and 1000 mg. Typical pill or capsule ingredient sources or types include vegetarian, bovine, porcine, synthetic and chewable.
In an embodiment of the present invention, excipients include those well known in the art, typically emulsifiers such as lecithin and beeswax; stabilizers such as vitamin E, tocopherols, ascorbyl palmitate, and rosemary extract; and coloring agents including natural coloring agents such as annatto (for example in the capsule coating). Other contemplated additives include: minerals, including magnesium, zinc, chromium, calcium and selenium; vitamins, including beta-carotene, vitamin A, vitamin D, vitamin E, and vitamin B-complex; and nutraceuticals, including lutein, zeaxanthin, and resveratrol.
In a contemplated embodiment, the packaging provides a convenient reminder of when pills have been or should be taken, or a convenient number of doses. For example, in a contemplated embodiment where the dose should be taken once each day, convenient packaging may provide a package where each row of the blister package contains 7 indentations for storing one week's worth of unitary dosage items. The number of rows may correspond to the number of weeks in a month. Or, if multiple doses are to be taken in a single day, a contemplated embodiment has rows representing different times of day, and a weeks worth of columns. It is to be understood that each dosage amount and frequency will dictate a variety of convenient arrangements of doses in a single blister pack. For example, in an embodiment where two unitary dosage items are to be taken each day, and each row of the blister package contains 14 indentations of regular depth for storing one week's worth of unitary dosage items.
In a contemplated embodiment, the blister package contains a convenient number of unitary dosage items to provide a reminder to the consumer as to whether a particular dose has been taken or when the next dose should be taken. Preferably the rows and columns of the blister package or the labeling thereupon provide a reminder to the consumer as to whether or not a particular unitary dosage item has been consumed. For example, a blister pack may have a row containing seven indented chambers for a unitary dosage items that should be taken once a day. The blister pack may then have from one to four such rows to provide sufficient conveniently portable doses for a week or a month. In another example, a unitary dosage item should be taken three times each day. Then it may be convenient to provide a blister package that has three rows containing seven doses, so that each day, one dose is taken from each of the three rows.
In order to provide a convenient dosage amount in a convenient-sized package, in a contemplated embodiment, a package for a plurality of unitary dosage items according the present invention is stacked together with a number of like packages inside an outer package. The outer package is constructed by any of the many known methods common in the art. Simple boxes for holding several contemplated packages for a plurality of unitary dosage items are contemplated, preferably sized to hold a number of packages that are convenient for the end-user. Dispenser packages are also contemplated that permit simple removal of a single contemplated package for a plurality of unitary dosage items.
In an embodiment with an outer package that is a simple box, the outer package is conveniently constructed of a folded single piece of paperboard that has a substantially rectangular base unit that folds to form a base unit box (16). This embodiment is conveniently illustrated in FIG. 3. In an embodiment, the box lid is a self-lid, which is a substantially rectangular lid unit (15) that extends from a box wall (21) and folds to form a lid (19) with a flap (17) that tucks into the base unit box (16). In this description of such a box with unitary construction, the base unit box has an open top and a folded-closed bottom. In a typical embodiment, the base unit box is a rectangular prism, with two short sides (26) and a front long side (34) and a back long side (21). In the most common of those typical embodiments, the lid unit portion of the paperboard extends from the top of the back long side of the base unit box once it is folded to form a crease (20) at the attached part of the lid. The edge of the rectangular lid unit opposite the side that folds along the long side of the base unit folds down (18) to become a lid flap (17), to conveniently hold the lid in place. In its folded form, the substantially rectangular base unit (16) has a second 90° fold across its long side (20) to form the top long side of a base unit box that creases to form the extending lid, and a third 90° fold (24) parallel to the first fold that forms the bottom long side of the base unit box and sets the depth of the box. The depth of the box is preferably a multiple M of the depth, D of the narrow opening of the sleeves of the package according to the invention. To form convenient tabs (22, 30) for holding the shape of the box, the third fold (24) has slits (23) from the outside of the base unit box to the outer edge of the unfolded base unit at either end of the third fold. These tabs (22) fold 90° toward the inside of the box prior to folding up the base unit box sides to become side-supporting tabs. A fourth fold (33) parallel to the second and third folds becomes the bottom long side of the base unit box. This fourth fold also has slits (29) from the outside of the base unit box bottom to the outer edge of the unfolded base unit at either end of the fourth fold (33); these slits also become tabs (30) that help support the shape of the box. The spacing between the slit beginnings determine the length of the base unit box bottom (24, 33) and are preferably a multiple N of one rectangular edge length L of the folded sleeve of the package for unitary dosage items. These slits form a tab (30) that folds 90° toward the inside of the box prior to folding up the base unit box sides to become side-supporting tabs. When the tabs (22, 30) are folded, two remaining center sections (26) are left on opposite sides of the bottom. The spacing between the slits of the second and third folds defines the width of the base unit box which should be a multiple P of the other rectangular edge W of the folded sleeve of the package for unitary dosage items. The fourth 90° fold parallel to the first, second and third folds forms the bottom front long side of the base unit box. The two remaining center sections (26) fold up 90° from the short sides of the base of the base unit box, typically with the side-supporting tabs (22, 30) inside. As shown in FIG. 3, in a very stable outer package embodiment, the sides of the base unit box (26) are twice the height of the base unit box depth. The sides form bottom box corners at the ends of the third and fourth fold slits (23, 29). A final fold (27) of the portion of the short sides of the base unit box that extends up above the base unit box depth 180° down, preferably over the side-supporting tabs, adds further shape stability. These folded down side flaps are either glued down, or small tabs (35) at the outer edge slipped into slits (36) at the box side bottom fold lines, as shown in the drawing. The side height after folding is only once the height of the base unit box depth. Thus is formed a rectangular base unit box that is closed at the bottom and open at the top that can hold a stacked plurality that is the multiples of L, W and D of the packages for unitary dosage items.