| WO/2004/083057 | PACKAGING FOR GRANULAR, FLUID OR POWDER PRODUCTS |
| JP2598605 | CONTAINER TO HOLD AROMATIC SUBSTANCE |
| WO/1996/015046 | SELF-SUPPORTING POURABLE SUBSTANCE PACKAGE |
Martinsen, Bo Reidar (1721 South Creek Drive, Osprey, FL, 34229, US)
| 1. | A dosage package comprising a unit dosage of a liquid Omega3 dietary supplement, wherein said dosage package comprises a discharge portion and a container portion manually compressible for expelling the liquid Omega3 dietary supplement through said discharge portion. |
| 2. | The dosage package of claim 19 wherein the unit dosage comprises an amount from about 2 to about milliliters of the liquid Omega3 dietary supplement. |
| 3. | The dosage package of claim 2, wherein the unit dosage comprises an amount from about 2 to about 7 milliliters of the liquid Omega3 dietary supplement. |
| 4. | The dosage package of claim 3, wherein the unit dosage comprises an amount from about 3 to about 6 milliliters of the liquid Omega3 dietary supplement. |
| 5. | The dosage package of claim 4, wherein the unit dosage comprises an amount from about 3.5 to about 5 milliliters of the liquid Omega3 dietary supplement. |
| 6. | The dosage package of claim 2, wherein the unit dosage has a volume of about 2 milliliters, or about 2.5 milliliters, or about 3 milliliters, or about 3.5 milliliters, or about 4 milliliters, or about 4.5 milliliters, or about 5 milliliters, or about 5.5 milliliters, or about 6 milliliters, or about 6.5 milliliters, or about 7 milliliters, or about 7.5 milliliters, or about 8 milliliters. |
| 7. | The dosage package of claim 6, wherein the volume is about 3, or about 4, or about 5 milliliters. |
| 8. | The dosage package of claim 1, wherein said discharge portion comprises a scored region to facilitate opening. |
| 9. | The dosage package of claim 1, wherein said discharge portion comprises a tapered portion. |
| 10. | The dosage package of claim 1, wherein said container portion has a maximum width and said discharge portion comprises a tapered portion having a maximum width less than the maximum width of said container portion. |
| 11. | The dosage package of claim 1, wherein said container portion has a maximum width and said discharge portion comprises a tapered portion having a maximum width equal to the maximum width of said flexible container portion. |
| 12. | The dosage package of claim 1, wherein the liquid Omega3 dietary supplement comprises, by weight, at least 5% eicosapentaenoic acid (EPA) and 5% docosahexaenoic (DHA). |
| 13. | The dosage package of claim 1, wherein the liquid Omega3 dietary supplement comprises, by weight, at least 10% EPA and 10% DHA. |
| 14. | The dosage package of claim 1, wherein the liquid Omega3 dietary supplement comprises, by weight, between about 10% and about 35% EPA and between about 10% and about 35% DHA. |
| 15. | The dosage package of claim 1, wherein the liquid Omega3 dietary supplement comprises, by weight, between about 14% and about 18% EPA and between about 12% and about 16% DHA. |
| 16. | The dosage package of claim 12, wherein the liquid Omega3 dietary supplement comprises one or more added flavorings. |
| 17. | The dosage package of claim 16, wherein the liquid Omega3 dietary supplement comprises one or more added flavorings selected from the group consisting of orange, lemon, lime, strawberry, raspberry, banana and vanilla. |
| 18. | The dosage package of claim 12, wherein the liquid Omega3 dietary supplement comprises vitamin E and/or lutein. |
| 19. | The dosage package of claim 12, wherein the liquid Omega3 dietary supplement comprises one or more antioxidants. |
| 20. | The dosage package of claim 19, wherein the liquid Omega3 dietary supplement comprises vitamin C and/or vitamin E. |
| 21. | The dosage package of claim 1, wherein the liquid Omega3 dietary supplement is not an oilinwater emulsion. |
| 22. | The dosage package of claim 21, wherein the liquid Omega3 dietary supplement is prepared by a process that does not include formation of an oilinwater emulsion. |
| 23. | The dosage package of claim 1, wherein manual compression of the container portion discharges at least 75% of the liquid Omega3 dietary supplement contained within the dosage package. |
| 24. | The dosage package of claim 23, wherein manual compression of the container portion discharges liquid Omega3 dietary supplement through the discharge region in any desired direction, including upward and against gravity. |
| 25. | The dosage package of claim 1, wherein the dosage package has a maximum capacity and the unit dosage fills the dosage package to at least 75% of the maximum capacity. |
| 26. | The dosage package of claim 25, wherein the dosage package comprises a portion not filled with the liquid Omega3 dietary. |
| 27. | The dosage package of claim 26, wherein the portion not filled with the liquid Omega3 dietary supplement comprises an inert gas. |
| 28. | The dosage package of claim 27, wherein the inert gas comprises nitrogen or carbon dioxide. |
| 29. | The dosage package of claim 1, wherein the container portion includes a polymer as a material. |
| 30. | The dosage package of claim 29, wherein the polymer comprises one or more materials selected from a polyethylene, a polypropylene and a polyester. |
| 31. | The dosage package of claim 29, wherein the polymer comprises polyethylene terephthalate (PET). |
| 32. | The dosage package of claim 29, wherein the polymer comprises pigments or other light absorbing substances. |
| 33. | The dosage package of claim 1, wherein the dosage package comprises a secondary container portion containing a substance differing from said liquid Omega3 dietary supplement. |
| 34. | The dosage package of claim 33, wherein the discharge portion is proximal to the container portion. |
| 35. | The dosage package of claim 33, wherein the discharge portion is proximal to the secondary container portion. |
| 36. | The dosage package of claim 33, wherein a border area separates the container portion from the secondary container portion to impede the liquid Omega3 dietary supplement of the container portion from mixing with the substance of the secondary container portion. |
| 37. | The dosage package of claim 36, wherein the border area may be manually manipulated to join the container portion with the secondary container portion and thereby facilitate mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 38. | The dosage package of claim 37, wherein manually applying pressure to the container portion and/or the secondary container portion, joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 39. | The dosage package of claim 37, wherein manually bending the border area joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 40. | The dosage package of claim 37, wherein manually squeezing the border area joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 41. | The dosage package of claim 36, wherein an ampule contained within the container portion comprises the secondary container portion, and wherein a portion of the ampule comprises the border area. |
| 42. | The dosage package of claim 36, wherein an ampule contained within the secondary container portion comprises the container portion, and wherein a portion of the ampule comprises the border area. |
| 43. | The dosage package of claim 36, wherein the substance of the secondary container portion comprises a pharmaceutical compound. |
| 44. | The dosage package of claim 43, wherein the substance of the secondary container portion comprises a unit dosage the pharmaceutical compound. |
| 45. | The dosage package of claim 43, wherein the substance of the secondary container comprises one or more of : a statin ; a medication for treating type II diabetes ; an anti depressive medication; antipsychotic medication; an antiseizure medication; an anti glaucoma medication ; or a nonsteroidal antiinflammatory (NSAID) medication. |
| 46. | The dosage package of claim 43, wherein the substance of the secondary container comprises one or more of : a vitamin, an herb or a mineral. |
| 47. | The dosage package of claim 1, wherein a blister of a blister pack comprises said container portion manually compressible for expelling the liquid Omega3 dietary supplement through said discharge portion. |
| 48. | The dosage package of claim 47, wherein the dosage package comprises a secondary container portion containing a substance differing from said liquid Omega3 dietary supplement. |
| 49. | The dosage package of claim 1, wherein said dosage package comprises a blister having wall portions defining an open cavity that, when covered with a sheetlike cover attached to a flange extending around the periphery of the cavity, comprises the container portion. |
| 50. | The dosage package of claim 49, wherein the wall portions define an open cavity that, when covered with a sheetlike cover attached to a flange extending around the periphery of the cavity, comprises the container portion and a portion of the discharge portion that is open to the container portion, where the discharge portion comprises a hollow extension from the container portion with one end opening into the container portion and another end being sealed. |
| 51. | The dosage package of claim 50, wherein the hollow extension of the discharge portion comprises a breakoff region to facilitate removal of the sealed end from the end that opens into the container portion. |
| 52. | The dosage package of claim 49, wherein the dosage package comprises a secondary container portion containing a substance differing from said liquid Omega3 dietary supplement. |
| 53. | The dosage package of claim 52, wherein a border area separates the container portion from the secondary container portion to impede the liquid Omega3 dietary supplement of the container portion from mixing with the substance of the secondary container portion. |
| 54. | The dosage package of claim 53, wherein the border area may be manually manipulated to join the container portion with the secondary container portion and thereby facilitate mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 55. | The dosage package of claim 54, wherein manually applying pressure to the container portion and/or the secondary container portion joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 56. | The dosage package of claim 54, wherein manually bending the border area joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 57. | The dosage package of claim 54, wherein manually squeezing the border area joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega3 dietary supplement of the container portion with the substance of the secondary container portion. |
| 58. | The dosage package of claim 54, wherein an ampule contained within the container portion comprises the secondary container portion, and wherein a portion of the ampule comprises the border area. |
| 59. | The dosage package of claim 53, wherein an arnpule contained within the secondary container portion comprises the container portion, and wherein a portion of the ampule comprises the border area. |
| 60. | The dosage package of claim 53, wherein the substance of the secondary container portion comprises a pharmaceutical compound. |
| 61. | The dosage package of claim 60, wherein the substance of the secondary container portion comprises a unit dosage the pharmaceutical compound. |
| 62. | The dosage package of claim 60, wherein the substance of the secondary container comprises one or more of : a statin; a medication for treating type II diabetes; an anti depressive medication; antipsychotic medication; an antiseizure medication; an anti glaucoma medication; or a nonsteroidal antiinflammatory (NSAID) medication medication. |
| 63. | The dosage package of claim 60, wherein the substance of the secondary container comprises one or more of : a vitamin, an herb or a mineral. |
BACKGROUND OF THE INVENTION Field of the Invention The invention relates to improved products that promote the use of Omega-3 dietary supplements and to methods using said improved products.
Description of Related Art Considerable evidence has accumulated suggesting that the proper dietary intake of the Omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), plays a vital role in maintaining good health. For example, low blood levels of Omega 3 are clearly linked to increased risk of heart disease. One recent study suggests that those who took Omega 3 were significantly less prone to cardiovascular death (Lancet 1999,354 : 447-455). Taking Omega 3 has been shown to slow the developing blockages in coronary arteries (Annals of Internal Medicine 1999; 130 nr. 7) and to enhance the action of the drug pravastatin, which is a drug that is used to reduce fats in the blood (Nephron 88 (4): 329-33,200).
Moreover, a study in men has shown that those who ate the most fish were less likely
to die of heart disease than those who ate the least fish (J. Am. Med Assoc 1998; 279: 23-28).
The benefits of proper dietary intake of the Omega-3 fatty acids go well beyond promoting a healthy heart. For example, DHA is known to be an important fatty acid in the development and the maintenance of the retina. Studies suggest that regular intake of Omega-3 fatty acids EPA and DHA may have a prophylactic effect on the two most common eye diseases leading to blindness: macular degeneration and glaucoma. Moreover, it has been suggested that those with low levels of Omega-3 are significantly more likely to develop Alzheimer's disease (Lipids Vol. 34.1999, 245).
The benefits of a diet high in Omega-3 have also been demonstrated in patients suffering from bipolar disorder, a mental condition resulting in cyclic mood swings between depression and dangerously exaggerated elation and energy (Archives of General Psychiatry. Vol. 569 May 1999 407-12). The benefits of a diet rich in Omega-3 fatty acids are underscored by the fact that the human eye's main center of vision and the thinking part of the brain (the cerebral cortex) each comprise substantial concentrations of these important fatty acids.
Despite the well established medical benefits of a diet supplemented with Omega-3 fatty acids, such as those benefits described above, many people continue to resist supplementing their diets with these important nutrients. In view of this resistance, many attempts have been made in recent years to develop improved products that appeal to a broader section of the consumer population and that promote the use of Omega-3 dietary supplements.
U. S. Patent 4,966, 734, the entirety of which is herein incorporated by reference, discloses methods for removing undesirable odors from fatty ester mixtures which, in addition to other components, contain the esters of highly unsaturated fatty acids, in particular of highly unsaturated 3-fatty acids, such as eicosapentaenoic acid or docosahexaenoic acid, by a process in which the fatty ester mixture is treated with a complex hydride, in particular with sodium borohydride solution. The disclosure teaches that the process is particularly suitable for removing undesirable odors from fatty ester mixtures obtained from fish oil. However, among various other disadvantages, a problem is that such odors are prone to return upon exposure of the product to air or other oxidants.
U. S. Patent 4, 853, 247, the entirety of which is herein incorporated by reference, discloses a product comprising an unpleasant edible oil, such as one high in Omega-3 fatty acids, and an oil soluble sensory masking agent. The sensory masking agent is purported to be capable of producing a taste masking and/or odor masking sensation for the unpleasant edible oil. Indeed, liquid Omega-3 dietary supplements that employ taste and/or odor masking approaches have become commercially available in the form of bottles containing more than one unit dosage. However, such an embodiment suffers from various disadvantages including the inconvenience associated with measuring a single unit dosage from such a bottle and the limited product life span resulting from the need to repeatedly expose the product to the oxidizing effects of air in order to measure such a dosage.
U. S. Patent 6,346, 231, the entirety of which is herein incorporated by reference, discloses flavored gelatin capsules and a method of manufacturing the
flavored capsules. The capsule may comprise (a) from about 10 to about 70 parts by weight of gelatin; (b) from about 10 to about 35 parts by weight of a suitable polyol, such as glycerol ; (c) from about 8 parts by weight of water; and (c) various parts by weight of particular water soluble flavorings. The contents of the capsule may also be flavored. It is suggested that the composition is particularly useful in improving the palatability of fish oil medicinals. However, gelatin capsules suffer from various disadvantages including that several large capsules may be required to supply a given dosage of Omega-3 dietary supplement and that many people can swallow such capsules, if at all, only when accompanied with a liquid, which may not be conveniently available.
In EP 0 493 439 Bl, the entirety of which is herein incorporated by reference, Myhre describes a product comprising a tube or a soft plastic container made of an airtight material and containing an unhydrogenated preparation in the form of an oil- in-water emulsion. The tube or container is described as being designed in such a manner that when it is used, it is compressed proportionally with the amount of emulsion remaining after one dosage, with the result that no air space is formed in the container and therefore no appreciable oxidation will occur in the cod liver oil product. The disclosure explains that, during the manufacturing process, the product is not in contact with air and this absence of air prevents oxidation of the fish oil in the product. The oil component of the oil-in-water emulsion contained in the tube or a soft plastic container is described to be mainly polyunsaturated and to constitute between 66 and 88 weight % of the emulsion. The inventor discloses that the oil-in- water emulsion has a"mayonnaise or paste-like consistency"and purports several
advantages for this property. For example, it is suggested that the thick, paste consistency of the emulsions makes them easy to apply on food, e. g. bread or fish, and therefore could be used in the same way as mayonnaise. The inventor also submits that the impact of an added flavor is far more favorable when using a thick emulsion than when using a thin emulsion. However, among various other disadvantages, it has been reported that such viscous"mayonnaise-like"oil-in-water emulsions do not appeal to a significant segment of the consumer population. Indeed, as subsequently discussed by Myhre in WO 01/47377 A, such products produce the disadvantageous effect that many youngsters and children are not motivated to use and consume them, and if they are forced by their parents they may produce a serious dislike.
In WO 01/47377 A2, the entirety of which is herein incorporated by reference, Mylzre describes liquid nutritional drinks and methods for making them. The products are described to be manufactured by a process including preparing an oil-in- water emulsion, such as that disclosed in EP 0493 439 Bl, and adding it to a desired water-based liquid drink. The disclosure explains that the ratio between emulsion and drink may vary from 1: 10 to 1: 100, preferably 1: 20 to 1: 40. Myhre explains that the objects of the invention disclosed in WO 01/47377 A include overcoming the disadvantages of viscous"mayonnaise-like"oil-in-water emulsions, such as those disclosed in EP 0 493 439 Bl, and providing ordinary consumer goods which taste and look like orange juice, skimmed milk or breast milk substitute which, despite the addition of fish oil with polyunsaturates, still tastes and is perceived like the pure juice or milk product, with no trace of a fish oil taste. However, given the specified
ratios between emulsion and drink, the volume of drink required to supply a recommended dosage of Omega-3 dietary supplement may be more than is desired or convenient.
Despite the attempts by others to develop Omega-3 dietary supplements that appeal to a broader section of the consumer population, many people continue to resist supplementing their diets with these important nutrients. Indeed, it has been estimated that, despite the evidence supporting a vital role of dietary Omega-3 fatty acids in maintaining good health, few people in the Western World meet their Omega- 3 needs through their diet. Given this continued resistance, a need exists for improved products that promote the use of Omega-3 dietary supplements.
SUMMARY OF THE INVENTION The invention is drawn to a dosage package comprising a unit dosage of a liquid Omega-3 dietary supplement as well as methods using such a dosage package. The dosage package comprises a discharge portion and a container portion that is manually compressible for expelling the liquid Omega-3 dietary supplement through the discharge portion. The invention is also directed to methods using the dosage package, including dietary regimens.
An object of this invention is to provide an improved dosage package that promotes the use of Omega-3 dietary supplements. Other objects, features and advantages of the present invention will be more readily apparent from the detailed description of the preferred embodiments set forth below taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 depicts elements of a preferred embodiment as exemplified in Example 4.
Figure 2 depicts elements of preferred embodiments as exemplified in Examples 7 and 8.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The instant invention contemplates a variety of dosage packages suitable for delivering a unit dosage of a liquid Omega-3 dietary supplement. Although not limited to any particular dosage package, the invention contemplates that suitable
dosage packages comprise a container portion operable to be manually compressed for expelling the liquid Omega-3 dietary supplement contained within. The container portion may be fabricated from any material having suitably flexible qualities such that the container portion is manually compressible, such as through pinching with fingers or squeezing by hand, to discharge the liquid contents. The container portion, or portions thereof, may additionally include rigid materials so long as those rigid materials do not prevent the container portion from being manually compressed to expel the liquid Omega-3 dietary supplement. As one skilled in the art would recognize, a given material may be either flexible or rigid depending on thickness and other factors. In one preferred embodiment, the container portion includes a polymer as a material. In one preferred embodiment, the container portion includes one or more materials selected from a polyethylene, a polypropylene or a polyester. A particularly preferred example of a polyethylene is polyethylene terephthalate (PET) If desired, the materials may include pigments or other light absorbing substances, including those for protecting the liquid Omega-3 dietary supplement from the damaging effect of light.
All suitable dosage packages additionally comprise a discharge portion through which the liquid Omega-3 dietary supplement may be discharged from the container portion. The discharge portion may comprise any pore, passage, or potential passage, suitable for discharge of the liquid. In one embodiment, the discharge portion consists of a pore through which liquid may be discharged. The discharge portion may also be a perforation or area to be torn or perforated. The discharge portion may additionally include a hollow extension through which the
liquid may flow. In a preferred embodiment, the extension may function as a nozzle for directing the flow of the liquid.
Prior to its use, the contemplated dosage package is filled with the liquid Omega-3 dietary supplement, and the discharge portion of said dosage package is thereafter sealed to prevent its unintended discharge and to maintain the freshness of the liquid Omega-3 dietary supplement contained within. In a preferred embodiment, the dosage package is filled and sealed in an inert environment to reduce exposure of the liquid Omega-3 dietary supplement to oxygen and other substances potentially detrimental to the stability of the fatty acids contained within. One of skill in the art would recognize many inert environments appropriate for use during the filling and sealing process. In a preferred embodiment, the dosage package is filled and sealed under nitrogen and/or carbon dioxide.
The contemplated invention is not limited by any particular means for sealing the discharge portion and may employ any means that one of skill in the art would recognize as suitable. Among such suitable means are stoppers, caps, adhesive barriers, foil barriers, tearable regions, removably secured break-off regions, and the like. In preferred embodiments, the discharge portion comprises a hollow extension with one end opening into the container portion and another end being sealed. In a particularly preferred embodiment, the hollow extension includes a break-off region to facilitate removal of the sealed end from the end that opens into the container portion. As a non-limiting example of such a break-off region, the hollow extension may include a shear line, such as one defined by a thin walled section, to facilitate
removal of the sealed end from the end that opens into the interior of the container portion. The exterior of the sealed end may include a tab to further facilitate removal.
In the use of a preferred embodiment, the means for sealing the discharge portion is first removed, and then the container portion is manually compressed to discharge the liquid Omega-3 dietary supplement through the discharge portion. In a preferred embodiment, manual compression of the container portion discharges at least 65% by volume of the liquid Omega-3 dietary supplement contained within the dosage package. In another preferred embodiment, manual compression of the container portion discharges at least 75% by volume of the liquid Omega-3 dietary supplement contained within the dosage package. In another preferred embodiment, manual compression of the container portion discharges at least 85% by volume of the liquid Omega-3 dietary supplement contained within the dosage package. In an especially preferred embodiment, manual compression of the container portion discharges at least 95% by volume of the liquid Omega-3 dietary supplement contained within the dosage package. In another especially preferred embodiment, manual compression of the container portion discharges at least 98% by volume of the liquid Omega-3 dietary supplement contained within the dosage package. In a particularly preferred embodiment, the liquid to be discharged may be discharged through the discharge region in any desired direction, including upward and against gravity. In a preferred embodiment, the dosage package is disposable subsequent to use.
The invention is also directed to methods using a contemplated dosage package. In a preferred embodiment, a unit dosage of a liquid Omega-3 dietary
supplement is administered to a subject in need thereof, the method comprising discharging from the dosage package a unit dosage of the liquid Omega-3 dietary supplement contained therein, and administering the dosage to the subject in need thereof. In a preferred embodiment, the subject is a mammal. In a more preferred embodiment, the subject is a human. The subject may also be other animals, with examples including livestock and pets, such as a horse or a dog or a cat or goat or a sheep or the like.
The internal volume of the dosage package comprises the internal volume of the container portion. Where the discharge portion includes a portion open to the interior of the container portion, the internal volume of the dosage package further comprises the internal volume of that portion of the discharge portion that is open to the container portion. The maximum capacity of the dosage package is the internal volume of the container portion combined with the internal volume of any other portion that is open to the container portion. In a preferred embodiment, a unit dosage of the liquid Omega-3 dietary supplement has a volume that fills the dosage package to at least 65% of its maximum capacity. In another preferred embodiment, a unit dosage of the liquid Omega-3 dietary supplement has a volume that fills the dosage package to at least 75% of its maximum capacity. In another preferred embodiment, a unit dosage of the liquid Omega-3 dietary supplement has a volume that fills the dosage package to at least 85% of its maximum capacity. In another preferred embodiment, a unit dosage of the liquid Omega-3 dietary supplement has a volume that fills the dosage package to at least 95% of its maximum capacity. In another preferred embodiment, a unit dosage of the liquid Omega-3 dietary supplement has a
volume that fills the dosage package to at least 98% of its maximum capacity. In a preferred embodiment, that portion of the dosage package not filled with the liquid Omega-3 dietary supplement comprises a gas. In a preferred embodiment, the gas is predominantly an inert gas. In another preferred embodiment, the inert gas is nitrogen or carbon dioxide.
As is well known in the art, a"blister package"includes a blister and a sheet- like cover attached to the blister so that the blister and the cover cooperatively enclose a product contained in the package. (See for example, US Patent 4,415, 084, the entirety of which is herein incorporated by reference. ) As used herein, a"blister"is a tray-like container formed by drawing a sheet material to form a cavity in a desired shape. Examples of such desired shapes include a semi-cylindrical-like shape or a semi-spherical-like shape or a tub-like shape as well as other desired shapes. Among the embodiments, a preferred blister package incorporates a blister having wall portions defining an open cavity, the cavity having a desired shape, and a flange extending around the periphery of the open cavity. In one such embodiment, the sheet-like cover, which for example may comprise an aluminum foil material, is attached to this flange so that the cover closely overlies the flange and occludes the opening of the cavity. The space so enclosed includes the container portion. While in certain embodiments the discharge portion may comprise a pore, a perforation, or an area operable to be torn of perforated, additional embodiments are contemplated. For example, in preferred embodiments, the discharge portion comprises a hollow extension with one end opening into the container portion and another end being sealed. In a particularly preferred embodiment, the hollow extension includes a
break-off region to facilitate removal of the sealed end from the end that opens into the container portion. As a non-limiting example of such a break-off region, the hollow extension may include a shear line, such as one defined by a thin walled section, to facilitate removal of the sealed end from the end that opens into the interior of the container portion. In a preferred embodiment, the sheet material is drawn to form a blister having a wall portion defining a cavity that, when covered with a sheet- like cover attached to a flange extending around the periphery of the cavity, comprises a container portion. In a preferred embodiment, the sheet material is drawn to form a blister having wall portions defining an open cavity that, when covered with a sheet- like cover attached to a flange extending around the periphery of the cavity, comprises the container portion and a portion of the discharge portion that is open to the container portion, where the discharge portion comprises a hollow extension from the container portion with one end opening into the container portion and another end being sealed. In a preferred embodiment, the hollow extension functions as a nozzle to direct the flow of the liquid Omega-3 dietary supplement. In a particularly preferred embodiment, the hollow extension of the discharge region includes a break- off region to facilitate removal of the sealed end from the end that opens into the container portion.
As used herein, the term"unit dosage"refers to a dosage to be taken as a single dose in a single administration. In a preferred embodiment, a unit dosage is a dosage to be taken once daily as a single dose in a single administration. As one of skill in the art would recognize, situations may arise where it may be indicated to administer at a given time multiple unit dosages. For example, situations may arise
where administering 1 or 2 or 3 unit dosages at a given time may be indicated. In a particularly preferred embodiment, administering 1 or 2 unit dosages at a given time may be indicated. In another particularly preferred embodiment, administering 1 unit dosage at a given time may be indicated. Where multiple unit dosages are indicated, the corresponding number of dosage packages, each comprising a unit dosage of a liquid Omega-3 dietary supplement, are administered. In a preferred embodiment, a unit dosage has a given volume, the unit dosage comprising a liquid Omega-3 dietary supplement, the given volume of the unit dosage being a volume within a range from about 2 to about 8 milliliters, or from about 3 to about 8 milliliters, or from about 2 to about 7 milliliters, or from about 2 to about 5 milliliters, or from about 2 to about 6 milliliters, or from about 3 to about 6 milliliters, or from about 3.5 to about 5 milliliters, or from about 3. 5 to about 7 milliliters. In a preferred embodiment, the volume of the unit dosage is about 2 milliliters, or about 2.5 milliliters, or about 3 milliliters, or about 3.5 milliliters, or about 4 milliliters, or about 4.5 milliliters, or about 5 milliliters, or about 5.5 milliliters, or about 6 milliliters, or about 6.5 milliliters, or about 7 milliliters, or about 7.5 milliliters, or about 8 milliliters. In a preferred embodiment, a unit dosage comprises an amount from about 2 to about 8 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 2 to about 6 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 3 to about 8 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 2 to about 7 milliliters of a liquid Omega-3 dietary supplement. In another
preferred embodiment, a unit dosage comprises an amount from about 2 to about 5 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 3 to about 6 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 3 to about 6 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 3.5 to about 5 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount from about 3.5 to about 7 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises an amount about 4.5 milliliters of a liquid Omega-3 dietary supplement. In another preferred embodiment, a unit dosage comprises about 3 milliliters or about 3.5 milliliters or about 4 milliliters or about 4.5 milliliters or about 5 milliliters or about 5.5 milliliters of the liquid Omega-3 dietary supplement.
As would be recognized by one of skill in the art, the term Omega-3 dietary supplement"refers to a dietary supplement comprising Omega-3 fatty acids. In a preferred embodiment, an Omega-3 dietary supplement comprises eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA), and optionally other oils, most preferably polyunsaturated oils. Omega-3 dietary supplements may optionally comprise additional components, with non-limiting examples being other nutritional components such as vitamin E and/or lutein, for example. In a preferred embodiment, the Omega-3 dietary supplement comprises marine oil or marine oil concentrates or mixture of such oils high in eicosapentaenoic acid (EPA) and docosahexaenoic acid
(DHA) content. Preferred sources of marine oils and marine oil concentrates include cod, sardine, anchovy, pilchard, menhaden, horse mackerel, salmon and capelin, among others. In one embodiment, the marine oil comprises cod liver oil and/or an oil from any other marine source high in EPA and/or DHA. In a preferred embodiment, the liquid Omega-3 dietary supplement is prepared by a process that does not include formation of an oil-in-water emulsion. In a preferred embodiment, the liquid Omega-3 dietary supplement is not an oil-in-water emulsion. In a preferred embodiment, the dosage package dose not comprise an oil-in-water emulsion. In another preferred embodiment, the liquid Omega-3 dietary supplement is prepared by a process that does not include addition of water. In an especially preferred embodiment, the Omega-3 dietary supplement is substantially devoid of water. In an especially preferred embodiment, the Omega-3 dietary supplement is substantially devoid of egg yolk. In another preferred embodiment, the liquid Omega-3 dietary supplement comprises, by weight, at least 5% EPA and 5% DHA. In another preferred embodiment, the liquid Omega-3 dietary supplement comprises, by weight, at least 10% EPA and 10% DHA. In another preferred embodiment, the Omega-3 dietary supplement comprises, by weight, between about 10% and about 35% EPA and between about 10% and about 35% DHA. In another preferred embodiment, the liquid Omega-3 dietary supplement comprises, by weight, between about 14% and about 18% EPA and between about 12% and about 16% DHA. The supplement may also include one or more added flavorings, including natural flavorings. Preferred flavors include, for example, orange, lemon, lime, strawberry, raspberry, banana, vanilla. Citrus fruit flavors are particularly preferred. In an especially preferred
embodiment, the liquid Omega-3 dietary supplement is OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida. In another especially preferred embodiment, the liquid Omega-3 dietary supplement is OMEGAFOCUS, also available from doc's Guide, Inc. In another embodiment, the liquid Omega-3 dietary supplement is protected or stabilized with one or more anti-oxidants and/or stabilizers. In another embodiment, the liquid Omega-3 dietary supplement is protected or stabilized with one or more naturally occurring nutrients that functions as an anti-oxidant and/or stabilizer, such as vitamins including vitamins C and/or E. In another embodiment, the liquid Omega-3 dietary supplement is devoid of any added anti-oxidants and/or stabilizers other than one or more naturally occurring nutrients that function as an anti-oxidant and/or stabilizer, for example vitamins C and/or E.
The term'liquid99 as used herein in relation to an Omega-3 dietary supplement has an art recognized meaning. As one of skill in the art would recognize, the term "liquid Omega-3 dietary supplement"as used herein excludes any oil-in-water emulsion that is described as a"paste"or"paste-like"or"creamy"or"pudding-like" or"mayonnaise-like"in U. S. Patent 5,346, 709, the entirety of which is herein incorporated by reference. That is, the term as used herein excludes any Omega-3 dietary supplement that is an oil-in-water emulsion having an absolute or kinematic viscosity at 20°C equal to or greater than that of an oil-in-water emulsion containing 66-88% by weight of marine oil or marine oil concentrates or mixture of such oils, or the amount of oil calculated to give 19-25% by weight of polyunsaturated fatty acids in the form of the same oils. The term as used herein further excludes any Omega-3 dietary supplement that is an oil-in-water emulsion having an absolute or kinematic
viscosity (at a give temperature) equal to or greater than the absolute or kinematic viscosity (at the same temperature) of an oil-in-water emulsion containing 60-95 % by weight of marine oil or marine oil concentrates or mixture of such oils. In a preferred embodiment, the liquid Omega-3 dietary supplement encompasses an Omega-3 dietary supplement having an absolute viscosity at 20°C less than that of an oil-in- water emulsion produced with at least 60 % by weight of marine oil or marine oil concentrates or mixture of such oils (i. e. an oil-in-water emulsion having an oil : water weight ratio less than 60: 40). In a preferred embodiment, the liquid Omega-3 dietary supplement encompasses an Omega-3 dietary supplement having a kinematic viscosity at 20°C less than that of an oil-in-water emulsion produced with at least 60 % by weight of marine oil or marine oil concentrates or mixture of such oils. In another preferred embodiment, the liquid Omega-3 dietary supplement encompasses an Omega-3 dietary supplement having an absolute viscosity at 20°C less than that of an oil-in-water emulsion produced with at least 50 % by weight of marine oil or marine oil concentrates or mixture of such oils (i. e. an oil-in-water emulsion having an oil : water weight ratio less than 50: 50). In another preferred embodiment, the liquid Omega-3 dietary supplement encompasses Omega-3 dietary supplements having a kinematic viscosity at 20°C less than that of an oil-in-water emulsion produced with at least 50 % by weight of marine oil or marine oil concentrates or mixture of such oils. In another preferred embodiment, the liquid Omega-3 dietary supplement is not an oil-in-water emulsion. In a preferred embodiment, the liquid Omega-3 dietary supplement is prepared by a process that does not include formation of an oil-in-water emulsion. In a preferred embodiment, the liquid Omega-3 dietary
supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 25,000 cP, which is about that of chocolate syrup at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 10,000 cP, which is about that of honey at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 2,500 cP, which is about that of pancake syrup at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 1,490 cP, which is about that of glycerin at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20'C no more than about 986 cP, which is about that of caster oil at 20°C. In anotler preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C viscosity no more than about 233 cP, which is about that of heavy machine oil at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 102 cP, which is about that of light machine oil at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 84 cP, which is about that of olive oil at 20°C. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than about 69 cP, which is about that of Soya bean oil at 20°C. In
another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C no more than that of OMEGA3000 or OMEGAFOCUS, each available from doc's Guide, Inc. of Sarasota Florida. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplement having an absolute viscosity at 20°C about that of OMEGA3000 or OMEGAFOCUS. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplements having an absolute viscosity at 20°C in a range between 60-25,000 cP or in a range between 60-10,000 cP or in a range between 60-2,500 cP, or in a range between 60-1,000 cP or in a range between 60-500 cP or in a range between 60-250 cP. In another preferred embodiment, the liquid Omega-3 dietary supplement is an Omega-3 dietary supplements having an absolute viscosity at 20°C in a range between 100-25, 000 cP, or in a range between 100-10,000 CP9 or in a range between 100-2, 500 cP, or in a range between 100-1,000 cP, or in a range between 100-500 cP, or in a range between 100-250 cP. The viscosity of liquid Omega-3 dietary supplements may be adjusted as desired by adding appropriate thickening or thinning agents, such as, for example, foodstuffs including honey, syrup or animal oil or vegetable oil.
The term"viscosity"as used herein, and as recognized in the art, refers to a fluid's resistance to flow. As one of skill in the art would recognize, viscosity can be measured as absolute viscosity or as kinematic viscosity. The common metric unit of absolute viscosity is the poise, but for convenience the centipoise (cP) is the unit customarily used. However, laboratory measurements of viscosity commonly measure kinematic viscosity, the customary unit for which is the centistoke (cSt).
Kinematic viscosity measurements are generally made using gravity to regulate flow of the liquid so the density of the liquid (weight per unit volume) affects the result.
Preferred viscometers are the Saybolt Universal version and the Saybolt Furol version. A preferred temperature for measuring viscosity is 20°C (68°F).
Among the advantageous aspects of a preferred embodiment, a dosage package comprising a unit dosage of an Omega-3 dietary supplement facilitates the convenient and accurate administration of a unit dosage of said Omega-3 dietary supplement. A dosage package comprising a unit dosage facilitates administration without need for a measuring step, which is a step that is not only potentially inconvenient but may also be prone to inaccuracy. Moreover, a dosage package that facilitates administration without need for a measuring step may be especially advantageous for certain consumer populations, including the very young, the very old, and those with physical challenges, such as for example visual impairment, for whom a measuring step may be problematic. Among other convenient aspects of a preferred embodiment is the small size of each dosage packet, which lends to ease in carrying. Another advantage associated with a preferred embodiment includes enhanced product life span. Since each unit dosage package contains a single unit dosage, the package need only be opened once, averting the need for repeatedly exposing the products to the oxidizing effects of air. Another advantage associated with a preferred embodiment includes appeal to consumers who may not be inclined or able to use other available Omega-3 dietary supplements. Moreover, while the consumer may optionally mix the unit dosage of liquid Omega-3 dietary supplement with a food or beverage product, in a preferred embodiment, there is no need to do so.
Indeed, in a preferred embodiment, the unit dosage of liquid Omega-3 dietary supplement is not mixed with a food or beverage product. In an especially preferred embodiment, the unit dosage of liquid Omega-3 dietary supplement is discharged from the dosage package directly to the consumer's mouth.
As described above, the instant invention contemplates that a suitable dosage package comprises a container portion operable to be manually compressed for expelling the liquid Omega-3 dietary supplement contained within and additionally comprises a discharge portion through which the liquid Omega-3 dietary supplement may be discharged from the container portion. Among such suitable dosage packages are those that further comprise one or more additional container portions. A preferred embodiment of such a dosage package is one comprising an additional container portion that contains a substance differing from the aforementioned liquid Omega-3 dietary supplement. As used herein, the term"secondary container portion"refers to any such additional container portion that contains a substance differing from the aforementioned liquid Omega-3 dietary supplement. In certain preferred embodiments, the dosage package comprises a single discharge portion through which the contents of the container portion and the contents of the secondary container portion may both be discharged, either separately or together as a mixture, from the dosage package. Other preferred embodiments may optionally and additionally comprise one or more secondary discharge portions through which the contents of the secondary container portion may be discharged.
Preferred embodiments of a dosage package that comprises a secondary container portion include those in which the liquid Omega-3 dietary supplement
contained within the container portion may be discharged directly from the container portion through the discharge portion. Other embodiments of a dosage package that comprises a secondary container portion include those in which the liquid Omega-3 dietary supplement portion may be discharged from the container portion through the discharge portion, the liquid Omega-3 dietary supplement being first discharged into a secondary container portion before ultimately being discharged through the discharge portion. For example, in certain preferred embodiments the liquid Omega-3 dietary supplement of the container portion may first be discharged by manual compression into a secondary container portion, and then mixed with the contents of the secondary container portion to form a mixture comprising all or part of the liquid Omega-3 dietary supplement and all or part of the contents of the secondary container portion, the mixture being discharged back into the container portion and then discharged from the container portion through the discharge portion. Or as another example, in certain embodiments the liquid Omega-3 dietary supplement of the container portion may first be discharged by manual compression into a secondary container portion, and then mixed with the contents of the secondary container portion to form a mixture comprising all or part of the liquid Omega-3 dietary supplement and all or part of the contents of the secondary container portion, the mixture being discharged from the secondary container portion through the discharge portion. To facilitate discharging the mixture from the secondary container portion, the secondary container portion may also be operable to be manually compressed. Thus, a method for discharging the liquid Omega-3 dietary supplement from a preferred dosage package of the instant invention comprises manually compressing the container portion. Where a secondary
container portion that is operable to be manually compressed is present, such a method may optionally comprise compressing the secondary container portion. In one preferred embodiment, alternately compressing the container portion and the secondary container portion may further facilitate mixing the liquid Omega-3 dietary supplement with the contents of the secondary container portion.
A particularly preferred embodiment of a contemplated dosage package comprises a container portion and a secondary container portion, where a border area separates the container portion from the secondary container portion, thereby impeding the liquid Omega-3 dietary supplement of the container portion from mixing with the substance of the secondary container portion. In such an embodiment, the border area may be manually manipulated to join the container portion with the secondary container portion, the joining of which thereby facilitates mixing the liquid Omega-3 dietary supplement of the container portion with the substance of the secondary container portion. In preferred embodiments, manually manipulating the border area to join the container portion with the secondary container portion comprises, directly or indirectly, altering the border area so that the border area no longer separates the container portion from the secondary container portion. Breaking, squeezing, twisting, bending and removing the border area are among preferred ways to alter the border area so that the border area no longer separates the container portion from the secondary container portion. That is, manually manipulating the border area so that the border area no longer separates the container portion from the secondary container portion results in joining the container portion with the secondary container portion. Once joined, mixing of the contents of
the container portion and contents of the secondary container portion is facilitated. In a particularly preferred embodiment, manually manipulating the border area to facilitate mixing the contents of the container portion with the contents of the secondary container portion comprises manually applying pressure to the container portion and/or the secondary container portion. In such an embodiment, manually applying pressure to the container portion and/or the secondary container portion, such as by pinching for example, joins the container portion with the secondary container portion and thereby facilitates mixing the liquid Omega-3 dietary supplement of the container portion with the substance of the secondary container portion.
A non-limiting example of an appropriate border area for a preferred embodiment is illustrated in WO 95/05327, the entirety of which is herein incorporated by reference. An additional non-limiting example of an appropriate border area is a seal extending across and joining together overlying walls of a package, such as disclosed in US Patent 3, 60y, 709, the entirety of which is herein incorporated by reference. In an additional non-limiting example, an ampule comprises a wall, the wall comprising the border area, such as that disclosed in US Patent 4,927, 012, the entirety of which is herein incorporated by reference. In one embodiment of such an example, the ampule comprises the container portion, which container portion is contained within the secondary container portion. In another embodiment of such an example, the ampule comprises the secondary container portion, which secondary container portion is contained within the container portion.
Substances that may be contained in the secondary container portion include, but are not limited to, liquids and solids, including powders and crystals. An especially preferred substance that may be contained in the secondary container portion comprises a pharmaceutical compound, such as a pharmaceutical compound found in a prescription drug or a non-prescription drug. In preferred embodiments, the substance of the secondary container portion comprises a unit dosage of a pharmaceutical compound. Particularly preferred examples of such pharmaceutical compounds may include one or more of : a statin; a medication for treating type II diabetes; an anti-depressive medication; an anti-psychotic medication; an anti-seizure medication ; an anti-glaucoma medication; or a non-steroidal anti-inflammatory (NSAID) medication. Other substances that may be contained in the secondary container portion include one or more of : a vitamin, as herb, a mineral, or another dietary supplement.
Preferred embodiments of statins include pravastatin, simvastatin and lovastatin. Preferred embodiments of medications for treating type II diabetes include metformin, sulfonyl ureas and the glitazones. Preferred embodiments of anti- depressive medications include cilatopram as well as other anti-depressants classified among the tricyclic and SSRI medications. Preferred embodiments of anti-psychotic medications include haloperidol and chlorpromazine. Preferred embodiments of anti- seizure medications include phenytoin. Preferred embodiments of anti-glaucoma medications include acetazolamid. Preferred embodiments of a non-steroidal anti- inflammatory (NSAID) medications include ibuprofen and paracetamol. Additional preferred embodiments include diuretics, calcium antagonists, p-blockers,
vasodilators, digitoxin, orlistat, fosamax, as well as any other pharmaceutical compound or composition.
Preferred embodiments of a dosage package comprising a secondary container portion include those dosage packages that advantageously increase the compliance of taking the liquid Omega-3 dietary supplement concurrently with a compound as contained the secondary container portion. Preferred embodiments of a dosage package comprising a secondary container portion include those dosage packages that advantageously facilitate individualizing the dose of a compound as contained the secondary container portion.
Example 1 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGAFOCUS available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement. The liquid Omega-3 dietary supplement comprises about 14% EPA and about 16% DHA as well as added fruit flavoring. In addition to the liquid Omega-3 dietary supplement contained within, the exemplified dosage package comprises a unitary molded container including: an elongated continuously curvilinear middle portion ; a hemi- ellipsoidal portion closing one end of said middle portion; a truncated conical portion having its larger end connected to said middle portion opposite said hemi-ellipsoidal portion; a substantially cylindrical portion connected to said truncated conical portion; a first integral tab closing one end of said cylindrical portion; a second integral tab
connected to said hemi-ellipsoidal portion; whereby when said first and second tabs are rotated in opposite directions said cylindrical portion shears adjacent said first tab defining a discharge orifice. The exemplified dosage package, devoid of an Omega-3 dietary supplement, is further described in U. S. Patent 3,993, 223, the entirety of which is herein incorporated by reference.
Example 2 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement. The liquid Omega-3 dietary supplement comprises about 18% EPA and about 12% DHA as well as added fruit flavoring. In addition to the liquid Omega-3 dietary supplement contained within, the exemplified dosage package comprises a disposable container of molded plastic to be manually opened, without the need for accessories, for dispensing the liquid Omega-3 dietary supplement, said container being molded as an integral piece so that its several parts disposed along a central longitudinal axis of the container are of sequentially narrower widths, said sequential parts consisting of : a wide flexible body to be compressed for expelling the contents of the container ; a narrow, more rigid nozzle to be held with the thumb and finger on opening the container, and an even narrower, solid tip portion of substantially constant cross- section; at least said wide flexible body and said nozzle portion defining therein a hollow cavity for receiving the liquid for dispensing from the container; said tip
portion being of sufficient length for holding with the thumb and finger and having sufficient cross-section area and having an outer gripping contour of a polygonal cross-section to form three or more graspable flat sides so that, while gripping the tip, oppositely directed motion between the thumb and finger along a path transverse to the longitudinal axis of the container imparts a rotating movement to the tip about said longitudinal axis sufficient to break off said tip at a point adjacent the joining of the tip and the nozzle whereby to open the container and to permit expelling the liquid Omega-3 dietary supplement through a resulting dispensing orifice communicating with the hollow cavity, said rigid nozzle having sufficient wall thickness that when gripped the container is maintained in a secure and steady condition during the breaking-off of the tip portion. The exemplified dosage package, devoid of an Omega-3 dietary supplement, is further described in U. S. Patent 4, 358, 028, the entirety of which is herein incorporated by reference.
Example 3 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida the liquid Omega-3 dietary supplement. In addition to the liquid Omega-3 dietary supplement contained within, the exemplified dosage package comprises a squeezing thermoplastic container portion and a discharge portion, said container portion and discharge portion being parts of a unitary member, said container portion having a closed all around extending circular cylindrical shaped
substantially rigid edge wall portion to which said discharge portion is joined, two opposite side wall portions, at least one of which includes an outwardly curved portion which is compressible to an inwardly similarly curved position so as to measure and discharge a specific dosage when the outwardly curved portion is compressed to the inwardly curved position, and an annular bulged portion forming a juncture between the edge wall portion and the outwardly curved portion so as to form and to limit the outwardly curved portion and also limit the inwardly curved position of the outwardly curved portion, said edge wall portion and said side wall portions having a substantially equal thickness, said thickness being sufficient so that substantially no fluid is diffusable through said wall portions, and so that the side wall portions are incompressible without said annular bulged portion and said discharge portion being configured so as to prevent discharge of the product stored in the container in the absence of compression of said outwardly curved portion to the inwardly curved position. The exemplified dosage package, devoid of an Omega-3 dietary supplement, is further described in U. S. Patent 4, 787, 536, the entirety of which is herein incorporated by reference.
Example 4 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement. In addition to the liquid Omega-3 dietary supplement contained within, the dosage package
comprises a blister having wall portions defining an open cavity that, when covered with a sheet-like cover attached to a flange extending around the periphery of the cavity, comprises the container portion and a portion of the discharge portion that is open to the container portion, where the discharge portion comprises a hollow extension from the container portion with one end opening into the container portion and another end being sealed. The hollow extension of the discharge portion further comprises a break-off region to facilitate removal of the sealed end from the end that opens into the container portion. Elements of the exemplified embodiment as seen from the top are depicted in Figure 1. The depicted elements include: (1) a discharge portion including a hollow extension to direct the flow of the liquid Omega-3 dietary supplement; (2) a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion ; (3) a sealed end of the discharge portion ; (4) a section defining a shear line to facilitate removal of the sealed end of the discharge portion, and thereby providing a passage through which the liquid Omega-3 dietary supplement may be discharged from the interior of the dosage package ; (5) wall portions defining a cavity open on one side having a desired shape, the interior of which cavity comprises the interior of the container portion and the interior of the discharge portion that is open to the interior of the container portion; and (6) a flange extending around the periphery of the cavity, said flange comprising (7) a tab portion proximal to the sealed end of the discharge portion, operable to further facilitate removal of the sealed end of the discharge portion, the flange being covered with a sheet-like cover extending around the periphery of the cavity to enclose the liquid Omega-3 dietary supplement within the container portion and that
portion of the discharge portion that is open to the container portion. The exemplified dosage package, devoid of an Omega-3 dietary supplement, is of the blister package type similar to that disclosed in WO 02/42176 Al, the entirety of which is herein incorporated by reference, and is commercially available from Klocke of America, Inc. of Fort Myers, Florida (www. klockeamerica. com).
Example 5 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement. In addition to the liquid Omega-3 dietary supplement, the exemplified dosage package comprises a packaging assembly for substances that are to be post-mixed, comprising : a tube that is integrally formed as a single piece from a synthetic resinous material, having <BR> forward and rearward ends with a continuous cavity offbrwardly diminishing cross section extending therethrough and containing the liquid Omega-3 dietary supplement, said tube including a closed, pliant body portion at said rearward end to form a container portion manually compressible for expelling the liquid Omega-3 dietary supplement and a closed nozzle portion at said forward end thereof; and an ampule, functioning as a secondary container portion, smaller than and contained within said tube and integrally formed as a single piece from a synthetic resinous material, said ampule having forward and rearward ends with a continuous cavity of forwardly diminishing cross section extending therethrough and containing a unit
dose of a pharmaceutical compound therewithin, and including a border area comprising a closed, pliant body portion at said rearward end and a closed frangible portion at said forward end thereof, said frangible portion being adapted to be fractured under manually applied compressive force to open said ampule, and being comprised of ; (a) a generally cylindrical sidewall element with an outer end; (b) a blunt end wall element extending transversely across said forward end of said ampule ; and (c) a transition element extending between said outer end of said sidewall element and said end wall element, and connecting them to one another, said transition element forming a sharp internal angle having a value of about 90° or less at one of the intersections with said sidewall element and said end wall element, over which angle said material is relatively thin; whereby compressive force applied in the region of said transition element will concentrate stress at said one intersection, thereby tending to cause fracture threat. The nozzle portion of said tube is formed to provide integral frangible means for permitting opening thereof by the application of direct manual force thereto to function as a discharge portion. The exemplified dosage package, devoid of an Omega-3 dietary supplement and a unit dose of a pharmaceutical compound is further described in U. S. Patent 4,927, 012, the entirety of which is herein incorporated by reference.
Example 6 A dosage package comprising a discharge portion and a container portion manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion is filled with a unit dose of OMEGA3000 available from doc's
Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement. In addition to the liquid Omega-3 dietary supplement, the exemplified dosage package comprises a multiple compartment package for holding substances in separate compartments, comprising: a pair of overlying walls of thin flexible sheet material joined together to define between the walls an interior product-holding space, each of said walls having a plurality of layers bonded together and at least one wall having a release area at which the bond between adjoining layers is reduced in strength; means dividing the interior product-holding space into two separate compartments, one functioning as a container portion and the other functioning as a secondary container portion, said means comprising a seal forming a border area and joining together said walls and extending transversely across the package and crossing the release area ; and a unit dose of OMEGA3000 in the compartment functioning as a container portion and a unit dose of a pharmaceutical compound in the compartment functioning as a secondary container portion; whereby product transfer between the two compartments can be established by rupture of the inner layer at said release area to alter said border area and thereby facilitate mixing the unit dose of OMEGA3000 the unit dose of a pharmaceutical compound. The exemplified dosage package, devoid of an Omega-3 dietary supplement and a unit dose of a pharmaceutical compound is further described in U. S. Patent 3,608, 709, the entirety of which is herein incorporated by reference.
Example 7
A dosage package is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement as well as a unit dose of a pharmaceutical compound. Similar to the dosage package of Example 4, the dosage package comprises a discharge portion and a container portion for the Omega-3 dietary supplement, that container portion being a first container portion manually compressible for expelling the liquid Omega-3 dietary supplement, or the contents of the secondary container portion, or a mixture comprising all or part of the liquid Omega-3 dietary supplement and all or part of the contents of the secondary container portion, through said discharge portion. In the instant example, the dosage package additionally comprises a second container portion for the unit dose of a pharmaceutical compound. Thus, in addition to the liquid Omega-3 dietary supplement and the a pharmaceutical compound contained within, the dosage package comprises a blister having wall portions defining a first open cavity and a second open cavity that, when each is covered with a sheet-like cover attached to a flange extending around the periphery of the cavities, comprises a container portion and a secondary container portion. In the instant example, the first cavity comprises the container portion and a portion of the discharge portion that is open to the container portion, where the discharge portion comprises a hollow extension from the container portion with one end opening into the container portion and another end being sealed.
As such, the discharge portion is proximal to the container portion. The hollow extension of the discharge portion further comprises a break-off region to facilitate removal of the sealed end from the end that opens into the container portion. In the instant example, the second cavity comprises the secondary container portion. As
such, the discharge portion is distal to the secondary container portion. The container portion and the secondary container portion are separated by a border area of the type disclosed in WO 95/05327, the entirety of which is herein incorporated by reference.
Elements of the exemplified embodiment as seen from the top are depicted in Figure 2. The depicted elements include: (1) a discharge portion including a hollow extension to direct the flow of the liquid Omega-3 dietary supplement, or the contents of the secondary container portion, or a mixture comprising all or part of the liquid Omega-3 dietary supplement and all or part of the contents of the secondary container portion; (2) a container portion containing liquid Omega-3 dietary supplement, the container portion being manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion; (3) a sealed end of the discharge portion ; (4) a section defining a shear line to facilitate removal of the sealed end of the discharge portion, and thereby providing a passage through which the liquid Omega-3 dietary supplement may be discharged from the interior of the dosage package ; (5) wall portions defining a first cavity open on one side having a desired shape, the interior of which cavity comprises the interior of the container portion and the interior of the discharge portion that is open to the interior of the container portion ; (8) a manually compressible secondary container portion containing a pharmaceutical compound; (9) wall portions defining a second cavity open on one side having a desired shape, the interior of which cavity comprises the interior of the secondary container portion; (6) a flange extending around the peripheries of the first and second cavities, said flange comprising (7) a tab portion proximal to the sealed end of the discharge portion, operable to further facilitate removal of the sealed end of the
discharge portion, the flange being covered with a sheet-like cover extending around the periphery of the first cavity to enclose the liquid Omega-3 dietary supplement within the container portion and that portion of the discharge portion that is open to the container portion, the sheet-like cover further extending around the periphery of the second cavity to enclose the unit dose of a pharmaceutical compound within the secondary container portion; and (10) a border area that may be manually manipulated to join the container portion with the secondary container portion, the joining of which thereby facilitates mixing the liquid Omega-3 dietary supplement of the container portion with the substance of the secondary container portion. The exemplified dosage package, devoid of an Omega-3 dietary supplement and a unit dose of a pharmaceutical compound, is of a blister package type commercially available from Klocke of America, Inc. of Fort Myers, Florida (www. klockeamerica. com).
Example 8 A dosage package is filled with a unit dose of OMEGA3000 available from doc's Guide, Inc. of Sarasota Florida as the liquid Omega-3 dietary supplement as well as a unit dose of a pharmaceutical compound. Similar to the dosage package of Example 4, the dosage package comprises a discharge portion and a container portion for the Omega-3 dietary supplement, that container portion being a first container portion manually compressible for expelling the liquid Omega-3 dietary supplement, or the contents of the secondary container portion, or a mixture comprising all or part of the liquid Omega-3 dietary supplement and all or part of the contents of the
secondary container portion, through said discharge portion. In the instant example, the dosage package additionally comprises a second container portion for the unit dose of a pharmaceutical compound. Thus, in addition to the liquid Omega-3 dietary supplement and the a pharmaceutical compound contained within, the dosage package comprises a blister having wall portions defining a first open cavity and a second open cavity that, when each is covered with a sheet-like cover attached to a flange extending around the periphery of the cavities, comprises a container portion and a secondary container portion. In the instant example, the first cavity comprises the secondary container portion and a portion of the discharge portion that is open to the secondary container portion, where the discharge portion comprises a hollow extension from the secondary container portion with one end opening into the secondary container portion and another end being sealed. As such, the discharge portion is proximal to the secondary container portion. The hollow extension of the discharge portion further comprises a break-off region to facilitate removal of the sealed end from the end that opens into the secondary container portion. In the instant example, the second cavity comprises the container portion. As such, the discharge portion is distal to the container portion. The container portion and the secondary container portion are separated by a border area of the type disclosed in WO 95/05327, the entirety of which is herein incorporated by reference. Elements of the exemplified embodiment as seen from the top are depicted in Figure 2. The depicted elements include: (1) a discharge portion including a hollow extension to direct the flow of the liquid Omega-3 dietary supplement, or the contents of the secondary container portion, or a mixture comprising all or part of the liquid Omega-3 dietary
supplement and all or part of the contents of the secondary container portion; (2) a manually compressible secondary container portion containing a pharmaceutical compound; (3) a sealed end of the discharge portion; (4) a section defining a shear line to facilitate removal of the sealed end of the discharge portion, and thereby providing a passage through which the liquid Omega-3 dietary supplement may be discharged from the interior of the dosage package; (5) wall portions defining a first cavity open on one side having a desired shape, the interior of which cavity comprises the interior of the secondary container portion and the interior of the discharge portion that is open to the interior of the secondary container portion; (8) a container portion containing liquid Omega-3 dietary supplement, the container portion being manually compressible for expelling the liquid Omega-3 dietary supplement through said discharge portion, the liquid Omega-3 dietary supplement being first discharged into a secondary container portion before ultimately being discharged through the discharge portion; (9) wall portions defining a second cavity open on one side having a desired shape, the interior of which cavity comprises the interior of the container portion; (6) a flange extending around the peripheries of the first and second cavities, said flange comprising (7) a tab portion proximal to the sealed end of the discharge portion, operable to further facilitate removal of the sealed end of the discharge portion, the flange being covered with a sheet-like cover extending around the periphery of the first cavity to enclose the unit dose of a pharmaceutical compound within the container portion and that portion of the discharge portion that is open to the container portion, the sheet-like cover further extending around the periphery of the second cavity to enclose the liquid Omega-3 dietary supplement within the secondary
container portion and (10) a border area that may be manually manipulated to join the container portion with the secondary container portion, the joining of which thereby facilitates mixing the liquid Omega-3 dietary supplement of the container portion with the substance of the secondary container portion. The exemplified dosage package, devoid of an Omega-3 dietary supplement and a unit dose of a pharmaceutical compound, is of a blister package type commercially available from Klocke of America, Inc. of Fort Myers, Florida (www. ldockeamerica. com).
While a number of embodiments of this invention have been herein before described, it is apparent that the basic embodiments can be altered to provide other embodiments of the disclosed invention. Therefore, it will be appreciated that the scope of this invention includes all alternative embodiments and variations which are described in the foregoing specification and by the claims appended hereto. The invention is not to be limited by the specific embodiments that have been presented herein by way of example.
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