Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2002-11-12
2003-11-04
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S455000, C424S456000, C424S523000
Reexamination Certificate
active
06641837
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to capsule formulations, medicinal and nutritive dose encapsulations and methods of manufacture of capsules. More specifically, the invention introduces flavoring into the manufacture of capsules and encapsulated doses.
2. Conventional Art
The taste of many medicinal and nutritive components can be quite distinctive and potentially unpleasant. Improvements in the taste of certain drugs and nutritional supplements can lead to a higher compliance by consumers. A higher compliance will result in greater commercial success for the drug and supplement manufacture and in increased health and well being particular consumers.
Taste is both a matter of purely subjective preference. Yet human taste is also strongly influenced by experience and cultural impressions. Broad generalizations about consumer taste presence can thus sometimes be relied upon in predicting market acceptance of specific drug and nutritive formulations. In Norway, for example the tastes of fish oils are far more palatable than in the United States. As a consequence of this United States market aversion to the taste of fish oils, many residents of the United States are less willing to ingest fish oils and will therefore not benefit from the nutritional and medicinal qualities of fish oils.
Yet the composition of certain fish oils includes elements that are identified in medical literature as providing significant health benefits. Polyunsaturated fatty acids, to include long chain Omega 3 fatty acids such as eicosapentenoic acid (EPA) and docosahexenoic acid (DHA) are present in the livers of lean fish and other tissues of fatty fish. The human body cannot synthesize these fatty acids nor can it derive them from other fatty acids. As these fatty acids provide both medicinal and nutritional benefits, an intake of up two grams per day has been recommended by certain medical authorities.
It is suspected that Eicosanoids derived from EPA might have an anti-inflammatory effect on humans. It has been suggested that EPA might decrease blood levels of TG lipids, increase blood levels of high density lipids (HDL), decrease blood clotting, reduce the incidence of cardiac arrhythmia and stabilize heart rhythm.
It has been suggested that DHA may also decrease blood levels of TG lipids, increases blood levels of high density lipids (HDL). Furthermore, DHA might lower blood pressure, attack early phases of inflammation, facilitate the growth, development and function of the central nervous system and improves the clinical symptoms of depression and schizophrenia.
Increasing the consumption of recommended doses of certain Omega-3 fatty acids might therefore have a medically and nutritionally beneficial affect on many consumers and patients. Yet conventional techniques to improve the palatability of fish oils and other subjectively harsh tasting substances are limited in the prior art to the addition of flavorings into a mixture of the substances themselves. The flavoring of capsules of encapsulated formulations has been absent in the conventional art.
OBJECTS OF THE INVENTION
It is therefore an object of the present invention to provide a method of manufacture of gelatin capsules.
It is another object of the present invention to provide a gelatin capsule comprising a flavor.
It is an additional object of the present invention to optionally provide a flavored gelatin capsule containing a fish oil.
It is an yet another object of the present invention to optionally provide a flavored gelatin capsule containing a flavored fish oil.
SUMMARY OF THE INVENTION
These and other objects and advantages of the present invention are achieved by providing a flavored gelatin capsule comprising a water soluble flavor. The flavored gelatin capsule may include about 10 to about 70 parts by weight of a gelatin, about 10 to about 35 parts by weight of a glycerol, about 8 to about 35 parts by weight of a moisturizer and about 1 parts by weight of the water soluble flavoring. The flavoring of the capsule improves the taste and palatability of the capsule and will subjectively improve the taste of the gelatin and a dose or contents contained within the flavored gelatin capsule to individual consumers or patients.
The flavor may be one of, or a combination of suitable flavors known in the art, to include berry, strawberry, chocolate, cocoa, vanilla, lemon, nut, almond, cashew, macadamia nut, coconut, blueberry, blackberry, raspberry, peach, lemon, lime, mint, peppermint, orange, banana, chili pepper, pepper, cinnamon, and pineapple.
The gelatin capsule composition may include a polyol, such as sorbitol, glycerol or other suitable softening agent known in the art.
A preferred embodiment of the present invention includes flavoring the contents of the gelatin capsule in addition to flavoring the gelatin capsule. In particular, an oil soluble flavoring may be optionally mixed with a fish oil that is encapsulated within the capsule. The oil soluble flavoring may be similar to the taste of the flavor of the capsule, e.g., strawberry and strawberry, or the taste of the oil flavoring may be complementary to the capsule flavoring, e.g., banana and strawberry.
Fish oil containing Omega 3 fatty acids such as eicosapentenoic acid (EPA) and docosahexenoic acid (DHA) are one appropriate subject of inclusion into certain preferred embodiments of the present invention. The capsule of these certain preferred embodiments is flavored and the fish oil may optionally be flavored.
The method of the present invention includes the manufacturing process steps of combining gelatin, a glycerol or a polyol like sorbitol as a softener, water or a moisturizer containing water, a flavoring agent and optionally a coloring agent such as a titanium oxide, keratin or other suitable coloring agent known in the art.
Modified vegetable starch is substituted for gelatin in certain preferred embodiments of the present invention. Where gelatin is used, the gelatin may be a suitable mammalian or fish gelatin known in the art. The suitable gelatin or vegetable starch selected is used as a principal forming agent of the capsule.
REFERENCES:
patent: 5141961 (1992-08-01), Coapman
patent: 5656667 (1997-08-01), Breivik
patent: 5874418 (1999-02-01), Stella et al.
patent: 5955102 (1999-09-01), Gorenbein
patent: 6346231 (2002-02-01), Opheim
Ghali Isis
Lebowitz Howard E.
Page Thurman K.
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