Drug – bio-affecting and body treating compositions – Containing designated ingredient to reduce noxious effects...
Utility Patent
1999-11-04
2001-01-02
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Containing designated ingredient to reduce noxious effects...
C424S049000, C424S401000, C424S464000, C514S494000, C514S849000
Utility Patent
active
06169118
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates to a flavoring method and flavor composition for masking flavor and taste of compositions for oral absorption and administration by humans which contain zinc compounds.
2. General Background
The value of the element zinc is well-established. Zinc has a vital role in a number of pharmaceutical formulations. Zinc deficiency is an important feature of many cases of sickle cell anemia characterized by growth retardation and hypogonadism, and zinc appears to have an antisickling effect. Zinc has also been shown to be beneficial in the relief of acute inflammatory conditions associated with rheumatoid arthritis. Use of zinc gluconate and zinc acetate has been described as a method for reducing duration of common cold symptoms. Zinc oxides are used in a number of dental products such as dentifrices, denture adhesives, dental fillings, dental cements, and dental impression materials. Zinc salts are generally reported to enhance activity of triclosan and cationic anti-microbials in dentifrices and mouthwashes. Zinc chloride has been recognized as possessing anti-odor properties in oral health care products. Zinc citrates are useful in reducing dental calculus formation.
In recent years, formulations for oral administration and /or absorption such as tablets, powders, lozenges, syrups, sprays, dentifrices, mouthwashes, etc. have been formulated containing a zinc component. One of the major drawbacks of the incorporation of zinc compounds into various orally absorbed or administered products has been the characteristic bitterness of zinc that is experienced as soon as the zinc compound is released and proceeds to break down in the mouth. A variety of formulations and methods have been prepared and attempted to lessen or mask entirely the bitter taste and aftertaste of zinc compounds.
U.S. Pat. Nos. 4,684,528 and 4,758,439 disclose the formulation of zinc compounds with glycine and certain other amino acids to reduce the unpalatable and undesirable aftertaste of prior zinc formulations. U.S. Pat. No. 5,095,035 teaches masking compositions which contain zinc acetate with the addition of extramolar citric acid. U.S. Pat. No. 5,002,970 discloses that ionizable zinc compounds can be masked with anethole to eliminate or reduce the taste and after taste of zinc. U.S. Pat. No. 5,766,622 teaches the use of phosphorylated amino acid in oral compositions to inhibit bitter and/or metallic taste from a pharmaceutical active component. U.S. Pat. No. 5,817,295 discloses a tripartite blend of peppermint oils that provides for a pleasant tasting mouthwash and masking the bitter taste of essential oils used for antimicrobial efficacy in the mouthwash.
There is still a need for a new way to eliminate the objectionable taste and after taste of zinc compounds using new technologies.
SUMMARY OF THE INVENTION
The present invention relates to an orally administered formulation comprising about 0.1 to 25 wt. % of an ionizable zinc compound having an undesirable taste, and a synergistic flavoring combination of at least two flavoring oils and lauryl alcohol in an amount effective to mask the undesirable taste of said ionizable zinc compound.
The invention also provides a method for improving the taste of an orally administered formulation containing about 0.1 to 25 wt. % of an ionizable zinc compound with undesirable taste, by mixing into said formulation a synergistic flavoring combination of at least two flavoring oils and lauryl alcohol in an amount effective to mask the undesirable taste of said ionizable zinc.
DESCRIPTION OF THE INVENTION
The present invention provides an orally administered formulation containing an ionizable zinc compound with undesirable taste, but without the unpleasant metallic taste of zinc. The formulation can be in the form of foods, pharmaceuticals, toiletries, etc. The formulation contains an insoluble zinc compound and a carrier medium making up the balance.
Zinc Compounds. The orally administered formulations may contain one or more insoluble zinc compounds depending on the application. Zinc compounds include both inorganic and organic zinc salts and, in particular, salts such as the halides, nitrates, sulfates, chromates, silicates, and compounds comprising complexes of these materials constituting the inorganic salts contemplated herein. Organic salts of zinc include but not limited zinc gluconate, zinc formate, zinc succinate, zinc aspartate and the like. Particular zinc halides include zinc chloride, zinc bromide, zinc fluoride, and mixtures.
In terms of specific applications, typical zinc compounds used in dental formulations include such materials as zinc oxide for use in inhibiting bacterial attack in dentifrices. Zinc oxide is also used as a binding materials in denture adhesives. Zinc chloride and zinc citrate are used as anti-odor ingredients in dental formulations. Zinc acetate and hydroxide is used for their anti-plaque properties. Zinc citrate, polyphospohates such as disodium ethane-1-hydroxy-1,1-diphosphonate (EHDP), pyrophosphate, tetrametaphosphate, metaphosphate and orthophosphate salts of zinc for tartar removal effects in dentifrices. Zinc glycerophosphate, zinc phenolsulfonate, zinc fluorosilicate, zinc fluorozirconate are known for their astringent and deodorant capabilities. Zinc citrate is preferred for dental formulations. Zinc acetate and zinc gluconate are favored in compositions for treating common colds.
In general, the concentration of zinc compounds in orally administered formulations varies from about 0.1 to 15 wt. %. The concentration can range up to as much as 25% depending on the particular formulation in which the zinc compound is incorporated. A more preferred amount is about 0.2 to 2 wt. %. A most preferred amount is from about 0.5 to 2 wt. %.
Flavoring/masking components: The taste masking/flavoring combination of the present invention is made up of a mixture of flavoring oils and lauryl alcohol.
For the purpose of this invention, flavoring oils used herein refer to both entire essential oils and the aroma chemicals making up the essential oils. Esential oils are predominately volatile materials from botanical sources. The most widely used process for the isolation of essential oils is steam distillation of plant matter, although dry distillation and solvent extraction are also used. Essential oils are generally recognized as safe compositions that can be included in ingested materials. Aroma chemicals refer to chemicals which may be synthetic or natural, derived from essential oils, i.e., derived from plants by distillation, expression, or extraction, and which usually carry the flavor of the plant from which they are derived.
Although the invention is not limited to the specific essential oils listed individually in this specification, a number of important essential oils include spearmint oil; peppermint oil; wintergreen oil; lavender oil; sassafras oil; ginger oil; clove oil; sage oil; basil oil; eucalyptus oil; laurel oil; mayonara oil; cinnamon oil; chamomile oil; thyme oil; citrus oils such as lemon oil, orange oil, grapefruit oil, tangerine oil; oil of anise; camphor oil; and the like.
Aroma chemicals include but not limited to anethole, carvone, cintronellal, camphor, linalool, menthol, menthone, thymol, and the like.
It has been found that in an orally administered formulation of the claimed invention, the additional presence of lauryl alcohol in combination with a mixture of flavoring oils as a flavoring composition, enhances the organoleptic properties, imparts freshness in the mouth and masks the unpleasant taste and aftertaste of the zinc compound in the formulation. The flavoring oils appear to be operating in synergistic combination, perhaps with the lauryl alcohol or perhaps because of the ability of various components of the flavoring oils themselves to inhibit different biological pathways associated with bioavailability.
The individual flavoring oils can be mixed and matched as desired to provide the intended flavor in the orally administered compos
Block Drug Company Inc.
Dodson Shelley A.
George Konata M.
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