Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-01-19
2002-04-23
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S065000, C424S401000, C424S404000, C424S436000
Reexamination Certificate
active
06375976
ABSTRACT:
BACKGROUND
1. Field of the Invention
The present invention relates to acid compositions that are useful in food, medical, commercial and military industries and also as general household products. These compositions have a low pH, are relatively non-corrosive to metals, do not harm skin and are safe for use in food and beverages. The invention also relates to formulations that contain these acid compositions and to methods for using such formulations.
2. Description of the Background
Low pH compositions and solutions containing acidic compositions are used for various industrial and general household purposes, such as cleaning and sterilizing surfaces and articles of manufacture. Examples include well-known household cleansers and disinfectants, industrial microchip production and cleaning agents, and anti-microbials. To work both effectively and efficiently, these solutions typically contain strong acids or organic solvents, which present health concerns to the user, may be corrosive to the substances they are designed to clean (e.g. metals) and pose an ecological hazard with respect to disposal.
There have been a number of efforts aimed at developing less corrosive and less toxic acidic products. For example, U.S. Pat. No. 4,459,202 is directed to an acidic composition for recovering bituminous products from tar sands. Two strong and two weak acids are combined to form an acidic solvent that can be used to remove and recover the bituminous products. The composition is described as being non-corrosive and less hazardous to handle than other strongly acidic solutions.
The molecular effect of combining first and second strong acids with the third and fourth weaker acids forces the weaker acids to act as conjugate bases for the strong acids and to accept hydrogen ions (actually hydronium ions in aqueous solution) from the strong acids. The resulting acidic solution has a very low pH value, and a large amount of free hydrogen ions. However, the ability of this strong acidic composition to effectively function as a solvent may sometimes require more acid than would be considered safe or non-hazardous to human tissue. Moreover, there is no suggestion that this composition can be used in other applications, such as in products which come into contact with food. In fact, the composition cannot be used in connection with food and drink, as one or more of its components are not listed on the U.S. Food and Drug Administration list of substances considered generally recognized as safe (GRAS).
Various formulations using multiple acid compositions are disclosed in U.S. Pat. Nos. 4,675,120, 4,970,014, 4,970,015 and 5,019,288. Each of these compositions is described as either useful for well-acidizing, tertiary oil recovery, removing rust from metal, cleaning aluminum, radiator cleaning, boiler and heat exchanger cleaning, or copper cleaning. These compositions are described as generally non-corrosive to metal and relatively inert when contacted with human tissue. In addition, U.S. Pat. No. 4,483,887 describes a multiple acid solution useful for metal plating. U.S. Pat. No. 4,477,364 describes a multiple acid solution useful for cleaning glassware.
Although these acid-based solutions may be effective for the various described purposes, a major drawback is that certain formulations can cause skin irritation. For example, studies conducted using a topical skin disinfectant containing the core composition of U.S. Pat. No. 4,459,202 found that the product caused reddening of the skin and a burning sensation. Similar reddening of the skin and burning sensation resulted with a cleaning solution containing the core acid composition of U.S. Pat. No.4,459,202. As such, these acid compositions cannot be safely used in products where skin contact is a possibility. In addition, such compositions cannot be used in products associated with foods or beverages. Further, many of these compositions require a multiplicity of components, leading to increased production costs.
U.S. Pat. No. 5,512,200 is directed to a multiple acid composition described as non-irritating to the skin and useful as a component of products such as cleansers, cosmetics and pharmaceutical agents. However, at least one of the components is not considered GRAS. Thus, despite the relatively inert nature of this composition, it cannot be used in foods or drinks, or in products associated with foods or drinks.
There is therefore a need for acid compositions comprising a minimum number of component acids, all of which components are approved by the Food and Drug Administration as GRAS, with broad utility for cleaning, sterilizing and anti-microbial uses that are effective, non-toxic and safe for use with food and food-related products.
SUMMARY OF THE INVENTION
The invention overcomes the problems and disadvantages associated with current strategies and designs and provides novel low pH compositions useful in medical, military, industrial and household settings. These acid compositions can be used as the sole or core component of solutions including cleansers, anti-microbial agents, disinfectants, decontaminants, pharmaceuticals, cosmetics, anti-odor agents and sterilants.
The low pH compositions of the present invention are safe for use as either the sole or major component of solutions including, but not limited to, disinfectants, cleansers, sterilizers, cosmetics, and pharmaceutical agents, and can be used in industrial, medical, military and general household settings. The compositions of the present invention are safe not only for use in products which contact human skin, but also for use in ingestible products.
One embodiment of the invention is directed to an acid solution for inhibiting microbial growth comprising an aqueous acidic core composition which makes up 50% to 100% of the solution. The acidic core composition consists of acids that are safe for use in food and drink products and food- and drink-associated products (i.e. GRAS substances). The acidic core composition may be prepared by admixing from about zero to about 25%, by volume, of a first acid, preferably between about 0.1% to about 15%, and more preferably between about 0.5% and about 10%, with between about 1% and about 25%, by volume, preferably between about 2% and about 15%, and more prferably between about 5% and about 10%, of a second acid to produce a first acidic composition.
The first acid is an inorganic acid that dissociates nearly to completion in water. The second acid is an inorganic acid less strong than the first, having a dissociation constant of less than about 10
−1
. A second acidic composition is formed by mixing from about 0.5% to about 20%, by weight, preferably from about 2% to about 15%, and more preferably from about 6% to 10%, of an organic hydroxy acid with water. The organic hydroxy acid has a greater chelating capability (generally at least twice) or iron binding efficiency as one or the other of the first and second inorganic acids. Acids with at least twice the ion binding efficiency of the inorganic acids include, for example, ascorbic acid, citric acid, lactic acid, malic acid and taltaric acid.
The two acidic compositions or solutions are then mixed to produce an acid core composition that inhibits microbial growth and is safe for use in food products. This composition preferably has a pH of less than one, yet will not adversely react with human tissue.
In a preferred embodiment, the first acid is hydrochloric acid, the second acid is phosphoric acid, and the organic hydroxy acid is citric acid. Generally, the quantities of the first acid will balance the quantity of the second acid such that less of the first acid will be required when using more of the second acid. A maximum quantity of the second acid is that amount which will require the addition of no first acid when admixed with the organic hydroxy acid to produce the low pH composition of the invention.
The acid composition of the present invention maintains the low pH and non-toxic qualities of conventional acidic compositions, yet, unlike these compositions, is safe t
Dankert John R.
Roden Ernest G.
Heller Ehrman White & McAuliffe LLP
Page Thurman K.
SteriFx, Inc.
Tran S.
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