Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Alkali or alkaline earth chloride
Reexamination Certificate
1999-09-27
2001-11-27
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Alkali or alkaline earth chloride
C424S438000, C424S600000, C424S617000, C424S646000, C424S679000, C424S681000, C424S682000, C424S686000, C424S687000, C424S688000, C424S689000, C424S693000, C424S696000, C424S702000, C514S077000, C514S079000, C514S080000, C514S081000, C514S082000, C514S167000, C514S168000, C514S248000, C514S249000, C514S251000, C514S276000, C514S345000, C514S356000, C514S458000, C514S474000, C514S557000, C514S563000, C514S725000, C514S738000, C514S904000, C514S905000
Reexamination Certificate
active
06322821
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
REFERENCE TO A MICROFICHE APPENDIX
Not applicable.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates, generally to veterinary pharmaceutical and feed supplement compositions and to methods of administering the compositions. More particularly, the invention relates to a composition of calcium, B-vitamins and propylene glycol and to a method of orally administering or dispensing the composition to a recently freshened dairy cow.
2. Background Information
The process of a cow giving birth to a calf is called “freshening” in the dairy industry. The first milk or colostrum of a fresh cow has a high level of calcium and antibodies to benefit the newborn calf's immune system. The calcium found in the colostrum is taken from the bloodstream, thus lowering the serum calcium level of the cow, and is replaced either by intestinal calcium absorption or by bone calcium resorption. Calcium replacement is a special concern in today's dairy industry because fresh cows are milked soon after freshening, and thus can lose a considerable amount of calcium.
Low serum calcium levels in the blood of freshening cows can cause hypocalcemia, commonly referred to as milk fever. Hypocalcemia occurs because calcium enters the mammary gland faster than it is replaced. A cow suffering from milk fever will typically stagger and have cold ears. However, even though freshening cows do not show symptoms of milk fever, they still may develop typically asymptomatic subclinical milk fever.
The normal level of serum calcium in a cow's blood is 8.0 mg/100 cc of blood. Subclinical milk fever occurs when the serum calcium level drops below 7.5 mg/100 cc. The cow's rumen shuts down at 6.0 mg/100 cc and the cow is down at 4.0 mg/100 cc. Other problems related to low serum calcium levels include a displaced abomasum, slow calving, a retained placenta, ketosis, downer cow syndrome, uterine prolapse, and metritis. Milk fever and the other problems associated with low serum calcium can be prevented in freshening cows by keeping serum calcium in the blood at or above the level of 7.5 mg/100 cc of blood. Should a cow develop subclinical milk fever, it is extremely important to treat the cow immediately both to prevent the serum calcium levels from dropping further and to quickly raise the serum calcium back to near normal levels.
In the past, various devices and/or methods have been used to raise serum calcium levels in freshening cows. These include intravenous dosing, gel tube solutions placed into the mouth with a caulking gun, and liquid solutions poured into the cow's mouth from a bottle. However, these devices and methods have significant limitations and shortcomings.
Dry Feed Supplements may contain calcium chloride and other minerals. These supplements are fed to an entire herd, often weeks before they freshen. See Goff (Journal of Dairy Science, 77 no. 4, April 1994, 1451-1456) and Moore (U.S. Pat. No. 5,556,634). Therefore, dry feed supplements are not an efficient treatment for an individual freshening cow.
Intravenous dosing (IV) is generally administered by a veterinarian. It is time consuming due to the importance of a slow administration rate. It also tends to spike the blood with a large amount of calcium. The cow responds to the spike by releasing a hormone called calcitonin that temporarily prevents the cow from naturally restoring its own serum calcium levels. Relapse can occur within 12 hours after an IV calcium treatment. Thus, IV dosing tends to be a temporary solution and, therefore, is not good for milk fever prevention. Furthermore, IV treatments shock the cow's system, stress the animal, and may even cause death.
Gel tubes are difficult to administer. Viscous gels and pastes are forced from a caulking gun and are placed over the cow's tongue. A 300 cc dose of gel contains about 50 grams of calcium in the form of 150-200 grams of calcium chloride. This high amount of calcium chloride gives the gel a harsh salty taste. The cow's natural reflex is to cough out the bad tasting substance, resulting in considerable waste. Furthermore, the high levels of calcium chloride in the gel can cause acidosis and can irritate the throat, both of which can limit additional feedings if the first feeding does not produce the desired results. Additionally, forcing the gels over the tongue excites the cow, which has been shown to reduce calcium absorption. The harsh tasting gels enter into the rumen rather than the omasum, which is not desirable because the rumen absorbs calcium slower than the omasum. This slow rate of absorption encourages using higher levels of calcium chloride in the gels which, as addressed above, causes acidosis and irritation. Furthermore, an excited cow can inhale the product into its lungs, which may result in aspiration pneumonia and death.
Liquid calciums are orally administered calcium solutions that typically consist of calcium chloride, potassium, magnesium, phosphorous and water. They are usually administered by pouring the low viscosity liquid drench liquid into a cow's mouth using a long-necked bottle. As with the gels, the cow becomes excited and is at risk of aspirating the fluid, which may result in pneumonia and death. Because of this danger, the known art teaches away from using liquid compositions in favor of using viscous gels or dry feed supplements in spite of the fact that the liquid compositions are generally absorbed faster (Goff, page 1454, col. 1 line 1 to col. 2 line 6). Conventional liquid calciums also contain a high level of calcium chloride, typically 150-200 grams in a 300 to 400 cc dose. Therefore, a dose of conventional liquid calciums can cause acidosis and irritate the throat. Furthermore, forcing a cow's mouth open, inserting a long neck bottle, and pouring the fluid into the cow's mouth excites the cow because it is not a natural swallowing action. Therefore, this method fails to stimulate receptors in the mouth and pharynx to close the cow's esophageal groove and to allow the liquid calcium to enter and be quickly absorbed in the omasum. Additionally, these conventional liquid calciums do not contain vitamins or carriers, such as propylene glycol, to improve the effectiveness of the calcium solution.
Problematic side-affects for the above-mentioned treatments include their tendency to cause the freshening cow to lose its appetite at a time when proper nourishment is vital. A well-nourished cow is less likely to develop milk fever, ketosis, a displaced abomassum or a retained placenta, and is more likely to quickly recover from the effects of low serum calcium levels. Furthermore, the high levels of calcium chloride used by the known art are associated with severe and fatal risks, including metabolic acidosis, loss of appetite, and irritation/ulceration of the mouth and throat (Goff, page 1455, column 1, lines 3-25).
It is a general object of this invention to provide a milk fever treatment and preventative for cows which overcomes the limitations and shortcomings of the known art described above.
It is a further object of this invention to provide a calcium treatment for cows which does not cause the cow to lose its appetite, but rather stimulates the cow's appetite.
It is a further object of this invention to provide a calcium treatment for cows which does not shock the cow's system.
It is a further object of this invention to provide an oral calcium treatment which stimulates the esophageal groove reflex, thereby allowing the composition into the omasum rather than in the rumen.
It is a further object of this invention to provide an oral calcium treatment for cows which reduces the risk of acidosis.
It is a further object of this invention to provide an oral calcium treatment for cows which does not irritate the throat.
It is a further object of this invention to provide an oral calcium treatment for cows which is not harsh or bitter tasting.
It is a further object of this inve
Pak John
Skinner & Associates
LandOfFree
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