Dry dairy cow supplement

Details Dry dairy cow supplement Dry dairy cow supplement

1999-03-31

2002-03-12

Dees, Jose′ G. (Department: 1616)

Drug, bio-affecting and body treating compositions

Inorganic active ingredient containing

Hydrochloric acid

C424S439000, C424S442000, C424S683000, C424S687000, C424S692000, C424S725000, C424S750000, C424S757000, C424S773000, C424S776000, C426S623000, C426S630000, C426S635000, C426S807000, C514S769000, C514S770000, C514S783000, C514S974000

Reexamination Certificate

active

06355278

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to a range of products and the art of preparing those products for inhibiting the effects of or reducing the risk of contracting a disease which, in many cases, has a significant impact on the economics of dairy farming.
The disease is parturient hypocalcemia or milk fever. This is a condition, to quote Ensminger, (“Dairy Cattle Science,” M. E. Ensminger, Third edition (1993), Interstate Publishers, p. 287): “At or soon after calving (generally within 48 to 72 hours), a sharp decrease in blood calcium (hypocalcemia) occurs in some cows, resulting in a loss of appetite, subnormal temperature, and an unsteady gait. This is followed by nervousness, and, finally, collapse or complete loss of consciousness.” The triggering mechanism for the hypocalcemia, i.e., drop in blood calcium is the onset of lactation which causes an intensive mobilization of calcium. Unless treated, the disease can cause death and, therefore, the loss of the animal as a future milk producer.
The losses to the dairy farm economic sector can be significant. The total number of milk cows in the United States is in the order of 10 million. (See, for example, Ensminger, op. cit., p. 9), of which perhaps 60% are pari-parturient and at risk for the disease. From a total milk production point of view alone, the 10 million milk cows represent about 1,500 billion pounds of milk in a given year. It is estimated that approximately 8% of all lactating cows are affected by clinical milk fever. It has also been estimated (Horst, et al., 1997) that the disease can reduce the productive life of a dairy cow by 3.5 years. Based upon its studies (C. Guard, Cornell Veterinary College, as reported in Hoard's Dairyman, January 1996) Cornell University further estimated that the average cost per milk fever case was $334. This value represented the direct cost of treating the clinical cases and the estimated production losses of milk. Multiplying the number of potential cases by the $334 per case yields an estimated total loss to the U.S. dairy industry of $160 million per year. Another factor affecting economic losses is that milk cows contracting milk fever are also more susceptible to a host of secondary problems, which include ketosis, mastitis, dystocia, retained placenta, displaced abomassum and uterine prolapse (Horst et al., 1997). Each of these secondary problems has as the least consequence a reduction or further reduction of milk production.
Since milk fever has such a major impact on the economy of dairy farming in the United States and elsewhere in the world, a considerable amount of research has been directed towards its prevention and cure.
Perhaps the most significant early research was reported by a group of Norwegian researchers (Ender, F. and I. W. Dishington, 1967, “Comparative Studies on Calcium Balance Levels in Parturient Cows Fed Diets Inducing and Preventing Milk Fever.” 557Am XVIIIth World Veterinary, Congress, Paris, France) who demonstrated that the effect of various cations in dietary rations of a dairy cow in terms of promoting milk fever incidence could be prevented by adding anions in the form of hydrochloric and sulfuric acid. However, they realized that with the other feed ingredients at their disposal at the time, using these highly corrosive acids in their un-reacted forms would pose a serious hazard to both dairy cattle and dairy farm personnel. Thus, the conclusion of these researchers was that instead of these pure acids, related anionic salts, such as calcium chloride, ammonium sulfate, aluminum sulfate and magnesium sulfate, should be considered.
Based upon these findings, other researchers (most prominently Goff and Horst) then started evaluating these anionic salts. They found that while these salts are relatively easy to handle, there are a) problems of palatability and b) the intrinsic problem that while salts contain anions, they also contain cations which, depending upon their rate of absorption, will negate some of the positive effects of the anions.
The same paper (J. R. Goff and R. L. Horst, “Using Hydrochloric Acid as a Source of Anions for Prevention of Milk Fever”, USDA Prepublication (1997)) compares hydrochloric acid with the anionic salt calcium chloride and shows the advantage of the former over the latter. The authors also discuss in some detail comparative feeding studies involving dairy cow diets with or without hydrochloric acid and show the ability of a diet with hydrochloric acid to control milk fever. In a subsequent paper, “Use of Hydrochloric Acid as a Source of Anions for Prevention of Milk Fever”, J. Dairy Science, November 1998, p. 2874-2880), the same authors, Goff and Horst, provide further evidence for their earlier conclusions.
While this paper is substantive in its proof that, to quote the authors, “hydrochloric acid is an inexpensive, ‘palatable’ alternative to anionic salts as a means of controlling milk fever,” the palatability is only improved as compared to those of the anionic salts. Hydrochloric acid used with the formulations studied is still difficult to administer as the dairy cow does not want to consume it in the quantities required.
Because of the problems mentioned, with respect to acids, past research was focused on preparing formulations using anionic salts and not those using hydrochloric or sulfuric acids.
For example, Rebhan (Herbert J. Rebhan, U.S. Pat. No. 4,931,290, “Milk Fever Prophylactic Treatment and Composition) describes a method for “reducing the propensity of a dairy cow to develop severe milk fever upon calving comprising of administering thereto a composition (consisting) of a water soluble calcium compound and a complexing agent for serum phosphorus.” That patent discusses the use of (anionic) calcium salts of hydrochloric and organic acids supplemented with a complexing agent to form water-insoluble compounds of serum phosphorus. The combinations of these compounds are presented as having a favorable effect on the blood anion-cation balance and, thereby reducing the incidence or curing milk fever.
A further example, Kjems (Gunnar Kjems, U.S. Pat. No. 5,393,535, “Orally Administrable Calcium Supplement for Cattle”), describes a composition wherein a calcium ion, i.e., an anionic salt is dissolved in water but the water phase is dispersed into a continuous oil phase, forming an emulsion by means of a nonionic emulsifier. This method of preparation is presented as compatible with oral administration of the composition and as palatable to the dairy cow because of the oily phase.
In another example, Goff and Horst (Jesse P. Goff and Ronald L. Horst, U.S. Pat. No. 5,560,920, “Calcium Formulations for Prevention of Parturient Hypocalcemia”) present that calcium propionate, i.e., an anionic organic salt may be mixed with propylene glycol and either citric or phosphoric acid to form a nonhardening paste or with sodium chloride to form a liquid drench. It is stated that these formulations are particularly effective in treating the hypocalcemia associated with the onset of lactation in dairy cows. The inventors argue that calcium-containing gels can be made with water-insoluble carriers (as discussed by Kjems) such as oils or with water-soluble carriers such as propylene glycol. They state that the former tends to decrease the availability of calcium for absorption, but that the gels formed with propylene glycol are more readily soluble in water and thereby increase the availability of calcium.
In still another example, Abele (Ulf Abele, U.S. Pat. No. 5,631,289, “Use of Calcium Formate in Orally Administrable Compositions”), discusses the advantages of an anionic salt of formic acid, i.e., calcium formate in the prophylaxis and metaphylaxis of calcium deficiency in dairy cows. It is stated that the resorption of calcium formate is comparable to that of calcium chloride, but that the former is not corrosive or irritating to the membranes of the digestive tract and thus it is both more palatable and is also less dangerous to the animal if per chance the formulation is inhaled in the

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