Feed supplement pill with active yeast

Abstract

A ruminant dietary supplement in the form of a compressed shelf-stable solid pill or pill that effervesces and releases calcium and active dry yeast when administered into the reticulum of a ruminant.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a continuation-in-part of USSN 18 / 080,371, filed December 13, 2022, which is a continuation-in-part of USSN 15 / 670,285, filed August 7, 2017, both of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present invention relates generally to feed supplement formulations for administration to ruminants, and more particularly to a solid tablet or bolus that provides release of calcium and active dry yeast particles into the reticulum of large ruminants for the prevention or treatment of hypocalcemia, as well as providing additional dietary supplement materials for augmentation. Background Art

[0004] Female domesticated animals, including dairy cows, lactate after giving birth to their calves ("farming"). This lactation involves the secretion of milk from the cow's mammary glands and the resulting amount of time the cow lactates to feed her calf. The primary purpose of lactation is to provide nutrition and immune protection to the calf after birth. Lactation allows a cow and calf pair to survive even when food is scarce or difficult for the calf to obtain.

[0005] However, cows need calcium to begin this lactation process after giving birth. If this calcium demand for colostrum and milk production exceeds the cow's body's ability to mobilize calcium from the bloodstream, a decrease in blood calcium levels ("hypocalcemia") occurs. More technically known as "postpartum hypocalcemia" or "parturient paresis" and more colloquially as "milk fever," this condition is a matter of great concern to dairy producers and the dairy industry. "Fever" is a misnomer because the body temperature of a cow experiencing hypocalcemia (a drop in blood calcium concentration below a critical threshold) does not typically rise. But if left untreated, such hypocalcemia can quickly lead to a potentially life-threatening recumbency.

[0006] In the normal process of calcium regulation, a drop in plasma calcium levels causes the cow's parathyroid glands to secrete parathyroid hormone ("PTH"), which regulates the activity of vitamin D3 in the kidneys. These two compounds act to increase blood calcium levels by increasing the absorption of dietary calcium from the intestine, increasing tubular reabsorption of calcium in the kidneys, and increasing calcium reabsorption from the bones. It has been found that tissues are less responsive to parathyroid hormone before calving than after calving. Therefore, it is believed that the hypocalcemia that causes milk fever is due to the lower level of responsiveness of cow tissues to circulating parathyroid hormone after calving.

[0007] Cows typically go through three stages of clinical symptoms of hypocalcemia. First, the cow is able to move freely but shows signs of hypersensitivity and excitability, such as restlessness, tremors, ear twitching, head bobbing, and mild ataxia. If these symptoms are not treated, the cow usually progresses to the second stage, in which the cow is no longer able to stand and assumes sternal recumbency. Tachycardia, weakened heart contractions, and peripheral pulses then occur. The cow appears sluggish, with a dry mouth and nose, cold extremities, and subnormal body temperature. Smooth muscle paralysis may cause bloating and an inability to urinate or defecate. Cows often draw their heads into their flanks. The third stage of hypocalcemia manifests as lying on the side, with relaxed muscles, no response to stimuli, and loss of consciousness, progressing to coma. The cow's heart rate may approach 120 bpm, with peripheral pulses becoming undetectable. If untreated, the cow may die.

[0008] Farmers typically try to manage the cow's diet before calving (particularly with respect to mineral and fiber levels) to reduce the development of milk fever after calving. However, this is not always possible. Injecting synthetic analogs of 25-hydroxycholecalciferol within the first few days of calving has been tried, but the timing of this pretreatment makes it difficult to implement.

[0009] Once hypocalcemia becomes apparent in cows after calving, intravenous calcium injections are often used. However, such calcium injections often result in "heart block," which can be fatal, or a temporary high calcium level in the cow that stops the heart. In addition, some cows may relapse the day after the injection, or even relapse a third time the day after the injection. Without treatment, 60-80% of cows suffering from hypocalcemia typically die.

[0010] Solid pellets containing calcium chloride have been produced and orally administered to cows after calving. See, for example, the FRESHCAL calcium pellet product sold by MB Nutritional Sciences of Lubbock, Texas, which contains a 50 gram dose of calcium and 70,000 IU of vitamin D3. Such a product is advertised as being administered to help combat subclinical hypocalcemia and immune system disorders after calving.

[0011] Published U.S. application 2013 / 0344005 filed by LeJean discloses two pill tablets used in combination to deliver calcium to cows in an effervescent form. The first tablet contains calcium carbonate, calcium formate, and acid and is administered to cows just before calving, where the calcium is rapidly absorbed by the cows due to the effervescent effect. The second tablet is a sustained-release tablet containing calcium formate and calcium carbonate, which does not exhibit effervescent properties. This sustained-release calcium source is administered to the cows at least twelve hours after the first pill tablet. It is important to note that neither calcium formate nor calcium carbonate represents an acid-producing calcium source.

[0012] Another serious problem associated with cows is that their dry matter intake decreases, in some cases dramatically, in the days leading up to calving. With the industry's increasing emphasis on selecting high-yielding genetics for breeding, the severity of this peripartum depression of dry matter intake has become a greater concern. A 20-25% decrease in dry matter intake is common in the first 24-48 hours after calving, regardless of calcium status. If dry matter intake does not increase in tandem with milk production, fresh cows are at increased risk for hypocalcemia (milk fever), displaced abomasum, ketosis, and poor lactation performance.

[0013] The shift in the rumen microbiome within the cow to a diet that is higher in carbohydrates (specifically rapidly fermentable starch) and lower in fiber than the cow was exposed to pre-calving also impacts dry matter intake and nutrient absorption after calving. To promote the growth and prefoliation of starch-digesting bacteria quickly in response to energy demands, dietary supplements are needed that serve as food for these bacteria and ultimately enable the cow to maintain higher levels of dry matter feed intake and result in more energy available to support lactation immediately after calving.

[0014] It is well known that yeast can be used to break down starch in agricultural by-products such as flour and grains. Thus, U.S. Patent No. 3,843,800 to Langejan discloses active dry baker's yeast, which has a high level of activity retained for baking bread and other baked products. It causes bread to expand by converting the fermentable sugars present in the dough into carbon dioxide and ethanol. Given the high dry matter content of such active dry yeast, the yeast product is more stable than other forms of yeast (such as instant yeast) before it is rehydrated, and is therefore suitable for use in countries with warmer temperatures. It also does not require refrigeration. However, unlike instant yeast, active dry yeast granules cannot be mixed directly into dry ingredients, and therefore a separate rehydration step must first be performed. Saccharomyces cerevisiae is a common yeast species used in baker's yeast. It is a common form of brewer's yeast used for urine and beer fermentation. See Paul P. Sniegowski et al., "Saccharomyces Cerevisiae and Saccharomyces Paradoxus Coexist in a Natural Woodland Site in North America and Display Different Levels of Reproductive Isolation from European Conspecifics," FEMS Yeast Research, Vol. 1, pp. 299-306 (2002).

[0015] Yeast microorganisms can also be used as feed supplements to break down starch in forage and grains consumed by dairy cows and other animals, and thus reside in, for example, the reticulo-rumen of a cow to make the forage and grains easier to digest, thereby increasing the cow's dry matter intake. Published PCT application WO 2012 / 017363 filed by Cherry et al. discloses tablets for delivering probiotic yeast microorganisms or vitamins to ruminants via their drinking water. The tablets may contain probiotics and an acidic component in the form of citric acid and an alkaline component in the form of sodium bicarbonate that produces effervescence. The tablets are dropped into water to cause effervescence, and the resulting solution is added to a drinking trough used by a group of cows. The probiotic microorganisms float in the trough for the cows to eat, and the effervescence may be intended to accelerate the absorption of the probiotics by the animals.

[0016] Active dry yeast granules in the form of feed supplements are also used in the industry to be added to cow rations. Such active dry yeast granules can be of the Saccharomyces cerevisiae variety, where the yeast and other ingredients contained in the feed supplement are pelleted to facilitate mixing with other feed ingredients by the farmer for use in the cow's diet. Lallemand SA of Toulouse, France, is one such manufacturer. Furthermore, Lallemand coats some of its active dry yeast products with, for example, a 50:50 mixture of stearic acid and palmitic acid to increase the product's shelf life. See European Patent No. 2,099,898 to Degre et al. and published PCT application WO 2001 / 068808 filed by Durand et al., both of which are incorporated herein by reference in their entireties.

[0017] Abd-Talib et al., "Survival of Encapsulated Probiotics Through Spray Drying and Non-Refrigerated Storage for Animal Feeds Application," Agricultural Sciences (Vol. 4, No. 5B, pp. 78-83) (2013) discloses a research study involving a process for spray-drying probiotics, wherein the resulting product is used in animal feed. They disclose several different experiments conducted in the research study. First, the probiotics were dispersed in coconut oil using a homogenizer at 3000 rpm for 10-15 minutes. The coconut oil-probiotic mixture was then mixed with an aqueous phase mixture using a homogenizer at 3000 rpm for 10 minutes. This preparation was transferred to a petri dish containing agar for each probiotic, and the number of probiotic colonies grown in the petri dish was counted after 24 hours.

[0018] Separately, Formulation A "encapsulant" containing gum arabic, gelatin, and coconut oil, or Formulation D "encapsulant" containing gelatin, lecithin, and coconut oil, was mixed with the probiotic granules, wherein the resulting blend was passed through a spray dryer at an inlet temperature of 110°C and an outlet temperature of 70-75°C to reduce the moisture content of the resulting powder to less than 4%. These Formulations A and D were identified by Abd-Talib as the only stable encapsulants tested. The resulting emulsified, spray-dried probiotic product exhibited a cell count increase from 2.99 × 10 9 cfu / ml to 7.4 × 10 7The results indicate a decrease in cfu / ml. However, it is highly doubtful that the spray-drying process can produce a uniformly coated product like the applicant's active dry yeast granules, which, without the aid of spray drying, are uniformly coated around their exterior with a hydrophobic fat or fatty acid substance (such as a vegetable wax, preferably carnauba wax). In contrast, Abd-Talib's formulation consists of a blend of probiotic particles adjacent to each other and emulsion molecules (which will exit the spray dryer nozzle in a similar discrete arrangement). The resulting powder product is equally likely to have probiotic particles surrounding emulsion molecules, just as emulsion molecules surround the probiotic particles. In fact, the spray-drying process is more likely to remove water from the product than a coated product. Therefore, it is doubtful that Abd-Talib's product meets his own definition of "encapsulated."

[0019] Therefore, the probiotics tested by Abd-Talib do not appear to be coated with the A or D formulation materials as the term is commonly understood, and he appears to use the term "encapsulated" in a broader sense to indicate a certain shelf stability of his probiotic powder products. He does not appear to have sprayed his material around the exterior of the probiotic granules. Furthermore, Abd-Talib appears to have achieved the substantial shelf stability reported for his products by leveraging the reduced moisture content of his probiotic products, produced via a spray-drying process. Regardless, the results reported by Abd-Talib suggest that his probiotic granular powders were not actually well protected. Of a starting population of 2,990,000,000 cfu / ml, only 19,000,000 cfu / ml of probiotic microbial cells remained after two weeks. This 2,971,000,000 cfu / ml reduction in cell count represents a 99.3% reduction in cell number, which does not represent a substantial protective coating of the probiotics, especially considering that Abd-Talib's experiments were conducted over a period of only two weeks.

[0020] In the animal nutrition industry, calcium and active dry yeast granules are often more easily administered to cows and other ruminants in the form of pills or tablets, rather than injections or liquid supplements. Such pills contain a pre-measured dose of a calcium compound or active dry yeast granules to produce a specified concentration of calcium or active dry yeast granules in the animal's rumen-reticulum. Pills can be conveniently swallowed by animals without the need to force a liquid dose into the animal's mouth or inject the dose into the animal's bloodstream. However, the processes used to produce pills inevitably result in elevated temperatures and pressures during the manufacturing process, which can easily reduce the viability of the active dry yeast granules. Therefore, while it would be highly beneficial for farmers to provide a pill containing a pre-measured dose of a calcium compound (such as calcium chloride) in combination with active dry yeast granules that can be easily administered to cows after calving to treat or reduce the incidence of hypocalcemia, there is also a need to protect the viability of the active dry yeast granules contained within the pills from the effects of heat and pressure conditions during the pill manufacturing process. The calcium in the resulting pellet product will directly treat or reduce the incidence of hypocalcemia in the cow, while the active dry yeast granules will break down the starch in the forage located in the cow's rumen reticulum, making the forage more easily digestible by the cow, thereby increasing the cow's dry matter intake for colostrum and milk production in the newborn calf. Summary of the Invention

[0021] The present invention provides a solid pellet feed supplement for use in ruminants, such as cows, for the treatment of hypocalcemia (also known as "milk fever"). The solid pellet feed supplement comprises an acidogenic calcium source (e.g., CaCl2) in combination with active dry yeast granules coated with a hydrophobic fat or fatty acid material, which helps reduce cell degradation in the yeast granules and maintains their viability when the yeast granules are homogeneously incorporated into the compressed solid pellet. The hydrophobic fat or fatty acid coating material is applied separately to the active dry yeast granules to coat them. In other words, the hydrophobic fat or fatty acid material is not admixed with the active dry yeast granules and then sprayed together (such as by a spray drying process).

[0022] The resulting pellets are swallowed whole by, for example, a cow that has recently given birth. The active dry yeast granules will break down the starch in the forage remaining in the cow's rumen reticulum, making the forage more digestible, thereby increasing the cow's dry matter intake, while the acid-producing supplemental calcium is rapidly absorbed in the cow's rumen, thereby treating hypocalcemic conditions. The ability to combine active dry yeast granules and calcium chloride in a compressed pellet is surprising given the toxic and corrosive environment typically created by calcium chloride, as well as the pressure exerted on active dry yeast granules during the physical process of producing the compressed pellets.

[0023] The dietary feed supplement of the present invention may additionally comprise an acidic component (e.g., citric acid) and an alkaline component (e.g., calcium carbonate). These acidic and alkaline components in the solid pellet react in combination with the moisture present in the cow's rumen-reticulum to produce effervescence, which is believed to cause the pellet to dissolve faster and the nutrients contained in the pellet to be dispersed more quickly and evenly through the rumen-reticulum. Thus, the dietary feed supplement of the present invention may combine two different mechanisms for rapid absorption of a calcium source in the cow's rumen-reticulum: (1) the acidogenic properties of the particular calcium source selected; and (2) the effervescent effect produced by the presence of the acidic and alkaline components within the supplement pellet or pellets.

[0024] The dietary feed supplement of the present invention may also contain minerals such as magnesium, potassium and zinc to improve the health of the cow. Electrolytes may also be included. DETAILED DESCRIPTION

[0025] The present invention provides a unique formulation for a dietary feed supplement for post-calving ruminants (e.g., cows) to treat or reduce the incidence of hypocalcemia. The formulation delivers an acidogenic calcium source, such as calcium chloride (CaCl2), in combination with active dry yeast granules that maintain its viability in an anhydrous compressed solid pellet dosage form. The acidogenic calcium enters the cow's bloodstream via the reticulum to treat hypocalcemia, while the active dry yeast granules promote the breakdown of forage in the cow's reticulum to improve the cow's energy status and increase dry matter intake.

[0026] For the purposes of this application covering dietary feed supplement products administered to ruminants to treat or reduce the incidence of hypocalcemia, the term "rumen-reticulum" needs to be clarified. Ruminants have four "stomachs," the first two of which are the reticulum and the rumen. When a bolus is swallowed by an animal, it is highly likely that it will be deposited in the reticulum. Since the bolus will dissolve and produce effervescence if the necessary acidic and alkaline components are present, the resulting components within the bolus will be distributed to the reticulum and rumen. The vast majority of animal feed will remain in the rumen, and this is where the yeast particles contained in the bolus will come into play. The animal nutrition and dairy industries use the term "rumen-reticulum" to describe the reticulum and rumen together because they are not always unrelated organs and digestive activities. In contrast, once the ingesta leaves the rumen in an animal, it will flow through the rest of the gastrointestinal tract in sequence. Applicants have incorporated the term "rumen-reticulum" in their claims to reflect the fact that the boluses of the present invention are not guaranteed to end up in the reticulum (as opposed to the rumen) of an animal, as this concept is understood in the art.

[0027] For the purposes of this invention, "ruminant" means any ungulate herbivorous or gnawing mammal that is able to obtain nutrition from plant-based foods by fermenting them in a specialized stomach (primarily by microbial action) before digestion. This process (which occurs in the front of the digestive system and is therefore called foregut fermentation) typically requires that the fermented ingested material (called the "cud") be regurgitated and rechewed. The process of rechewing the cud to further break down plant matter and stimulate digestion is called "rumination." Examples of such ruminants include, but are not limited to, cows, cattle, goats, sheep, giraffes, deer, gazelles, antelopes, and camels.

[0028] As used in this application, "pellet" means any solid pellet or tablet containing a pre-measured dose of at least one active ingredient (such as calcium acidogen or active dry yeast granules) intended for administration to ruminants (such as cows).

[0029] While this application discusses the dietary feed supplement pellets of the present invention for administration to cows or "mother cows," this is done by way of illustration for the convenience of the reader, with it being understood that any other ruminant animal may be administered the pellet product.

[0030] It has been found that administering a dietary feed supplement containing large amounts of calcium to cows is more successful if a stable compressed solid pellet is used so that the animal swallows the pellet whole into the fluid contained in the reticulum where it dissolves and reacts. It has also been found that effervescent release of calcium (aided by the acid-base pair contained in the pellet) is very effective in accelerating the uptake of calcium into the cattle's bloodstream to threaten hypocalcemia.

[0031] The dietary feed supplement of the present invention contains an acidogenic calcium source. "Acidogenic" means "acid forming" or "producing acid" in which an ionic compound (such as a calcium-containing salt) decomposes into Ca 2+ Cations (which form Lewis acids) and anions (such as Cl - ), wherein a salt (e.g., CaCl2) provides a source of calcium for acid production. Thus, for the purposes of the present invention, any calcium salt compound that can be broken down into its corresponding calcium cation and separate anions in the cow's rumen reticulum can be utilized within the bolus for the purpose of accelerating the delivery of calcium cations into the cow's bloodstream.

[0032] It is important to note that calcium carbonate (CaCO3), often used as the base in effervescent acid-base pairs in prior art products, is not acidogenic. Calcium carbonate is not a salt, but rather an alkaline calcium source, as opposed to an acid. Calcium carbonate is insoluble in water because the enthalpy of hydration is not large enough to overcome the lattice energy. For this reason, CaCO3 simply cannot provide the cow's rumen with the rapidly absorbable form of calcium required to treat hypocalcemic conditions.

[0033] Therefore, the acid-producing calcium source for dietary feed supplement purposes should comprise a calcium salt compound, including but not limited to calcium chloride (CaCl2) or calcium propionate [Ca(C2H5COO)2]. Calcium chloride is preferred and should be present in the pellet in an amount of about 30-70% by weight, preferably about 50-70% by weight. Such CaCl2 is very acidic and, therefore, will be rapidly absorbed in the cow's rumen in less than an hour to produce the rapidly available calcium source required to treat the cow's hypocalcemic condition. In contrast, CaCO3 is much less acidic and will be absorbed in the cow's intestines rather than in the cow's rumen. This absorption process for CaCO3 will typically take 6-8 hours and will not provide the rapidly available calcium source required to treat hypocalcemia.

[0034] If calcium propionate is used as a source of acid-producing calcium in the pellets, it should be present in an amount of about 50-80% by weight, preferably about 65-80% by weight, of the pellets. For the purposes of the present invention, one of the benefits of calcium propionate as a source of acid-producing calcium for use in the pellets is that, while it contains a similar dose of calcium as CaCl2 for delivery to cows, it is also less reactive with the active dry yeast granules contained in the pellets. Therefore, during pellet manufacturing, calcium propionate should be less detrimental to the viability of the active dry yeast granules than would be the case with CaCl2.

[0035] One commercial benefit of using CaCl or calcium propionate as an acid-generating calcium source for dietary feed supplement pellets is that they represent the only two calcium compounds currently generally recognized as safe ("GRAS") for ruminants. They have been approved by the Association of American Feed Control Officials ("AAFCO") for use in supplements fed to ruminants, such as cows. However, this does not mean that alternative acid-generating calcium salt sources cannot be used in dietary feed supplement pellets if the manufacturer wishes to go through the process of obtaining approval from AAFCO for animal feed safety.

[0036] The present invention has also successfully incorporated stable active dry yeast into an anhydrous compressed solid pellet dosage form. Consequently, the supplement not only provides the ruminant with the calcium it needs, but also produces previously undocumented positive increases in dry matter feed intake and milk production. In this way, the supplement addresses two of the greatest problems encountered by cows after calving: hypocalcemia and low feed intake, demonstrating direct economic benefits for farmers. It is believed that the yeast successfully enhances the microbial action that stimulates rumen fermentation.

[0037] Yeast granules for the dietary feed supplement pellets of the present invention should be in the form of active dry yeast granules. This means that, unlike active yeast, they have been dehydrated by pressing and drying to reduce moisture content, rendering the yeast granules dormant. Unlike fresh yeast granules, such active dry yeast granules do not require refrigeration to maintain their activity. When the pellets are swallowed by cows, the active dry yeast granules contained within the pellets mix with warm water contained within the cow's rumen-reticulum, and then return to their active state from their dormant state. If fresh yeast were instead incorporated into the dietary feed supplement pellets of the present invention, the resulting pellets would exhibit significantly shorter shelf-life stability (in terms of the yeast component). This would adversely affect the degradation of forage material within the rumen-reticulum of cows fed the pellets, thereby reducing the animal's energy status and dry matter intake. The yeast species must be able to break down the forage material contained within the cow's rumen-reticulum to aid digestion while regulating the rumen pH to a range of approximately 5.8-6.5.

[0038] Such active dry yeast granules should preferably contain the Saccharomyces cerevisiae variety of yeast. Such Saccharomyces cerevisiae varieties exist in nature as part of the Saccharomyces stricto complex. Other varieties include Saccharomyces paradoxus, Sacchaormyces bayanus, Saccharomyces carinocanus, Saccharomyces kudriavzevii, and Saccharomyces mikatae. A large number of different species of Saccharomyces cerevisiae varieties are known and can be used for the purpose of dietary feed supplement pellets. However, the Saccharomyces cerevisiae species named CNCM I-1077 is preferred.

[0039] The yeast is preferably in the form of microparticles of active dry yeast particles coated with a homogenous hydrophobic substance such as a hydrophobic fat or fatty acid material that stabilizes the active dry yeast particles against physical and chemical stresses, including heat and compression. This is particularly important when using CaCl2 as the source of acid-producing calcium in pellet products due to the corrosive environment within the pellets contributed by CaCl2.

[0040] In particular, if an acid-generating calcium source such as CaCl2 is incorporated into a dietary food supplement pellet (which typically creates a toxic and corrosive environment during the physical processes used to produce the pellet), the active dry yeast particles should be pre-coated with a hydrophobic fat or fatty acid material. Such a material helps reduce degradation of the cells in the yeast particles and enables them to remain viable when the yeast particles are homogeneously incorporated into the compressed solid pellet.

[0041] Such hydrophobic fats or fatty acid materials include long-chain fatty acids such as oleic acid, olenic acid, palmitic acid, stearic acid, linoleic acid, or linolenic acid. More preferably, two or more of these long-chain fatty acids may be used in combination. The blend of long-chain fatty acids should evenly coat the exterior of the active dry yeast particles to protect them from the toxic and corrosive environment created by the CaCl2 acid-producing calcium source during pellet formation.

[0042] In a preferred embodiment of the present invention, the hydrophobic fat or fatty acid protective material surrounding the active dry yeast particles can be a mixture of stearic acid and palmitic acid, even more preferably a 50:50 mixture of stearic acid and palmitic acid. See European Patent No. 2,099,898 to Degre et al.; and published PCT application WO 2001 / 068808 to Durand et al., both of which are incorporated herein by reference in their entireties. Lallemand SA of Toulouse, France, also known as its Levucell SC ® A product (which is suitable for use in the present application) is commercialized under the trademark HYDROLYZER® comprising active dry yeast granules coated with a 50:50 mixture of palmitic and stearic acids.

[0043] For the purposes of the pellet product of the present invention, the coated active dry yeast particles should comprise about 1-5% by weight, preferably about 2-4% by weight of the pellet composition.

[0044] In another embodiment of the dietary feed supplement pellets of the present invention, an acid-base pair can be added to the pellet composition to produce an effervescent effect when the cow swallows the pellet, thereby delivering it to the reticulum where it is exposed to the fluid contained therein. The acidic component can include an organic acid or an inorganic acid. Such organic acids include citric acid, malic acid, fumaric acid, lactic acid, and adipic acid. Such inorganic acids include sulfuric acid, phosphoric acid, boric acid, and hydrochloric acid. Citric acid is preferably used for the acidic component.

[0045] The alkaline component may include calcium carbonate, or sodium bicarbonate, potassium carbonate, or sodium hydroxide in combination with a small amount of calcium carbonate. Calcium carbonate provides functional Ca to the cow. +2 It is important to note that if Ca is provided to cows in other ways (such as as another ingredient in a bolus or as a separate supplement administered to the cow), +2 cations, the alkaline component in larger amounts may include sodium bicarbonate, potassium carbonate, or sodium hydroxide added in combination with smaller amounts of CaCO3.

[0046] If an acid-base pair is added to the composition of a pill product, the acidic component should comprise about 5-40% by weight of the pill composition, preferably 20-30% by weight. The alkaline component should comprise about 5-40% by weight of the pill composition, preferably about 30-40% by weight.

[0047] In an alternative embodiment of the pill invention, corn starch, potato starch, amylose, or amylose pectin can be substituted for any acid-base pair included in the pill composition. Instead of generating effervescence within the cow's reticulum through the interaction of the acidic and alkaline components with water or other fluids within the reticulum to enhance the uptake of calcium from acid-producing calcium into the cow's bloodstream, the corn starch, potato starch, amylose, or amylose pectin will "explode" upon exposure to the fluids contained within the reticulum, causing the pill to disintegrate, thereby releasing calcium into the cow's bloodstream. Such corn starch, potato starch, amylose, or amylose pectin should be present in the pill composition in an amount of about 5-10% by weight, preferably about 6-10% by weight.

[0048] In addition to the acid-producing calcium source, active dry yeast granules (whether coated or not), and an acid and base pair, the dietary feed supplement pellets of the present invention may also contain other components. First, a sugar alcohol may be included in the pellet composition to serve as a bypass sugar. Such a sugar alcohol will not be available in the cow's rumen. However, it will be absorbed as glucose in the cow's small intestine. This sugar will then enter the cow's bloodstream to provide the cow with the energy it needs.

[0049] Sugar alcohols suitable as the bypass sugar component for the pill include sorbitol, maltitol, xylitol, lactitol, erythritol, mannitol, isomalt, or combinations thereof. Sugar alcohols may also include hydrogenated starch hydrolysate ("HSH"). Once wetted in the rumen reticulum, the HSH starch decomposes, thereby also accelerating the absorption of calcium from the acid-producing calcium source into the cow's bloodstream, replacing the effervescence generated by the acid-base pair in the pill composition. This can be helpful for cows struggling with hypocalcemia.

[0050] Sorbitol is the preferred sugar alcohol in the pill composition.The sugar alcohol component should comprise about 5-25% by weight of the pill composition, preferably about 10-20% by weight.

[0051] Second, the dietary feed supplement pellets may include a binder such as sorbitol or monocrystalline cellulose ("MCC"). The binder facilitates compression of the pellet composition blend during the pellet manufacturing process. It makes the resulting pellets harder, allowing for greater durability and shelf stability. Such binders should comprise about 5-20% by weight of the pellet composition, preferably about 10-15% by weight.

[0052] It is to be noted that for the purpose of the dietary feed supplement pellet invention, sorbitol can contribute dual functionality to the pellet product as both a bypass sugar glucose source and a binder. This is why if sorbitol is used in the pellet composition, it should comprise about 5-25% by weight, preferably about 10-20% by weight of the pellet composition.

[0053] The third, dietary feed supplement pill composition can include lubricants such as magnesium stearate, calcium stearate, sodium benzoate, adipic acid or polyethylene glycol. During the pill manufacturing process, the pill composition is pushed through a die to form an extrudate under a pressure of about 25-37.5 metric tons (27.5-41 tons), which is then cut into individual pills. Heat buildup can occur around the die opening. The binder contained in the pill composition acts to reduce this heat buildup by promoting the pill mixture to pass through the die opening for the extrudate. For the purpose of the pill product of the present invention, the example of suitable polyethylene glycol ("PEG") includes PEG-4000, PEG-6000 or PEG 8000.

[0054] Magnesium stearate is a preferred lubricant. If magnesium stearate or calcium stearate is used as a binder material, it should account for about 0.5-2.0% by weight of the pill composition. If sodium benzoate or polyethylene glycol is used as a binder, it should account for about 5.0% by weight of the pill composition.

[0055] Fourth, the dietary feed supplement pellet composition may include one or more nutritional supplements for promoting the health of the cow. This is particularly beneficial if the cow suffers from hypocalcemia. Such nutritional supplement components may include:

[0056] • Potassium chloride (approximately 2.3-15.0% by weight of the pellet composition).

[0057] • Niacin RP (about 1.5-5.0 wt %, preferably about 3.0 wt % of the pellet composition).

[0058] • Magnesium sulfate (about 1.0-5.0% by weight, preferably about 2.0-3.0% by weight of the pellet composition).

[0059] • Vitamin E (about 0-4.0% by weight, preferably about 0-1.0% by weight of the pill composition).

[0060] • Betaine HCl (about 0.025-5.0 wt %, preferably about 0.025-1.0 wt % of the pellet composition).

[0061] • Zinc sulfate (about 0.02-0.5%, preferably about 0.05% by weight of the pellet composition).

[0062] One successful formulation for the dietary feed supplement pellets of the present invention has the following ranges of ingredients.

[0063] Product composition (weight)

[0064]

[0065] One example of a successful product has about 2-3% active dry yeast granules, about 8% calcium carbonate, and about 60% calcium chloride by weight. The formula may contain varying amounts of active dry yeast granules, ranging from about 1-5% by weight, with 2%-3% being typical.

[0066] The method for preparing the dietary feed supplement pellets for treating hypocalcemia of the present invention is generally as follows:

[0067] 1. Add the dry ingredients of the pellet composition (except the lubricant) together to form a homogenous premix.

[0068] 2. Add lubricant to form a premix for pellet composition blend.

[0069] 3. The pellet composition blend is introduced into a pellet extruder to be pushed through a die opening at a pressure of about 25-37.5 metric tons (27.5-41 tons) and a maximum temperature of about 120°F at a relative humidity of less than 20% to produce an extrudate.

[0070] 4. Cut the extrudate into individual pellets.

[0071] 5. Package the pellets promptly to prevent moisture absorption which could adversely affect the shelf life stability of the pellet product.

[0072] A typical pill of the present invention will contain a dose of about 110 g of the pill composition.

[0073] The bolus product can be administered orally to calving cows to treat hypocalcemia. Preferably, two boluses should be administered to the cow once daily. Repeat the administration to the cow as needed after 12-24 hours.

[0074] The above specification provides a complete description of the components and preparation methods for the dietary supplement product for newborn calves of the present invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.

Claims

1. A ruminant dietary supplement in the form of a compressed, shelf-stable solid pellet or pellets for administration to the reticulum of a ruminant, the ruminant dietary supplement comprising: (a) at least 30% by weight of an acidogenic calcium salt compound capable of being decomposed into its corresponding calcium cation and separate anion in the reticulum of the ruminant; and (b) active dry yeast particles pre-coated with a hydrophobic fat or fatty acid material, wherein the coating of the hydrophobic fat or fatty acid material is separate from the active dry yeast particles before and during the period of spraying the hydrophobic fat or fatty acid material around the exterior of the active dry yeast particles; (c) wherein the hydrophobic fat or fatty acid coating contributes to reduced cell degradation in the yeast particles and enables the yeast particles to remain viable when they are homogeneously incorporated into the compressed solid pellets or pills.

2. The ruminant dietary supplement of claim 1, wherein the active dry yeast granules comprise the Saccharomyces cerevisiae variety of yeast.

3. The ruminant dietary supplement according to claim 2, wherein the S. cerevisiae species is designated CNCM I-1077.

4. The ruminant dietary supplement of claim 1, wherein the amount of active dry yeast is about 1-5% by weight of the pellet or pill.

5. The ruminant dietary supplement of claim 4, wherein the amount of active dry yeast is about 2-4% by weight of the pellet or pill.

6. The ruminant dietary supplement according to claim 1, wherein the hydrophobic fat or fatty acid pre-coating material comprises a long-chain fatty acid such as oleic acid, olenic acid, palmitic acid, stearic acid, linoleic acid or linolenic acid. 7 . The ruminant dietary supplement according to claim 6 , wherein two or more of the long-chain fatty acids may be used in combination with each other in the hydrophobic fat or fatty acid pre-coating material.

8. The ruminant dietary supplement of claim 7, wherein the hydrophobic fat or fatty acid pre-coating material comprises a 50:50 mixture of stearic acid and palmitic acid.

9. The ruminant dietary supplement of claim 1, wherein the acid-generating calcium salt compound comprises calcium chloride or calcium propionate [Ca(C2H5COO)2].

10. The ruminant dietary supplement of claim 9, wherein the compressed shelf-stable solid pellets or pellets comprise about 30-70% by weight calcium chloride or about 50-80% by weight calcium propionate. 11 . The ruminant dietary supplement according to claim 1 , further comprising an acidic component and an alkaline component.

12. The ruminant dietary supplement according to claim 11, wherein the acidic component comprises an organic acid such as citric acid, malic acid, fumaric acid, lactic acid, sorbic acid, formic acid, or an inorganic acid such as sulfuric acid, phosphoric acid, boric acid, and hydrochloric acid, or a combination thereof.

13. The ruminant dietary supplement of claim 11, wherein the alkaline ingredient comprises calcium carbonate, sodium bicarbonate in combination with a smaller amount of calcium carbonate, potassium carbonate, or sodium hydroxide.

14. The ruminant dietary supplement of claim 11, wherein the acidic component comprises about 20-40% by weight of the compressed shelf-stable solid pellet or pellets.

15. The ruminant dietary supplement of claim 11, wherein the alkaline component comprises about 5-40% by weight of the compressed shelf-stable solid pellet or pellet.

16. The ruminant dietary supplement of claim 1 , further comprising corn starch, potato starch, amylose, or amylose pectin, which, when the compressed, shelf-stable solid pellet or pellet swallowed by the ruminant is exposed to liquid contained in the reticulum of the animal, will "explode" causing the pellet or pellet to rupture, thereby releasing the calcium into the animal's bloodstream.

17. The ruminant dietary supplement according to claim 1, further comprising a sugar alcohol within the solid compressed pellet or pellet to serve as a bypass sugar to be absorbed as glucose in the small intestine of the ruminant.

18. The ruminant dietary supplement of claim 17, wherein the sugar alcohol comprises sorbitol, maltitol, xylitol, lactitol, erythritol, mannitol, isomalt, or a combination thereof, or hydrogenated starch hydrolysate ("HSH").

19. The ruminant dietary supplement of claim 18, wherein the sugar alcohol comprises sorbitol in an amount of about 5-25% by weight of the compressed shelf-stable solid pellet or pellet.

20. The ruminant dietary supplement of claim 1, further comprising a binder such as sorbitol or monocrystalline cellulose ("MCC").

21. The ruminant dietary supplement according to claim 1, further comprising a lubricant such as magnesium stearate, calcium stearate, sodium benzoate, adipic acid or polyethylene glycol.

22. The ruminant dietary supplement of claim 21, wherein the lubricant comprises magnesium stearate in an amount of about 0.5-2.0% by weight of the compressed shelf-stable solid pellet or pellets.

23. The ruminant dietary supplement of claim 1, further comprising one or more minerals within the solid compressed pellet or pellets.

24. The ruminant dietary supplement of claim 23, wherein the one or more minerals comprise magnesium, potassium, zinc, or a combination thereof.

25. A ruminant dietary supplement in the form of a compressed, shelf-stable solid pellet or pellets for administration to the reticulum of a ruminant, the ruminant dietary supplement comprising about 2-4 weight % active dry yeast granules, about 8 weight % calcium carbonate, about 60 weight % calcium chloride as an acid-generating calcium source, and about 5 weight % acidic component for producing effervescence in the reticulum of the ruminant when the solid pellet or pellet is swallowed.

26. The ruminant dietary supplement of claim 25, further comprising a coating of a hydrophobic fat or fatty acid material around the active dry yeast particles, wherein the coating of material is separate from the active dry yeast particles before and during spraying of the hydrophobic fat or fatty acid material around the exterior of the active dry yeast particles, the coating contributing to reduced cell degradation in the active dry yeast particles and enabling the active dry yeast particles to remain viable when homogeneously incorporated into the compressed solid pellets or pellets.

27. A method for preparing a ruminant dietary supplement in the form of a compressed, shelf-stable solid pellet or pellets for administration to the reticulum of a ruminant, the method comprising: (a) forming a homogenous premix, the premix comprising: (i) at least 30% by weight of an acidogenic calcium salt compound capable of being decomposed into its corresponding calcium cation and separate anion in the reticulum of the ruminant; and (ii) about 1-5% by weight active dry yeast, the active dry yeast being pre-coated with a hydrophobic fat or fatty acid material, wherein the coating of the hydrophobic fat or fatty acid material is separate from the active dry yeast particles before and during the time the hydrophobic fat or fatty acid material is sprayed around the exterior of the active dry yeast particles; (b) adding a lubricant to the premix to form a blend; (c) introducing the blend into a pellet extruder having a die plate opening at a distal end thereof for forcing the blend through the die plate opening at a pressure of about 25-37.5 metric tons (27.5-41 tons) and a maximum temperature of about 120°F at less than 20% relative humidity to produce an extrudate; (d) cutting the extrudate into individual pellets; (e) packaging the pellets to prevent moisture absorption which could adversely affect the shelf life stability of the pellet product.

28. The method of claim 27, further comprising adding one or more additives selected from the group consisting of sugar alcohols, binders, and nutritional supplements to the premix.

29. The ruminant dietary supplement of claim 1, wherein the ruminant comprises a cow, sheep, goat, deer, giraffe, or camel.

30. The ruminant dietary supplement of claim 6, wherein the ruminant comprises a cow, sheep, goat, deer, giraffe, or camel.

31. A method of using a ruminant dietary supplement in the form of a compressed, shelf-stable solid pellet or pellets for administration to the reticulum of a ruminant, the ruminant dietary supplement comprising at least 30% by weight of an acidogenic calcium salt compound capable of decomposing into its corresponding calcium cation and separate anions in the reticulum of the ruminant, and active dry yeast particles pre-coated with a hydrophobic fat or fatty acid material, wherein the coating of the hydrophobic fat or fatty acid material is separate from the active dry yeast particles before and during spraying of the hydrophobic fat or fatty acid material around the exterior of the active dry yeast particles, the method comprising: (a) provided to ruminant mothers who have given birth to calves suffering from hypocalcemia; (b) administering to the female ruminant a dose of the ruminant dietary supplement comprising the acid-generating calcium salt compound and the active dry yeast particles pre-coated with a hydrophobic fat or fatty acid substance; and ； (c) wherein the ruminant dietary supplement is swallowed by the female ruminant to enter the reticulum of the ruminant, whereby the calcium salt compound is decomposed into its corresponding calcium cation and separate anion for the purpose of accelerating the delivery of the calcium cation into the bloodstream of the ruminant for the treatment of the hypocalcemia.

32. The method of claim 31, wherein the dosage of the ruminant dietary supplement comprises about two pills once daily, wherein the dosage is repeated 12-24 hours later as needed by the female ruminant.

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