Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
  • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
  • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
  • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/24—Heavy metals; Compounds thereof
  • A61K33/30—Zinc; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
  • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis

Definitions

• the present invention relates to feed for an animal. More particularly, the present invention relates to an electrolyte supplement that is orally administered to an animal in an aqueous solution and the method of using the electrolyte supplement.
• Diarrhea are caused by a number of infectious agents including bacteria such as Escherichia coli , salmonella species, viruses such as Rotavirus, Coronavirus, and Torovirus and other pathogens. Each of these pathogens causes symptoms including dehydration, acidosis, electrolyte abnormalities and hyperglycemia.
• a young calf may suffer permanent internal injuries which may result in lower weight gain and/or milk production as an adult mammal. In some instances, severe diarrhea can result in the death of a young animal.
• Aqueous supplements containing simple carbohydrates, such as glucose, fructose and/or dextrose, and electrolytes can be given to the calves with diarrhea to treat the symptoms caused by diarrhea, namely dehydration, acidosis, lack of energy and a reduction in electrolyte levels.
• aqueous electrolyte supplements that are currently being fed to calves including supplements containing electrolyte concentrations of less than 20 strong ion difference (SID).
• SID of a solution is determined by adding the mEq/l of sodium ion with the mEq/l of potassium ion and subtracting the mEq/l of chloride ion.
• An electrolyte supplement having a SID of 20 or less is considered to be “weak” by industry standards.
• “weak” electrolyte supplements provide adequate amounts of water, simple carbohydrates and electrolytes to treat the symptoms associated with diarrhea.
• a “weak” electrolyte supplement may not provide an adequate remedy for the young animal to reverse the effects of diarrhea.
• a “strong” aqueous electrolyte supplement may be orally administered to the calf.
• “Strong” electrolyte supplements have ion concentrations of between about 50 and about 80 SID. “Strong” electrolyte supplements generally replenish electrolyte levels in the calf and remedy the calf's other symptoms associated with diarrhea.
• “strong” electrolyte supplements typically contain ingredients that address virtually every symptom associated with diarrhea which may not be necessary to cure a particular calf of diarrhea. Because “strong” electrolyte supplements are designed to treat virtually every symptom associated with diarrhea, “strong” electrolyte supplements are expensive relative to “weak” electrolyte supplements. Because of the difference in cost, the producer is left with a decision of feeding the calf a “strong” supplement that will reduce the effect of diarrhea but will cost a significant amount of money or feeding the calf a “weak” supplement which costs considerably less money but may or may not improve the dehydration caused by diarrhea.
• the present invention includes a method of managing dehydration in an animal which includes administering a first aqueous electrolyte solution to the animal having a SID range at or below 25 mEq/l. After administering the first aqueous electrolyte solution, the animal's health is observed to determine the effect of the first electrolyte solution.
• a second aqueous electrolyte solution may be administered to the animal based on the animal's health conditions where the second solution comprises the first electrolyte solution supplemented with electrolyte components that raise the SID of the second aqueous electrolyte solution to at least 50 mEq/l.
• the present invention includes an aqueous electrolyte supplement that is fed to young animals, and preferably young bovine calves, to prevent the dehydration caused by diarrhea, shipping and hot weather.
• the electrolyte supplement includes a base electrolyte supplement that mixes into a selected amount of water for oral administration of dehydrated calves.
• an additional electrolyte supplement can be added to the base solution to increase the electrolyte concentration of the supplement to a “strong” solution which is orally administered to the calf.
• the base electrolyte supplement and the additional electrolyte supplement are preferably in powder form prior to use.
• the base electrolyte supplement and the additional electrolyte can be provided in a concentrated aqueous form or a ready to use solution.
• the base electrolyte supplement contains selected amounts of simple carbohydrates and electrolytes including but not limited to, salts of sodium, potassium and chloride.
• a selected amount of the base electrolyte supplement is added to a selected amount of water such that salts disassociate to produce a base solution with a SID of preferably less than or equal to 25 mEq/l. While a SID concentration of less than or equal to 25 is preferred, the aqueous base solution may have a SID of up to and including 35.
• the simple carbohydrate is preferably dextrose which the calf quickly processes to provide a quick supply of energy.
• Other simple carbohydrates or sugars such as, but not limited to, glucose and fructose may also be added to the base to provide a readily accessible supply of energy. While providing readily accessible energy, the simple carbohydrate also helps with the transport of sodium ions within the young animal.
• the sodium ions aid in absorbing the water into the young animal's body to combat dehydration.
• the potassium ions and the chloride ions are included in the base solution to replace the ions lost due to the diarrhea.
• the preferred ranges of the ingredients for the base electrolyte supplement follows in Table 1: TABLE 1 Preferred Range Ingredient Weight % Weight % Sodium 5.6 3.5-10.0 Chloride 8.35 5.0-15.0 Potassium 1.98 0.5-5.0 Dextrose 75 50-90 Gum 0.75 0.1-1.5
• the sodium is provided in a salt form including, but not limited to, sodium chloride, sodium citrate and monosodium phosphate.
• the chloride is added in a salt form, including, but not limited to, sodium chloride and potassium chloride.
• the potassium is added in a salt form including, but not limited to, potassium chloride, potassium citrate and potassium phosphate.
• the phosphate ion and the citrate ions are not accounted for in Table 1.
• an electrolyte solution having the above weight percentage is within the scope of the present invention.
• the gum is optionally added to retain the ingredients in suspension in the base solution and to slow the rate of freezing.
• the gum is not necessary to practice the present invention.
• the gum can include xanthan gum, processed guar gum and hemicellulose extract or any combination thereof.
• Other suspension agents are also within the scope of the present invention.
• the calf's physical condition is monitored to determine whether the calf's physical condition is improving over time.
• the calf's symptoms show improvement when the severity of the diarrhea normalizes the calf's energy increases and/or the calf's temperature decreases.
• the base solution will continue to be orally administered to the calf until the calf improves such that the base solution is not necessary to improve the calf's physical condition.
• the additional electrolyte supplement is added to the base solution which is subsequently orally administered to the calf.
• the additional electrolyte supplement which may alternatively be referred to as an “add pack”, includes an effective amount of glycine that allows the calf to utilize the simple carbohydrate and sodium more efficiently than an electrolyte supplement that does not contain glycine.
• a selected amount of sodium bicarbonate is also included in the additional electrolyte supplement in an amount effective to control acidosis.
• Sodium bicarbonate dissociates into a base or an alkalynizing agent in an aqueous solution that aids in controlling acidosis.
• bases or alkalynizing agents which are generally recognized as (GRAS) safe for the calf to ingest are also within the scope of the present invention.
• the additional electrolyte supplement also includes another effective amount of sodium preferably in a salt form.
• the sodium salt dissociates into its ionic form in an aqueous solution.
• the sodium in the additional electrolyte supplement is in the form of a salt including, but not limited to, sodium bicarbonate, sodium citrate, and sodium acetate.
• the additional electrolyte supplement includes at least the following ingredients listed in Table 2. However, other ingredients may be included in the additional electrolyte supplement while practicing the present invention. TABLE 2 Ingredient Preferred Weight % Weight % Glycine 53.2 40.0-60.0 Sodium Bicarbonate 42.5 25.0-50.0
• the additional electrolyte solution is not fed directly to the dehydrated calf, but orally administered as a supplement to the aqueous base solution.
• the aqueous supplement, having the additional electrolyte supplement added to the base solution forms a “strong” solution having about 64.4 mEq/l.
• the strong solution of the present invention may have a SID in a range of between about 50 and about 80.
• Table 3 is a tabulation of the concentrations of the critical ingredients in powdered form of the combined base electrolyte supplement and additional electrolyte supplement that are mixed into a selected amount of water to form the strong electrolyte solution of the present invention.
• the strong aqueous solution is orally administered to the calf to remedy diarrhea.
• the additional ingredients also significantly increase the cost of the electrolyte supplement. Therefore, initially administering the base solution provides a cost-effective method for attempting to remedy diarrhea and its symptoms. If the base solution does not adequately remedy diarrhea or does not cause improvement in the calf's condition, the additional electrolyte supplement is added to the base solution containing the base electrolytes.
• the additional electrolyte supplement includes the more expensive ingredients such as glycine and sodium bicarbonate which increases the cost of combating diarrhea in a calf while resulting in the improvement of the calf's physical condition.
• the ingredients of the base electrolyte supplement and the additional electrolyte supplement both mix into water without changing the color of the water. If more than one container is being utilized, the person tending to the calves may become confused whether the base electrolyte supplement has been added to the water to form the base solution and/or whether the additional electrolytic supplement has been added to the base solution to form the strong solution.
• a GRAS dye is optionally but typically added to both the base electrolyte supplement and to the additional electrolyte supplement.
• the base solution turns a distinguishing color such as yellow. While yellow is a typical color because it is easily viewed, other colors for the base solution are within the scope of the present invention.
• the additional electrolyte supplement When the additional electrolyte supplement is added to the base solution, the additional electrolyte supplement turns the “strong” SID solution to a different color than the color of the aqueous base solution. Typically, when the additional electrolyte supplement is added to the “weak” base solution, the solution changes from a yellow color to an orange color.
• the administrant of the electrolyte supplement will be readily able to ascertain whether the container contains water, the “weak” electrolyte supplement or the “strong” electrolyte supplement.
• the base solution optionally includes a suspension agent or mixture of suspension agents that prevent insoluble ingredients or soluble ingredients at saturation concentrations from settling out of the aqueous solution over time and to slow rate of freezing. While the suspension agent is not necessary to practice the present invention, the suspension agent maintains the ingredients in suspension in the aqueous solution such that the particles are substantially evenly dispersed within the aqueous solution.
• a typical suspension agent is a gum or combination of gums. The typical gums are xanthan gum, guar gum and hemicellulose extract or any combination thereof. Other suspension agents are also within the scope of the present invention.
• the suspension agent allows non-soluble ingredients to be added to the electrolytes supplement, such as zinc oxide, kaolin, pectin, and activated charcoal.
• Zinc oxide is known to be used successfully in the farm industry to reduce diarrhea when fed to swine in nursery diets. However, zinc oxide is insoluble in water and quickly settles out of an aqueous solution which limits the effectiveness of zinc oxides in threatening diarrhea in bovine calves. It has been discovered that the gum or combination of gums adequately suspends an amount of zinc oxide in solution that is effective to treat diarrhea when ingested by calves.
• Zinc oxide can be included in the base electrolyte solution in concentrations up to 10,000 ppm. The effect of zinc oxide being included with the base solution was tested on calves having diarrhea.
• a trial was performed to determine the effectiveness of the base solution with zinc oxide performed in comparison to Merrick's Blue Ribbon electrolyte supplement manufactured by Merrick's, Inc. of Middleton, Wis.
• 55 calves between 3 and 10 days of age weighing an average of about 100 pounds were purchased from sale barns in Wisconsin and were evaluated. Only calves with diarrhea were evaluated where the calves were fed a standardized milk replacer diet.
• D Diarrhea Days were calculated by totalling all days calves had a diarrhea score of 2 or higher.
• E Diarrhea Severity Index puts a value on intensity of the diarrhea combined with the duration of diarrhea days. Diarrhea Severity Index was calculated by multiplying the Average Diarrhea Score by the Total Diarrhea Days.
• C Base solution contained 0.5% Zinc Oxide (5000 ppm).
• D Re-sorb ® commercial product manufactured by Pfizer, Inc. of New York, New York.
• results show that there was a statistically equal preference for both the base solution with zinc oxide and the commercially available electrolyte supplements.
• the results indicate that the inclusion of zinc oxide at 5000 ppm does not hinder the palatability of the electrolyte system while the previous trials indicate that zinc oxide increases the effectiveness of the electrolyte supplement in reducing diarrhea.
• a trial was conducted to determine the costs of using the base solution of the present system with zinc oxide as compared to Merrick's Blue Ribbon electrolyte supplement.
• fifty-five calves between 3 and 10 days of age weighing an average of about 100 pounds were purchased from sale barns in Wisconsin and were evaluated.
• the calves were fed a standardized milk replacer diet where only calves with diarrhea were used during the trial.
• Diarrhea scores were taken daily.
• Thirty-three of the calves received the base solution with zinc oxide and thirty-two calves received Merrick's Blue Ribbon electrolyte supplement as needed for diarrhea and dehydration.
• the cost the of electrolyte supplement per calf was calculated including the cost of freight.
• the base solution with zinc oxide including the “Add Pack” electrolyte system cost a total of about $3.11 per calf while Pfizer's Re-sorb® electrolyte supplement cost on average $16.24 per calf.
• the trial also indicated that utilizing the base solution with zinc oxide resulted in a statistically significant reduction in cost when compared to the Re-sorb® electrolyte supplement.
• the base solution is typically made available to the calves in a pail for an extended period of time at or below freezing temperature. In colder climates, the aqueous electrolyte base solution has a tendency of forming an ice layer on the surface thereby making the electrolyte system undrinkable for the calf.
• the PDiff function of the GLM statistical procedure was used to characterize the mean values of the data by providing for comparisons between mean data values for the calves of different treatments for particular test parameters or variables.
• P used in the Tables above is a probability value. For purposes of comparing data in this document, P values of 0.10, or lower, are considered to be statistically significant.
• the Tables include a coefficient of variation (CV) for data in a particular row.
• the coefficient of variation is the standard deviation of a particular variable divided by the mean of the variable and then multiplied by 100.

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• 2006
  • 2006-01-12 US US11/331,245 patent/US20070160683A1/en not_active Abandoned
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