COLLAGEN REPLACEMENT/REGENERATION FORMULATION AND USES THEREOF

Abstract

Dietary supplements and formulations for a subject, including veterinary animals and humans, in an oral preparation and/or parenteral preparation, are provided. The formulations comprise elevated amounts of hydrolyzed collagen, a glucosamine salt, a glycosaminoglycan, a sulfone, a polysaccharide acid, an ascorbate salt, a transition metal, and a polyunsaturated fatty acid. A method for enhancing joint health and/or joint repair in a subject, including veterinary animals and humans, having a joint disorder or a disease associated therewith, is also provided, comprising administering the preparation comprising high amounts of hydrolyzed collagen.

Claims

1. A veterinary preparation comprising a combination of a glucosamine salt, a glycosaminoglycan, a sulfone, hydrolyzed collagen, a polysaccharide acid, an ascorbate salt, a transition metal, and a polyunsaturated fatty acid.

2. The veterinary preparation of claim 1 comprising an oral preparation.

3. The veterinary preparation of claim 1 comprising an oral preparation, said oral preparation comprising a powdered food additive.

4. The veterinary preparation of claim 1 comprising an intravenous preparation.

5. The preparation of claim 1 comprising an about 3000 milligram to an about 7000 milligram weight of hydrolyzed collagen per 50 gram weight of the preparation.

6. The preparation of claim 5 comprising about an about 3000 to an about 5000 milligram weight of hydrolyzed collagen per 50 gram weight of the preparation.

7. A method of enhancing collagen formation at a joint in a subject, the method comprising administering the preparation of claim 1 to the subject.

8. The method of claim 7, wherein the subject is a human or a veterinary animal.

9. The method of claim 8, wherein the veterinary animal is a canine.

10. The method of claim 8, wherein the veterinary animal is an equine.

11. The method of claim 7 wherein the preparation comprises an oral preparation.

12. The method of claim 7 wherein the subject is a human.

13. The method of claim 7 wherein the preparation is a powder, a liquid, or a solid preparation.

14. The method of claim 13 wherein the solid preparation is a biscuit or nutritional bar.

Description

DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0057] FIG. 1 illustrates a table showing a comparison of one embodiment of the oral formulation with other products that are currently marketed for animals such as horses. FIG. 1 includes the amounts of certain key ingredients for each product, as well as a listing of additional ingredients that are not found in the embodied oral formulation. As shown in FIG. 1, none of the marketed products have all of the compounds found in the embodiment of the oral formulation.

[0058] FIG. 2 illustrates a table showing a comparison of the ingredient weight fraction in one embodiment of the oral formulation with other products that are currently marketed for animals such as horses. The weight fraction is calculated by dividing the ingredient amount for the respective formulation by its respective recommended dosage.

[0059] FIG. 3 illustrates a table showing a comparison of an alternative embodiment of the oral formulation with other products that are currently marketed for animals such as horses. As shown in FIG. 3, none of the marketed products have all of the compounds found in the alternative embodiment of the oral formulation.

DETAILED DESCRIPTION OF THE INVENTION

[0060] The following examples present a description of various specific aspects of the intended invention, and are not presented to limit the intended invention in any way.

[0061] In the following description, for purposes of explanation, specific numbers, materials and configurations are set forth in order to provide a thorough understanding of the invention. It will be apparent, however, to one having ordinary skill in the art that the invention may be practiced without these specific details. In some instances, well-known features may be omitted or simplified so as not to obscure the present invention. Furthermore, reference in the specification to phrases such as “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of phrases such as “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.

Formulations

[0062] Various embodiments of the present oral formulation include a combination of ingredients that may be defined by weight fraction. Examples of these weight fraction percentages in the formulation are presented below.

[0063] Oral Formulation: In embodiments, the oral formulation ingredients may comprise hydrolyzed collagen, glucosamine sulfate, chondroitin sulfate, hyaluronic acid, MSM, vitamin C, manganese, and an omega-3 fatty acid. The amount of each ingredient may be based on a weight fraction calculation wherein the oral formulation has a 50 gram weight dosage.

[0064] In embodiments, the weight fraction of glucosamine sulfate may be about 25% or less, about 20% or less, about 15% or less, or about 10% or less of the total weight of the supplement composition.

[0065] The weight fraction of hydrolyzed collagen may be about 35% or less, about 30% or less, about 25% or less, about 20% or less, about 15% or less, about 10% or less, or about 5% or less of the total weight of the supplement composition. The present formulation is not essentially free of hydrolyzed collagen.

[0066] The weight fraction of MSM may be about 25% or less, about 20% or less, about 15% or less, or about 10% or less of the total weight of the supplement composition. The present formulation is not essentially free of MSM.

[0067] The weight fraction of manganese may be about 0.5% or less, about 0.1% or less, or about 0.05% or less of the total weight of the supplement composition.

[0068] In other embodiments, magnesium is used in conjunction with or in place of manganese. The weight fraction of magnesium may be about 0.5% or less, about 0.1% or less, or about 0.05% or less of the total weight of the supplement composition.

[0069] The weight fraction of chondroitin sulfate may be about 10% or less, about 6% or less, about 4% or less, or about 2% or less of the total weight of the supplement composition. The present formulation is not essentially free of chondroitin sulfate.

[0070] The weight fraction of hyaluronic acid may be about 1.0% or less, about 0.5% or less, about 0.2%, or about 0.1% or less of the total weight of the supplement composition. The present formulation is not essentially free of hyaluronic acid.

[0071] The weight fraction of vitamin C may be about 20% or less, about 15% or less, about 10% or less, or about 5% or less of the total weight of the supplement composition. The present formulation is not essentially free of vitamin C.

[0072] The weight fraction of the omega-3 fatty acid may be about 2.0% or less, about 1.0% or less, or about 0.5% or less of the total weight of the supplement composition. The present formulation is not essentially free of an omega-3 fatty acid.

[0073] In one embodiment, the oral formulation may be described as comprising a combination of ingredients based on the individual ingredient weight to be included in a 50 gram dose of the composition prepared as an oral preparation. For example, a 50 g dose of the oral formulation may comprise a combination of about 5000 mg glucosamine sulfate; about 3900 mg ascorbic acid; about 270 mg of omega-3 fatty acid; about 4715 mg MSM; about 1200 mg chondroitin sulfate; about 20 mg manganese; about 7000 mg hydrolyzed collagen; and about 100 mg hyaluronic acid, wherein the balance of the formulation may comprise one or more excipients.

[0074] Parenteral Formulation: The parenteral formulation in some embodiments may comprise a combination of the above ingredients wherein the glycosaminoglycan is hyaluronan, chondroitin, dermatin, keratin, heparan, or heparin, or pharmaceutically acceptable salts of these compounds.

[0075] In some embodiments, the formulations and compositions include a glycosaminoglycan in an amount of about 0.01 mg/kg to about 0.5 mg/kg. In some embodiments, when the glycosaminoglycan or a pharmaceutically acceptable salt thereof is administered intravenously, the glycosaminoglycan or a pharmaceutically acceptable salt thereof can be administered at a dose from about 0.01 to about 0.1 mg/kg. In some embodiments, the glycosaminoglycan is dissolved in hyaluronic acid in an amount from about 0.001 mg/kg to about 0.1 mg/kg. In certain embodiments, the parenteral formulation may comprise a mixture including between 0.05 to 1% hyaluronic acid, 1% to 10% of a glycosaminoglycan, and 0.05 to 1% of hydrolyzed collagen. In one embodiment, the glycosaminoglycan is chondroitin sulfate. In one embodiment, the subject is being treated for osteoarthritis. In one embodiment, the subject is being treated for a lameness or other loss of articular functionality.

[0076] In yet another embodiment, the parenteral formulation may be administered intravenously. In another embodiment, the parenteral formulation may be administered intramuscularly.

[0077] In one embodiment, the parenteral formulation may be in the form of a sterile aqueous solution which may contain other substances, for example enough salts or monosaccharides to make the solution isotonic with blood.

[0078] The term “carrier” refers to compositions of matter that are conventionally used in the art to facilitate the storage, administration, and/or the biological activity of an active compound. See, e.g., Remington's Pharmaceutical Sciences, 16th Ed., Mac Publishing Company (1980). A carrier may also reduce any undesirable side effects of the active compound. A suitable carrier is, for example, stable, e.g., incapable of reacting with other ingredients in the carrier. In one example, the carrier does not produce significant local or systemic adverse effect in recipients at the dosages and concentrations employed for treatment.

[0079] Suitable carriers for the parenteral formulation may include those conventionally used, e.g., water, saline, aqueous dextrose, lactose, a buffered solution, hyaluronan and glycols. Suitable pharmaceutical carriers include starch, cellulose, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, magnesium stearate, sodium stearate, glycerol monostearate, sodium chloride, glycerol, propylene glycol, water, ethanol, and the like.

EXAMPLES

[0080] The present invention is not to be limited in scope by the specific examples described herein. Functionally equivalent products, compositions and methods are clearly within the scope of the invention, as described herein.

Example 1—Cartilage Regeneration Via Oral Administration

[0081] The following is one example demonstrating the utility of the present invention for regenerating cartilage using one embodiment of the present formulation.

[0082] The present example demonstrates the regeneration of cartilage in an animal, particularly a horse, and more particularly a knee joint.

[0083] In this and other examples, the degree of lameness and pain may be evaluated using the Modified Obel Lameness Score. See Orsini J, Divers T. Management of special problems. Manual of Equine Emergencies, Treatment and Procedures. Philadelphia, Pa.: Saunders; 2003:749, 750. At grade 0 on the scale, a horse shows no gait abnormalities at a walk or trot. At grade 1 on the scale, the horse shows foot lifting at rest, a normal gait when walking, but a shortened stride, even head and neck lifting for each foot while trotting. At grade 2 on the scale, the walk was stilted, but there was no abnormal head or neck lifting; the trot showed obvious lameness with uneven head and neck lifting. At grade 3, lameness is obvious during a walk or trot, and the horse may resist attempts to have a forefoot lifted or show a reluctance to move. At grade 4, the horse has difficult bearing weight at rest or is reluctant to move.

[0084] In other examples, lameness may be evaluated using the scale provided by the American Association of Equine Practitioners (AAEP). See Anon (1991) Lameness scale. Definition and classification of lameness. American Association of Equine Practitioners. 19. At grade 0 on the scale, no lameness is perceptible under any circumstances. At grade 1 on the scale, lameness is difficult to observe and is not consistently apparent. At grade 2 on the scale, lameness is difficult to observe at a walk or when trotting in a straight line but consistently apparent under certain circumstances (e.g. weight-carrying, circling, inclines, hard surface). At grade 3, lameness is consistently observable at a trot under all circumstances. At grade 4, lameness is obvious at a walk. At grade 5, lameness produces minimal weight bearing in motion and/or at rest or a complete inability to move.

[0085] Prior to treatment, the horse underwent a routine lameness examination, including a flexion test for the front and hind legs. Flexion testing demonstrated pain for the horse's front right leg at the knee and ankle joints. The lameness examination showed a noticeable limp by the horse and a clear favoring of its left side due to joint damage on the right side, which indicated a Modified Obel Lameness grade of at least 3.

[0086] The horse was administered an oral formulation comprising about 14% hydrolyzed collagen, 10% glucosamine sulfate, 2.4% chondroitin sulfate, 0.2% hyaluronic acid, 9.4% MSM, 7.8% ascorbic acid, 0.04% manganese, and 0.5% omega-3 fatty acid. The oral formulation was administered for four months, and the horse ingested 50 g of the oral formulation once per day during the testing period.

[0087] Following one month of oral intake of the formulation, the horse showed decreased pain during lameness and flexion testing. While jogging, the horse demonstrated a decreased favoring of the left side and soundness evidencing less limping compared with the time period prior to administration of the oral formulation. The Modified Obel Lameness observably decreased to grade 1.

[0088] Following four months of treatment, x-rays showed cartilage regeneration in the affected joint. Measurements showed an approximately 5.0 mm layer of cartilage in the knee joint after four months. Prior to treatment, cartilage was present in trace amounts in the knee, but no greater than 0.5 mm in thickness.

Example 2—Alleviation of Arthritis Symptoms Via Oral Administration

[0089] The present example demonstrates alleviation of arthritis symptoms in the joints of an animal, more particularly a horse.

[0090] In this example the subject is a horse. Prior to treatment, the horse in this example underwent a hoof tester examination, which indicated that the horse had deep navicular pain in its right front leg. The horse also showed a favoring of its left side due to joint damage on the right side, and a lameness examination indicated a Modified Obel Lameness grade of at least 3 while the horse trotted or walked.

[0091] The horse was given an oral formulation comprising about 14% hydrolyzed collagen, 10% glucosamine sulfate, 2.4% chondroitin sulfate, 0.2% hyaluronic acid, 9.4% MSM, 7.8% ascorbic acid, 0.04% manganese, and 0.5% omega-3 fatty acid. The oral formulation was administered for four weeks, and the horse ingested 50 g of the oral formulation once per day during the testing period.

[0092] Following four weeks of intake of the oral formulation, the horse showed no evidence of navicular pain during a hoof tester examination. While jogging, the horse demonstrated a decreased favoring of the left side and soundness evidencing less limping compared with the period prior to administration of the oral formulation. The Modified Obel Lameness observably decreased to grade 1.

Example 3—Cartilage Regeneration Via Oral Administration

[0093] The following is one example demonstrating the utility of the present invention for regenerating cartilage using one embodiment of the present formulation.

[0094] The present example demonstrates the regeneration of cartilage in an animal, particularly a horse, and more particularly a knee joint.

[0095] This horse was 17 years old prior to beginning treatment with the oral formulation. This horse had also competed in events at the Pan American Games and was regularly involved in highly strenuous and athletic activity.

[0096] Prior to treatment, the horse underwent a routine lameness examination that showed a noticeable limp by the horse and a clear favoring of its left side due to joint damage on the right side.

[0097] The horse was administered an oral formulation comprising about 14% hydrolyzed collagen, 10% glucosamine sulfate, 2.4% chondroitin sulfate, 0.2% hyaluronic acid, 9.4% MSM, 7.8% ascorbic acid, 0.04% manganese, and 0.5% omega-3 fatty acid. The oral formulation was administered for three years, and the horse ingested 50 g of the oral formulation once per day during the testing period.

[0098] After three years of continuous treatment of the oral formulation, x-rays showed cartilage regeneration in the affected joints for the horse's front leg. Measurements showed an approximately 3.0 mm layer of cartilage in the front leg joints. Prior to treatment, cartilage was present in trace amounts in the joints, but no greater than 0.5 mm in each joint.

Example 4—Improved Soundness for Horse Following Oral Administration

[0099] The following is one example demonstrating the utility of the present invention for improving the soundness in an animal, particularly a horse.

[0100] The horse in this example was 15 years old prior to beginning treatment with the oral formulation. This horse had a medical history that included a medical diagnosis at 8 years old of degenerative joint disease in the left and right coffin joints, enlarged dorsal spurs, and bone spurs in its navicular proximal flexor articulations.

[0101] Prior to treatment, the horse underwent a routine lameness examination that showed a low level of soundness based on the horse's flight path and trotting ability due to the joint disease. A lameness examination indicated an AAEP Lameness grade of at least 3 while the horse trotted or walked, evidencing obvious lameness.

[0102] The horse was administered an oral formulation comprising about 14% hydrolyzed collagen, 10% glucosamine sulfate, 2.4% chondroitin sulfate, 0.2% hyaluronic acid, 9.4% MSM, 7.8% ascorbic acid, 0.04%, and 0.5% omega-3 fatty acid. The oral formulation was administered for 31 days, and the horse ingested 50 g of the oral formulation once per day during the testing period.

[0103] A soundness examination was conducted following the 31-day period of administering the oral formulation. The examination demonstrated improved soundness and briskness of pace, and a lameness examination showed that the AAEP Lameness grade decreased to 1, indicating an improvement in soundness. Observation of the left hind portions, including the gluteal muscles, the biceps femoris, and the semitendinous, showed an increased size for these muscles. The biceps femoris increased in circumference following the administration of the oral formulation.

Example 5—Improved Soundness for Canine Following Oral Administration

[0104] The following is one example demonstrating the utility of the present invention for improving the soundness in an animal, particularly a canine.

[0105] The canine was an 11 year-old Yorkie with a medical history that included a cruciate ligament tear and advanced arthritis in its left hind leg.

[0106] Prior to treatment, the canine underwent a routine lameness examination that showed a low level of soundness and complete inability to place any weight on the left hind leg.

[0107] The canine was administered an oral formulation comprising about 14% hydrolyzed collagen, 10% glucosamine sulfate, 2.4% chondroitin sulfate, 0.2% hyaluronic acid, 9.4% MSM, 7.8% ascorbic acid, 0.04% manganese, and 0.5% omega-3 fatty acid. The oral formulation was administered for 30 days, and the canine ingested 50 g of the oral formulation once per day during the testing period. The canine also underwent non-invasive laser therapy treatment for its nervous system as part of the recovery process.

[0108] A conventional tool used in assessing reduced pain is to assess the speed at which an animal is able to trot over a given period of 30 seconds. (The Trot Test). For example, this tool has been used to assess soundness and joint diseases in canines. For a canine, the “trotting” test may take the form of assessing the distance a canine can trot in a 1 minute period, after having been on a treatment regimen of the present formulation as a feed additive (at a dose of 0.6 g/kg, for example) for a period of time of at least 1 month. An improvement will be identified in an animal that shows an improvement as measured by the “Trot Test” of at least 20%.”

[0109] A Trotting Test was conducted on the canine following a 12-day period of administering the oral formulation. The examination demonstrated improved soundness, briskness of pace, and recovery of use for the left hind leg. Following a 30-day period of ingesting the oral formulation, the canine had completely regained use and functionality of its left hind leg and drastically improved its soundness compared to the time period prior to treatment. The canine's trotting pace increased by twice the speed that the canine could maintain prior to administration of the oral formulation.

Example 6—Collagen Regeneration Via Intravenous Administration

[0110] The present example demonstrates the utility of the present invention for regenerating collagen using one embodiment of the present formulation.

[0111] A formulation of the present preparations may be prepared that is suitable for intravenous administration employing techniques well known to those of ordinary skill in the medical arts. The preparations will include, among other things, an amount of hydrolyzed collagen sufficient to deliver a dosage of this ingredient that is essentially equivalent to the amount of hydrolyzed collagen provided to an animal administered a 50 gram oral dose of the formulation comprising about 7,000 mg of hydrolyzed collagen. An intravenous-administered preparation typically provides a greater percentage of the active ingredient to the animal, compared to an oral administration. Therefore, the intravenous formulation of the present invention in some embodiments will include a lower concentration of hydrolyzed collagen compared to amount of hydrolyzed collagen provided in the oral preparation.

Example 7—Powder Oral Formulation

[0112] The following illustrates one example of the present invention and a table comparing ingredients in the same.

TABLE-US-00001 TABLE 1 Comparison of Oral Formulation Embodiment With Other Products Vitamin C Hydrolyzed Glucosamine Chondroitin Hyaluronic Methyl- (ascorbic Omega Collagen Sulfate Sulfate Acid sulfonylmethane acid) Manganese 3 Dose Other (mg) (mg) (mg) (mg) (MSM) (mg) (mg) (mg) (mg) (g) Ingredients Oral 7000 5000 1200 100 4715 3900 20 270 50 excipient Formulation Embodiment COSEQUIN ® X 14400 2400 X 10000 610 100 X 34 avocado, ASU PLUS soy, green tea JOINT X X  600 X 750 104 16 638 56.7 omega-6, COMBO lysine, zinc, biotin STEADFAST ® X X X X X 500 X X 25 biotin, EQUINE cholecalciferol, phosphorus PLATINUM X 8820 X 90 8200 X 130 12000 156 macrominerals, PERFORMANCE ® trace CJ minerals, vitamins VITAFLEX ® X X X X 10000 X X X 10.1 PRO MSM JOINT AID X 10000 2000 100 7500 X X X 85 soy, turmeric FLEX + MAX X X 1200 150 5000 X X X 75 boswellia ABSORBINE ® serrata JOINT X 5000 2400 200 X X 200 X 14 ARMOR

[0113] The present formulation having the above components was prepared in a powder formulation.

[0114] The dose amount of the present formulation may vary depending upon the informed opinion of an attending medical professional. The dosage may be based on the size and/or type of animal being treated, or the disorder being treated.

[0115] The amount of any ingredient in the oral formulation dose may also be changed based on the size and/or type of animal being treated, or the disorder being treated.

[0116] In some embodiments, the present formulation does not include ingredients that are considered “other ingredients” that are present in other formulations, and are essentially free of these ingredients. Examples of “other ingredients” include lysine, zinc, green tea, soy, flavorings, turmeric, biotin, or Boswellia serrata, among others. This poses an advantage for the present formulation of avoiding possibly adverse side effects in a subject from the ingredient, such as allergies, as well as any pre-existing health condition. In other embodiments, the formula is created to avoid any allergenic reaction risk to the animal.

[0117] In some embodiments, the oral formulation is a dry powder that may comprise, per 50 g of the dry powder, a combination of about 5000 mg glucosamine sulfate; about 3900 mg ascorbic acid; about 270 mg of omega-3 fatty acid; about 4715 mg MSM; about 1200 mg chondroitin sulfate; about 20 mg manganese; about 7000 mg hydrolyzed collagen; and about 100 mg hyaluronic acid.

[0118] As demonstrated in Table 1 above, the present forms are not essentially free of hydrolyzed collaged, are not essentially free of chondroitin sulfate, are not essentially free of glucosamine sulfate, are not essentially free of hyaluronic acid, and/or are not essentially free of MSM.

[0119] The following Table 2 presents a comparison of the following products by weight percentage. These percentages were calculated by using the ingredient amounts and doses provided in Table 1.

TABLE-US-00002 TABLE 2 Comparison of Oral Powder Formulation Embodiment With Other Products by Weight Percentage Vitamin C Hydrolyzed Glucosamine Chondroitin Hyaluronic Methylsulfonylmethane (ascorbic Omega Collagen Sulfate Sulfate Acid (MSM) acid) Manganese 3 Oral 14.00% 10.00% 2.40% 0.20%  9.43% 7.80% 0.04% 0.54% Formulation Embodiment COSEQUIN ® X 42.35% 7.06% X 29.41% 1.79% 0.29% X ASU PLUS JOINT COMBO X X 1.06% X  1.32% 0.18% 0.03% 1.13% STEADFAST ® X X X X X 2.00% X X EQUINE PLATINUM X  5.65% X 0.06%  5.26% X 0.08% 7.69% PERFORMANCE ® CJ VITAFLEX ® PRO X X X X 99.01% X X X MSM JOINT AID X 11.76% 2.35% 0.12%  8.82% X X X FLEX + MAX X X 1.60% 0.20%  6.67% X X X ABSORBINE ® JOINT ARMOR X 35.71% 17.14% 1.43% X X 1.43% X

[0120] The following Table 3 presents a comparison of the various products with an alternative embodiment of the present oral formulation. In this alternative embodiment, the amount of hydrolyzed collagen may be reduced to about 3000 mg to about 5000 mg. in a 50 g oral dose preparation.

TABLE-US-00003 TABLE 3 Comparison of Alternative Oral Formulation Embodiment With Other Products Vitamin Hydrolyzed Glucosamine Chondroitin Hyaluronic C Omega Collagen Sulfate Sulfate Acid Methylsulfonylmethane (ascorbic Manganese 3 Dose (mg) (mg) (mg) (mg) (MSM) (mg) acid) (mg) (mg) (mg) (g) Oral 3000 to 5000 1200 100 4715 3900 20 270 50 Formulation 5000 Embodiment COSEQUIN ® ASU X 14400 2400 X 10000 610 100 X 34 PLUS JOINT COMBO X X 600 X 750 104 16 638 56.7 STEADFAST ® X X X X X 500 X X 25 EQUINE PLATINUM X 8820 X 90 8200 X 130 12000 156 PERFORMANCE ® CJ VITAFLEX ® PRO X X X X 10000 X X X 10.1 MSM JOINT AID X 10000 2000 100 7500 X X X 85 FLEX + MAX X X 1200 150 5000 X X X 75 ABSORBINE ® JOINT ARMOR X 5000 2400 200 X X 200 X 14

Example 8—Edible Biscuit and/or Food Bar Solid Formulation

[0121] The following illustrates an additional preparation of the formulations in a solid form, such as in a biscuit suitable for oral consumption, including consumption by both humans and veterinary animals.

[0122] In some embodiments, the solid form of the formulation may comprise a chewable supplement in a preparation comprising hydrolyzed collagen and other ingredients. The preparation may be suitable for animal consumption, including consumption by human, canine, equine, feline, or other animals.

[0123] In other embodiments, the solid form of the formulation may comprise an edible biscuit or other food product, such as a nutritional supplement bar. The biscuit or other food product will comprise a relatively high concentration of hydrolyzed collagen, along with the other ingredients as described herein. In this manner, it is envisioned that the biscuit or food bar will provide an amount of about 5,0000 mg to about 7,000 mg of hydrolyzed collagen to the human and/or veterinary animal upon consumption of the product.

[0124] The solid preparations may be prepared according to those routine and known formulation techniques known to those of skill in the art of consumable veterinary and/or human products.

BIBLIOGRAPHY

[0125] The following references are incorporated herein in their entirety. [0126] 1. Goodman & Gilman's “The Pharmacological Basis of Therapeutics” eds. Hardman et al. Ninth Edition, McGraw-Hill Publishing, 1996 [0127] 2. Camacho-Zambrano, M. M., et al. (2009). “A randomized controlled trial on the efficacy and safety of a food ingredient, collagen hydrolysate, for improving joint comfort”. International Journal of Food Sciences and Nutrition. 12: 1-15. [0128] 3. Osteoarthritis and Cartilage (2000) 8, 444-451, The effects of glucosamine derivatives on equine articular cartilage degradation in explant culture. J. I. Fenton, et al. [0129] 4. Forsyth R K, Brigden C V, Northrop A J. Double blind investigation of the effects of oral supplementation of combined glucosamine hydrochloride and chondroitin sulphate on stride characteristics of veteran horses. Equine Vet J (Suppl) 36:622-5, 2006. [0130] 5. Bartolucci, C., “Chondroprotective action of chondroitin sulfate,” Int. J. Tiss. Reac., XIII(6):311-317 (1991). [0131] 6. Manhart, D. & Scott, B. & Gibbs, P. & Coverdale, J. & Eller, E. & Honnas, C. & Hood, D. (2009). Markers of Inflammation in Arthritic Horses Fed Omega-3 Fatty Acids. The Professional Animal Scientist. 25. 10.15232/S1080-7446(15)30702-6. [0132] 7. V. Juliand, W. Martin-Rosset. (2005). The growing horse: nutrition and prevention of growth disorders. 190. [0133] 8. A. M. Johansson, et al. (2003) Hypomagnesemia in Hospitalized Horses. J. Vet. Intern. Med.; 17:860-867. [0134] 9. Butawan M, Benjamin R L, Bloomer R J. Methylsulfonylmethane: applications and safety of a novel dietary supplement. Nutrients. 2017; 9(pii):E290. doi: 10.3390/nu9030290. [0135] 10. Remington's Pharmaceutical Sciences, 16th Ed., Mac Publishing Company (1980). [0136] 11. Anon (1991) Lameness scale. Definition and classification of lameness. American Association of Equine Practitioners. 19. [0137] 12. Orsini J, Divers T. Management of special problems. Manual of Equine Emergencies, Treatment and Procedures. Philadelphia, Pa.: Saunders; 2003:749, 750.