Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1998-03-11
2001-05-01
Moezie, F. J. (Department: 1653)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S196110, C424S825000, C424S811000, C424S439000, C514S002600, C514S021800
Reexamination Certificate
active
06224871
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
Degenerative joint diseases, commonly known as orthroses, are most frequently found in bradytrophic tissue (tendon, cartilage) which is known to show little or no blood flow and, because of its slow metabolism, is incapable of responding to external noxious influences either with inflammatory and or with regenerative processes. As brought out in Koepff et al U.S. Pat. No. 4,804,745, clinical investigations have now led to the discovery that peptides soluble in cold water, and specifically those from a group of hydrolyzed collagens, are suitable for the treatment of orthoses. Particularly suitable is an enzymatically hydrolyzed collagen having an average molecular weight of from 10,000 to 80,000 daltons. Such enzymatically hydrolyzed collagen is almost flavorless or neutral in flavor, is soluble in cold water, and, unlike denatured collagen (gelatin) is incapable of binding significant amounts of water.
Collagen is a fiber protein forming the main constituent of the supporting tissue and connective tissue in animals (including humans) and, more particularly, is found in the skin, tendons and bones. Therefore, hydrolyzed collagen, and specifically enzymatically hydrolyzed collagen, may be produced from animal skin, animal bones, and other sufficiently purified connective tissue. Such enzymatically hydrolyzed collagens have previously been used in the pharmaceutical industry as tabletting aids, encasing agents and fillers. U.S. Pat. No. 4,804,745 describes that clinical investigations and double blind studies have now established that these enzymatically hydrolyzed collagens, taken in an amount of from 5 to 12 g per day, have alleviating effects on orthoses and also produce an analgesic effect which tends to reduce the need for administering other analgesics.
Recent studies have also shown the beneficial effects of glucosamine sulfate and its relationship with the symptoms of osteoarthritis, the most common form of arthritis. Glucosamine sulfate, which is naturally found in high concentrations in joint structures, is a stable, tasteless and water-soluble nutrient. It is readily absorbed from the intestines, stays in the blood for several hours, and very little is excreted. Glucosamine sulfate, taken as a dietary supplement, has been shown to exert a protective effect against joint destruction and is selectively used by joint tissues, exerting a dramatic positive effect in reducing arthritic symptoms and promoting healthy joint function. In particular, glucosamine stimulates the body's manufacture of collagen, the protein portion of the fibrous substance that holds joints together. Collagen is the main component of the shock-absorbing cushion called articular cartilage, and glucosamine is therefore a necessary nutrient in the production of cartilage and synovial fluid. However, the body's production of glucosamine decreases as a person ages, thereby inhibiting the new growth of cartilage destroyed through wear and tear.
The composition of this invention is a dietary supplement containing both glucosamine sulfate and protein derived from the enzymatic hydrolysis of collagen in combination with certain antioxidants, anti-inflammatory agents, thermonutrients for increasing absorption and utilization of other nutrients, and an herbal blend composed of ingredients that coact with other components to promote healthy joint function. More specifically, the dietary supplement takes the form of an essentially dry mixture of 78% to 90% protein derived from the enzymatic hydrolysis of collagen, 2% to 6% glucosamine sulfate, 2% to 5% ginkgo biloba (
Salsburia adiantifolia
) , 0.8% to 1.5% borage oil powder (
Borago officinalis
), 0.3% to 0.7% turmeric (
Curcuma longa
), 0.01% to 0.03%
Boswellia serrata
, 0.5% to 0.7% ashwagandha (
Withania sominfera
), 0.04% to 0.08%
Piper nigrum
extract, and 5% to 10% herbal blend. In a preferred embodiment, the herbal blend includes cat's claw powder (
Uncaria tomentosa
), sarsaparilla root (
Smilax ornata
), licorice root (
Glycyrrhiza glabra
), kelp (
Ascophyllum nodosum
), burdock root powder (
Arctium lappa
), alfalfa powder (
Medicajo sativa
), barley grass (
B. Hordeum vulgare L
.), echinacea root (
Echinacea purpurea
), yucca extract (
Yucca schidigera
), bilberry extract (
Vaccinium myrtillus
), devil's claw powder
Harpagophytum procumens
, capsicum powder (
Capsicum annum linne
var.
Longum sendt capsuccum
) celery seed powder, and aloe vera extract.
Once the essentially dry mixture has been blended, the. composition can be delivered enterally as a beverage. The beverage is prepared by dissolving the proper amount of the essentially dry mixture in water, juice, milk or any other drinkable liquid. The recommended serving size is 7 to 10 g of the essentially dry mixture, optimally 8.5 g of that mixture, in a selected beverage. The recommended serving should be consumed once each day.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
A major ingredient of the dietary supplement of this invention is hydrolyzed collagen, particularly enzymatically hydrolyzed collagen. Such material consists of a series of 19 amino acids joined in chains by peptide bonds. These are the same amino acids that comprise the framework of human cartilage, and are required for its generation. Enzymatically hydrolyzed collagen may be prepared by cutting, washing, and enzymatically hydrolyzing fresh or connective tissue in a tank fitted with a stir, followed by inactivation of the enzyme, separation, filtration, re-concentration, sterilization, and spray drying. The product is a whitish to yellow powder that is soluble in cold water, neutral in flavor, and of particle sizes less than about 0.5 mm. The average molecular weight falls generally within the range of about 10,000 to 80,000daltons. Higher molecular weight preparations are not sufficiently or as readily soluble in cold water, and lower molecular weight preparations are more difficult to bring into acceptable forms for application. Such enzymatically hydrolyzed collagen is commercially available under the designation “Arthred” from Traco Labs, Champaign, Ill. Further information concerning such enzymatically hydrolyzed collagen is set forth in Koepff et al U.S. Pat. No. 4,804,745, the disclosure of which is incorporated herein by reference. The patent discloses some of the double blind studies conducted with such enzymatically hydrolyzed collagen, the comparative clinical investigations revealing good compatability and intakeability with particularly good efficiency against orthroses being observed.
Glucosamine is an amino sugar normally found in humans and derived from glucose. It is considered the starting point for the synthesis of macro-molecules such as glycoproteins, glycolipids, and glyco-aminoglycans or mucopolysaccharides. Glycosamine sulfate is one of the biological chemicals involved in the formation of cushioning ingredients for joint fluids and surrounding tissues and contributes to make synovial fluid thick and elastic in joints and vertebrae.
Numerous studies have shown the beneficial effects of glucosamine sulfate and its relationship with the symptoms of osteoarthritis, the most common form of arthritis. Such double blind studies reveal that the oral administration of glucosamine sulfate is effective in reducing articular pain, joint tenderness and swelling, and the restrictions on active and passive movements, and tends to rebuild damaged cartilage, thereby restoring articular function in arthrosic patients.
The herbal components of the dietary supplement of this invention include ginkgo biloba and turmeric, both known for their properties as antioxidants and, in the case of turmeric, its anti-inflammatory properties. Turmeric is a rich source of curcuminoids, particularly curcumin, demethoxycurcumin, and bisdemethoxycurcumin. Continuing laboratory and clinical research indicate that turmeric and its phenolics have unique antioxidant and anti-inflammatory properties. Sharma, O. P., “Antioxidant Activity of Curcumin and Related Compounds,” Bioche
Barnes David J.
Daley Christine A.
Hastings Carl W.
Moezie F. J.
Reliv International, Inc.
Tilton Fallon Lungmus
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