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WO1998044929A1 - Composition renfermant une proteine de collagene hydrolysee et de la glucosamine, pour le traitement des arthroses - Google Patents

Composition renfermant une proteine de collagene hydrolysee et de la glucosamine, pour le traitement des arthroses Download PDF

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Publication number
WO1998044929A1
WO1998044929A1 PCT/US1998/006869 US9806869W WO9844929A1 WO 1998044929 A1 WO1998044929 A1 WO 1998044929A1 US 9806869 W US9806869 W US 9806869W WO 9844929 A1 WO9844929 A1 WO 9844929A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
glucosamine
collagen protein
patient
hydrolyzed collagen
Prior art date
Application number
PCT/US1998/006869
Other languages
English (en)
Inventor
Andrew E. Myers
Original Assignee
Richardson Labs, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Richardson Labs, Inc. filed Critical Richardson Labs, Inc.
Priority to EP98915336A priority Critical patent/EP0991413A1/fr
Priority to AU69545/98A priority patent/AU6954598A/en
Priority to JP54303598A priority patent/JP2001524080A/ja
Publication of WO1998044929A1 publication Critical patent/WO1998044929A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/01—Hydrolysed proteins; Derivatives thereof
    • A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
    • A61K38/014—Hydrolysed proteins; Derivatives thereof from animals from connective tissue peptides, e.g. gelatin, collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue

Definitions

  • the present invention relates to a composition for treatment of degenerative joint diseases, and to a method of treating arthroses.
  • Degenerative joint diseases or arthroses are conditions where degenerative changes in cartilage lead to a breakdown in the integrity of the structural matrix of cartilage or tendonous tissues.
  • Conventionally referred to as arthritis the complaints associated with the degenerative changes occur most frequently in individuals over 50.
  • Arthritis affects over 40 million 15 Americans (1 in 7). 80% of Americans over 50 have arthritis. Over 45, women experience arthritis 10 times more than men. In short, Arthritis is the primary cause of disability in Americans
  • Symptoms include early morning stiffness, 20 stiffness following periods of rest, pain that worsens on joint use and loss of joint function.
  • Cartilage provides the cushion and frictionless mobility of. joints.
  • cartilage is constantly under a process of natural repair and regeneration. 25 Because of overuse, injury or other causes, many individuals overwhelm their body's ability to keep up with the natural process of repair. The result is cartilage that becomes increasing dry and inflexible leading to pain and eventual joint restriction.
  • Steroids such as corticosteroids, and other anti-inflammatory materials, such as non-steroidal anti-inflammatory drugs ("NSAIDs") and high doses of aspirin, are widely used for the treatment of these ailments, Pharmocol. Res. Commun. 10:557-569 (1978) by Vidal et al. While these materials often relieve the pain and swelling associated with maladies arising from connective tissue problems, they offer no support for repair processes.
  • NSAIDs non-steroidal anti-inflammatory drugs
  • NSAIDs may also inhibit the body's own natural healing processes, leading to further deterioration of the connective tissue.
  • These prior efforts may be characterized as providing only temporary palliative or symptomatic relief in as much as they furnish no pharmacological support system for the repair and regeneration of connective tissue.
  • An object of the present invention is to provide agents for the treatment of arthroses that are suitable for alleviating and curing effects on arthroses.
  • a particular object of the present invention is to provide a novel therapeutic composition comprising nutritional elements in a synergistic combination that is effective in promoting the repair and regeneration of joint and connective tissues.
  • a further object of the present invention is to provide a method for treating arthritis by administering to a patient in need of such treatment an effective amount of the present novel therapeutic composition.
  • HCP hydrolyzed collagen protein
  • glucosamine or a therapeutically acceptable salt
  • the present therapeutic composition of HCP and glucosamine has a positive effect on connective tissue maintenance and is capable of offering additional nutritional support for osteoporotic individuals.
  • the present invention further contemplates a method of treating arthroses and a method of maintaining joint tissue health.
  • the present invention offers the surprising benefit of providing a therapeutic composition which supplies co-factors for the repair and regeneration of connecting tissue, such as cartilage, while concurrently functioning as an analgesic, and a method of treatment using such a composition.
  • the present composition includes two essential ingredients: hydrolyzed collagen protein in combination with glucosamine and/or pharmacologically acceptable salts thereof, which, in combination, act synergistically to stimulate both collagen and proteoglycan synthesis.
  • Hydrolyzed collagen protein particularly enzymatically hydrolyzed collagen having a molecular weight of up to 80 kilodaltons, capable of being synergistically combined with at least one of glucosamine and pharmacologically acceptable inorganic glucosamine salts herein is available, and is generally described in U.S. Patent No. 4,804,745, the complete disclosure of which is incorporated herein by reference.
  • the hydrolyzed collagen protein can have a molecular weight in the range of about 1 to about 300 kilodaltons.
  • Lower molecular weight fractions of hydrolysed collagen protein in the range of about 1 to 10 kilodaltons can, if desired, be used alone or in combination with one or more higher molecular weight fractions of hydrolyzed collagen protein.
  • Higher molecular weight fractions include hydrolyzed collagen protein and fractions thereof in the range of about 100 to 300 kilodaltons. It has been determined that particularly efficient assimilation characteristics and a particularly good efficiency against arthroses, are observable when hydrolyzed collagens having an average molecular weight of from 10,000 to 80,000 (10 to 80 kilodaltons) are employed. Higher molecular weight preparations are generally less readily soluble in cold water. Lower molecular weight products are also more difficult to prepare in acceptable forms for application.
  • glucosamine and pharmaceutically acceptable salts thereof are available, and, in general, are described in U.S. Patent No. 5,587,363 and U.S. Patent No. 5,364,845, the complete disclosures of which are incorporated herein by reference.
  • Suitable salts include, among others, glucosamine sulfate and glucosamine hydrochloride.
  • Glucosamine may, if desired, include or be comprised of crude forms thereof.
  • Glucosamine and its pharmaceutically acceptable salts combine well with the hydrolyzed collagen protein base of the composition, providing the primary substrates for both collagen and proteoglycan synthesis.
  • Glucosamine is the preferred substrate for proteoglycan synthesis, including chondroitin sulfates and hyaluronic acid.
  • the glucosamine is, preferably, in a salt form so as to facilitate its delivery and uptake by the patient.
  • the preferred salt forms are glucosamine sulfate and glucosamine hydrochloride.
  • patient includes veterinary patients, such as veterinary mammalian patients, and also human patients unless otherwise stated.
  • Glucosamine has been shown to be rapidly and almost completely absorbed into humans and animals after oral administration. A significant portion of the ingested glu ⁇ samine localizes to cartilage and joint tissues, where it remains for long time periods. This indicates that oral adrninistration of glucosamine reaches connective tissues, where glucosamine is incorporated into newly-synthesized connective tissue.
  • glucosamine can lead to increased synthesis of collagen and glycosaminoglycans from fibroblasts which is the first step in repair of connective tissues.
  • Glucosamine and its pharmaceutically acceptable salts have also exhibited reproducible improvement in symptoms and cartilage integrity in humans with osteoarthritis in a series of studies, such Tapadinhas
  • the present therapeutic composition manifests a number of unique and unexpected advantages.
  • Clinical research in arthroses indicates that the synergistic effects of the therapeutic composition exceed the benefits obtainable from adrrjinistration of the ingredients singly. This unexpected result obtains from effects seen at the level of connective tissue.
  • This increase in synthesis is exceptional in that the enzymatic mechanisms related to collagen and glycosaminglycan synthesis are enhanced well beyond normal activity levels.
  • chondrocyte inhibitory factors such as cytokines, interferons and prostoglandins may be responsible for this unexpectedly enhanced activity, or that the components themselves may have a catalytic or co-catalytic effect. Additional findings relate to a localized reduction in inflammatory products from activated mononuclear cells known to decrease fibroblast proliferation.
  • the present therapeutic composition in principle has the effect of maintaining and re-establishing overall composition of cartilage glycosaminoglycans, in spite of tissue age.
  • the data suggest that the proportion of chondroitin sulfate, which generally falls with increasing age, is maintained versus that of keratin sulfate and hyaluronate. Therefore, in vivio, the consistent supplementation with the present therapeutic composition may forestall at least some age-related changes in cartilage composition heretofore considered to affect the ability of proteoglycan elements to aggregate with one another or to interact with collagen.
  • Glucosamine sulfate and its pharmaceutically acceptable salts taken supplementary can be used by the patient to produce primarily glycosamineglycans ("GAGs"), and secondarily collagen.
  • GAGs glycosamineglycans
  • the present therapeutic composition advantageously enables a relative enhancement in GAG synthesis with a concomitant reduction in consumption of glucosamine and its salts in collagen synthesis.
  • the present invention offers further advantages over conventional compositions and methods of treatment. Among these, administration of the present therapeutic composition advantageously does not require ever increasing dosages of the essential ingredients during the treatment period. This advantage results because the present therapeutic composition provides an effective balanced combination of analgesia and pharmacological support for the treatment of the underlying disease. Maintenance dosing at a reduced dosage level can, where appropriate, be administered thereafter.
  • the present therapeutic composition can be administered to the patient in a number of efficacious forms.
  • the present composition can be supplied in a powder form which is at least substantially homogeneous compositionally and has a substantially homogeneous particle size distribution.
  • the substantially homogeneous particle size distribution means that as a result of mixing, blending or otherwise effectively combining the at least two essential ingredients, the hydrolyzed collagen protein plus the glucosamine and/or its acceptable salts each have the desired pre-selected particle sizes.
  • the two ingredients can be combined and the combined form can be rendered pulverulent such that the particles themselves are substantially homogeneous from the compositional standpoint.
  • fluidized bed techniques can be adapted for the preparation of the foregoing powder formulations.
  • the scoop form of the composition can be measured out dry, such as with a measuring scoop, for administration to the patient.
  • a measuring scoop for administration to the patient.
  • the dosage is scooped in dry form and can be added to the veterinary patient's diet, such as in the animal feed.
  • the scoop method can also be similarly used.
  • the present invention can also be administered to the patient, human or veterinary mammalian patient, in capsule or tablet form. Tablets can, if desired, be coated or uncoated. Suitable tableting procedures include those generally described in Perry's Chemical Engineer's Handbook, page 8-62 to 8- 64 (4 th Edition 1963), Ullmann's Encyclopedia of Industrial Chemistry, volume A19, pages 245-256 (Springer Verlag 1991), Ullmann's Encyclopedia of Industrial Chemistry, volume B2,pages 7-31 to 7-37 (Springer Verlag
  • the present therapeutic composition can also be administered in capsule or gel-cap form.
  • the size of each dosage and the interval of dosing to the patient effectively determines the size and shape of the tablet or capsule.
  • each capsule and each tablet contains both of the present essential ingredients in pre-determined amounts to simplify the patient's treatment regimen.
  • the present therapeutic composition can be administered orally. Oral administration is preferred because of convenience to the patient as well as the dosing schedule.
  • the composition can be administered in powder form, but is, for at least some patients, more readily administered in solution.
  • the solution media can be water or any consumable liquid or beverage.
  • the beverage and consumable liquids are non-carbonated, and can, if desired, also be non-alcoholic.
  • the therapeutic composition can be provided for administration in the form of a so- called instantized (powdered) formulation for ready swallowing or ready dissolution in the selected liquid for subsequent administration to the patient, or can be provided in pre-mixed solution for immediate use or as a pre-mixed dilutable concentrate.
  • the pre-mixed form can be packaged in suitable containers such as, cans, bottles or the like for storage prior to use.
  • a predetermined amount of a powdered solid pre-mix formulation can also be packaged in one or more sachets.
  • the composition can also be administered in the form of a paste, compact, emulsion, elixir, granules, syrup, lozenges, gum, or candied formulation.
  • the two essential ingredients are relatively neutral in taste, and thus they can, if desired, be combined with flavoring materials, sweeteners, and/or aroma ingredients.
  • the composition can also include other additives known in the nutritional and pharmaceutical arts such as, for instance, multi-vitamins, minerals, or nutritional elements, among others.
  • the composition includes relative amounts of the two essential ingredients.
  • compositions are formulated to provide an effective amount of hydrolyzed collagen protein, such as in adrninistration, e.g. dosing, to the patient.
  • the hydrolyzed collagen is, in general, dosed so that the patient, human or veterinary mammalian patient, can receive a hydrolyzed collagen dosage in the range of 0.5 to 12 grams.
  • An efficient therapy can involve daily doses of from 5 to 12 grams hydrolyzed collagen protein.
  • the present compositions are formulated to provide an effective amount of the glucosamine and/or its pharmaceutically acceptable salts, such as in the administration, e.g. dosing, to the patient.
  • the dosage is in a range of about 0.25 to 3.0 grams, depending on the patient, human or veterinary, receiving treatment.
  • the patent can receive about 0.75 gram to about 2.0 grams of the glucosamine and/or its pharmaceutically acceptable salts.
  • the present therapeutic composition is administered to a patient, such as a human patient, in which the daily dosage is about 7 to about 8 grams of hydrolyzed collagen protein in combination with about 1.5 to about 2.0 grams of the glucosamine and/or its pharmaceutically acceptable salts, e.g. in a weight ratio of about 3.5 to about 5.3.
  • the relative amounts of effective ingredients within a dose or dosing schedule can be adjusted as appropriate for efficacious administration to veterinary patients.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne une composition thérapeutique susceptible d'être utilisée comme analgésique tout en fournissant un soutien pharmacologique pour la réparation et la régénérescence du tissu conjonctif. Les constituants essentiels de la composition sont les suivants: protéine de collagène hydrolysée et glucosamine (et/ou sel thérapeutiquement acceptable de celle-ci).
PCT/US1998/006869 1997-04-10 1998-04-09 Composition renfermant une proteine de collagene hydrolysee et de la glucosamine, pour le traitement des arthroses WO1998044929A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP98915336A EP0991413A1 (fr) 1997-04-10 1998-04-09 Composition renfermant une proteine de collagene hydrolysee et de la glucosamine, pour le traitement des arthroses
AU69545/98A AU6954598A (en) 1997-04-10 1998-04-09 Composition comprising a hydrolysed collagen protein and glucosamine for the treatment of arthroses
JP54303598A JP2001524080A (ja) 1997-04-10 1998-04-09 関節炎の治療用加水分解コラーゲンタンパク質およびグルコサミンを含む組成物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US4322697P 1997-04-10 1997-04-10
US60/043,226 1997-04-10

Publications (1)

Publication Number Publication Date
WO1998044929A1 true WO1998044929A1 (fr) 1998-10-15

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PCT/US1998/006869 WO1998044929A1 (fr) 1997-04-10 1998-04-09 Composition renfermant une proteine de collagene hydrolysee et de la glucosamine, pour le traitement des arthroses

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Country Link
EP (1) EP0991413A1 (fr)
JP (1) JP2001524080A (fr)
AU (1) AU6954598A (fr)
WO (1) WO1998044929A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001072582A (ja) * 1999-09-07 2001-03-21 Sunstar Inc 機能性経口組成物
US6333304B1 (en) * 1999-04-20 2001-12-25 Teresa K. Bath Therapeutic compositions containing glucosamine, collagen and a bioflavanol for repair and maintenance of connective tissue
WO2001093832A3 (fr) * 2000-06-02 2002-04-25 Procter & Gamble Compositions aqueuses de protection des cartilages présentant des contraintes posologiques déterminées pour une administration efficace
WO2001093833A3 (fr) * 2000-06-02 2002-04-25 Procter & Gamble Necessaires et methodes pour optimiser l'efficacite de compositions de protection des cartilages
WO2002098449A1 (fr) * 2001-06-01 2002-12-12 Nippon Meat Packers, Inc. Medications pour lesions des articulations et aliments fonctionnels
JP2003081838A (ja) * 2001-09-11 2003-03-19 Rohto Pharmaceut Co Ltd グルコサミン製剤
JP2004507490A (ja) * 2000-08-29 2004-03-11 アナスタシアデス，タソース，ピー 関節炎の処置及びそれ用の組成物
WO2008009798A1 (fr) * 2006-07-19 2008-01-24 Bio Serae Laboratoires Sa Composition a base de d-glucosamine, de lactoferrine et de chondroitine sulfate pour prevenir et/ou pour traiter les maladies articulaires dégénératives
WO2018166807A1 (fr) * 2017-03-15 2018-09-20 Rousselot B.V. Compositions de peptides de collagène hydrolysé et de micro-organismes commensaux et leurs procédés

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4804745A (en) * 1986-07-25 1989-02-14 Deutsche Gelatine-Fabriken Stoess & Co. Gmbh Agents for the treatment of arthroses
WO1994022453A1 (fr) * 1993-03-31 1994-10-13 Nutramax Laboratories, Inc. Composition a base de sucres amines et de glycosaminoglycannes pour le traitement et la reparation du tissu conjonctif

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4804745A (en) * 1986-07-25 1989-02-14 Deutsche Gelatine-Fabriken Stoess & Co. Gmbh Agents for the treatment of arthroses
WO1994022453A1 (fr) * 1993-03-31 1994-10-13 Nutramax Laboratories, Inc. Composition a base de sucres amines et de glycosaminoglycannes pour le traitement et la reparation du tissu conjonctif

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6333304B1 (en) * 1999-04-20 2001-12-25 Teresa K. Bath Therapeutic compositions containing glucosamine, collagen and a bioflavanol for repair and maintenance of connective tissue
JP2001072582A (ja) * 1999-09-07 2001-03-21 Sunstar Inc 機能性経口組成物
WO2001093832A3 (fr) * 2000-06-02 2002-04-25 Procter & Gamble Compositions aqueuses de protection des cartilages présentant des contraintes posologiques déterminées pour une administration efficace
WO2001093833A3 (fr) * 2000-06-02 2002-04-25 Procter & Gamble Necessaires et methodes pour optimiser l'efficacite de compositions de protection des cartilages
JP2004507490A (ja) * 2000-08-29 2004-03-11 アナスタシアデス，タソース，ピー 関節炎の処置及びそれ用の組成物
WO2002098449A1 (fr) * 2001-06-01 2002-12-12 Nippon Meat Packers, Inc. Medications pour lesions des articulations et aliments fonctionnels
JP2003081838A (ja) * 2001-09-11 2003-03-19 Rohto Pharmaceut Co Ltd グルコサミン製剤
WO2008009798A1 (fr) * 2006-07-19 2008-01-24 Bio Serae Laboratoires Sa Composition a base de d-glucosamine, de lactoferrine et de chondroitine sulfate pour prevenir et/ou pour traiter les maladies articulaires dégénératives
FR2903906A1 (fr) * 2006-07-19 2008-01-25 Bio Serae Lab Composition pour prevenir et/ou traiter les maladies articulaires degeneratives.
WO2018166807A1 (fr) * 2017-03-15 2018-09-20 Rousselot B.V. Compositions de peptides de collagène hydrolysé et de micro-organismes commensaux et leurs procédés
US11110147B2 (en) 2017-03-15 2021-09-07 Rousselot B.V Collagen hydrolysates as a beneficial prebiotic and their effect on joint inflammation and osteoarthritis

Also Published As

Publication number Publication date
JP2001524080A (ja) 2001-11-27
EP0991413A1 (fr) 2000-04-12
AU6954598A (en) 1998-10-30

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