Composition and method for treating connective tissue damage

• US 8,455,458 B2
• Filed: 06/21/2007
• Issued: 06/04/2013
• Est. Priority Date: 10/16/2002
• Status: Active Grant

• Current Assignee: Arthrodynamic Holdings, LLC
• Original Assignee: Arthrodynamic Technologies, Animal Health Division Inc.
• Inventors: Marcum, Frank D., Seanor, John William, Northrop, Foster Harold
• Primary Examiner(s): BLAND, LAYLA D
• Application Number:
  US11/766,510
• Publication Number:
  US 20080003257A1
• Time in Patent Office: 2,175 Days
• Field of Search: None
• US Class Current: 514/54
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/7008 Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
• CPC Class Codes: A61K 31/715 Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 31/737 Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate A61K31/727 takes precedence
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 15/20 containing organic materials
• CPC Class Codes: A61L 15/225 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 17/10 containing macromolecular materials
• CPC Class Codes: A61L 2300/232 Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61P 19/00 : Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 : for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/08 : for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 : Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: C08L 5/08 : Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

The present invention provides a composition, and a method of use thereof for treating connective tissue damage in man and in animals, which comprises a therapeutically effective amount of chondroitin sulfate, N-acetyl D-glucosamine, and hyaluronan (hyaluronic acid). Particularly, the present invention provides a composition, and a method of use thereof, for treating connective tissue damage including, but not limited to, arthritic disease, osteoarthritis, rheumatoid arthritis, osterochondrosis dessicans, cartilage damage, joint injury, joint inflammation, joint synovitis, degenerative joint disease (DJD), post surgical DJD, traumatic injury, fracture, tendon damage, ligament damage, skeletal damage, musculoskeletal damage, fiber damage, adipose tissue damage, blood cell damage, and plasma damage. Compositions for delivery of the present invention include those for parenteral, oral, and transmucosal delivery and for direct surgical placement onto the affected tissues.

Claims

1. A method for treating connective tissue damage in a mammal comprising directly administering to a mammal in need thereof at an injury site, a therapeutically effective amount of a composition comprising therapeutic amounts of chondroitin sulfate, N-acetyl D-glucosamine, and hyaluronan, wherein said connective tissue is adipose tissue or reticular fibers.

2. The method of claim 1, wherein the therapeutically effective amount of chondroitin sulfate comprises from between about 0.5 grams to about 1.5 grams of a suitable chondroitin sulfate per unit dose of the composition.

3. The method of claim 2, wherein the suitable chondroitin sulfate is chondroitin 4-sulfate, chondroitin 6-sulfate, or a mixture thereof.

4. The method of claim 1, wherein the therapeutically effective amount of N-acetyl D-glucosamine is from about 0.5 grams to about 1.5 grams of N-acetyl D-glucosamine per unit dose of the composition.

5. The method of claim 1, wherein the therapeutically effective amount of hyaluronan is from about 10 mg to about 50 mg of hyaluronan per unit dose of said composition.

6. The method of claim 1, wherein the composition is a sterile solution.

7. The method of claim 6, wherein the composition is dispersed onto or within a deformable semi-solid or solid material adapted for implantation onto or between tissues of a human or animal body.

8. The method of claim 7, wherein said material is dissolvable or biodegradable and in the form of a mesh, gauze, bandage, a surgical suture, or staple material suitable for a surgical process or device.

9. The method of claim 1, wherein the composition is administered in combination with one or more therapeutic agents.

10. The method of claim 9, wherein the therapeutic agent is selected from the group consisting of a synthetic or a non-synthetic corticosteroid agent, nonsteroidal anti-inflammatory agent, antirheumatic agent, immunoregulation agent, immunosuppressant agent, articular function augmenter agent, and interleukin production inhibitor.

11. The method of claim 10, wherein said therapeutic agent is a corticosteroid agent.

12. The method of claim 10, wherein said therapeutic agent is a growth factor.

13. The method of claim 10, wherein said therapeutic agent is a tissue or a stem cell having a therapeutic effect.

14. A method for treating connective tissue damage in a mammal comprising directly administering to a mammal in need thereof at an injury site, a therapeutically effective amount of a composition consisting essentially of therapeutic amounts of chondroitin sulfate, N-acetyl D-glucosamine, and hyaluronan, wherein said connective tissue is adipose tissue or reticular fibers.

15. The method of claim 14, wherein the therapeutically effective amount of chondroitin sulfate comprises from between about 0.5 grams to about 1.5 grams of a suitable chondroitin sulfate per unit dose of the composition, and wherein the suitable chondroitin sulfate is chondroitin 4-sulfate, chondroitin 6-sulfate, or a mixture thereof.

16. The method of claim 14, wherein the therapeutically effective amount of N-acetyl D-glucosamine is from about 0.5 grams to about 1.5 grams of N-acetyl D-glucosamine per unit dose of the composition.

17. The method of claim 14, wherein the therapeutically effective amount of hyaluronan is from about 10 mg to about 50 mg of hyaluronan per unit dose of said composition.

18. The method of claim 14, wherein the composition is dispersed onto or within a deformable semi-solid or solid material adapted for implantation onto or between tissues of a human or animal body.

19. The method of claim 18, wherein said material is dissolvable or biodegradable and in the form of a mesh, gauze, bandage, a surgical suture, or staple material suitable for a surgical process or device.

20. The method of claim 14, wherein the composition is a sterile solution.