Dried and agglomerated hyaluronic acid product

• US 20050267068A1
• Filed: 05/19/2005
• Published: 12/01/2005
• Est. Priority Date: 05/27/2004
• Status: Active Grant

• Current Assignee: Novozymes Biopharma DK A/S (Novozymes)
• Original Assignee: Novozymes A/S (Novozymes)
• Inventors: Back, Poul, Thwaites, Eric
• Granted Patent: US 7,956,180 B2
• Time in Patent Office: Days
• US Class Current: 514/54
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 8/735 Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 7/00 Preparations for affecting hair growth
• CPC Class Codes: C08B 37/0072 Hyaluronic acid, i.e. HA or hyaluronan; Derivatives thereof, e.g. crosslinked hyaluronic acid (hylan) or hyaluronates
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

The present invention relates to products comprising hyaluronic acid or a salt thereof, which product is dried and agglomerated as defined herein, various compositions and articles comprising the product or compositions of the invention, methods of producing the product of the invention, and uses thereof.

Claims

1. A product comprising hyaluronic acid or a salt thereof, which product is dried and agglomerated.

2. The product according to claim 1, wherein the hyaluronic acid or salt thereof is recombinantly produced, preferably by a Gram-positive bacterium, more preferably by a bacterium of the genus Bacillus.

3. The product according to claim 1, wherein the hyaluronic acid or salt thereof has a molecular weight in the range of between 300,000 and 3,000,000;

preferably in the range of between 400,000 and 2,500,000;

more preferably in the range of between 500,000 and 2,000,000; and

most preferably in the range of between 600,000 and 1,800,000.

4. The product according to claim 1, wherein the hyaluronic acid or salt thereof has a low average molecular weight in the range of between 10,000 and 800,000 Da;

preferably in the range of between 20,000 and 600,000 Da;

more preferably in the range of between 30,000 and 500,000 Da;

even more preferably in the range of between 40,000 and 400,000 Da; and

most preferably in the range of between 50,000 and 300,000 Da.

5. The product according to claim 1, which comprises an inorganic salt of hyaluronic acid, preferably sodium hyaluronate, potassium hyaluronate, ammonium hyaluronate, calcium hyaluronate, magnesium hyaluronate, zinc hyaluronate, or cobalt hyaluronate.

6. The product according to claim 1, which comprises crosslinked hyaluronic acid or salt thereof, preferably the hyaluronic acid is crosslinked with boric acid, and more preferably the crosslinked hyaluronic acid comprises borate esters.

7. The product according to claim 1, which comprises less than 5% moisture, preferably less than 2%, and most preferably less than 1% moisture, as determined herein.

8. The product according to claim 1, which has a particle size the 50 percentile of which, D₅₀, is between 10 and 1,000 microns, preferably between 100 and 1,000 microns, more preferably between 150 and 900 microns, and even more preferably between 200 and 800 microns, as determined by laser diffraction measurement of the particles suspended in isopropanol.

9. The product according to claim 1, which has a dispersibility of less than 30 minutes in an aqueous solvent, preferably less than 20 minutes, more preferably less than 15 minutes, more preferably less than 10 minutes, more preferably less than 5 minutes, more preferably less than 3 minutes, more preferably less than 2 minutes, and most preferably less than 1 minute, as determined herein.

10. The product according to claim 1, which has a solubility of less than 60 minutes in an aqueous solvent, preferably less than 45 minutes, more preferably less than 40 minutes, even more preferably less than 35 minutes, 30 minutes, 25 minutes, 20 minutes, 15 minutes, 10 minutes, and most preferably less than 5 minutes, as determined herein.

16. A pharmaceutical composition comprising an effective amount of a product as defined in claims 1, together with a pharmaceutically acceptable carrier, excipient or diluent.

18. A cosmetic article comprising as an active ingredient an effective amount of a product as defined in claims 1.

19. A sanitary, medical or surgical article comprising a product as defined in claim 1;

preferably the article is a diaper, a sanitary towel, a surgical sponge, a wound healing sponge, or a part comprised in a band aid or other wound dressing material.

20. A medicament capsule or microcapsule comprising a product as defined in claim 1.

41. An ophthamological method of using a product as defined in claim 1.

42. A method of treating osteoarthritis, comprising administering an effective amount of a product as defined in claims 1 to a mammal, preferably the administering is dermal, transdermal, oral, or by injection.

43. A method of treating a wound, comprising administering an effective amount of a product as defined in claims 1 to a mammal.

44. A method of treating hair loss or baldness, comprising administering an effective amount of a product as defined in claims 1 to a mammal, preferably the administering is dermal, transdermal, oral, or by injection.

11-15. -15. (canceled)

17. (canceled)

21. A method of producing a dried and agglomerated product comprising hyaluronic acid or a salt thereof, the method comprising the steps of:

a) drying a product comprising hyaluronic acid or a salt thereof; and

b) agglomerating the dried product.

22-40. -40. (canceled)

45-51. -51. (canceled)