Multipurpose hydrogel compositions and products

• US 20100055153A1
• Filed: 12/03/2008
• Published: 03/04/2010
• Est. Priority Date: 09/03/2008
• Status: Active Grant

• Current Assignee: Transdermal Innovations, Inc.
• Original Assignee: Transdermal Innovations, Inc.
• Inventors: Majmudar, Advait
• Granted Patent: US 8,268,345 B2
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders

Abstract

Disclosed are sterile hydrogel compositions comprising polyvinyl alcohol (“PVA”), polyvinyl pyrrolidone (“PVP”), and a polysaccharide, wherein the combined amount of PVA and PVP present in the hydrogel compositions is from about 2% to about 12% weight by volume, based on the total volume of the composition, and wherein the hydrogel compositions has a gel fraction greater than or equal to 97%. Sterile hydrogel products including such sterile hydrogel compositions, and methods of making such sterile hydrogel compositions and sterile hydrogel products.

Claims

1. A hydrogel composition comprising polyvinyl alcohol (“

PVA”

), polyvinyl pyrrolidone (“

PVP”

), and a polysaccharide, wherein the combined amount of PVA and PVP present in the hydrogel composition is from about 2% to about 12% weight by volume, based on the total volume of the composition, and wherein the hydrogel composition has a gel fraction greater than or equal to about 97%.

2. A hydrogel composition according to claim 1, wherein the hydrogel composition has a gel fraction greater than or equal to about 99%.

3. A hydrogel composition according to claim 1, wherein the PVA is present in an amount of from about 1% to about 5% weight by volume, based on the total volume of the composition.

4. A hydrogel composition according to claim 1, wherein the PVP is present in an amount of from about 1% to about 8% weight by volume, based on the total volume of the composition.

5. A hydrogel composition according to claim 1, wherein the polysaccharide is present in an amount of from about 1% to about 4% weight by volume, based on the total volume of the composition.

6. A hydrogel composition according to claim 1, wherein the polysaccharide is selected from the group consisting of carrageenan, agar-agar, chitosan, starch, maltose, lactose, sucrose, trehalose, palatinose, reducing malt sugar, reducing palatinose, reducing lactose, starch syrup, isomaltooligosaccharides, fructooligosaccharides, milk sugar oligosaccharides, soybean oligosaccharides, xylooligosaccharides, coupling sugar, cyclodextrin compounds, pullulan, pectin, konnyaku mannan, and polydextrose, xanthan gum, and mixtures thereof.

7. A hydrogel composition according to claim 1, wherein the polysaccharide is selected from the group consisting of κ

-carrageenan, agar-agar, chitosan, starch, and mixtures thereof.

8. A hydrogel composition according to claim 1 further comprising an additional hydrophilic polymer.

9. A hydrogel composition according to claim 8, wherein the additional hydrophilic polymer is selected from the group consisting of polyacrylic acid, acryl amide, polyacryl amide, polyethylene oxide, carbopol, and mixtures thereof.

10. A hydrogel composition according to claim 1 further comprising an additive selected from the group consisting of preservatives, drugs and active agents, antibiotics, antifungals, humectants, gelling agents, antioxidants, water-sorption enhancing agents, compositions that produce a gas upon irradiation, free-radical producing agents, and mixtures thereof.

11. A hydrogel composition according to claim 10, wherein the preservative is selected from the group consisting of parabens, sorbates, benzoates, and mixtures thereof.

12. A hydrogel composition according to claim 10, wherein the humectant is selected from the group consisting of polyethylene glycol, ptopylene glycol, glycerols, and mixtures thereof.

13. A hydrogel composition according to claim 1 having a mechanical strength greater than about 400 grams/square centimeter.

14. A hydrogel composition according to claim 1 having a mechanical strength greater than about 700 grams/square centimeter.

15. A hydrogel product comprising a hydrogel composition according to claim 1 affixed to a backing material.

16. A hydrogel product according to claim 15, wherein the backing material is selected from the group consisting of cloth, fabric, tape, foam, plastic, paper, or combinations thereof.

17. A hydrogel product according to claim 15, wherein the hydrogel product is selected from the group consisting of cosmetic products, burn treatment products, fire blankets, absorbent sponges, drug or active agent delivery products, bandages, and wound dressings.

18. A hydrogel composition according to claim 1, comprising:

a) from about 2% to about 4% weight by volume of PVA, based on the total volume of the composition;

b) from about 3% to about 5% weight by volume of PVP, based on the total volume of the composition;

c) from about 1% to about 4% weight by volume, based on the total volume of the composition, of κ

-carrageenan, agar-agar, or a combination thereof; and

d) optionally, from about 0.04% to about 0.6% weight by volume, based on the total volume of the composition, of methylparaben, propylparaben, or a mixture thereof.

19. A hydrogel composition according to claim 18, comprising about 3% weight by volume of PVA, about 4% weight by volume of PVP, and about 1.5% weight by volume of κ

-carrageenan, agar-agar, or a combination thereof.

20. A method of making a hydrogel composition comprising:

a) forming a solution by dissolving;

i) polyvinyl alcohol (“

PVA”

),

ii) polyvinyl pyrrolidone (“

PVP”

),

iii) a polysaccharide, and

iv) optionally, a preservative

in water;

b) setting the solution to form a thermoreversible gel matrix;

c) crosslinking the thermoreversible gel matrix to produce a hydrogel composition,

wherein the combined amount of PVA and PVP present in the hydrogel composition is from about 2% to about 12% weight by volume, based on the total volume of the composition, and

wherein the hydrogel composition has a gel fraction greater than or equal to about 97%.

21. A method according to claim 20, wherein the setting step b) comprises:

b1) heating the solution to an elevated temperature; and

b2) cooling the solution to a temperature at or below room temperature to form a thermoreversible gel matrix.

22. A method according to claim 20, wherein the crosslinking step c) comprises irradiating the thermoreversible gel matrix with ionizing radiation at a dose of from about 15 kGy to about 65 kGy to form a sterile hydrogel composition.

23. A method according to claim 22, further comprising applying a backing material to the solution or thermoreversible gel matrix before irradiation or to the hydrogel after irradiation to form a sterile hydrogel product.

24. A method according to claim 22, further comprising sealing the set thermoreversible gel matrix within an airtight container prior to irradiation, wherein irradiating the set thermoreversible gel matrix sealed in the airtight container results in a sterile hydrogel composition that remains sterile until the sealed, airtight container is breached.

25. A method according to claim 20, further comprising introducing an additive into the solution or thermoreversible gel matrix before or during crosslinking.

26. A method according to claim 20, wherein the crosslinking step c) comprises:

c1) irradiating the thermoreversible gel matrix with ionizing radiation at a dose of from about 5 kGy to about 15 kGy to form a partially crosslinked thermoreversible gel matrix; and

c2) irradiating the partially crosslinked thermoreversible gel matrix with ionizing radiation at a dose of from about 10 kGy to about 60 kGy to sterilize and completely crosslink the thermoreversible gel matrix; and

further comprising introducing an additive into the partially crosslinked thermoreversible gel matrix produced by irradiating step c1) before irradiating step c2) to form a sterile hydrogel composition containing the additive.

28. A method according to claim 20, wherein the amount of PVA is about 3% weight by volume, the amount of PVP is about 4% weight by volume, and the amount of κ

-carrageenan, agar-agar, or combination thereof is about 1.5% weight by volume.

30. A hydrogel composition made by the method of claim 20.

27. A method of making a sterile hydrogel composition comprising:

a) forming a solution by mixing;

i) from about 2% to about 4% weight by volume of polyvinyl alcohol (“

PVA”

), based on the total volume of the composition,

ii) from about 3% to about 5% weight by volume of polyvinyl pyrrolidone (“

PVP”

), based on the total volume of the composition,

iii) from about 1% to about 4% weight by volume, based on the total volume of the composition, of κ

-carrageenan, agar-agar, or a combination thereof, and

iv) optionally, from about 0.04% to about 0.6% weight by volume, based on the total volume of the composition, of methylparaben, propylparaben, or a mixture thereof;

into water;

b) heating the solution to about 90°

C. for about 1 to about 10 minutes;

c) pouring the solution into a mold;

d) cooling the solution in the mold to about 15°

C. to about 25°

C. to form a thermoreversible gel matrix;

e) optionally, removing the thermoreversible gel matrix from the mold;

f) sealing the thermoreversible gel matrix in an airtight container; and

g) irradiating the thermoreversible gel matrix in the sealed container with ionizing radiation at a dose of about 25 kGy,

to produce a sterile hydrogel composition that remains sterile until the sealed, airtight container is breached, wherein the sterile hydrogel composition has a gel fraction greater than or equal to about 95%.

29. A method according to claim 27, wherein the sterile hydrogel composition has a gel fraction greater than or equal to about 99%.

31. A sterile hydrogel composition made by the method of claim 27.