Hydrogel composition and methods for making the same

• US 8,507,002 B2
• Filed: 07/25/2008
• Issued: 08/13/2013
• Est. Priority Date: 09/30/2004
• Status: Active Grant

• Current Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Products Incorporated (Johnson & Johnson)
• Inventors: King, Richard S., Grobe, George Lawrence III
• Primary Examiner(s): Sullivan, Daniel
• Assistant Examiner(s): LOVE, TREVOR M
• Application Number:
  US12/180,262
• Publication Number:
  US 20080292706A1
• Time in Patent Office: 1,845 Days
• Field of Search: 424/486
• US Class Current: 424/486
• CPC Class Codes: A61L 15/60 Liquid-swellable gel-forming materials, e.g. super-absorbents
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

The invention provides a hydrogel composition comprising water and a hydrophilic polymer, wherein the hydrogel composition has (a) an ultimate tensile strength of about 10 kPa or more, (b) a compressive strength of about 70 kPa or more, or (c) an ultimate tensile strength of about 10 kPa or more and a compressive strength of about 70 kPa or more. The invention further provides methods for producing a hydrogel composition.

Claims

1. A method for producing a hydrogel composition comprising water and a crosslinked hydrophilic polymer, wherein the hydrogel composition has (a) an ultimate tensile strength of about 10 kPa or more, (b) a compressive strength of about 70 kPa or more, or (c) an ultimate tensile strength of about 10 kPa or more and a compressive strength of about 70 kPa or more, the method comprising the steps of:

(a) providing a compression mold having an internal volume,

(b) providing a hydrogel precursor in powder or pellet form comprising a melt-processable, radiation crosslinkable, hydrophilic polymer which is poly(ethyleneoxide) having an average molecular weight of about 1,000,000 atomic mass units or greater,

(c) filling at least a portion of the internal volume of the compression mold with the precursor,

(d) compressing the precursor contained within the compression mold to form a molded body therefrom,

(e) irradiating at least a portion of the molded body by exposing the molded body to gamma, X-ray, or electron beam radiation the absence of water, to crosslink at least a portion of the hydrophilic polymer contained within the molded body, and

(f) hydrating the irradiated molded body to form a hydrogel composition therefrom;

wherein the hydrogel composition has a water content of at least 75% by weight,

wherein the molded body is hydrated by submerging at least a portion of the molded body in an aqueous solution having a temperature of about 50°

C. to about 90°

C. for about 120 hours to about 220 hours.

2. The method of claim 1, wherein the aqueous solution further comprises an active ingredient selected from the group consisting of a drug, a therapeutic agent, a humectant, and mixtures thereof.

3. A method for producing a hydrogel composition comprising water and a crosslinked hydrophilic polymer, wherein the hydrogel composition has (a) an ultimate tensile strength of about 10 kPa or more, (b) a compressive strength of about 70 kPa or more, or (c) an ultimate tensile strength of about 10 kPa or more and a compressive strength of about 70 kPa or more, the method comprising the steps of:

(a) providing a dispersion comprising a peroxide crosslinking agent,

(b) providing a hydrogel precursor in powder or pellet form comprising a melt-processable, hydrophilic polymer which is poly(ethyleneoxide) having an average molecular weight of about 1,000,000 atomic mass units or greater,

(c) coating at least a portion of the hydrogel precursor with the dispersion,

(d) providing a compression mold having an internal volume,

(e) filling at least a portion of the internal volume of the compression mold with the coated precursor produced in step (c),

(f) compressing the precursor contained within the compression mold to form a molded body therefrom and crosslink in the absence of water at least a portion of the hydrophilic polymer contained within the molded body, and

(g) hydrating the molded body to form a hydrogel composition therefrom;

wherein the hydrogel composition has a water content of at least 75% by weight.

4. The method of claim 3, wherein the peroxide crosslinking agent is benzoyl peroxide.

5. The method of claim 3, wherein the precursor is compressed at a pressure of about 3,800 kPa to about 14,000 kPa during step (f).

6. The method of claim 3, wherein the precursor is heated to a temperature of about 120°

C. to about 140°

C. during step (f).

7. The method of claim 3, wherein the precursor is compressed for about 5 to about 10 minutes during step (f).

8. The method of claim 3, wherein the molded body is hydrated by submerging at least a portion of the molded body in an aqueous solution having a temperature of about 50°

C. to about 90°

C. for about 120 hours to about 220 hours.

9. The method of claim 8, wherein the aqueous solution further comprises an active ingredient selected from the group consisting of a drug, a therapeutic agent, a humectant, and mixtures thereof.

10. The method of claim 3, wherein the hydrogel precursor further comprises an active ingredient selected from the group consisting of a drug, a therapeutic agent, a humectant, and mixtures thereof.

13. The method of claim 3, wherein the hydrogel precursor further comprises a second polymer.

14. The method of claim 3, which further includes incorporating a second polymer into the hydrogel.

11. A method for producing a hydrogel composition comprising water and a crosslinked hydrophilic polymer, wherein the hydrogel composition has (a) an ultimate tensile strength of about 10 kPa or more, (b) a compressive strength of about 70 kPa or more, or (c) an ultimate tensile strength of about 10 kPa or more and a compressive strength of about 70 kPa or more, the method comprising the steps of:

(a) providing a compression mold having an internal volume,

(b) providing a hydrogel precursor in powder or pellet form comprising a melt-processable, radiation crosslinkable, hydrophilic polymer which is poly(ethyleneoxide) having an average molecular weight of about 1,000,000 atomic mass units or greater,

(c) filling at least a portion of the internal volume of the compression mold with the precursor,

(d) compressing the precursor contained within the compression mold to form a molded body therefrom,

(e) irradiating at least a portion of the molded body by exposing the molded body to gamma, X-ray, or electron beam radiation the absence of water, to crosslink at least a portion of the hydrophilic polymer contained within the molded body, and

(f) hydrating the irradiated molded body to form a hydrogel composition therefrom;

wherein the hydrogel composition has a water content of at least 75% by weight,

wherein the hydrogel precursor further comprises a second polymer.

12. A method for producing a hydrogel composition comprising water and a crosslinked hydrophilic polymer, wherein the hydrogel composition has (a) an ultimate tensile strength of about 10 kPa or more, (b) a compressive strength of about 70 kPa or more, or (c) an ultimate tensile strength of about 10 kPa or more and a compressive strength of about 70 kPa or more, the method comprising the steps of:

(a) providing a compression mold having an internal volume,

(b) providing a hydrogel precursor in powder or pellet form comprising a melt-processable, radiation crosslinkable, hydrophilic polymer which is poly(ethyleneoxide) having an average molecular weight of about 1,000,000 atomic mass units or greater,

(c) filling at least a portion of the internal volume of the compression mold with the precursor,

(d) compressing the precursor contained within the compression mold to form a molded body therefrom,

(e) irradiating at least a portion of the molded body by exposing the molded body to gamma, X-ray, or electron beam radiation the absence of water, to crosslink at least a portion of the hydrophilic polymer contained within the molded body,

(f) hydrating the irradiated molded body to form a hydrogel composition therefrom, and

(g) incorporating a second polymer into the hydrogel composition;

wherein the hydrogel composition has a water content of at least 75% by weight.