Buffered adhesive compositions for skin-adhering medical products
Provided are buffered adhesive compositions comprising a high molecular weight non-neutralized polymeric acid and a high molecular weight partially neutralized polymeric acid and products such as wound dressings and ostomy skin barriers incorporating the compositions.
1. A composition having a high molecular weight polymeric buffer for a skin-adhering medical device comprising:
a water insoluble adhesive that includes a high molecular weight polymeric acid present in non-neutralized form and a high molecular weight polymeric acid present in partially neutralized form; and
wherein the high molecular weight polymeric acids are dry particles dispersed in the adhesive and are not pectin and provide both pH buffering and fluid absorption;
wherein the extent of fluid absorption and the extent of pH buffering can be independently modified.
2. The composition of claim 1 further comprising:
a hydrocolloid selected from CMC or pectin.
3. The composition of claim 1 , wherein the adhesive is a continuous phase.
4. The composition of claim 3 , wherein the non-neutralized and partially neutralized high molecular weight polymeric acids are a discontinuous phase within the continuous phase.
5. The composition of claim 1 , wherein the non-neutralized high molecular weight polymeric acid and the partially neutralized high molecular weight polymeric acid are each independently selected from the group consisting of polyacrylic acid, poly(2-alkyl acrylic acid), copolymers of acrylic acid and 2-alkyl acrylic acid monomers, copolymers of acrylic acid and 2-alkyl acrylic acid monomers with maleic acid, and olefinic polymers substituted with side chains containing free carboxylic acid groups; wherein alkyl is from one to five carbons in length and may be straight chain or branched chain.
6. The composition of claim 1 , wherein the adhesive is selected from the group consisting of natural rubbers, synthetic rubbers, styrene block copolymers, polyvinyl ethers, poly(meth) acrylates (including both acrylates and methacrylates), polyolefins and silicones.
7. The composition of claim 6 , wherein the adhesive is polyisobutylene.
8. The composition of claim 1 , further comprising styrene-isoprene-styrene block copolymer.
9. The composition of claim 1 , further comprising fibers selected from the group consisting of cotton fibers, polyethylene fibers, and polypropylene fibers.
10. The composition of claim 1 , wherein the high molecular weight polymeric acids are a high molecular weight polyacrylic acid present in partially neutralized form and a high molecular weight polyacrylic acid present in non-neutralized form.
11. The composition of claim 10 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is between about 50% and about 100%.
12. The composition of claim 10 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is about 75%.
13. The composition of claim 10 , wherein the proportion of non-neutralized polyacrylic acid and partially neutralized polyacrylic acid is from about 3:1 to about 1:4.
14. The composition of claim 10 , wherein the non-neutralized polyacrylic acid and partially neutralized polyacrylic acid together comprise from about 10 wt. % to about 25 wt. % of the adhesive composition.
15. The composition of claim 10 , which comprises about 55.5 wt. % polyisobutylene, about 14.5 wt. % styrene-isoprene-styrene block copolymer, about 5 wt. % polyethylene fibers, about 15 wt. % cross linked high molecular weight polyacrylic acid, and about 10 wt. % cross linked 75% neutralized high molecular weight polyacrylic acid.
16. The composition of claim 10 , which comprises about 66 wt. % polyisobutylene, about 6.5 wt.% styrene-isoprene-styrene block copolymer, about 4 wt. % polyethylene fibers, about 14.5 wt. % cross linked high molecular weight polyacrylic acid, and about 9 wt. % cross linked 75% neutralized high molecular weight polyacrylic acid.
17. A wound dressing comprising: a flexible outer layer; and a water insoluble high molecular weight polymeric buffering adhesive composition applied to a side of the flexible outer layer, the composition including a high molecular weight polymeric acid in non-neutralized form and a high molecular weight polymeric acid in partially neutralized form; and
wherein the high molecular weight polymeric acids are dry particles dispersed in the adhesive composition and are not pectin;
wherein the extent of fluid absorption of the composition and the extent of pH buffering of the composition can be independently modified.
18. The wound dressing of claim 17 , further comprising:
a hydrocolloid selected from CMC or pectin.
19. The wound dressing of claim 17 , wherein the non-neutralized high molecular weight polymeric acid and the partially neutralized high molecular weight polymeric acid are each independently selected from the group consisting of polyacrylic acid, poly(2-alkyl acrylic acid), copolymers of acrylic acid and 2-alkyl acrylic acid monomers, copolymers of acrylic acid and 2-alkyl acrylic acid monomers with maleic acid, and olefinic polymers substituted with side chains containing free carboxylic acid groups, wherein alkyl is from one to five carbons in length and may be straight chain or branched chain.
20. The wound dressing of claim 17 , wherein the non-neutralized high molecular weight polymeric acid is high molecular weight polyacrylic acid and the partially neutralized high molecular weight polymeric acid is partially neutralized high molecular weight polyacrylic acid.
21. The wound dressing of claim 20 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is between about 50% and about 100%.
22. The wound dressing of claim 20 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is about 75%.
23. The wound dressing of claim 20 , wherein the proportion of non-neutralized polyacrylic acid and partially neutralized polyacrylic acid is from about 3:1 to about 1:4.
24. The wound dressing of claim 20 , wherein the non-neutralized polyacrylic acid and partially neutralized polyacrylic acid together comprise from about 10 wt. % to about 25 wt. % of the adhesive composition.
25. The wound dressing of claim 20 , wherein the adhesive composition comprises about 55.5 wt. % polyisobutylene, about 14.5 wt. % styrene-isoprene-styrene block copolymer, about 5 wt. % polyethylene fibers, about 15 wt. % cross linked high molecular weight polyacrylic acid, and about 10 wt. % cross linked 75% neutralized high molecular weight polyacrylic acid.
26. The wound dressing of claim 20 , wherein the adhesive composition comprises about 66 wt. % polyisobutylene, about 6.5 wt. % styrene-isoprene-styrene block copolymer, about 4 wt. % polyethylene fibers, about 14.5 wt. % cross linked high molecular weight polyacrylic acid, and about 9 wt. % cross linked 75% neutralized high molecular weight polyacrylic acid.
27. An ostomy skin barrier having a composition comprising a water insoluble adhesive that includes a high molecular weight polymeric buffer, the adhesive having a high molecular weight polymeric acid present in non-neutralized form and a high molecular weight polymeric acid present in partially neutralized form, wherein the high molecular weight polymeric acids are dry particles dispersed in the adhesive and are not pectin;
wherein the extent of fluid absorption of the composition and the extent of pH buffering of the composition can be independently modified.
28. The ostomy skin barrier of claim 27 , wherein the composition further comprises a hydrocolloid selected from CMC or pectin.
29. The ostomy skin barrier of claim 27 , wherein the non-neutralized high molecular weight polymeric acid and the partially neutralized high molecular weight polymeric acid are each independently selected from the group consisting of polyacrylic acid, poly(2-alkyl acrylic acid), copolymers of acrylic acid and 2-alkyl acrylic acid monomers, copolymers of acrylic acid and 2-alkyl acrylic acid monomers with maleic acid, and olefinic polymers substituted with side chains containing free carboxylic acid groups, wherein alkyl is from one to five carbons in length and may be straight chain or branched chain.
30. The ostomy skin barrier of claim 27 , wherein the non-neutralized high molecular weight polymeric acid is high molecular weight polyacrylic acid and the partially neutralized high molecular weight polymeric acid is partially neutralized high molecular weight polyacrylic acid.
31. The ostomy skin barrier of claim 30 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is between about 50% and about 100%.
32. The ostomy skin barrier of claim 30 , wherein the degree of neutralization of the partially neutralized high molecular weight polyacrylic acid is about 75%.
33. The ostomy skin barrier of claim 30 , wherein the proportion of non-neutralized polyacrylic acid and partially neutralized polyacrylic acid is from about 3:1 to about 1:4.
34. The ostomy skin barrier of claim 30 , wherein the non-neutralized polyacrylic acid and partially neutralized polyacrylic acid together comprise from about 10 wt. % to about 25 wt. % of the adhesive composition.
35. The ostomy barrier of claim 30 , wherein the composition comprises about 55.5 wt. % polyisobutylene, about 14.5 wt. % styrene-isoprene-styrene block copolymer, about 5 wt. % polyethylene fibers, about 15 wt.% cross linked high molecular weight polyacrylic acid, and about 10 wt. % cross linked 75% neutralized high molecular weight polyacrylic acid.
36. The ostomy barrier of claim 30 , wherein the composition comprises about 66 wt. % polyisobutylene, about 6.5 wt. % styrene-isoprene-styrene block copolymer, about 4 wt. % polyethylene fibers, about 14.5 wt. % cross linked high molecular weight polyacrylic acid, and about 9 wt.% cross linked 75% neutralized high molecular weight polyacrylic acid.