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Details for Patent: 4,725,271

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Details for Patent: 4,725,271

Title: Synthetic resin matrix drug storage and topical drug delivery dressing for veterinary usage
Abstract:A synthetic resin matrix dressing is disclosed consisting essentially of a polymer, such as poly(2-hydroxyethylmethacrylate), referred to as PHEMA, an organic solvent, such as polyethylene glycol (PEG), and a hydrogen bonding plasticizer, such as dimethylsulfoxide (DMSO). The plasticizer regulates the set-up time of the synthetic resin so that the more plasticizer present, the shorter the set-up time. The dressing may be applied to the treatment site in veterninary use in the form of a paste for the in-situ curing or setting thereof, or the dressing may be preformed and then applied to the treatment site. A variety of drug agents may be incorporated in the synthetic resin matrix so as to result in the time released administration of the drug agent to the area of the skin covered by the dressing. A method of treatment using this dressing is also disclosed.
Inventor(s): Korol; Bernard (St. Louis, MO)
Assignee: Enquay Pharmaceutical Associates (Boca Rotan, FL)
Filing Date:Nov 27, 1985
Application Number:06/802,421
Claims:1. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary usage, comprising a particulate, hyrophillic, water swellable polymer, an inert, non-toxic water miscible organic solvent capable of forming a paste with said polymer, and a hydrogen bonding plasticizer selected from the group consisting of dimethylsulfoxide, dimethylphthalate, 2,3-butylene carbonate, dimethylformamide, dimethyltetramethylene sulfone, diethylsulfone, methylene glycolate, methylpropyl sulfone, or butyrolactone, said hydrogen bonding plasticizer mixed with the combined polymer and solvent, with said polymer ranging between about 30%-55% by weight of said dressing, with said solvent ranging between about 20%-60% by weight of said dressing, and with said plasticizer ranging up to about 20% by weight of said dressing.

2. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said polymer is poly(2-hydroxyethylmethacrylate).

3. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 2 wherein said solvent is polyethylene glycol having a molecular weight ranging between about 200-2000.

4. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 3 wherein said plasticizer is dimethylsulfoxide.

5. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said dressing comprises, when said polymer, solvent, and plasticizer are mixed, either a settable paste results which may be spread directly on the treatment site, or a precured dressing which may be stored until use.

6. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 5 wherein said dressing comprises a substrate having a layer of said paste applied to one face thereof.

7. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 6 wherein said substrate is a biaxially stretchable substrate.

8. A synthetic resin matrix dressing incorporating a polymer, a solvent, and a hydrogen bonding plasticizer, and for drug storage and topical drug delivery for veterinary usage as set forth in claim 1 and further comprising a medicament agent, such as an antiviral agent, a germicide, a fungicide, an antimicrobial agent, an antibiotic, an analgesic, a hormone agent, an anti-inflammatory agent, and antihistamine, a cardiovascular agent, an anticonvulsant agent, a pulmonary agent, a muscle relaxant, a growth factor, or a healing enhancer.

9. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 8 wherein said antimicrobial agent is silver sulfadiazine.

10. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 9 wherein said silver sulfadiazine is present in said dressing ranging between about 0.5 to about 7% by weight.

11. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 8 wherein said antimicrobial agent is nitrofurazone.

12. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 11 wherein said nitrofurazone is present in said dressing ranging between about 0.5 to about 10% by weight.

13. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 8 wherein said antimicrobial agent is silver nitrate.

14. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 13 wherein said silver nitrate is present in said dressing ranging between about 0.5 to about 10% by weight.

15. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 8 wherein said antimicrobial agent consists essentially of silver sulfadiazine, nitrofurazone, or silver nitrate with the weight of said antimicrobial agent ranging between about 0.5 to about 10% by weight of said dressing.

16. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 8 wherein said antimicrobial agent is mafenide acetate.

17. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 16 wherein said mafenide acetate is present in said dressing ranging between about 0.5 to about 10% by weight.

18. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said polymer is preferably poly(2-hydroxyethylmethacrylate), said solvent is preferably polyethylene glycol, and said plasticizer is preferably dimethylsulfoxide with the amount of said plasticizer directly controlling the time for the resulting paste to form a substantially non-tacky occlusive film, referred to as set-up time, with the length of the set-up time decreasing as the quantity of the plasticizer increases such that set-up times of less than about 30 seconds or less may be realized when the above-stated maximum quantity of said plasticizer is present, to about 45 minutes when a minimal amount of said plasticizer is present.

19. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said polymer is a polymer of hydroxy(C.sub.2 -C.sub.4 -alkyl)methacrylate, hydroxy(C.sub.2 -C.sub.4 alkyl)acrylate, hydroxy(C.sub.2 -C.sub.4 alkoxyC.sub.2 -C.sub.4 -alkyl)methacrylate, hydroxy(C.sub.2 -C.sub.4 alkoxyC.sub.2 -C.sub.4 alkyl)acrylate, alkoxy(C.sub.2 -C.sub.4 alkoxyC.sub.2 -C.sub.4 alkyl)methacrylate, alkoxy(C.sub.2 -C.sub.4 alkoxyC.sub.2 -C.sub.4 alkyl)acrylate, N-(C.sub.1 -C.sub.4 alkyl)acrylamide, N-(C.sub.1 -C.sub.4 alkyl)methacrylamide, N,N-di(C.sub.1 -C.sub.4 -alkyl)acrylamide, N,N-(di(C.sub.1 -C.sub.4 alkyl)methacrylamide, vicinal-epoxy(C.sub.1 -C.sub.4 alkyl)methacrylate, or vicinal-epoxy(C.sub.1 -C.sub.4 alkyl)acrylate.

20. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 18 wherein said polymer is at least slightly crosslinked and has a molecular weight of at least 50,000.

21. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said plasticizer is a liquid having a solubility parameter ranging between about 10.7 to about 12.6.

22. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 1 wherein said solvent is polyethylene glycol of the general formula H(OCH.sub.2 CH.sub.2).sub.n OH, where n is greater than or equal to 4.

23. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 22 wherein said polyethylene glycol solvent has a molecular weight ranging between about 200-2000, and has a boiling point of about 200.degree. C.

24. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use as set forth in claim 23 wherein said polyethylene glycol even more preferably has a molecular weight ranging between about 200-800.

25. A synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use comprising a polymer of poly(hydroxyethylmethacrylate), a solvent of polyethylene glycol, a plasticizer of dimethylsulfoxide, and a medicinal agent of silver sulfadiazine, nitrofurazone, silver nitrate, or mafenide acetate, wherein said poly(hydroxyethylmethacrylate) ranges between about 30%-55% by weight of said dressing, said polyethylene glycol ranges between about 20%-60% by weight of said dressing, said dimethylsulfoxide ranges up to about 20% by weight of said dressing, and said medicinal agent, or combinations thereof, ranges from between about 0.5% to about 10% by weight of said dressing.

26. A process of treating a topical condition by applying a synthetic resin matrix dressing for drug storage and topical drug delivery for veterinary use to said treatment site, said dressing consisting essentially of a hydrophilic, water swellable polymer, an inert, non-toxic water miscible organic solvent capable of forming a paste with said polymer, and a hydrogen bonding plasticizer, the said polymer ranging between about 30%-55% by weight of said dressing, with said solvent ranging between about 20%-60% by weight of said dressing, and with said plasticizer ranging up to about 20% by weight of said dressing.

27. The process of claim 26 wherein, when said polymer, solvent, and plasticizer are initially mixed, a settable paste results which may be spread directly on the treatment site.

28. The process of claim 27 further comprising applying said paste to an adherent substrate and permitting said paste to cure thereby to form said preformed bandage-type dressing.

29. The process of claim 27 further comprising applying said paste to a non-adherent surface and permitting said paste to cure thereby to form said preformed bandage-type dressing.

30. The process of claim 26 further comprising adding a medicament agent, such as a germicide, a fungicide, an antivirol agent, an antimicrobial agent, an antibiotic, an analgesic, a hormone agent, an anti-inflammatory agent, a cardiovascular agent, an antihistamine, an anticonvulsant agent, a pulmonary agent, a muscle relaxant, a growth factor, or a healing enhancer.

31. The process of claim 26 wherein said plasticizer is from the group of dimethylsulfoxide, dimethylphthalate, 2,3-butylene carbonate, dimethylformamide, dimethyltetramethylene sulfone, diethyl sulfone, methylene glycolate, methyl propyl sulfone or butyrolactone.

32. The process of claim 26 wherein said polymer is poly(2-hydroxyethylmethacrylate).

33. The process of claim 32 wherein said solvent is polyethylene glycol having a molecular weight ranging between about 200-2,000.

34. The process of claim 33 wherein said plasticizer is preferably dimethylsulfoxide.

35. The process of claim 26 wherein the dressing is applied to a topical treatment site.

36. The process of claim 35 wherein the dressing comprises an antimicrobial agent such as silver sulfadiazine, silver nitrate, nitrofurazone, mafenide acetate, or mixtures thereof, said antimicrobial agent ranging up to about 10% by weight of said dressing.
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