Wound healing compositions based on cyanoacrylates and 5,5-disubstitutedhydantoins, including phenytoin
A monomeric adhesive composition includes a stabilized polymerizable monomer, such as a 1,1-disubstituted monomer, including a cyanoacrylate, and a wound healing agent, wherein the wound healing agent is 5,5-disubstitutedhydantoin, including phenyloin; and a method for making said composition.
1. A monomeric adhesive composition, comprising an alpha cyanoacrylate monomer selected from the group consisting of 2-octyl cyanoacrylate, n-butyl cyanoacrylate, and a mixture that is 80% by weight 2-octyl cyanoacrylate and 20% by weight n-butyl cyanoacrylate, an amount of butylated hydroxyl anisole and sulfur dioxide effective to stabilize the alpha cyanoacrylate monomer, and 0.05% to 0.3% by weight of the composition of phenytoin; wherein the composition is a homogeneous mixture, wherein the composition is packaged in an applicator having an inner layer comprising a nitrile polymer and an outer layer comprising polypropylene or aluminum and sterilized, and wherein the sterilized composition remains in a fluid consistency in the applicator following accelerated aging testing at 80 degrees C.
2. A method of treating tissue comprising applying the adhesive composition of claim 1 to a tissue surface, and allowing said composition to polymerize on said tissue surface.
3. A polymer film formed by polymerizing the composition of claim 1 .
4. The monomeric adhesive composition of claim 1 , further comprising a polymerization accelerator.
5. The monomeric adhesive composition of claim 1 , further comprising a plasticizing agent.
6. The monomeric adhesive composition of claim 1 , further comprising a thickening agent.
7. The monomeric adhesive composition of claim 1 , wherein the composition is sterilized by irradiation.
8. The monomeric adhesive composition of claim 7 , wherein the composition is sterilized by electron beam (E-beams) irradiation.
9. The monomeric adhesive composition of claim 1 , wherein the viscosity of the composition increases between 0% and 40% following sterilization.
10. The monomeric adhesive composition of claim 1 , wherein the composition has a shelf life of at least 24 months.
11. The monomeric adhesive composition of claim 1 , wherein the composition comprises 2-octyl cyanoacrylate and an amount of butylated hydroxyl anisole and sulfur dioxide effective to stabilize the 2-octyl cyanoacrylate, homogenously mixed together with 0.1% to 0.2% by weight of the composition of phenytoin.