Methods of using ophthalmic compositions comprising povidone-iodine
View Patent ↗A topical ophthalmic composition comprised of povidone-iodine 0.01% to 10.0% combined with a steroid or non-steroidal anti-inflammatory drug. This solution is useful in the treatment of active infections of at least one tissue of the eye (e.g., conjunctiva and cornea) from bacterial, mycobacterial, viral, fungal, or amoebic causes, as well as treatment to prevent such infections in appropriate clinical settings (e.g. corneal abrasion, postoperative prophylaxis, post-LASIK/LASEK prophylaxis). Additionally the solution is effective in the prevention of infection and inflammation in the post-operative ophthalmic patient.
1. A composition comprising a mixture of
a) povidone-iodine in a concentration between 0.1% and 4.5% by weight, and
b) a steroid at a concentration of between 0.01 and 10% by weight, wherein the steroid is dexamethasone, and wherein, after a period of one month after mixing the steroid and povidone-iodine to form the composition, the steroid concentration is at least 90% by weight of the steroid starting concentration.
2. The composition of claim 1 , wherein said povidone-iodine is between 0.1% and 2.5% by weight.
3. The composition of claim 1 , wherein said povidone-iodine is between 0.5% and 2% by weight.
4. The composition of claim 1 , wherein said steroid is at a concentration of between 0.05 and 2% by weight.
5. The composition of claim 1 , wherein said composition further comprises an antimicrobial preservative.
6. The composition of claim 5 , wherein said antimicrobial preservative is selected from the group consisting of benzalkonium chloride, thimerosal, chlorobutanol, methyl paraben, propylparaben, phenyl ethyl alcohol, EDTA, sorbic acid, polyquarternium 1 and a combination thereof.
7. The composition of claim 5 , wherein said antimicrobial preservative is at a concentration of about 0.001% to 1.0% by weight in said composition.
8. The composition of claim 1 , wherein said composition further comprises a co-solvent/surfactant.
9. The composition of claim 8 , wherein said co-solvent/surfactant is selected from the group consisting of polysorbate 20, polysorbate 60, polysorbate 80, Pluronic F-68, Pluronic F-84, Pluronic P-103, cyclodextrin, tyloxapol and a combination thereof.
10. The composition of claim 8 , wherein said co-solvent/surfactant is at a concentration of about 0.01% to 2% by weight in said composition.
11. The composition of claim 1 , wherein said composition further comprises a viscosity increasing agent.
12. The composition of claim 11 , wherein said viscosity increasing agent is selected from the group consisting of polyvinyl alcohol, polyvinylpyrrolidone, methyl cellulose, hydroxy propyl methylcellulose, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxy propyl cellulose, and a combination thereof.
13. The composition of claim 11 , wherein said viscosity increasing agent is at a concentration of about 0.01% to 2% by weight in said composition.
14. The composition of claim 1 , wherein said composition is in the form of a solution, suspension, emulsion, ointment, cream, gel, or a controlled-release/sustainrelease vehicle.
15. The composition of claim 1 , comprising: 0.5 to 2% (w/w) polyvinylpyrrolidinone-iodine complex; 0.05 to 2% (w/w) steroid; 0.005% to 0.02% (w/w) EDTA; 0.01 to 0.5% (w/w) sodium chloride; 0.02 to 0.1% (w/w) tyloxapol; 0.5% to 2% (w/w) sodium sulfate; and 0.1 to 0.5% (w/w) hydroxyethylcellulose.
16. The composition of claim 1 , comprising: 1.0% (w/w) polyvinylpyrrolidinone-iodine complex; 0.1% (w/w) steroid; 0.01% (w/w) EDTA; 0.3% (w/w) sodium chloride salt; 0.05% (w/w) tyloxapol; 1.2% (w/w) sodium sulfate; and 0.25% (w/w) hydroxyethylcellulose.
17. The composition of claim 1 , wherein said composition retains 90% by weight of its polyvinylpyrrolidinone-iodine and 90% by weight of its steroid after a period of 3 months in a lighted environment.
18. The composition of claim 1 , wherein said composition retains 90% by weight of its polyvinylpyrrolidinone-iodine and 90% by weight of its steroid after a period of 1 year in a lighted environment.
19. The composition of claim 1 , wherein said composition is an aqueous solution.