Claims
- 1. A lysostaphin intranasal composition comprising a) a viscous formulation and b) at least 0.125% lysostaphin.
- 2. The composition of claim 1, comprising 0.125%-10% lysostaphin.
- 3. The composition of claim 1, wherein the lysostaphin is selected from any wild-type lysostaphin, human or animal lysostaphin, lysostaphin mutant, variant or fragment, synthetic lysostaphin, or recombinantly expressed lysostaphin; wherein the lysostaphin has proteolytic activity against glycine-containing bridges in the cell wall peptidoglycan of staphylococci.
- 4. The composition of claim 1, further comprising at least one antibiotic, antibacterial agent, or staphyolytic enzyme other than lysostaphin.
- 5. The composition of claim 1, further comprising bacitracin.
- 6. The composition of claim 1, further comprising phi11 hydrolase.
- 7. The composition of claim 1, wherein the viscous formulation is a viscous liquid formulation.
- 8. The composition of claim 1, wherein the viscous formulation is a cream formulation.
- 9. The composition of claim 1, comprising a cream base, at least one consistency regulator, at least one emulsifier, and at least one stabilizer.
- 10. The composition of claim 1, comprising at least one of petrolatum, SOFTISAN 649, paraffin, beeswax, MIGLYOL 812, zinc stearate, and aluminum stearate (metal stearate).
- 11. The composition of claim 1, comprising about: 15%-50% MIGLYOL 812, 15%-50% SOFTISAN 649, 15%-50% White Petrolatum, 0%-10% Paraffin, 0%-10% Beeswax, and 0%-5% Aluminum Stearate, and 0%-5% Zinc or aluminum Stearate (metal stearate).
- 12. The composition of claim 1, comprising 36% MIGLYOL 812 (Caprylic/Capric Triglyceride), 24.2% SOFTISAN 649 (Bis-Diglyceryl Polyacyladipate-2), 27.5% white petrolatum, 3.4% paraffin, 3.4% beeswax, and 0.5% zinc or aluminum stearate (metal stearate).
- 13. The composition of claim 1, comprising at least one of polyphosphoesters, polyethylene glycol, and high molecular weight poly (lactic acid), hydroxypropyl cellulose, chitosan, and polystyrene sulfanate.
- 14. The composition of claim 1, comprising at least one microencapsulating agent.
- 15. The composition of claim 1, comprising at least one of polystyrene sulfonate and chitosan.
- 16. The composition of claim 1, comprising about 0.5% polystyrene sulfonate.
- 17. A method for treating a patient comprising, administering to the nose of a human or non-human patient via one or more instillations, an effective amount of a composition comprising a) a viscous formulation and b) at least 0.125% lysostaphin.
- 18. The method of claim 17, wherein the composition is instilled into the patient's nose by any of: swabbing with a finger or applicator; squeezing a tube, syringe, or applicator of the composition into the nares; via aerosol, mist, nasal spray, or nasal drops.
- 19. The method of claim 17, wherein administration results in a beneficial outcome selected from one or more of:
a) no nasal colonization by staphylococci for at least 12 hours after a final instillation of the composition, b) a discernable decrease in the number of staphylococcal colonies in the nares within a time after a final instillation of the composition, wherein said time is selected from within 4 hours, within 12 hours, and within 24 hours after a final instillation, c) a decrease in the frequency of positive cultures taken from the nares within a time after a final instillation of the composition, wherein said time is selected from within 4 hours, within 12 hours, and within 24 hours after a final instillation; d) continued activity of the lysostaphin in the nares for a time after a final instillation of the composition, wherein said time is selected from at least 8 hours, at least 12 hours, at least 12 hours, and at least 48 hours after a final instillation; e) eradication, alleviation, or blockage of colonization of the patient's nares by staphylococci by a single dose of the composition; f) eradication, alleviation, or blockage of colonization of the patient's nares by staphylococci by up to 10 instillations of the composition; g) a blocking or prophylaxis against future staphylococcal colonization in the patient's nares; and h) any discernable reduction in the likelihood of staphylococcal infection in the patient.
- 20. The method of claim 19, wherein the staphylococci are S. aureus.
- 21. The method of claim 17, wherein the composition comprises 0.125%-10% lysostaphin.
- 22. The method of claim 17, wherein the lysostaphin is selected from any wild-type lysostaphin, human or animal lysostaphin, lysostaphin mutant, variant or fragment, synthetic lysostaphin, or recombinantly expressed lysostaphin; wherein the lysostaphin has proteolytic activity against glycine-containing bridges in the cell wall peptidoglycan of staphylococci.
- 23. The method of claim 17, wherein the composition further comprises at least one antibiotic, antibacterial agent, or staphyolytic enzyme other than lysostaphin.
- 24. The method of claim 17, wherein the composition further comprises bacitracin.
- 25. The method of claim 17, wherein the composition further comprises phi11 hydrolase.
- 26. The method of claim 17, wherein the viscous formulation is a viscous liquid formulation.
- 27. The method of claim 17, wherein the viscous formulation is a cream formulation.
- 28. The method of claim 17, wherein the viscous formulation comprises about: 15%-50% MIGLYOL 812, 15%-50% SOFTISAN 649, 15%-50% White Petrolatum, 0%-10% Paraffin, 0%-10% Beeswax, and 0%-5% Aluminum Stearate, and 0%-5% Zinc or aluminum Stearate (metal stearate).
- 29. The method of claim 17, wherein the viscous formulation comprises 36% MIGLYOL 812 (Caprylic/Capric Triglyceride), 24.2% SOFTISAN 649 (Bis-Diglyceryl Polyacyladipate-2), 27.5% white petrolatum, 3.4% paraffin, 3.4% beeswax, and 0.5% zinc or aluminum stearate (metal stearate).
- 30. The method of claim 17, wherein the composition comprises at least one of polyphosphoesters, polyethylene glycol, and high molecular weight poly (lactic acid), hydroxypropyl cellulose, chitosan, and polystyrene sulfanate.
- 31. The method of claim 17, wherein the composition comprises, comprising at least one microencapsulating agent.
- 32. The method of claim 17, wherein the composition comprises at least one of polystyrene sulfonate and chitosan.
- 33. The method of claim 17, wherein the composition comprises about 0.5% polystyrene sulfonate.
- 34. A method for reducing the emergence of lysostaphin resistant bacteria in a population of patients comprising administering the composition of claim 1 to the nares of patients in that population.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is based on and claims the benefit of U.S. Provisional Application S. No. 60/341,802, filed Dec. 21, 2001 (Attorney Docket No. 7787.6009). The entire disclosure of this provisional application is relied upon and incorporated by reference herein.
Provisional Applications (1)
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Number |
Date |
Country |
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60341802 |
Dec 2001 |
US |