Compositions and Methods for Enhancing Reduction of Spore-Forming Microorganisms

• US 20110319502A1
• Filed: 05/26/2011
• Published: 12/29/2011
• Est. Priority Date: 06/25/2010
• Status: Abandoned Application

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Coffey, Martin J., Shawer, Mohannad
• Application Number:
  US13/116,100
• Publication Number:
  US 20110319502A1
• Time in Patent Office: Days
• US Class Current: 514/777
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/7004 Monosaccharides having only carbon, hydrogen and oxygen atoms
• CPC Class Codes: A61K 31/7016 Disaccharides, e.g. lactose, lactulose lactobionic acid A61K31/7032
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics

Abstract

A pharmaceutical formulation comprises a pharmaceutically acceptable preservative and a material selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof, wherein the formulation has enhanced preservative efficacy against spore-forming microorganisms. The formulation can further comprise boric acid and/or phosphate. A method for enhancing the preservative efficacy of a pharmaceutical formulation against spore-forming microorganisms, comprising adding a pharmaceutically acceptable preservative, and a material selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof, to the pharmaceutical formulation. The formulation optionally includes an active agent for treating or controlling a disease or disorder of the eye. The formulation may be used to treat, clean, disinfect, store, wet, or rewet contact lenses.

Claims

1. A pharmaceutical formulation comprising a pharmaceutically acceptable preservative and a preservative efficacy-enhancing material selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof, wherein the formulation has enhanced preservative efficacy against a spore-forming microorganism, and wherein the pharmaceutically acceptable preservative is present in an amount that does not result in irritation or discomfort to an average user.

2. The pharmaceutical formulation of claim 1, wherein the pharmaceutically acceptable preservative is present in an amount that alone does not provide a EP-A preservative efficacy criteria.

3. The pharmaceutical formulation of claim 1, wherein said pharmaceutical formulation further comprises boric acid or borate buffer.

4. The pharmaceutical formulation of claim 2, wherein said pharmaceutical formulation further comprises boric acid or borate buffer.

5. The pharmaceutical formulation of claim 3, wherein said pharmaceutical formulation further comprises a phosphate.

6. The pharmaceutical formulation of claim 4, wherein said pharmaceutical formulation further comprises a phosphate.

7. The pharmaceutical formulation of claim 1, further comprising a therapeutic agent.

8. The pharmaceutical formulation of claim 6, further comprising a therapeutic agent.

9. The pharmaceutical formulation of claim 1, wherein the formulation comprises a solution, a suspension, an emulsion, a dispersion, an ointment, or a cream.

10. The pharmaceutical formulation of claim 8, wherein the formulation comprises a solution or a suspension.

11. The pharmaceutical formulation of claim 8, wherein the formulation comprises an aqueous solution.

12. A method for enhancing the preservative efficacy of a pharmaceutical formulation against a spore-forming microorganism, comprising adding a pharmaceutically acceptable preservative, and a preservative efficacy-enhancing material selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof, to the pharmaceutical formulation.

13. The method of claim 12, further comprising adding boric acid or borate buffer to the pharmaceutical formulation.

14. The method of claim 13, further comprising adding phosphate to the pharmaceutical formulation.

15. The method of claim 12, wherein the preservative efficacy-enhancing material is selected from the group consisting of D-glucose, sucrose, and combinations thereof.

16. The method of claim 12, wherein the preservative efficacy-enhancing material comprises D-glucose.

17. The method of claim 12, wherein the preservative efficacy-enhancing material comprises sucrose.

18. The method of claim 12, wherein the formulation meets the EP-A preservative efficacy criteria.

19. The method of claim 12, wherein the formulation meets the EP-A preservative efficacy criteria.

20. The method of claim 12, wherein the formulation meets the EP-A preservative efficacy criteria, wherein the spore-forming microorganism is A. brasiliensis.