Compositions and Methods for Enhancing Reduction of Spore-Forming Microorganisms
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.
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.