Claims for Patent: 9,789,057

Summary for Patent: 9,789,057

Title:	Pharmaceutical delivery system
Abstract:	A pharmaceutical formulation to treat vaginal conditions in a human patient comprises: at least one active agent; a modified release dosage form which provides extended release of the anti-infective agent upon vaginal administration to the patient; and wherein the formulation, when containing a total dose of the anti-infective agent of about 25 .mu.g to about 500 mg based on the active agent will produce a plasma concentration versus time curve (ng/mL versus hours) having an area under the curve (AUC) of less than about 600 ng/mLhr.
Inventor(s):	Riley; Thomas C. (Manchester, MO), Levinson; R. Saul (Chesterfield, MO), Cuca; Robert C. (Glen Carbon, IL), Mariani; Elio (Chesterfield, MO)
Assignee:	Perrigo Pharma International Designated Activity Company (Dublin, IE)
Application Number:	13/555,472
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,789,057
Patent Claims:	1. A pharmaceutical formulation to treat vaginal conditions in a human patient comprising: an effective amount of clindamycin phosphate; and a modified release dosage form which provides modified release of said clindamycin phosphate upon vaginal administration to said patient; wherein said formulation, when containing a total dose of clindamycin phosphate of about 25 .mu.g to about 500 mg based on clindamycin will produce a plasma concentration versus time curve (ng/ml versus hours) having an area under the curve (AUC) of less than about 600 ng/mLhr; and wherein said dosage form comprises: a. an emulsion comprising an external lipoidal phase and an internal non-lipoidal phase wherein said lipoidal phase is continuous and said non-lipoidal phase comprises at least 70% by volume of said emulsion; b. one or more lecithins as primary stabilizing surfactants; and c. one or more auxiliary stabilizing surfactants. 2. The pharmaceutical formulation as recited in claim 1, wherein said clindamycin phosphate is present in an amount of less than about 5% weight/weight based on clindamycin. 3. The pharmaceutical formulation as recited in claim 1 further comprising an antifungal agent. 4. The pharmaceutical formulation as recited in claim 1 further comprising an acid buffered phase. 5. The pharmaceutical formulation as recited in claim 1, wherein said one or more lecithins are selected from the group consisting of lecithin, refined lecithin and mixtures thereof. 6. The pharmaceutical formulation as recited in claim 1 wherein said one or more lecithins contain less than about 96% phosphatidylcholine. 7. The pharmaceutical formulation as recited in claim 1 wherein said one or more lecithins contain about 90% phosphatidylcholine. 8. The pharmaceutical formulation as recited in claim 1, wherein said auxiliary stabilizing surfactants are selected from the group consisting of polyglycerol-3-oleate, glycerol monoisostearate and mixtures thereof. 9. The pharmaceutical formulation as recited in claim 1, wherein said auxiliary stabilizing surfactants are present in said pharmaceutical formulation in amounts of about 2 to 15% weight/weight. 10. The pharmaceutical formulation as recited in claim 1, wherein said one or more lecithins contain not less than about 80% phosphatidylcholine. 11. The pharmaceutical formulation as recited in claim 1, wherein said one or more lecithins contain not less than about 70% phosphatidylcholine. 12. The pharmaceutical formulation as recited in claim 1, wherein the auxiliary stabilizing surfactants comprise polyglycerol-3-oleate and glycerol monoisostearate. 13. The pharmaceutical formulation as recited in claim 12, wherein the polyglycerol-3-oleate and glycerol monoisostearate are each present at a concentration of about 2.7% weight/weight. 14. The pharmaceutical formulation as recited in claim 1, wherein the one or more lecithins are present in an amount of about 1% weight/weight. 15. The pharmaceutical formulation as recited in claim 13, wherein the one or more lecithins are present in an amount of about 1% weight/weight. 16. A method of treating a vaginal infection by administering a therapeutically effective amount of a pharmaceutical formulation to treat said vaginal condition comprising administering to said patient a formulation which accomplishes a biologic endpoint of claim 1; wherein the pharmaceutical formulation comprises an effective amount of clindamycin phosphate and a modified release dosage form comprising: a. an emulsion comprising an external lipoidal phase and an internal non-lipoidal phase wherein said lipoidal phase is continuous and said non-lipoidal phase comprises at least 70% by volume of said emulsion; b. one or more lecithins as primary stabilizing surfactants; and c. one or more auxiliary stabilizing surfactants. 17. A method of stabilizing a clindamycin phosphate formulation by adding one or more lecithins as primary stabilizing surfactants and one or more auxiliary stabilizing surfactants.