Claims for Patent: 10,010,537

Summary for Patent: 10,010,537

Title:	Clevidipine emulsion formulations containing antimicrobial agents
Abstract:	Pharmaceutical formulations comprising clevidipine and an antimicrobial agent exhibit a reduced propensity for microbial growth and provide increased convenience to health care workers administering clevidipine-containing formulations to patients.
Inventor(s):	Motheram; Rajeshwar (Randolph, NJ), Williams; Gregory Charles (Bernardsville, NJ)
Assignee:	Chiesi Farmaceutici S.p.A. (Parma, IT)
Application Number:	13/270,004
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,010,537
Patent Claims:	1. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) soybean oil, present at about 4 to about 30% w/v, (d) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (e) glycerin, present at about 2 to about 3% w/v, and (f) water up to 100%. 2. The pharmaceutical formulation of claim 1, wherein the formulation has a pH of about 6 to about 8.8. 3. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) soybean oil, present at about 4 to about 30% w/v, (d) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (e) sodium citrate, present at about 0.005 to about 0.5% w/v, (f) glycerin, present at about 2 to about 3% w/v, and (g) water to 100% w/v. 4. The pharmaceutical formulation of claim 3, wherein the formulation has a pH of about 6 to about 8.8. 5. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) soybean oil, present at about 4 to about 30% w/v, (d) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (e) sodium ascorbate, present at about 0.01 to about 1% w/v, (f) glycerin, present at about 2 to about 3% w/v, and (g) water, to 100%% w/v. 6. The pharmaceutical formulation of claim 5, wherein the formulation has a pH of about 6 to about 8.8. 7. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) oleic acid, present at about 0.01 to about 2.0% w/v, (d) soybean oil, present at about 4 to about 30% w/v, (e) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (f) glycerin, present at about 2 to about 3% w/v, and (g) water, up to 100% w/v. 8. The pharmaceutical formulation of claim 7, wherein the formulation has a pH of about 6 to about 8.8. 9. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) oleic acid, present at about 0.01 to about 2.0% w/v, (d) soybean oil, present at about 4 to about 30% w/v, (e) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (f) sodium citrate, present at about 0.005 to about 0.5% w/v, (g) glycerin, present at about 2 to about 3% w/v, and (h) water, up to 100% w/v. 10. The pharmaceutical formulation of claim 9, wherein the formulation has a pH of about 6 to about 8.8. 11. A pharmaceutical formulation comprising, (a) clevidipine butyrate, present at about 0.01 to about 1% w/v, (b) EDTA, present at about 0.001 to about 0.1% w/v, (c) oleic acid, present t about 0.01 to about 2% w/v, (d) soybean oil, present at about 4 to about 30% w/v, (e) purified egg yolk phospholipids, present at about 0.2 to about 2% w/v, (f) sodium ascorbate, present at about 0.05 to about 1.0% w/v, (g) glycerin, present at about 2 to about 3% w/v, and (h) water, up to 100%. 12. The pharmaceutical formulation of claim 11, wherein the formulation has a pH of about 6 to about 8.5.