Claims for Patent: 10,357,535

Summary for Patent: 10,357,535

Title:	Daptomycin formulations and uses thereof
Abstract:	Lyophilized daptomycin formulations having improved reconstitution times are provided. The lyophilized daptomycin formulations include an additive, which can be a pharmaceutically acceptable antioxidant, a pharmaceutically acceptable organic acid or a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable glucose derivative or a pharmaceutically acceptable salt thereof, or a combination thereof. Also provided are methods of methods of preparing the lyophilized daptomycin formulations, and methods of treating bacterial infections and treating or preventing biofilms by using the lyophilized daptomycin formulations.
Inventor(s):	Alexiou; Jim (Oakleigh East, AU), Knill; Andrew Malcolm (Bittern, AU), Norris; Noel (Victoria, AU), Whittaker; Darryl (Vermont, AU)
Assignee:	Hospira Australia Pty Ltd (Victoria, AU)
Application Number:	15/903,764
Patent Claims:	1. A lyophilized daptomycin formulation comprising from about 200 mg to about 600 mg of daptomycin and citric acid, wherein the amount of citric acid in the lyophilized formulation is such that when the formulation is reconstituted with from 5 mL to 15 mL of a pharmaceutically acceptable diluent, the citric acid is from 10 mM to 500 mM in the reconstituted formulation. 2. A lyophilized daptomycin formulation according to claim 1, wherein the amount of citric acid in the lyophilized formulation is such that when the formulation is reconstituted with from 5 mL to 15 mL of a pharmaceutically acceptable diluent, the citric acid is from 25 mM to 75 mM in the reconstituted formulation. 3. A reconstituted daptomycin formulation comprising the lyophilized daptomycin formulation of claim 1 and a pharmaceutically acceptable diluent. 4. A reconstituted daptomycin formulation according to claim 3, wherein the volume of the pharmaceutically acceptable diluent is from about 5 mL to about 15 mL. 5. A reconstituted daptomycin formulation according to claim 3, wherein the pH of the reconstituted formulation is from about 4.0 to about 5.0. 6. A reconstituted daptomycin formulation according to claim 4, wherein the pH of the reconstituted formulation is from about 4.0 to about 5.0. 7. A reconstituted daptomycin formulation according to claim 3, wherein the diluent is selected from the group consisting of sterile water for injection, bacteriostatic water for injection, 0.45% sodium chloride solution for injection, 0.9% sodium chloride solution for injection, Ringer's solution, lactated Ringer's solution, and combinations thereof. 8. A reconstituted daptomycin formulation according to claim 7, wherein the diluent is sterile water for injection or 0.9% sterile sodium chloride solution for injection. 9. A reconstituted daptomycin formulation according to claim 3, wherein the concentration of citric acid in the reconstituted daptomycin formulation is from about 25 mM to about 75 mM. 10. A lyophilized daptomycin formulation comprising citric acid and about 500 mg of daptomycin, wherein the amount of citric acid in the lyophilized formulation is such that when the formulation is reconstituted with from 5 mL to 15 mL of a pharmaceutically acceptable diluent, the citric acid is from 25 mM to 75 mM in the reconstituted formulation. 11. A lyophilized daptomycin formulation comprising citric acid and about 350 mg of daptomycin, wherein the amount of citric acid in the lyophilized formulation is such that when the formulation is reconstituted with from 5 mL to 15 mL of a pharmaceutically acceptable diluent, the citric acid is from 25 mM to 75 mM in the reconstituted formulation. 12. A method of treating a bacterial infection in a subject in need thereof comprising a) obtaining a lyophilized daptomycin formulation according to claim 1, b) reconstituting the lyophilized daptomycin formulation with a pharmaceutically acceptable diluent to obtain a reconstituted daptomycin formulation, and c) administering to said subject an effective amount of the reconstituted daptomycin formulation of (b). 13. A method of treating a biofilm comprising a) obtaining a lyophilized daptomycin formulation according to claim 1, b) reconstituting the lyophilized daptomycin formulation with a pharmaceutically acceptable diluent to obtain a reconstituted daptomycin formulation, and c) exposing a surface of a device to a solution of an effective amount of the reconstituted daptomycin formulation of (b).

Details for Patent 10,357,535

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2032-09-11