Claims for Patent: 9,393,307

Summary for Patent: 9,393,307

Title:	Caspofungin composition
Abstract:	The present invention relates to a composition comprising caspofungin or a pharmaceutical acceptable salt thereof and succinate or lactate as a buffering agent.
Inventor(s):	Shirode; Swapnil P. (Masharashtra, IN), Patel; Piyush (Maharashtra, IN), Gidwani; Suresh (Mumbai, IN), Parikh; Neil (Irvine, CA), Patil; Atul (Maharashtra, IN), Mochnik; Anita Bevetek (Sesvetski Kraljevec, HR)
Assignee:	XELLIA PHARMACEUTICALS APS (Kobenhaven, DK)
Application Number:	14/547,742
Patent Claims:	1. A composition consisting of: a) a pharmaceutically effective amount of an acetate salt of caspofungin; b) a pharmaceutically acceptable amount of one or more pharmaceutically acceptable excipients effective to form a lyophilized cake; and c) a pharmaceutically effective amount of a succinate buffering agent. 2. The composition according to claim 1, wherein the one or more excipients is selected from the group consisting of diluents, antioxidants, and preservatives. 3. The composition according to claim 1, wherein the excipient is selected from the group consisting of sucrose, mannitol; and a combination thereof. 4. The compositing according to claim 1, wherein the composition consists of: a) a pharmaceutically acceptable amount of caspofungin or a pharmaceutically acceptable salt thereof; b) about 10-200 mg/ml of one or more pharmaceutically acceptable excipients effective to form a lyophilized cake; c) a pharmaceutically effective amount of succinate effective to provide a pharmaceutically acceptable pH. 5. The composition according to claim 4, wherein the composition includes an amount of caspofungin or a salt thereof corresponding to about 42 mg/ml caspofungin. 6. The composition according to claim 5, wherein the composition consists of: a) about 46 mg/ml diacetate salt of caspofungin; b) about 30 mg/ml sucrose and about 20 mg/ml mannitol; and c) about 1.5 mg/ml succinate. 7. A process for making a caspofungin composition according to claim 1 comprising the steps of: a) mixing an aqueous solution comprising a pharmaceutically acceptable amount of one or more excipients with a pharmaceutically effective amount of a succinate buffering agent; b) optional adjusting the pH by adding a base to obtain a pharmaceutically acceptable pH; c) adding to the mixture of a) a pharmaceutically acceptable amount of caspofungin or a pharmaceutically acceptable salt thereof; d) optional adjusting the pH by adding a base to obtain a pharmaceutically acceptable pH; e) filtering the solution obtained in d). 8. The process for making a caspofungin composition according to claim 7, wherein step a) is performed by firstly preparing an aqueous solution comprising a pharmaceutically effective amount of a succinate buffering agent; and then adding to said solution of buffering agent a pharmaceutically acceptable amount of one or more excipients dissolved in water. 9. The process for making a caspofungin composition according to claim 7, wherein step a) is performed by firstly dissolving a pharmaceutically acceptable amount of one or more excipients in water; then adding to said solution of excipient(s) a pharmaceutically effective amount of a succinate buffering agent. 10. The process according to claim 7, wherein the pH is adjusted to 5.0-5.7 in step b). 11. The process according to claim 7, wherein the pH is adjusted to about 6 in step d). 12. The process according to claim 7, wherein caspofungin diacetate is added in step c). 13. A lyophilized formulation consisting of a composition which prior to lyophilization corresponds to a composition according to claim 1. 14. The formulation for parenteral administration consisting of a lyophilized formulation according to claim 13, wherein said lyophilized formulation is dissolved in a pharmaceutically acceptable reconstitution solution suitable for parenteral administration to a patient in need thereof. 15. The formulation for parenteral administration according to claim 14, wherein the pharmaceutically acceptable reconstitution solution is selected from the group consisting of distilled water, sterile water, physiologic saline, and bacteriostatic water. 16. A kit comprising a first container comprising the lyophilized formulation according to claim 13 and a second container comprising a parenterally acceptable solvent for reconstitution thereof, and optionally a container comprising means for administrating the reconstituted solution to a patient in need thereof. 17. A method of treating or preventing a fungal infection, comprising parenterally administering to an individual in need thereof a composition according to claim 5. 18. The method according to claim 17, wherein the infection is caused by a fungus belonging to the species Candida or Aspergillus. 19. The method according to claim 18, wherein the infection is caused by a fungus belonging to the species infection is caused by C. albicans, C. tropicalis, C. krusei, C. glabrata, A. fumigatus, A. flavus or A. niger.

Details for Patent 9,393,307

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		2030-09-20