Claims for Patent: 7,829,577

Summary for Patent: 7,829,577

Title:	Pharmaceutical compositions of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrolidinyl]-4-oxo- -1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid
Abstract:	The present invention relates to SNS-595 and methods of treating cancer using the same.
Inventor(s):	Higaki; Masaru (Osaka, JP), Nakao; Satoshi (Osaka, JP)
Assignee:	Dainippon Sumitomo Pharma Co., Ltd. (JP) Sunesis Pharmaceuticals, Inc. (So. San Francisco, CA)
Application Number:	11/478,765
Patent Claims:	1. A pharmaceutical composition comprising (+)-1,4-dihydro -7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazoly- l)-1,8-naphthyridine-3-carboxylic acid and methanesulfonic acid, wherein the pH of the composition is 2-3.5when measured in an aqueous solution in which the (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolid- inyl]-4-oxo-1-(2-thiazolyl) -1,8-naphthyridine-3-carboxylic acid is present in an amount of 10 mg per mL. 2. The pharmaceutical composition of claim 1 further comprising water. 3. The pharmaceutical composition of claim 1, wherein the pH of the composition is 2.3-2.7 when measured in aqueous solution. 4. The pharmaceutical composition of claim 1 further comprising a tonicity agent. 5. The pharmaceutical composition of claim 4, wherein the tonicity agent is selected from the group consisting of amino acids, electrolytes, monosaccharides, disaccharides, and hexahydric alcohols. 6. The pharmaceutical composition of claim 5, wherein the tonicity agent comprises sorbitol. 7. The pharmaceutical composition of claim 2, wherein (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid is present in an amount of 10 mg/mL. 8. The pharmaceutical composition of claim 2 further comprising sorbitol in an amount of 45 mg per ml. 9. The pharmaceutical composition of claim 1, wherein the pH of the composition is about 2.5 when measured in aqueous solution. 10. A powder comprising the composition of claim 1. 11. An aqueous pharmaceutical composition comprising about 100 mg of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid per 10 mL of the composition, about 450 mg of sorbitol per 10 mL of the composition and methanesulfonic acid, wherein the pH of the composition is about 2.3 to about 2.7. 12. The pharmaceutical composition of claim 2, wherein the composition comprises about 100 mg of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid and about 450 mg of sorbitol per 10 mL of the composition. 13. The pharmaceutical composition of claim 11, wherein the pH is about 2.5. 14. A lyophilized powder comprising the composition of claim 1. 15. A lyophilized powder comprising (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid and methanesulfonic acid, wherein the lyophilized powder is suitable for reconstitution in sterile water to obtain a composition at pH 2-3.5 when measured in an aqueous solution in which the (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid is present in an amount of 10 mg per mL. 16. A method of treating cancer comprising administering the composition of claim 1 to a patient in need of treatment of cancer. 17. A method of treating cancer comprising administering the composition of claim 14 to a patient in need of treatment of cancer. 18. An aqueous pharmaceutical composition comprising about 10 mg/mL of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, about 45 mg/mL of sorbitol, and sufficient methanesulfonic acid to render the pH of the composition about 2.3 to about 2.7. 19. An aqueous pharmaceutical composition comprising about 10 mg/mL of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, about 45 mg/mL of sorbitol, and sufficient methanesulfonic acid to render the pH of the composition about 2.5. 20. The pharmaceutical composition of claim 1, wherein the pH of the composition is 2-3 when measured in aqueous solution. 21. An aqueous pharmaceutical composition comprising about 100 mg of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid per 10 mL of the composition, about 450 mg of sorbitol per 10 mL of the composition, and methanesulfonic acid, wherein the pH of the composition is about 2-3.5. 22. A product formed by the process of contacting about 100 mg of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid per 10 mL of the product, about 450 mg of sorbitol per 10 mL of the product and methanesulfonic acid, wherein the pH of the product is about 2.3 to about 2.7. 23. A product formed by the process of contacting about 10 mg/mL of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, about 45 mg/mL of sorbitol, and sufficient methanesulfonic acid to render the pH of the product about 2.3 to about 2.7. 24. An aqueous pharmaceutical composition comprising about 10 mg/mL of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, about 45 mg/mL of sorbitol, and sufficient methanesulfonic acid to render the pH of the composition about 2.5. 25. The pharmaceutical composition of claim 1 formulated for intravenous administration. 26. An aqueous pharmaceutical composition comprising (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, and methanesulfonic acid, wherein the pH of the composition is 2-3.5. 27. An aqueous pharmaceutical composition comprising (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-ox- o-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, and methanesulfonic acid, wherein the pH of the composition is 2.3-2.7. 28. A method of treating cancer comprising administering the composition of claim 11 to a patient in need of treatment of cancer.

Details for Patent 7,829,577

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		2024-03-15