METHOD OF PREPARING (+)-1,4-DIHYDRO-7-[(3S,4S)-3-METHOXY-4-(METHYLAMINO)-1-PYRROLIDINYL]-4-OXO-1-(2-THIAZOLYL)-1,8-NAPHTHYRIDINE-3-CARBOXYLIC ACID
Methods of preparing (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid are disclosed. Also provided are pharmaceutical compositions comprising (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid, and methods of treatment using such compositions.
1 - 44 . (canceled)
45 . A single unit dosage form comprising a composition consisting essentially of at least 99.95% (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid and less than 0.05% (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-amino-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid based on total weight of the composition.
46 . The single unit dosage form of claim 45 , wherein the composition is a lyophilized powder.
47 . The single unit dosage form of claim 45 comprising sufficient (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid to permit administration of doses of (+)-1,4-dihydro-7-[(3S,4S)-3-methoxy-4-(methylamino)-1-pyrrolidinyl]-4-oxo-1-(2-thiazolyl)-1,8-naphthyridine-3-carboxylic acid within the range of about 10-100 mg/m 2 .
48 . The single unit dosage form of claim 45 , wherein the dosage form is for intravenous administration.
49 . The single unit dosage form of claim 45 comprising about 1-50 mg of the composition.
50 . The single unit dosage form of claim 49 comprising about 25 mg of the composition.
51 . The single unit dosage form of claim 49 further comprising methanesulfonic acid.
52 . The single unit dosage form of claim 51 further comprising sorbitol.
53 . The single unit dosage form of claim 51 suitable for reconstitution with water to provide a liquid dosage form for intravenous administration.