Process for the preparation of a freeze-dried pharmaceutical composition containing mitomycin C
A process is described for the preparation of freeze-dried pharmaceutical compositions of mitomycin C, which are characterized by high stability and can be rapidly reconstituted to form solutions.
1. Freeze-dried pharmaceutical composition comprising mitomycin C and urea, wherein the composition comprises urea at a concentration of 0.2 to 0.99 grams (g) per gram of composition.
2. Composition according to claim 1 , which comprises urea at a concentration of 0.5 to 0.99 g per gram of composition.
3. Composition according to claim 2 , which comprises urea at a concentration of 0.8 to 0.95 g per gram of composition.
4. Composition according to claim 3 , which comprises urea at a concentration of 0.93 to 0.94 g per gram of composition.
5. The composition according to claim 1 , which comprises the impurities D1, D2 and albomitomycin C in a total quantity of less than 2.0%, wherein the quantity of these impurities is determined according to the impurities process according to Ph Eur 8.0 Mitomycin Monograph January 2008: 1655.
6. The composition according to claim 5 , which comprises the impurities D1, D2 and albomitomycin C in a total quantity of less than 1.0%, wherein the quantity of these impurities is determined according to the impurities process according to Ph Eur 8.0 Mitomycin Monograph January 2008: 1655.
7. The composition according to claim 6 , which comprises the impurities D1, D2 and albomitomycin C in a total quantity of less than 0.6%, wherein the quantity of these impurities is determined according to the impurities process according to Ph Eur 8.0 Mitomycin Monograph January 2008:1655.
8. Freeze-dried pharmaceutical composition comprising mitomycin C, wherein the composition is obtainable by a process comprising freeze-drying a solution of mitomycin C, wherein the solution comprises a mixture of tert.-butanol and water, and wherein the mixture comprises 84 to 95 wt. % tert.-butanol.