Drug compound and purification methods thereof
AssigneeOtsuka Pharmaceutical Co., Ltd.
InventorsRajashree Joshi-Hangal, Nipun Davar, Stephen R. Priebe
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Abstract
The invention provides a method of preparing a lyophilized pharmaceutical composition containing a compound described herein or a pharmaceutically-acceptable salt thereof. The process comprises dissolving the compound in a solvent comprising dimethylsulfoxide and optionally one or more co-solvents to form a solution, and then removing the solvent and any co-solvents by a freeze-drying process. Also provided by the invention are lyophilized pharmaceutical compositions and their use in medicine and in particular in the treatment of cancer.
Claims24
A composition comprising:
- a) a compound of the formula:
- or a pharmaceutically acceptable salt thereof,
- wherein the composition comprises at least 95% of the compound of Formula (1);
- and
- b) a nucleotide-based compound that is not a compound of Formula (1), wherein the nucleotide-based compound is a compound of formula (2):
- or a pharmaceutically acceptable salt thereof,
- wherein:
- R1 is 4-amino-2H-1λ2,3,5-triazin-2-one or a carbamide, each of which is independently substituted or unsubstituted;
- each R2 and R3 is independently alkyl, which is substituted or unsubstituted;
- or hydrogen;
- and
- R4 is an acyl group, which is independently substituted or unsubstituted, or hydrogen.
A composition comprising:
- a) a compound of the formula:
- or a pharmaceutically acceptable salt thereof,
- wherein the composition comprises at least 95% of the compound of Formula (1);
- and
- b) a nucleotide-based compound that is not a compound of Formula (1), wherein the nucleotide-based compound is a compound of formula (3):
- or a pharmaceutically acceptable salt thereof, wherein R1 is heteroaryl or a carbamide, each of which is independently substituted or unsubstituted.
A composition comprising:
- a) a compound of the formula:
- or a pharmaceutically acceptable salt thereof,
- wherein the composition comprises at least 95% of the compound of Formula (1);
- and
- b) a nucleotide-based compound that is not a compound of Formula (1), wherein the nucleotide-based compound is a compound of formula (4):
- or a pharmaceutically acceptable salt thereof, wherein R1 is heteroaryl, which is substituted or unsubstituted;
- and R5 is hydroxy or a nucleotide.
Dependencies are inferred from the claim text.