Crystalline salts of quinoline compounds and methods for preparing them
First Claim
1. A stable solid pharmaceutical composition comprising a salt of N-ethyl-N-phenyl-1,2-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide, at least one pharmaceutical excipient, and a component which neutralizes protons diffusing from the at least one pharmaceutical excipient.
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Abstract
A stable solid pharmaceutical composition consisting essentially of an effective amount of a crystalline salt of formula (II)
together with an alkaline-reacting component maintaining the pH preferably above 8, or a salt with a divalent metal cation; and
at least one pharmaceutical excipient;
said salt of formula (II) being essentially stable during storage at room temperature for a period of at least 3 years. A process for stabilizing the salt of formula (II).
A crystalline salt of formula (II) and a process for preparing said salt.
26 Citations
20 Claims
- 1. A stable solid pharmaceutical composition comprising a salt of N-ethyl-N-phenyl-1,2-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide, at least one pharmaceutical excipient, and a component which neutralizes protons diffusing from the at least one pharmaceutical excipient.
Specification