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Last Updated: December 12, 2025

Claims for Patent: 4,925,860

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Summary for Patent: 4,925,860

Title:	Stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester
Abstract:	Described is a stable pharmaceutical composition of 3-(hydroxymethyl-5,5-diphenylhydantoin disodium phosphate ester, the prodrug of 5,5-diphenylhydantoin (phenytoin) a commonly used drug for the treatment and management of epilepsy and other types of convulsive states. It has been found that degradation of the prodrug to phenytoin can be controlled by controlling the pH of the composition. Controlling the pH to between 8.3 to 9.4 results in the production of diphenylglycinamide as the primary degradant and minimization of degradation to phenytoin. If the pH is maintained at a lower or higher value, then the degradation pattern changes, with earlier than expected product failure.
Inventor(s):	Dale E. Herbranson, Earl R. Speicher, Leonard S. Rosenberg
Assignee:	Bristol Myers Squibb Pharma Co
Application Number:	US07/356,948
Patent Claims:

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