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|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):||Herbranson; Dale E. (Lindenhurst, IL), Speicher; Earl R. (Buffalo Grove, IL), Rosenberg; Leonard S. (Flemington, NJ)|
|Assignee:||E. I. Du Pont de Nemours and Company (Wilmington, DE)|
Patent Claim Types:|
see list of patent claims
|Use; Composition; Formulation; Compound;|
|Country||Document Number||Estimated Expiration||Supplementary Protection Certificate||SPC Country||SPC Expiration|
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