PROCESS FOR PRODUCING STABLE PHARMACEUTICAL COMPOSITIONS CONTAINING 3-(HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN-DISODIUM PHOSPHATE ESTER

PROCESS FOR PRODUCING STABLE PHARMACEUTICAL COMPOSITIONS CONTAINING 3-(HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN-DISODIUM PHOSPHATE ESTER

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 degrada...

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Hauptverfasser: SPEICHER,EARL R, ROSENBERG,LEONARD S, HERBRANSON,DALE E
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Sprache:eng
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HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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creator SPEICHER,EARL R
ROSENBERG,LEONARD S
HERBRANSON,DALE E
description 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.
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subjects HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
title PROCESS FOR PRODUCING STABLE PHARMACEUTICAL COMPOSITIONS CONTAINING 3-(HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN-DISODIUM PHOSPHATE ESTER
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