Hydrolysis in Pharmaceutical Formulations

Kenneth C. Waterman Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Roger C. Adami Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Karen M. Alsante Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Amy S. Antipas Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Dan R. Arenson Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Rebecca Carrier Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Jinyang Hong Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Margaret S. Landis Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Franco Lombardo Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Jaymin C. Shah Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Evgenyi Shalaev Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Scott W. Smith Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

Hai Wang Pfizer Global Research and Development, Eastern Point Road, Groton, CT, 06340, U.S.A.

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Abstract

This literature review presents hydrolysis of active pharmaceutical ingredients as well as the effects on dosage form stability due to hydrolysis of excipients. Mechanisms and measurement methods are discussed and recommendations for formulation stabilization are listed.

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Hydrolysis in Pharmaceutical Formulations

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Hydrolysis in Pharmaceutical Formulations

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