Merck + Co., Inc.

Jerome P Draper

Michael J Kaufman

David C Dubost

Richard John Varsolona

James A McCauley

Mandana Asgharnejad

Jennifer L Vandrilla

David Storey

Wet granulation formulation of a growth hormone secretagogue

This invention is concerned with polymorphic forms of the compound N-�1(R)-�(1,2-dihydro-1-methanesulfonylspiro�3H-indole-3,4'-piperdin!-1'-y l)carbonyl!-2-(phenylmethyloxy)ethyl!-2-amino-2-methylpropanamide methanesulfonate which is a growth hormone secretagogue that is useful in food animals to promote their growth thereby rendering the production of edible meat products more efficient, and in humans, to treat physiological or medical conditions characterized by a deficiency in growth hormone secretion, and to treat medical conditions which are improved by the anabolic effects of growth hormone. The instant polymorphic forms have advantages over the other known forms of N-�1(R)-�(1,2-dihydro-1-methanesulfonylspiro�3H-indole-3,4'-piperdin!-1'-y l)carbonyl!-2-(phenylmethyloxy)-ethyl!-2-amino-2-methylpropanamide methanesulfonate in terms of thermodynamic stability and suitability for inclusion in pharmaceutical formulations. The present invention is also concerned with processes for preparing these polymorphic forms, pharmaceutical formulations comprising these polymorphic forms as active ingredients and the use of the polymorphic form of the compound and their formulations in the treatment of certain disorders.

Polymorphic forms of a growth hormone secretagogue

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Elkins Park, PA, United States of America

Jerome P Draper