Formulations of growth hormone releasing factor (GRF) molecules with improved stability
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United States of America Patent
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Oct 28, 2014
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app pub date -
Mar 14, 2013
filing date -
Mar 1, 2013
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Abstract
Stabilized solid and liquid pharmaceutical formulations comprising a GRF molecule as active ingredient, such as GRF analogs including those comprising an N-terminal-attached hydrophobic moiety, such as [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises a GRF molecule or a pharmaceutically acceptable salt thereof and a β-cyclodextrin which is not conjugated to the GRF molecule or salt thereof. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it. Methods of stabilizing (e.g., with respect to chemical stability) such GRF molecules, as well as methods of inhibiting their deamidation at Asn8, are also disclosed.
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