Prevention of molecular weight reduction of the polymer, impurity formation and gelling in polymer compositions
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United States of America Patent
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Jan 1, 2013
Grant Date -
Feb 24, 2005
app pub date -
Jul 19, 2004
filing date -
Jul 18, 2003
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Abstract
Polymer and drug containing compositions and method of preparing such compositions are disclosed. The dispersed phase formulation has a polymer, a pharmaceutically or biologically active agent and a small fraction of low pKa acid additive. Stable, filter sterilizable, non-gelling solutions containing GnRH analogues at least at levels typically used in sustained release formulations and a method of increasing solubility of a high level of a GnRH analogue or a freeze-dried antagonist of GnRH in a polymer containing solution are also disclosed. The amount of the acid additive in the polymer solution is such that it is sufficient to increase the solubility of the high level of the GnRH analogue in the polymer solution without affecting the release characteristics of the microspheres prepared therefrom.
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