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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Apr 28, 2015
Grant Date -
Jun 27, 2013
app pub date -
Nov 5, 2012
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 analogs at least at levels typically used in sustained release formulations and a method of increasing solubility of a high level of a GnRH analog or a freeze-dried antgonist 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 analog in the polymer solution without affecting the release characteristics of the microspheres prepared therefrom.
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