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.

Abstract: A process and apparatus for making and formulating microcapsules and microspheres which can easily be maintained aseptic throughout all stages of the production process.

Abstract: A process and apparatus for making and formulating microcapsules and microspheres which can easily be maintained aseptic throughout all stages of the production process.

Abstract: A continuous process for producing microspheres wherein small particle sizes can be obtained without the problem of foaming. A drug and polymer containing dispersed phase is continuously introduced into a high intensity emulsification vessel along with a continuous phase. An emulsion of the dispersed phase is formed in the continuous phase by high intensity mixing effective to quickly solidify the dispersed phase polymer without having to take steps to address foaming.