Abstract: An aqueous pharmaceutical composition for intravenous administration that includes dalbavancin or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable buffer having a pH of from about 4.0 to about 8.0. The aqueous composition further includes either or both of a pharmaceutically acceptable divalent salt wherein the divalent salt is distinct from the buffer and/or a pharmaceutically acceptable cyclodextrin. The formulation demonstrates improved long-term stability for storage at room or elevated temperatures. Methods of using the aqueous pharmaceutical composition of dalbavancin to treat skin infections.

Abstract: A liquid pharmaceutical composition for intravenous administration that includes vasopressin or a pharmaceutically acceptable salt thereof. The formulation further includes a lactate buffer or lactic acid, optionally in combination with a pH adjuster. The pharmaceutical composition can have a pH of from about 3.0 to about 4.1 and demonstrates improved stability for long term storage, particularly at room temperature.

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 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 analogue in the polymer solution without affecting the release characteristics of the microspheres prepared therefrom.

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 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 analogue in the polymer solution without affecting the release characteristics of the microspheres prepared therefrom.

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: 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.

Abstract: Antagonistic peptides of GnRH having improved water solubility are disclosed. These peptides are capable of suppressing serum testosterone levels in vivo to chemical castration levels of ?0.5 ng/ml. Stable, filter sterilizable, non-gelling solutions containing the GnRH antagonists at least at levels typically used in sustained release formulations also are disclosed, as is a method of increasing the solubility of GnRH antagonist in a polymer containing dispersed phase, which method comprises addition of an acid to the dispersed phase.

Abstract: Antagonistic peptides of GnRH having improved water solubility are disclosed. These peptides are capable of suppressing serum testosterone levels in vivo to chemical castration levels of ?0.5 ng/ml. Stable, filter sterilizable, non-gelling solutions containing the GnRH antagonists at least at levels typically used in sustained release formulations also are disclosed, as is a method of increasing the solubility of GnRH antagonist in a polymer containing dispersed phase, which method comprises addition of an acid to the dispersed phase.

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 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 analogue 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.