Abstract: Formulations and methods are provided for improving the stability upon exposure to aqueous media of polypeptides present in non-aqueous suspension vehicles. In particular aspects of the invention, formulations are provided that comprise a complex of a metal ion and a polypeptide suspended in a non-aqueous, biocompatible suspension vehicle. Aggregation of individual polypeptide molecules is reduced when aqueous media is introduced to such formulations, serving to stabilize the polypeptide.

Abstract: A suspension formulation of interferon includes a non-aqueous, single-phase vehicle including at least one polymer and at least one solvent, the vehicle exhibiting viscous fluid characteristics, and an interferon contained in a particle formulation dispersed in the vehicle. The particle formulation includes a stabilizing component comprising one or more stabilizers selected from the group consisting of carbohydrates, antioxidants, and amino acids. The suspension formulation is characterized in that less than 10% of the interferon degrades over 3 months under an accelerated storage condition.

Abstract: An implantable device includes a reservoir containing a suspension of an interferon in an amount sufficient to provide continuous delivery of the interferon at a therapeutically effective rate of 1 ng/day to 600 ?g/day to maintain and achieve therapeutic blood or plasma levels of the interferon throughout a substantial period of the administration period.

Abstract: Liquid polyoxaester polymer materials are provided as suspending vehicles suitable for dispensing of pharmaceutically active agents, such as proteins, from delivery devices, for example, pump-driven dosage forms. Polyoxaesters are made from at least one diacid and at least one diol. Through the use of polyoxaesters virtually solvent-free pharmaceutical suspensions can be created.

Abstract: Suspending vehicles and pharmaceutical suspensions that include a biocompatible polymer that can be combined with a hydrophobic solvent and a hydrophilic solvent to provide vehicles and suspensions that are substantially free of stiff gels upon contact with an aqueous medium are provided. Vehicles and suspensions remain flowable out of a pump-driven dosage form over the life of the dosage form. Such vehicles and suspensions are also biocompatible, suitable for creating and maintaining drug suspensions, and capable of providing stable drug formulations.

Abstract: A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.

Abstract: The present invention is related to materials and methods for forming polymeric delivery vehicles that reduces risk of oxidative degradation of a carried drug and the resulting compositions.

Abstract: A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

Abstract: The present invention includes materials and methods for providing vehicles useful for providing drug formulations that address the potential drawbacks of known nonaqueous formulations. In particular, the present invention includes nonaqueous vehicles that are formed using a combination of polymer and solvent that results in a vehicle that is miscible in water. The nonaqueous vehicles facilitate the formulation of drug formulations that are stable over time, even when stored at, or exposed to, elevated temperatures. Moreover, the miscible vehicles of the present invention allow the preparation of drug formulations that work to reduce the occurrence of partial or complete occlusions of the delivery conduits included in delivery devices used to administer the drug formulations.