| abstract |
High concentration drug particle formulations are described. The drug accounts for about 25 wt% to about 80 wt% of the particle formulation. The particle formulation of the present invention comprises, for example, macromolecules such as proteins and / or small molecules (eg steroid hormones). A particle formulation typically further comprises one or more additional ingredients, such as one or more stabilizers (eg, carbohydrates, antioxidants, amino acids, and buffers). A suspension formulation can be formed by combining such a high concentration particle formulation with a suspension vehicle. The suspension formulation includes (i) a non-aqueous single phase vehicle exhibiting viscous fluid properties comprising one or more polymers and one or more solvents, and (ii) a high concentration drug particle formulation. Also described are suspension delivery devices and methods of use. The present invention provides the necessary improvements in drug formulation and delivery to improve patient compliance and broaden drug availability. |