Abstract: Methods of forming compositions for the sustained release of water soluble active agents, including biologically active polypeptides and products produced by the process are described. Improved product characteristics and ease of scale-up can be achieved using a novel coacervation process wherein at least one coacervation agent is added to the mixture comprising the active agent and the polymer in at least two distinct stages.

Abstract: The present invention provides coacervation methods forming compositions for the sustained release water soluble active agents, including biologically active polypeptides. The invention further relates to the discovery of improved non-aqueous quench liquids and washing systems, which enable a reduction in the amount and concentration of hardening agents such as heptane used to produce microparticles, while providing acceptable product yields and residual solvent levels.

Abstract: Methods of forming compositions for the sustained release of water soluble active agents, including biologically active polypeptides and products produced by the process are described. Improved product characteristics and ease of scale-up can be achieved using a novel coacervation process wherein at least one coacervation agent is added to the mixture comprising the active agent and the polymer in at least two distinct stages.

Abstract: There is disclosed an improved rooflight 100. A first aspect of the rooflight provides a perimeter lip 1401 which protects an edge of a pane 210 of glass from being accidentally chipped or cracked. A second aspect of the present invention provides a channel for a blind 1100, which channel is formed by two cooperating channel sections 1601, 1602. A third aspect of the present invention provides a flashing system 1700. Another aspect of the rooflight 100 provides a water deflector 450 for preventing rain water from impinging directly onto a weather seal between a casement 120 and baseplate 110. Another aspect provides removable linings 610, 620, 1210, 1220 which can be mounted an interior face of the casement 120 and/or baseplate 110. Another aspect provides a slot 1000, for securing flashing 800, 810, which extends around the perimeter of the baseplate 110.

Abstract: A method for forming microparticles includes fragmenting solid particles that include a biologically active agent, a biocompatible polymer and a solvent, thereby producing fragmented solid particles, and separating the solvent from the fragmented solid particles, thereby forming the microparticles. The method can also include the steps of forming a mixture of the biologically active agent, the biocompatible polymer and the solvent, and freezing the mixture to form the solid particles. The present invention also relates to methods for producing injectable pharmaceutical compositions that include an injectable microparticle population.