Abstract:
Processes for precipitating a polymer from a polymer-containing fluid are disclosed, which include providing a vessel housing a medium that provides one or more precipitation surfaces. A polymer-containing fluid, e.g., a polymer solution, dispersion or mixed solution/dispersion, and an anti-solvent can be introduced into the vessel so as to cause precipitation of at least a portion of the polymer on at least one of the precipitation surfaces. In some embodiments, the polymer contains one or more cyclic oligosaccharide moieties, such as one or more cyclodextrin moieties (e.g., α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin). The polymer can be any of a linear or branched polymer. The polymer can be any of polycation, a polyanion, or a non-ionic polymer. Also disclosed herein are precipitation surfaces with polymer precipitated thereon.
Abstract:
Processes for precipitating a polymer from a polymer-containing fluid are disclosed, which include providing a vessel housing a medium that provides one or more precipitation surfaces. A polymer-containing fluid, e.g., a polymer solution, dispersion or mixed solution/dispersion, and an anti-solvent can be introduced into the vessel so as to cause precipitation of at least a portion of the polymer on at least one of the precipitation surfaces. In some embodiments, the polymer contains one or more cyclic oligosaccharide moieties, such as one or more cyclodextrin moieties (e.g., α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin). The polymer can be any of a linear or branched polymer. The polymer can be any of polycation, a polyanion, or a non-ionic polymer. Also disclosed herein are precipitation surfaces with polymer precipitated thereon.
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:
Methods for preparing microparticles having improved flowability to facilitate processing in automated equipment. Microparticles are conditioned so that a flowability index of the microparticles is greater than about 60. The conditioning preferably includes maintaining the microparticles at a conditioning temperature for a period of time. The conditioning can be used with microparticles containing an active agent, and with placebo microparticles, and it is reversible.
Abstract:
Methods for preparing microparticles having improved flowability to facilitate processing in automated equipment. Microparticles are conditioned so that a flowability index of the microparticles is greater than about 60. The conditioning preferably includes maintaining the microparticles at a conditioning temperature for a period of time. The conditioning can be used with microparticles containing an active agent, and with placebo microparticles, and it is reversible.
Abstract:
Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Abstract:
Systems and methods are provided for filtering a fluid containing nanoparticles. The systems and methods generally include introducing a stream of the nanoparticle-containing fluid into a holding vessel, and extracting at least a part of a nanoparticle-containing fluid accumulated in the holding vessel. The extracted nanoparticle-containing fluid is passed through a filtration module to separate a nanoparticle-containing retentate from a permeate, and the retentate is returned to the vessel. The filtration cycle can be repeated until a desired concentration of the nanoparticles is achieved in the holding vessel. In many embodiments, the generation of the nanoparticle-containing fluid and its filtration are performed concurrently.
Abstract:
In one aspect, the present invention provides a process for forming polymeric nanoparticles, which comprises using a static mixer to create a mixed flowing stream of an anti-solvent, e.g., by introducing a liquid anti-solvent into a static mixer, and introducing a polymer solution into the mixed flowing anti-solvent stream such that controlled precipitation of polymeric nanoparticles occurs. The nanoparticles can then be separated from the anti-solvent stream.
Abstract:
Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Abstract:
An improved method for preparing microparticles that exhibit controlled release of an effective amount of an active agent over an extended period of time. More particularly, a method is provided for preparing microparticles having a selected release profile for release of active agent contained in the microparticles. By adjusting the degree of drying that is performed during the preparation of the microparticles, the release profile can be controlled. By performing no intermediate drying, an initial burst and a substantially linear release profile is achieved. By performing substantially complete intermediate drying, an initial lag phase and a substantially sigmoidal release profile is achieved.