Abstract: A single pass, continuous, automated system for producing a pharmaceutical granulation includes multiple feeders to feed powders and liquids, a twin screw processor to granulate, a radio frequency or microwave based drying apparatus to dry the granulation, and at least one mill to process the dried granulation to desired particle sizes. The system incorporates means for monitoring key process parameters on-line, all of which are controlled by a controller provided with feedback at each component of the system. The granulation produced can be compressed into a tablet or incorporated into a capsule, both having a uniform distribution of the active ingredient. The system produces product having consistent properties even when production is scaled up for manufacture of the tablet in commercial volume.

Abstract: A single pass, continuous, automated system for producing a pharmaceutical granulation includes multiple feeders to feed powders and liquids, a twin screw processor to granulate, a radio frequency or microwave based drying apparatus to dry the granulation, and at least one mill to process the dried granulation to desired particle sizes. The system incorporates means for monitoring key process parameters on-line, all of which are controlled by a controller provided with feedback at each component of the system. The granulation produced can be compressed into a tablet or incorporated into a capsule, both having a uniform distribution of the active ingredient. The system produces product having consistent properties even when production is scaled up for manufacture of the tablet in commercial volume.

Abstract: A controlled-release dosage form for a pharmaceutically-active agent comprises a core, in which the agent is dispersed, surrounded by a diffusion-limiting sleeve. The agent is released at a zero-order or approximately linear rate because the release rate of the agent will be governed entirely by erosion from exposed core surfaces; the surface area of which does not change substantially during the release process. Such a product may be made by co-extruding the core and sleeve material and slicing the extrudate.