Extrudable core system: development of a single-layer osmotic controlled-release tablet.
A new controlled-release, extrudable core system (ECS) tablet has been developed which osmotically delivers high doses of low solubility active pharmaceutical ingredients (API's). The tablet has a single core formed in a modified oval shape with a semi-permeable coating. The core contains hydroxyethylcellulose, which serves to entrain the API particles as they are extruded out a hole in the coating at one end of the tablet, and a sugar, which provides the osmotic driving force for water imbibing. The dosage form has been successfully shown to control delivery of API over a range of delivery rates even with 50% of the tablet being API (up to about 500 mg).
Waterman
Kenneth C
KC
Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA. ken.waterman@pfizer.com
MacDonald
Bruce C
BC
Roy
Michael C
MC
D000284:Administration, Oral; D002482:Cellulose / Q000031:analogs & derivatives / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000737:chemistry*; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding; D006863:Hydrogen-Ion Concentration; D009995:Osmosis; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D014783:Viscosity
D003692:Delayed-Action Preparations; D004337:Drug Carriers; D011108:Polymers; D013607:Tablets; D002482:Cellulose; C002283:hydroxyethylcellulose