The present invention is a multiparticulate dosage form containing Tramadol HCI as the drug filled in acapsule. Tramadol HCI is a dual-action analgesic agent indicated for the management of moderate to moderately severe pain. With fewer gastrointestinal side effects than NSAIDS andnon-addictive/non-narcotic properties,Tramadol HCI currently sells in excess of US$1.3 billion worldwide (ChemicalBusiness News, 22 Jan 2003). The dosage form is a hard capsule that contains coated multiparticulates to provide extended drug delivery and uncoated multiparticluates to provide immediatedrug release. This product provides rapid pain relief as well as extended relief. The multiparticulate system has several advantages relative to an overcoated monolithic tablet. The first advantage is that catastrophic failure in a monolithic tablet results in dosedumping and associated safety concerns.Failure in a multiparticulate system would result in dumping of only that part of the dose contained in each particulate that fails and,statistically, if failure occurs it will only occur in a small fraction of particulates. From a regulatory standpoint, multiparticulates require considerably less process validation since one process is developed and validated to make the uncoated particulates and a second process is developed to coat these particulates for extended delivery. The coated and uncoated particulates are then filled into the capsule at metered levels representing the final product. The multiparticulate system also lends itself to faster development of combination products thereby offering advantages in time to market for productline extensions.

File Number: KUCR # 2006 fy 28