Drug delivery system comprising a reservoir containing a plurality of tiny pills

Claim 1

A device dimensioned and adapted for oral admittance into a gastro intestinal tract environment of use for extended residency into the fluid environment of the stomach as an in vivo resevoir for executing therein a therapeutic program over a prolonged period of time, the device comprising; (a) a matrix formed of a pharmaceutically acceptable non-toxic, non-hydrated hydrogel that absorbs and imbibes fluid from the fluid environment of the stomach, expands and swells exhibiting a 2 to 50 fold volume increase for retaining the device in the stomach over an extended period of time, said hydrogel being a hydrophilic hydrogel that is non cross-linked or a hydrophilic hydrogel cross-linked with acid mobile covalent or ionic bonds, said hydrophilic hydrogel selected from the group consisting of naturally occurring or synthetic polymeric materials and colloids; (b) a plurality of tiny pills dispersed throughout the matrix, the tiny pills comprising: (1) a core of beneficial drug; and, (2) a wall formed of a drug release rate controlling fatty acid and wax wall composition that surrounds the core of beneficial drug, and, (c) wherein, when the device is in the environment of use, the device executes the therapeutic program by delivering drug in the stomach for absorption in the stomach, and for passage into the intestine for absorption in the intestine.

Claim 2

A device dimensioned and adapted for oral admittance into a gastro intestinal tract environment of use for extended residency into the fluid environment of the stomach as an in vivo resevoir for executing therein a therapeutic program over a prolonged period of time, the device comprising; (a) a matrix formed of a pharmaceutically acceptable non-toxic, non-hydrated hydrogel that absorbs and imbibes fluid from the fluid environment of the stomach, expands and swells exhibiting a 2 to 50 fold volume increase for retaining the device in the stomach over an extended period of time, said hydrogel being a hydrophilic hydrogel that is non cross-linked or a hydrophilic hydrogel cross-linked with acid mobile covalent or ionic bonds, said hydrophilic hydrogel selected from the group consisting of naturally occurring or synthetic polymeric materials and colloids; (b) a plurality of tiny pills dispersed throughout the matrix, the tiny pills comprising: (1) a core of beneficial drug; and, (2) a wall formed of a drug release rate controlling fatty acid and wax wall composition that surrounds the core of beneficial drug, and, (c) wherein, when the device is in the environment of use, the device executes the therapeutic program by delivering drug in the stomach for absorption in the stomach, and for passage into the intestine for absorption in the intestine.