Patent ID: 7419684

Claim:
A method, comprising: manufacturing a plurality of oral osmotic drug delivery devices, each of which comprises a bi-layer core comprising (1) an active layer comprising particles of a mixture of a drug and one or more excipients wherein the particles have a particle size distribution as determined by the percentage of the particles that pass through a #120 mesh screen, and (2) an osmotic layer, and a semi-permeable outer coating substantially surrounding the bi-layer core; collecting measurements on the particle size distribution in the active layer, a weight value of a plurality of bi-layer cores, and a weight value of the outer coating used in the manufacturing of the plurality of osmotic drug delivery devices, and determining a release rate for the plurality of osmotic drug delivery devices; deriving a relational mechanism relating the particle size distribution, the weight value of the plurality of bi-layer cores, and the weight value of the outer coating to obtain a selected release rate using the collected measurements; selecting at least one parameter of the particle size distribution, the weight value of the plurality of bi-layer cores, and the weight value of the outer coating; determining at least one of the remaining parameters to obtain the selected release rate in a further plurality of oral osmotic drug delivery devices using the relational mechanism; manufacturing the further plurality of oral osmotic drug delivery devices utilizing information obtained from the determining step; and administering to a subject at least one of the oral osmotic drug delivery devices.