System and method for manufacturing oral osmotic drug delivery devices, and methods of administering same

Abstract

A system and method for manufacturing oral osmotic drug delivery devices including the use of a mathematical model in deriving relationships between parameters used in manufacturing the devices for a desired release rate of the active drug substance contained therein. The derived relationship is then used to control the parameters so that the active substance within the device is delivered at a desired rate. Methods of administering the oral osmotic drug delivery devices are also provided. Use of a mathematical model in deriving relationships between parameters used in the drug granulation process for a desired range of percentage fines of the drug granulation substance. The derived relationship is then used to control the parameters in the drug granulation process so that the desired percentage fines are obtained in the drug granulation substance.

1 - 8 . (canceled) 
     
     
         9 . A method, comprising:
 deriving a relationship between (a) an electrical current level and/or a power level of a mixing device used for mixing a drug and one or more excipients to produce particles, and (b) a corresponding particle size distribution as determined by the percentage of the particles that pass through a #120 mesh screen, wherein the current level and the power level of the mixing device vary as a function of the constituency of the drug and the one or more excipients being mixed;   selecting a desired particle size distribution to be obtained in the particles;   thereafter determining, using the derived relationship, a current level and/or a power level that produces the desired particle size distribution;   thereafter utilizing the mixing device to manufacture a plurality of particles containing the desired particle size distribution;   thereafter manufacturing a composition comprising the plurality of particles; and   thereafter administering the composition to a subject.   
     
     
         10 . The method according to  claim 9 , wherein the deriving step includes collecting measurements of the current level and/or the power level used in the mixing device and the corresponding particle size distribution obtained in the particles. 
     
     
         11 . The method according to  claim 10 , wherein the deriving step includes correlating a measured current level and/or power level to the corresponding particle size distribution. 
     
     
         12 . The method according to  claim 11 , wherein the correlating step includes generating a plot of the collected measurements. 
     
     
         13 . The method according to  claim 12 , further comprising fitting a nonlinear regression model to the generated plot to derive the relationship between the current level and/or the power level and the particle size distribution. 
     
     
         14 . The method according to  claim 9 , wherein the drug comprises an antihypertensive drug. 
     
     
         15 . The method according to  claim 9 , wherein the drug comprises isradipine. 
     
     
         16 . The method according to  claim 9 , wherein about 20% to 25% of the particles pass through a #120 mesh screen. 
     
     
         17 . The method according to  claim 9 , wherein the derived relationship is obtained by utilizing the following formula: Amps=(1093.6)e (-O.4258)percentage fines  +29.44.