Extended release dosage form

Abstract

A membrane system comprising an interior wall, a fluid-permeable exterior wall surrounding the interior wall and an internal compartment defined by the membrane system, wherein fluid permeability of the interior wall is responsive to osmolarity of an osmotic core within the internal compartment are disclosed. A controlled release dosage form comprising the membrane system and a process for delivering an osmotically active formulation from an osmotic pump over an extended period of time are also disclosed.

1 - 53 . (canceled) 
     
     
         54 . A controlled release dosage form comprising:
 an osmotic core comprising an analgesic composition;   an interior wall surrounding at least a portion of said osmotic core, wherein fluid permeability of the interior wall is responsive to osmolarity of said osmotic core;   and a fluid-permeable exterior wall surrounding the interior wall.   
     
     
         55 . The controlled release dosage form of  claim 54 , wherein the analgesic composition comprises an opioid analgesic. 
     
     
         56 . The controlled release dosage form of  claim 55 , wherein the opioid analgesic comprises hydrocodone. 
     
     
         57 . The controlled release dosage form of  claim 55 , wherein the analgesic composition further comprises a nonopioid analgesic. 
     
     
         58 . The controlled release dosage form of  claim 57 , wherein the nonopioid analgesic is selected from the group consisting of acetaminophen, aspirin, benoxaprofen, flurbiprofen, ibuprofen, indoprofen, propoxyphene, salicylamide, zenazocine and zomepirar. 
     
     
         59 . The controlled release dosage form of  claim 57 , wherein the opioid analgesic comprises hydrocodone and the nonopioid analgesic comprises acetaminophen. 
     
     
         60 . The controlled release dosage form of  claim 57 , wherein the analgesic composition further comprises a pharmaceutically acceptable carrier for both the opioid analgesic and nonopioid analgesic. 
     
     
         61 . The controlled release dosage form of  claim 60 , wherein the pharmaceutically acceptable carrier is polyethylene oxide carrier. 
     
     
         62 . The controlled release dosage form of  claim 60 , wherein the analgesic composition comprises polyvinyl pyrrolidone. 
     
     
         63 . The controlled release dosage form of  claim 54 , wherein the interior wall comprises ethyl cellulose and hydroxypropylcellulose. 
     
     
         64 . The controlled release dosage form of  claim 54 , wherein the exterior wall comprises cellulose acetate. 
     
     
         65 . The controlled release dosage form of  claim 54 , wherein the internal wall and the external wall act in concert to provide a controlled delivery of the analgesic composition over an extended or sustained-release period of time. 
     
     
         66 . The controlled release dosage form of  claim 54 , wherein the analgesic composition is delivered over a period of about 30 minutes to about 24 hours. 
     
     
         67 . The controlled release dosage form of  claim 54 , wherein the analgesic composition is delivered over a period of about 4 hours to about 24 hours. 
     
     
         68 . The controlled release dosage form of  claim 54 , wherein the interior wall comprises a hydrophobic substance and a hydrophilic substance and the exterior wall is semipermeable. 
     
     
         69 . The controlled release dosage form of  claim 68 , wherein hydrophilicity of the hydrophilic substance is osmosensitive. 
     
     
         70 . The controlled release dosage form of  claim 68 , wherein the hydrophilic substance exhibits an aqueous solubility responsive to osmotic pressure and/or ionic strength of the osmotic core. 
     
     
         71 . The controlled release dosage form of  claim 68 , wherein the hydrophilic substance provides increased permeability of the interior wall in response to a decrease in the osmotic pressure and/or ionic strength of the osmotic core. 
     
     
         72 . The controlled release dosage form of  claim 68 , wherein the hydrophobic substance comprises ethyl acetate or cellulose acetate, the hydrophilic substance comprises hydroxyalkylcellulose, and the semipermeable substance comprises cellulose acetate.