US2017189339A1PendingUtilityA1

Abuse deterrent immediate release biphasic matrix solid dosage form

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Assignee: SUN PHARMA ADVANCED RES CO LTDPriority: Mar 26, 2014Filed: Mar 23, 2017Published: Jul 6, 2017
Est. expiryMar 26, 2034(~7.7 yrs left)· nominal 20-yr term from priority
A61P 25/24A61P 25/04A61K 9/2009A61K 31/167A61K 9/2013A61K 9/4858A61K 9/2077A61K 9/2054A61K 31/5517A61K 9/4808A61K 31/433A61K 9/4866A61K 9/2027A61K 9/2846A61K 9/2081A61K 9/485A61K 31/137A61K 9/2059A61K 31/135A61K 9/2031A61K 9/5026
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Claims

Abstract

An abuse deterrent immediate release biphasic matrix solid dosage form that releases the drug at a desired rate for quick onset of action when a single unit or prescribed units of the dosage form are orally administered but exhibits a reduced rate of release when more than the prescribed number of units, are administered.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An abuse deterrent immediate release biphasic matrix solid dosage form comprising:
 an intragranular phase comprising a mixture of a drug susceptible to abuse and a reverse enteric polymer;   an extragranular phase;   and an alkalizer,   wherein the intragranular phase further comprises a first part of the alkalizer and the extragranular phase comprises a second part of the alkalizer.   
     
     
         2 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 1   wherein the drug susceptible to abuse and the reverse enteric polymer are melt extruded to form a solid dispersion characterized by the absence of X-ray diffraction peaks characteristic of the crystalline drug.   
     
     
         3 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 1 , further comprising an alcohol dose dumping resistance polymer located only in the intragranular phase. 
     
     
         4 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 1 , further comprising an alcohol dose dumping resistance polymer located in both the intragranular phase and extragranular phase. 
     
     
         5 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 1 , further comprising an alcohol dose dumping resistance polymer that covers the intragranular phase. 
     
     
         6 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 5 , wherein the alcohol dose dumping resistance polymer is also present in the intragranular phase. 
     
     
         7 . The abuse deterrent immediate release biphasic matrix solid dosage form according to  claim 6 , wherein the alcohol dose dumping resistance polymer is also present in the extragranular phase.

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