US2021052502A1PendingUtilityA1

Therapeutic compositions for treatment of human immunodeficiency virus

Assignee: GILEAD SCIENCES INCPriority: Nov 9, 2015Filed: Aug 6, 2020Published: Feb 25, 2021
Est. expiryNov 9, 2035(~9.3 yrs left)· nominal 20-yr term from priority
A61K 31/537A61K 9/2833A61K 9/2027A61P 31/18A61K 31/675A61K 31/5365A61K 31/513A61K 9/282A61K 9/209A61K 9/2054A61K 9/2013A61K 9/0053A61K 9/20A61K 2300/00A61K 9/28A61K 9/2086A61K 9/2095A61K 31/553
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Claims

Abstract

A solid oral dosage form is provided, comprising a compound of Formula I or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof.

Claims

exact text as granted — not AI-modified
1 - 30 . (canceled) 
     
     
         31 . A method of producing a multilayer tablet comprising the compound of Formula I: 
       
         
           
           
               
               
           
         
         or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof, wherein the method comprises (a) compressing the a compound of Formula I or a pharmaceutically acceptable salt thereof as a first layer, and (b) compressing the tenofovir alafenamide or a pharmaceutically acceptable salt thereof and emtricitabine or a pharmaceutically acceptable salt thereof as a second layer. 
       
     
     
         32 . The method of  claim 31 , wherein the first layer and second layer are compressed separately and subsequently combined. 
     
     
         33 . The method of  claim 31 , wherein the first layer is formed by compression and subsequently the second layer is compressed onto the first layer. 
     
     
         34 . The first layer obtainable by the method of  claim 31 . 
     
     
         35 . The second layer obtainable by the method of  claim 31 . 
     
     
         36 - 51 . (canceled) 
     
     
         52 . The method of  claim 31 , wherein the tablet comprises 50 mg of the compound of Formula I or a pharmaceutically acceptable salt thereof, 25 mg tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and 200 mg emtricitabine or a pharmaceutically acceptable salt thereof wherein the tablet has a total weight of less than about 1000 mg. 
     
     
         53 . The method of  claim 31 , wherein the tablet comprises 50 mg of the compound of Formula I as a pharmaceutically acceptable salt thereof, 25 mg tenofovir alafenamide as a pharmaceutically acceptable salt thereof, and 200 mg emtricitabine. 
     
     
         54 . The method of  claim 53 , wherein the tablet comprises 52 mg of the sodium salt of the compound of Formula I and 28 mg tenofovir alafenamide hemifumarate. 
     
     
         55 . The method of  claim 54 , wherein the tablet the tablet has a total weight of less than about 800 mg. 
     
     
         56 . The method of  claim 54 , wherein the tablet has a total weight of less than about 730 mg.

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