Oral liquid compositions of guanfacine

Abstract

The present invention relates to oral liquid compositions of guanfacine. The liquid compositions can be immediate release or extended release compositions. The compositions comprise guanfacine in a concentration from about 0.1 mg/mL to about 12.0 mg/mL of the composition. The liquid compositions can be in the form of ready-to use liquid compositions or reconstituted liquid compositions. It further relates to processes for the preparation of said oral liquid compositions.

1 - 29 . (canceled) 
     
     
         30 . A stable extended release oral liquid composition of guanfacine in a concentration from about 0.1 mg/ml to about 7.0 mg/mL of the composition comprising
 i) a core in the form of bead, pellets, granule, or spheroid comprising guanfacine and an acid;   ii) a coating over the core comprising a release-controlling agent; and   iii) a pharmaceutically acceptable carrier comprising one or more of liquid adjuvants.   
     
     
         31 . The stable extended release oral liquid composition of  claim 30 , wherein the composition comprises less than about 3.0% w/w of total related substances when stored at 40° C. and 75% relative humidity (RH) for at least 3 months. 
     
     
         32 . The stable extended release oral liquid composition of  claim 31 , wherein the composition comprises less than about 2.0% w/w of total related substances when stored at 40° C. and 75% RH for at least 3 months. 
     
     
         33 . The stable extended release oral liquid composition of  claim 30 , wherein the composition comprises less than about 1.0% w/w of 2,6-dichlorophenyl acetic acid when stored at 40° C. and 75% RH for at least 3 months. 
     
     
         34 . The stable extended release oral liquid composition of  claim 33 , wherein the composition comprises less than about 0.7% w/w of 2, 6-dichlorophenyl acetic acid when stored at 40° C. and 75% RH for at least 3 months. 
     
     
         35 . The stable extended release oral liquid composition of  claim 30 , wherein guanfacine is present in the core or layered over an inert particle to form a core. 
     
     
         36 . The stable extended release oral liquid composition of  claim 30 , wherein the core further comprises pharmaceutically acceptable excipients selected from the group consisting of osmogents, binders, glidants, and combinations thereof. 
     
     
         37 . The stable extended release oral liquid composition of  claim 30 , wherein the release-controlling agent is selected from the group consisting of a pH-dependent release-controlling agent, a pH-independent release-controlling agent, and mixtures thereof. 
     
     
         38 . The oral liquid composition of  claim 30 , wherein the composition is a ready-to-use liquid composition or a reconstituted liquid composition. 
     
     
         39 . The oral liquid composition of  claim 38 , wherein the ready-to-use liquid composition is a solution, a suspension, a syrup, a concentrate, an elixir, or an emulsion.