Pharmaceutical composition of s-ketamine hydrochloride

Abstract

The present invention is directed to an aqueous formulation of S-ketamine hydrochloride, preferably for nasal administration, wherein the formulation does not contain an antimicrobial preservative.

We claim: 
     
         1 . A pharmaceutical composition comprising S-ketamine hydrochloride and water; wherein the pharmaceutical composition does not contain an antimicrobial preservative. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , which
 (i) additionally contains a buffer; and/or   (ii) has a pH value within the range of from 4.0 to 6.5.   
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the S-ketamine hydrochloride is present in a concentration in the range of eq. 100 mg/mL to eq. 200 mg/mL, based on the total volume of the composition. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the S-ketamine hydrochloride is present in a concentration in the range of eq. 125 mg/mL to eq. 150 mg/mL, based on the total volume of the composition. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein the S-ketamine hydrochloride is present in a concentration in the range of 126 mg/mL to 162 mg/mL, based on the total volume of the composition. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition is formulated for nasal administration. 
     
     
         7 . The pharmaceutical composition according to  claim 2 , wherein the pharmaceutical composition further contains a buffer. 
     
     
         8 . The pharmaceutical composition according to  claim 6 , wherein the buffer is 1N NaOH. 
     
     
         9 . The pharmaceutical composition according to  claim 6 , wherein the buffer is present in an amount sufficient to adjust the pH of the pharmaceutical composition to a pH in the range of from pH 3.5 to pH 6.5. 
     
     
         10 . The pharmaceutical composition according to  claim 6 , wherein the buffer is present in an amount sufficient to adjust the pH of the composition to a pH in the range of from pH 4.5 to pH 5.5. 
     
     
         11 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition exhibits a shelf-life under accelerated storage conditions of at least 3 months. 
     
     
         12 . The pharmaceutical composition according to  claim 1 ; wherein the pharmaceutical composition further contains a penetrating agent. 
     
     
         13 . The pharmaceutical composition according to  claim 11 ; wherein the penetrating agent is tauroursodeoxycholic acid. 
     
     
         14 . The pharmaceutical composition according to  claim 1 ; wherein the pharmaceutical composition further contains tauroursodeoxycholic acid in a concentration in the range of from 1 mg/mL to 25 mg/mL, based on the total volume of the composition. 
     
     
         15 . The pharmaceutical composition according to  claim 2 ; wherein the pharmaceutical composition further contains tauroursodeoxycholic acid in a concentration in the range of from 5 mg/mL to 10 mg/mL. 
     
     
         16 . A pharmaceutical dosage form comprising the pharmaceutical composition according to any of  claims 1 . 
     
     
         17 . The dosage form according to  claim 15 , which is adapted for nasal administration. 
     
     
         18 . The pharmaceutical composition according to  claim 1  or the pharmaceutical dosage form according to  claim 16  for use in the treatment of depression. 
     
     
         19 . The pharmaceutical composition or the pharmaceutical dosage form according to  claim 18 , wherein the depression is selected from the group consisting of major depressive disorder, unipolar depression, treatment-refractory depression, resistant depression, anxious depression and bipolar depression. 
     
     
         20 . The pharmaceutical composition or the pharmaceutical dosage form according to  claim 18 , wherein the depression is selected from the group consisting of resistant depression or treatment refractory depression.