US2023241009A1PendingUtilityA1

Pharmaceutical Composition Of S-Ketamine Hydrochloride

71
Assignee: JANSSEN PHARMACEUTICA NVPriority: Mar 15, 2013Filed: Apr 6, 2023Published: Aug 3, 2023
Est. expiryMar 15, 2033(~6.7 yrs left)· nominal 20-yr term from priority
Inventors:Esther D.G. BasstanieJohanna BentzRoger C.A. EmbrechtsNico Rudolph Niemeijer
A61K 31/135A61K 9/0043A61K 31/575A61K 47/02A61K 47/28A61K 31/136A61P 25/00Y02A50/30
71
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Claims

Abstract

The present invention is directed to an aqueous formulation of S-ketamine hydrochloride, preferably for nasal administration.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A pharmaceutical composition comprising:
 (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride,   water,   citric acid,   ethylene diamine tetraacetic acid or a sodium or calcium salt thereof, and sodium hydroxide,   wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride is present in a concentration in the range of from about eq. 140 mg/ml to about eq. 160 mg/ml, based on the total volume of the pharmaceutical composition, and the pH of the pharmaceutical composition is in the range of from about 4.0 to about 5.5.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutical composition is formulated for nasal administration. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride is present in a concentration of about eq. 140 mg/ml. 
     
     
         4 . The pharmaceutical composition of  claim 2 , wherein the pH of the pharmaceutical composition is about 4.5. 
     
     
         5 . The pharmaceutical composition of  claim 3 , wherein the pH of the pharmaceutical composition is about 4.5. 
     
     
         6 . A pharmaceutical dosage form comprising the pharmaceutical composition of  claim 2 . 
     
     
         7 . A pharmaceutical dosage form comprising the pharmaceutical composition of  claim 5 . 
     
     
         8 . A pharmaceutical composition comprising:
 (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride,   water,   a buffer, and   a chelating agent or an antioxidant,   wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride is present in a concentration in the range of from about eq. 140 mg/ml to about eq. 160 mg/ml, based on the total volume of the pharmaceutical composition, and the pH of the pharmaceutical composition is in the range of from about 4.0 to about 5.5.   
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein the buffer adjusts the pH of the pharmaceutical composition. 
     
     
         10 . The pharmaceutical composition of  claim 8 , wherein the buffer is citric acid, sodium hydroxide, or both. 
     
     
         11 . The pharmaceutical composition of  claim 8 , wherein the pharmaceutical composition is formulated for nasal administration. 
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein the (S)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride is present in a concentration of about eq. 140 mg/ml. 
     
     
         13 . The pharmaceutical composition of  claim 11 , wherein the pH of the pharmaceutical composition is about 4.5. 
     
     
         14 . The pharmaceutical composition of  claim 12 , wherein the pH of the pharmaceutical composition is about 4.5. 
     
     
         15 . A pharmaceutical dosage form comprising the pharmaceutical composition of  claim 11 . 
     
     
         16 . A pharmaceutical dosage form comprising the pharmaceutical composition of  claim 14 .

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