US2015359790A1PendingUtilityA1

Stability of hydromorphone hydrochloride solutions

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Assignee: MALLINCKRODT LLCPriority: Mar 7, 2012Filed: Aug 25, 2015Published: Dec 17, 2015
Est. expiryMar 7, 2032(~5.6 yrs left)· nominal 20-yr term from priority
Inventors:John J. FosterThomas R. Prentice
A61P 25/04A61K 31/485A61K 9/0085A61K 9/08A61K 9/0019
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Claims

Abstract

The present invention relates generally to a sterile hydromorphone hydrochloride solution that is substantially free of buffer.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride and less than about 1.0% of one or more hydromorphone degradation products. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the hydromorphone degradation product is pseudo-hydromorphone, and the composition contains less than 1.0% of pseudo-hydromorphone. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein the composition contains less than 0.1% of pseudo-hydromorphone. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the hydromorphone degradation product is hydromorphone N-oxide, and the composition contains less than 0.2% of hydromorphone N-oxide. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the composition is substantially free of hydromorphone N-oxide. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the hydromorphone degradation product is dihydromorphone, and the composition is substantia free of dihydromorphone. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the hydromorphone degradation product is 6-β-tetrahydrooripavine, and the composition is substantially free of 6-β-tetrahydrooripavine. 
     
     
         8 . The pharmaceutical composition of  claim 1 , wherein the composition is substantially free of particulates. 
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the composition is suitable for intrathecal delivery. 
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein the sterile aqueous solution has a concentration of hydromorphone hydrochloride of about 10.0 mg/mL. 
     
     
         11 . The pharmaceutical composition of  claim 1 , wherein the sterile aqueous solution has a concentration of hydromorphone hydrochloride of about 2.0 mg/mL. 
     
     
         12 . The pharmaceutical composition of  claim 1 , wherein the sterile aqueous solution was sterilized by aseptic processing. 
     
     
         13 . A method for treating pain comprising administering intrathecally the pharmaceutical composition of  claim 1 .

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