Semisolid Aqueous Pharmaceutical Composition Containing Tapentadol

Abstract

A semisolid aqueous pharmaceutical composition containing tapentadol or a physiologically acceptable salt thereof.

1 . A pharmaceutical composition comprising water and tapentadol or a physiologically acceptable salt thereof, wherein said composition is a semi-solid. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein said composition is adapted for topical or local administration. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein said composition has an aqueous phase pH value of at least 5.5. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein said composition is selected from the group consisting of ointments, creams, magmas, gels, emulsions, suspensions, lotions, liniments, pastes, poultices, suspension gels and emulsion gels. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein said composition is a bi-phasic formulation or a multi-phase formulation. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein said composition has a tapentadol content amounting to at least 0.55 wt.-%, based on the total weight of the composition. 
     
     
         7 . The pharmaceutical composition according  claim 1 , wherein said composition is free of any preservative. 
     
     
         8 . The pharmaceutical composition according to  claim 1 , wherein said composition further comprises a preservative in an amount that in the absence of tapentadol is insufficient to preserve the pharmaceutical composition according to the Ph. Eur. 
     
     
         9 . The pharmaceutical composition according to  claim 8 , wherein preservative content is at most 5.0 wt.-%, based on the total weight of the composition. 
     
     
         10 . The pharmaceutical composition according to  claim 1 , wherein said composition further comprises at least one substance selected from the group consisting of lipids and surfactants. 
     
     
         11 . The pharmaceutical composition according to  claim 10 , wherein said composition comprises a lipid selected from the group consisting of monoglycerides, diglycerides, triglycerides, and mixtures of two or more thereof. 
     
     
         12 . The pharmaceutical composition according to  claim 10 , wherein said composition comprises a surfactant having an HLB value of at least 12. 
     
     
         13 . The pharmaceutical composition according to  claim 1 , wherein said composition exhibits fluid characteristics of a pseudoplastic fluid. 
     
     
         14 . The pharmaceutical composition according to  claim 1 , wherein said composition has a shelf-life under accelerated storage conditions of at least 3 months. 
     
     
         15 . A method of treating pain in a subject in need thereof, said method comprising administering to said subject a pharamacologically effective amount of a semi-solid composition according to  claim 1 . 
     
     
         16 . A method according to  claim 15 , wherein said pain is selected from the group consisting of chronic pain and acute pain. 
     
     
         17 . A method according to  claim 15 , wherein said pain is related to rheumatic disorders, arthritic disorders, painful joints, postoperative complaints, dental surgery, dermatitis, skin lesions, skin cancer, mouth sores or athletic injuries.