Formulations for respiratory tract administration

Abstract

A dosage form for intranasal and/or inhalation administration of an analgesic having low opioid receptor binding activity to a warm blooded animal, that includes a pharmaceutically effective amount of the analgesic. A preferred analgesic is tramadol, a tramadol and/or a pharmaceutically acceptable salt, metabolite or derivative thereof. Methods of making and using the formulation according to the invention are also provided.

What is claimed is:  
     
         1 . A dosage form for respiratory tract administration of an analgesic medicament to a warm blooded animal, the dosage form comprising a pharmaceutically effective amount of tramadol or a pharmaceutically acceptable derivative or salt thereof and a pharmaceutically acceptable carrier suitable for respiratory tract administration.  
     
     
         2 . The dosage form according to    claim 1    wherein said pharmaceutically acceptable carrier is suitable for intranasal administration.  
     
     
         3 . The dosage form according to    claim 1    wherein said pharmaceutically acceptable carrier is suitable for inhalation administration.  
     
     
         4 . The dosage form according to    claim 2    wherein said pharmaceutically acceptable carrier is selected from the group consisting of a liquid, a suspension, an emulsion, a liposome, a paste, a gauze packing and a gel.  
     
     
         5 . The dosage form according to    claim 3    wherein said pharmaceutically acceptable carrier is selected from the group consisting of a liquid, a suspension, an emulsion, a liposome and a powder.  
     
     
         6 . The dosage form according to    claim 1    wherein said pharmaceutically acceptable carrier comprises isotonic saline solution or suspension.  
     
     
         7 . The dosage form according to    claim 1    wherein said pharmaceutically acceptable carrier has a pH ranging from about 4.0 to about pH 7.4.  
     
     
         8 . The dosage form according to    claim 1    wherein said warm blooded animal is a human patient.  
     
     
         9 . The dosage form according to    claim 1    wherein the analgesic medicament comprises a pharmaceutically effective amount of tramadol hydrochloride.  
     
     
         10 . The dosage form according to    claim 9    wherein the tramadol is present in an amount ranging from about 10 to about 300 mg per ml.  
     
     
         11 . The dosage form according to    claim 1    wherein the analgesic medicament comprises a pharmaceutically effective amount of mono-O-desmethyltramadol.  
     
     
         12 . The dosage form according to    claim 1    wherein the analgesic medicament comprises a pharmaceutically effective combination of tramadol HCl and mono-O-desmethyltramadol.  
     
     
         13 . A method for producing analgesia in a warm blooded animal comprising contacting a respiratory tract mucosal surface of a warm blooded animal in need thereof with a pharmaceutical formulation comprising a pharmaceutically effective amount of tramadol or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable carrier.  
     
     
         14 . The method according to    claim 13    comprising intranasal administration.  
     
     
         15 . The method according to    claim 13    comprising administration by inhalation.  
     
     
         16 . The method according to    claim 14    wherein said pharmaceutically acceptable carrier is selected from the group consisting of a liquid, an emulsion, a liposome, a paste and a gel.  
     
     
         17 . The method according to    claim 15   , wherein said pharmaceutically acceptable carrier is selected from the group consisting of a liquid, an emulsion, a liposome and a powder.  
     
     
         18 . The method according to    claim 16    wherein said pharmaceutically acceptable carrier comprises isotonic saline.  
     
     
         19 . The method according to    claim 13    wherein said pharmaceutically acceptable carrier has a pH ranging from about 4.0 to about pH 7.4.  
     
     
         20 . The method according to    claim 13    wherein said warm blooded animal is a human patient.  
     
     
         21 . The method according to    claim 13    wherein the tramadol comprises a pharmaceutically effective amount of tramadol hydrochloride.  
     
     
         22 . The method according to    claim 21    wherein the tramadol hydrochloride is present in an amount ranging from about 10 to about 300 mg per ml.  
     
     
         23 . The method according to    claim 13    wherein the tramadol derivative comprises a pharmaceutically effective amount of mono-O-desmethyltramadol.  
     
     
         24 . The method according to    claim 13    wherein the tramadol comprises a pharmaceutically effective combination of tramadol HCl and mono-O-desmethyltramadol.  
     
     
         25 . A method for providing analgesia in a patent comprising the steps of inhaling a dosage form comprising a pharmaceutically effective amount of tramadol or a pharmaceutical acceptable salt or derivative thereof and a pharmaceutically acceptable carrier for administration by inhalation.  
     
     
         26 . A method for providing analgesia in a patent comprising the steps of intranasally administering a dosage form comprising a pharmaceutically effective amount of tramadol or a pharmaceutical acceptable salt or derivative thereof and a pharmaceutically acceptable carrier for intranasal administration.