Dexamethasone oral film

Abstract

The present invention relates to an oral film consisting essentially of dexamethasone and hydroxypropyl methylcellulose, wherein the concentration of dexamethasone is 30% w/w or more and the concentration of hydroxypropyl methylcellulose is between 35 and 70% w/w based on total dry matter.

1 .- 18 . (canceled) 
     
     
         19 . An oral film consisting essentially of dexamethasone and hydroxypropyl methylcellulose, wherein the concentration of dexamethasone is 30% w/w or more and the concentration of hydroxypropyl methylcellulose is between 35 and 70% w/w, all based on total dry matter. 
     
     
         20 . An oral film according to  claim 19 , wherein the sum of the concentrations of dexamethasone and hydroxypropyl methylcellulose is from 95% to 100% w/w. 
     
     
         21 . An oral film according to  claim 19 , wherein the hydroxypropyl methylcellulose is hypromellosum, Ph. Eur. 
     
     
         22 . An oral film according to  claim 19 , wherein the hydroxypropyl methylcellulose is hypromellose, USP. 
     
     
         23 . An oral film according to  claim 19 , wherein the hydroxypropyl methylcellulose is type 2910. 
     
     
         24 . An oral film according to  claim 19 , wherein the hydroxypropyl methylcellulose is a mixture of two or more hydroxypropyl methylcelluloses having different viscosity. 
     
     
         25 . An oral film according to  claim 24 , wherein the hydroxypropyl methylcellulose is a mixture of two hydroxypropyl methylcelluloses having different viscosity, wherein the concentrations of the two hydroxypropyl methylcelluloses in the film are the same. 
     
     
         26 . An oral film according to  claim 19 , wherein the hydroxypropyl methylcellulose is a mixture of hydroxypropyl methylcelluloses having a viscosity of 3 mPa s and 50 mPa s, respectively. 
     
     
         27 . An oral film according to  claim 19 , wherein the concentration of dexamethasone is from 35 to 45% w/w. 
     
     
         28 . An oral film according to  claim 27 , wherein the concentration of dexamethasone is 40% w/w. 
     
     
         29 . An oral film according to  claim 19 , wherein the total concentration of hydroxypropyl methylcellulose is from 55 to 65% w/w. 
     
     
         30 . An oral film according to  claim 19 , containing a mixture of two hydroxypropyl methylcelluloses having a viscosity of 3 mPa s and 50 mPa s, respectively, wherein the total concentration of the mixture is 60% w/w. 
     
     
         31 . An oral film according to  claim 19 , wherein dexamethasone is present in micronized form. 
     
     
         32 . An oral film according  claim 19 , wherein the film has a thickness of from 15 to 50 μm. 
     
     
         33 . An oral film according to  claim 19  in unit dosage form. 
     
     
         34 . An oral film according to  claim 33 , wherein the unit dosage form contains from 4 to 10 mg of dexamethasone. 
     
     
         35 . A method of treating a condition selected from chemotherapy induced nausea, chemotherapy induced vomiting, croup, acute allergic conditions, anaphylactic conditions, brain oedema, and high-altitude disease, comprising orally administering an oral film according to  claim 19  to a subject in need thereof. 
     
     
         36 . A method for preparing an oral film according to  claim 19 , comprising:
 i) dispersing dexamethasone in water to obtain a dispersion,   ii) dissolving hydroxypropyl methylcellulose in said dispersion,   iii) coating the dispersion resulting from step ii) on an intermediate layer to obtain a wet film,   iv) drying the wet film, and   v) removing the intermediate layer.   
     
     
         37 . A method for preparing an oral film according to  claim 19 , comprising:
 i) dissolving hydroxypropyl methylcellulose in water to obtain a homogeneous viscous solution,   ii) dispersing dexamethasone in said solution, and obtaining a homogeneous viscous dispersion containing all ingredients,   iii) coating the dispersion resulting from step ii) on an intermediate layer to obtain a wet film,   iv) drying the wet film, and   v) removing the intermediate layer.