Packaging of Solid Pharmaceutical Preparations Containing the Active Substance Glyceryl Trinitrate

Abstract

Solid pharmaceutical preparation containing the active substance glyceryl trinitrate in the form of a single dose for sublingual or oral administration, which is packaged in a composite film, wherein the composite film contains a layer comprising polyacrylonitrile (PAN) on the side facing the preparation.

1 - 13 . (canceled) 
     
     
         14 . A solid pharmaceutical preparation, comprising: glyceryl trinitrate (GTN) packaged in a composite film, wherein the composite film contains a layer comprising polyacrylonitrile (PAN) on the side facing the pharmaceutical preparation. 
     
     
         15 . The pharmaceutical preparation of  claim 14 , wherein the composite film is an aluminum composite film. 
     
     
         16 . The pharmaceutical preparation of  claim 14 , wherein the composite film is a thermoplastic composite film. 
     
     
         17 . The pharmaceutical preparation of  claim 14 , wherein the layer of the composite film on the side facing the pharmaceutical preparation comprises acrylonitrile-methylacrylate copolymer. 
     
     
         18 . The pharmaceutical preparation of  claim 14 , wherein the layer of the composite film on the side facing the pharmaceutical preparation comprises impact-modified acrylonitrile-methylacrylate copolymer. 
     
     
         19 . The pharmaceutical preparation of  claim 14 , wherein the GTN content is between 0.05 and 2% by weight. 
     
     
         20 . The pharmaceutical preparation of  claim 14 , further comprising at least one other excipient suitable for sublingual administration selected from the group consisting of fructose, glucose, isomalt, lactose, maltitol, maltose, mannitol, saccharose, sorbitol, trehalose and xylitol, and mixtures thereof. 
     
     
         21 . The pharmaceutical preparation of  claim 20 , wherein the at least one other excipient suitable for sublingual administration is xylitol and/or isomalt at concentrations of 20 to 95% by weight. 
     
     
         22 . The pharmaceutical preparation of  claim 14 , further comprising at least one flavoring agent. 
     
     
         23 . The pharmaceutical preparation of  claim 14 , wherein the GTN is formulated in the form of granules. 
     
     
         24 . The pharmaceutical preparation of  claim 14 , wherein the GTN is formulated in the form of a tablet. 
     
     
         25 . The pharmaceutical preparation of  claim 14 , wherein the GTN is formulated in the form of an oral fast dissolving film. 
     
     
         26 . The pharmaceutical preparation of  claim 14 , wherein the GTN is packaged in the form of a single dose for oromucosal or oral administration. 
     
     
         27 . The pharmaceutical preparation of  claim 26 , wherein the single dose form is contained in a stick pack.