Compositions of Glycopyrronium Salt for Inhalation

Abstract

A process for preparing dry powder formulations of a glycopyrronium salt for inhalation that have good stability. The process involves (a) micronising a glycopyrronium salt together with an anti-adherent agent, and (b) admixing carrier particles to form the dry powder formulation.

1 . A process for preparing a dry powder formulation of a glycopyrronium salt for inhalation that comprises the steps of (a) mixing a glycopyrronium salt and to 5% by mass of magnesium stearate, based on the total amount of glycopyrronium salt and magnesium stearate, to give a homogeneous blend; (b) micronising the blend; and (c) admixing carrier particles to the micronized blend to form a dry powder formulation, wherein the carrier particles are mixed with the blend of micronized glycopyrronium salt and magnesium stearate in a ratio of 200:1 to 20:1 by mass. 
     
     
         2 . A process according to  claim 1  wherein the carrier particles are crystalline sugars. 
     
     
         3 . A process according to  claim 1  wherein the glycopyrronium salt is glycopyrronium bromide, glycopyrronium chloride or glycopyrronium iodide. 
     
     
         4 . A process according to  claim 3  wherein the glycopyrronium salt is glycopyrronium bromide. 
     
     
         5 . A process according to  claim 1  in which the blend of glycopyrronium salt and the magnesium stearate are micronised together with an additional active ingredients. 
     
     
         6 . A process according to  claim 5  in which the additional active ingredients is selected from the group consisting of salmeterol, indacaterol and mometasone.