Process for cleaning hard gelatine capsules

Abstract

A process which can be used in the laboratory or on an industrial scale for cleaning the inner wall of hard gelatine capsules, in which the sealed capsules are cleaned with a powder formulation.

We claim:  
     
         1 . A process for cleaning the inner wall of a hard gelatine capsule for use in inhalation therapy, the process comprising cleaning the capsule with a powder formulation.  
     
     
         2 . The process according to  claim 1 , wherein the powder formulation is pharmaceutically acceptable.  
     
     
         3 . The process according to one of claims  1  or  2 , wherein the powder formulation constitutes an ingredient of the active substance formulation.  
     
     
         4 . The process according to one of claims  1  or  2 , wherein the powder formulation is the active substance formulation for inhalation.  
     
     
         5 . The process according to one of  claims 1  to  4 , wherein the cleaning is carried out in a sealed capsule.  
     
     
         6 . The process according to one of  claims 1  to  5 , wherein the cleaning is carried out without the use of solvents.  
     
     
         7 . The process according to one of  claims 1  to  6 , wherein the cleaning is carried out in a gravity mixer or on a vibrating table.  
     
     
         8 . The process according to one of  claims 1  to  7 , wherein the cleaning is carried out at a temperature of 15° C. to 50° C.  
     
     
         9 . The process according to one of  claims 1  to  8 , wherein the mixing time is 20 to 150 minutes.  
     
     
         10 . The process according to one of  claims 1  to  9 , wherein some or all of the grains of the powder formulation accumulate impurities.  
     
     
         11 . The process according to one of  claims 1  to  10 , wherein some or all of the grains of the powder formulation accumulate lubricants and/or mould release agents.  
     
     
         12 . The process according to one of  claims 1  to  11 , wherein the content of the powder formulation is from 6% to 50% of the theoretical total capacity of the capsule.  
     
     
         13 . The process according to one of  claims 1  to  12 , wherein the powder formulation contains at least one excipient with particle sizes of 10 μm to 50 μm in aerodynamic diameter.  
     
     
         14 . The process according to one of  claims 1  to  13 , wherein the powder formulation contains lactose and/or lactose monohydrate.  
     
     
         15 . The process according to one of  claims 1  to  14 , the process comprising: 
 (a) subjecting the powder formulation to one or more screenings and mixings;  
 (b) transferring the powder formulation obtained from step (b) into a gelatine capsule for inhalation;  
 (c) agitating the gelatine capsules from step (b) in a mixing container;  
 (d) visually monitoring the cleaning process to a selected endpoint; and  
 (e) placing the gelatine capsule directly in the inhaler or optionally emptying and refilling the gelatine capsule with the active substance formulation.  
 
     
     
         16 . A gelatine capsule containing a tiotropium powder formulation, the gelatine capsule obtained by shaking the filled gelatine capsules in a gravity mixer or on a vibrating table.