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.

1 - 14 . (canceled)  
   
   
       15 . A process for cleaning the inner wall of a hard gelatine capsule for use in inhalation therapy, wherein the process comprises: 
 (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 . (canceled)  
   
   
       17 . The process according to  claim 15 , wherein the powder formulation is pharmaceutically acceptable.  
   
   
       18 . The process according to  claim 15 , wherein the powder formulation constitutes an ingredient of the active substance formulation.  
   
   
       19 . The process according to  claim 18 , wherein the active substance formulation is for inhalation.  
   
   
       20 . The process according to  claim 19 , wherein the active substance formulation contains a tiotropium powder.  
   
   
       21 . The process according to  claim 15 , wherein the cleaning is carried out in a sealed capsule.  
   
   
       22 . The process according to  claim 15 , wherein the cleaning is carried out without the use of solvents.  
   
   
       23 . The process according to  claim 15 , wherein the cleaning is carried out in a gravity mixer or on a vibrating table.  
   
   
       24 . The process according to  claim 15 , wherein the cleaning is carried out at a temperature of 15° C. to 50° C.  
   
   
       25 . The process according to  claim 15 , wherein the mixing time is 20 to 150 minutes.  
   
   
       26 . The process according to  claim 15 , wherein some or all of the grains of the powder formulation accumulate impurities.  
   
   
       27 . The process according to  claim 15 , wherein some or all of the grains of the powder formulation accumulate lubricants and/or mould release agents.  
   
   
       28 . The process according to  claim 15 , wherein the content of the powder formulation is from 6% to 50% of the theoretical total capacity of the capsule.  
   
   
       29 . The process according to  claim 15 , wherein the powder formulation contains at least one excipient with particle sizes of 10 μm to 50 μm in aerodynamic diameter.  
   
   
       30 . The process according to  claim 15 , wherein the powder formulation contains lactose and/or lactose monohydrate.