Luftstrahlmahlung von homogenen Vormischungen aus Fenoterol-Hydrobromid und Glucose für den Einsatz in Pulverinhalatoren
Katharina Brodka-Pfeiffera, b, Heribert Häuslerb, Peter Graßb und Peter Langgutha
Institut für Pharmazie, Biopharmazie und pharmazeutische Technologie, Johannes Gutenberg-Universitäta, Mainz (Germany), und Boehringer Ingelheim Pharma GmbH & Co. KGb, Ingelheim am Rhein (Germany)Air Jet Milling with Homogeneous Premixes of Fenoterol Hydrobromide and Glucose for the Application in Dry Powder Inhalers
Dry powder inhalers are a very good alternative to metered dose inhalers. The here described analysis refers to a 4 % mixture of fenoterol hydrobromide and glucose as model substance. The task of this assignment is to merge the comminution step with the following mixing step in one process and to evaluate the results.
Different homogeneous premixtures are being produced and micronised using air jet milling.
Throughout the process of micronisation the components are supposed to be reduced to small particles and at the same time glucose as carrier is being loaded with the drug substance. In order to evaluate the influence of the air jet milling more closely, the used starting materials are being tested individually for particle morphology, -size and hardness. For the mixture homogeneity the standard deviation of the active component in the particular sample is determined as the measuring parameter. The analytical methods used are laser diffractometry, scanning electron microscopy, HPLC and hardness measurement.
Summing up, it can be assessed that this process in not useful for inhalative powders. This method provides only very inhomogeneous mixtures.
Key words Luftstrahlmahlung • Mikronisierung • Pulverinhalatoren • Pulvermischungen
pharmind 2005, Nr. 6, Seite 713