Formulation and In Vitro Analysis of a Spray-Dried Albuterol Sulfate and Ipratropium Bromide Combination Inhalation Powder

The goal of this work was to determine the feasibility of formulating and testing a spray-dried combination powder using pharmaceutical compounds typically used to treat asthma and chronic obstructive pulmonary disease (COPD).  Specifically, we describe the manufacturing approach and in vitro test for a spray-dried ipratropium bromide/albuterol sulfate dry-powder combination formulation that contained dextran as an excipient.

A combination powder fit for pulmonary delivery via inhalation was developed and spray-dried on a small-scale custom Bend Research spray dryer.  Solid-state characteristics were evaluated using scanning electron microscopy (SEM), next-generation impaction (NGI), modified differential scanning calorimetry (mDSC), and powder x-ray diffraction (PXRD) analyses.  Humidity-exposure studies were performed to determine the glass-transition temperature (Tg) of the formulation after water uptake.

In vitro solid-state characterization revealed that the spray-dried combination ipratropium bromide/albuterol sulfate powder was amorphous with a single Tg.  The size of the powder particles was in the range needed for delivery throughout the lung airways.

Using aerosol and solid-state characterization analytical tools, we confirmed the feasibility of manufacturing a combination spray-dried powder fit for inhalation and lung delivery using two compounds typically used to treat asthma and COPD.

This poster was presented at the 2014 PBP World Meeting.