Inhalation

INH1018

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Inhalation OctOber 2018 19 to be free-flowing and comparable to lactose (ffc Parteck M DPI = 46, ffc Lactose = 39). When subjected to moisture, it adsorbed a small amount of water (1.65% ± 0.20% at 90% RH). Pronounced adsorption of water vapor did not start below 80% RH (Figure 3). This low amount of water indicates a very slightly hygroscopic and crystalline 9 material with high physical stability. Consequently, Parteck M DPI possesses an important characteristic for storage stability. Influence of blender type During the blending process, coarse API agglomerates should break up and be distributed homogenously over the surface of the carrier material. In this study, the results from a low shear tumble blender were compared to those from a high shear mixer. In preliminary experi- ated using Windox 5.4.2.0 software (Sympatec GmbH, Clausthal-Zellerfeld, Germany). Span values were calculated by: span = (x 90 -x 10 )/x 50 ). Reported data is the average of six measurements. In order to measure the hygroscopicity of the carrier material, dynamic vapor sorption (DVS) was used (DVS1, Surface Measurement Systems Ltd., London, United Kingdom). Measurements were executed at iso- thermal conditions (25°C). In one run, relative humid- ity starts at 0% RH and rises to 90% RH in 10% incre- ments. After, it declines in 10% increments to 0% RH and then the process begins again. erefore, one run consists of two cycles. By using scanning electron microscopy (SEM), particle surface and morphology were visualized. Powder was fixed with a carbon sticker and coated with gold using a BAL-TEC SCP 050 Sputter Coater (Leica Instru- ments, Wetzlar, Germany). Samples were evaluated with a Zeiss Ultra 55 plus (Carl Zeiss NTS GmbH, Oberkochen, Germany) using the SE-2 detector and a working voltage of 2 kV. Results and discussion Carrier characterization Parteck M DPI is a spray-granulated mannitol with a wide particle size distribution (mean particle size 114 ± 9 µm, span: 2.3) and a unique, large and rough surface area (Figure 2). Despite its irregular structure and broad particle size distribution, its powder flowability appears Figure 2 SEM images of Parteck M DPI, representing an overview of the powder (left, magnification 250x) and a detailed surface image (right, magnification 500x) 20 μm 20 μm 3 easy ways to book management-forum.co.uk +44 (0)20 7749 4730 info@management-forum.co.uk Now in its 10 th year 1-2 November 2018, London Benefits in attending: • A valuable update on the advances in inhalation technology and inhaled drug delivery • Case studies, regulatory updates, latest therapies and technology innovations • An opportunity to keep abreast of trends in the market • The chance to develop business relationships in this highly innovative industry Media Partner SAVE £300/€420 when using promotional code INHMG18 when registering online Inhaled Drug Delivery Exhibition opportunities are available! For more information contact Customer Services on +44 (0)20 7749 4730 or email: info@management-forum.co.uk Media Partner

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