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22 OctOber 2018 Inhalation philic carrier (lactose) in comparison to BUD and lac- tose. SBS acquired counteracting electrostatic charges, 15 which were expected to disappear with an uptake of humidity over storage time. It was seen that at 0% RH, FPF remained at the same level over storage time. At 0% RH, no water adsorption can take place; therefore the influence of electrostatic charge is more important. At 45% RH, FPF initially increased until the one-month data point due to reduction of electro- static charge and therefore reduced particle adherence. Over prolonged storage time, the adsorption of water and, consequently, the adherence of SBS particles on the mannitol carrier increased so that FPF was reduced again to the starting level (i.e., no significant difference between values at day 0 and after 14 months). is was different at the increased humidity of 75% RH where FPF continuously decreased. Here, the effect of water adsorption increases capillary forces and therefore adhesion of API particles to the carrier is predominant. Similar results, also using mannitol as a carrier, could be seen by Harjunen, et al. 16 Conclusion Physico-chemical characterization of Parteck M DPI demonstrated that it is a suitable carrier for DPI formu- lations. is mannitol substance is a crystalline, slightly hygroscopic and solid material. Homogeneous blends with a low API content were produced with a tumble blender as well as with a high shear mixer and resulted in suitable FPFs. Generally, blends exhibited good storage stability with constant FPF values, if they were stored under moderate relative humidity (< 45% RH for SBS and < 75% RH for BUD). ese results underline the suitability of the mannitol carrier Parteck M DPI as an alternative in DPI formulations. References 1. Timsina M, Martin G, Marriott C, Ganderton D, Yianneskis M: Drug delivery to the respiratory tract using dry powder inhalers. International Journal of Pharmaceutics, 1994; 101: 1-13. 2. Rahimpour Y, Kouhsoltani M, Hamishehkar H: Alternative carriers in dry powder inhaler formulations. Drug Discovery Today, 2014; 19(5) 618-626. 3. Garnier S, Petit S, Mallet F, Petit M-N, Lemarchand D, Coste S, Lefebvre J, Coquerel G: Influence of age- ing, grinding and preheating on the thermal behavior of alpha-lactose monohydrate. International Journal of Pharmaceutics, 2008; 361: 131-140. 4. Steckel H, Bolzen N; Alternative sugars as potential carriers for dry powder inhalations. International Jour- nal of Pharmaceutics, 2004; 270(1-2): 297-306. 5. United States Food and Drug Administration: Inac- tive Ingredient Search for Approved Drug Products— Mannitol. Internet data base; accessed July 20, 2016. 6. Kaialy W, Martin GP, Ticehurst MD, Momin M, Nokhodchi A: e enhanced aerosol performance of salbutamol from dry powders containing engineered mannitol as excipient. International Journal of Pharma- ceutics, 2010; 392: 178-188. 7. Rhein N, Birk G, Scherließ R: Parteck ® M DPI— A novel mannitol as carrier in dry powder inhalation for- mulations. Drug Delivery to the Lungs 27, 2016; Edinburgh, UK. 8. Rhein N, Birk G, Scherließ R: Influence of drug con- centration on dry powder inhaler formulations based on a mannitol and a lactose carrier system. Dalby, R. et al. (Ed.), Respiratory Drug Delivery. Davies Healthcare International Publishing, Tucson, AZ, USA (2018). 9. Rhein N, Birk G, Scherließ R: Characterization of particle engineered mannitol as alternative carriers in dry powder inhalation formulations. Drug Delivery to the Lungs 26, 2015; Edinburgh, UK. 10. Hertel M, Schwarz E, Kobler M, Hauptstein S, Steckel H, Scherließ R: e influence of high shear mix- ing on ternary dry powder inhaler formulations. Inter- national Journal of Pharmaceutics, 2017; 534: 242-250. 11. Kobler M, Hertel M, Hauptstein S, Steckel H, Scherließ R: Influence of storage conditions on micron- ized lactose and the resulting ternary dry powder Figure 7 Fine particle fraction of the two formulations (BUD = gray, SBS = blue) tested with the Novolizer in up to 14 months of storage at three different relative humidities; mean values with standard deviation; n = 3 60 40 20 0 Fine particle fraction (%) Time (months) 0 2 4 6 8 10 12 14 16 0% RH, BUD 45% RH, BUD 75% RH, BUD 0% RH, SBS 45% RH, SBS 75% RH, SBS