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44 October 2016 Tablets & Capsules capsules or blisters should work fine with carriers that have a smaller parti- cle size, such as InhaLac 120, InhaLac 230, and InhaLac 251. Typically, lac- tose fines are added in concentrations ranging between 5 and 15 percent. However, especially in the develop- ment of generic DPI formulations, the goal is not always to achieve the best possible performance of the DPI. Rather, it is to match the performance of the innovator's product. In order to do that, mixtures with different coarse carriers are as conceivable as special, customized particle size distributions. T&C References 1. P. Zanen, L.T. Go, J.W. Lammers, Thorax 51 (10), 977-980 (1996). 2. J.C. Feeley, P. York, B.S. Sumby and H. Dicks, Int. J. Pharm. 172 (1-2), 89-96 (1998). 3. FDA, "Guidance for Industry, Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients" (Rockville, MD, May 2005). 4. J. Visser, Powder Technol. 58 (1), 1-10 (1989). 5. A.J. Hickey, N.M. Concessio, M. M Van Oort and R.M. Platz, Pharm. Technol. 18 (8), 58-64 (1994). 6. A.H. de Boer, P. Hagedoorn, D. Gjaltema, J. Goede, and H.W. Frijlink, Int. J. Pharm. 310 (1-2), 81-89 (2006). 7. M. Hertel, E. Schwarz, E.M. Littringer, M. Dogru, R. Scherließ and H. Steckel, Proceedings of Drug Delivery to the Lungs 26, (UK, Edinburgh, 2015). 8. InhaLac is a registered trademark of Meggle. 9. A.H. de Boer, P. Hagedoorn, D. Gjaltema, J. Goede and H.W. Frijlink, Int. J. Pharm., 260 (2), 187-200 (2003). 10. M.S. Coates, D.F. Fletcher, H.K. Chan and J.A. Raper, Pharm. Res., 22 (6), 923-932 (2005). 11. L. Jiang, Y. Tang, H. Zhang, X. Lu, X. Chen and J. Zhu, J. Aerosol. Med. Pulm. Drug. Deliv. 25 (5), 265- 279 (2012). 12. X.M. Zeng, G.P. Martin, C. Marriott and J. Pritchard, J. Pharm. Pharmacol., 52 (10), 1211-1221 (2000). 13. J. Shur, H. Harris, M.D. Jones, J.S. Kaerger and R. Price, Pharm. Res., 25 (7), 1631-1640 (2008). 14. E.M. Littringer, M. Dogru and E. Schwarz, Inhalation (Feburary 2015). 15. H.W. Frijlink and A.H. De Boer, Expert Opin. Drug Deliv., 1 (1) 67-86 (2004). 16. X. M. Zeng, G.P. Martin, S.K. Tee and C. Mariott, Int. J. Pharmaceut., 176 (1), 99-110 (1988). 17. H. Hamishehkar, Y. Rahimpour and Y. Javadzadeh, "The Role of Carrier in Dry Powder Inhaler" in Recent Advances in Novel Drug Carrier Systems, A.D. Sezer, Ed. (InTech d.o.o, Croatia, 51000 Rijeka Janeza Trdine 9, 2012). 18. P. Lucas, K. Anderson and J.N. Staniforth, Pharm. Res. 15 (4), 562-569 (1998). 19. H. Dickhoff, A.H. de Boer, D. Lambregts and H.W. Frijlink, Int. J. Pharm. 327 (1-2), 17-25 (2006). 20. E.M. Littringer, M. Lober E. Schwarz and K. Seyfang, Proceedings of Drug Delivery to the Lungs 24, (UK, Edinburgh, 2013). Sabine Hauptstein, PhD, is project man- ager, dry powder inhaler, and the corre- sponding author; Mirjam Kobler, PhD, is senior project manager of analytics; Eva Lit- tringer, PhD, is senior project manager, dry powder inhaler; and Eugen Schwarz, PhD, is head of R&D at Meggle Excipients and Technology, Megglestrasse 6-12, D-83512 Wasserburg, Germany. Tel. +49 8071 73 499. E-mail: sabine.hauptstein@meggle.de. p c ese E oun er 100 c ve t in o en pr y w ompan Global c Pharma e in t ellenc c Ex a atin Americ tries and the leader in L n e, xperienc ears of ex e than 30 ye with mor cipients eutical Exc ac e of actur the Manuf p O SO o I Micr MI AB® OLUTAB® stalline Cellulose y ocr ICROCEL® OSE SC® ABUL TABUL e olat c ch Gly Sodium Star OSOL® EXPL ® se ® USA Office | Phones oduction an r or P f echnical S Global T Technical Suppor (561) 416 – 5513 / (561) 416 – 56 : d R&D t Suppor ns o i t ormula f e R lopme e v e D w e N t s ssi A al c ni ch e Te os s acturing Plant: Cr Manuf 63 Itap e vic Ser e Specializ p u e al c S and ents, r o f e c tan scarmellose Sodium om c er v blan azil | www aulo | Br vi | São P pe omer t ed Cus m tics ogis L t in Time Jus Cellulose Colloidal Microcrystalline (561) 416 5513 / (561) 416 56 (561) 416 5513 / (561) 416 56 USA Office | Phones: USA Office | Phones: acturing Plant: acturing Plant: Manuf Manuf 63 63 blan .blan azil | www azil | www aulo | Br aulo | Br vi | São P vi | São P Itape Itape om om c er. er v n