Application of spray granulation for conversion of a nanosuspension into a dry powder form

European Journal of Pharmaceutical Sciences

Volumn 47, Issue 1, 2012, Pages 35-43

  Bose, Sonali ^a   Schenck, Daniel ^b   Ghosh, Indrajit ^a   Hollywood, Al ^a   Maulit, Ester ^a   Ruegger, Colleen ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

^b UNIVERSITY OF IOWA   (United States)

Author keywords

Fluid bed granulation; HPMC 3 cps; Poorly water soluble; Surface hydrophobicity; Vitamin E TPGS; Wet media milling

Indexed keywords

ALPHA TOCOPHEROL; MACROGOL 10000;

AEROSOL; ANIMAL EXPERIMENT; ARTICLE; BLOOD SAMPLING; DRUG FORMULATION; DRUG SOLUBILITY; DRY POWDER; HYDROPHOBICITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MOISTURE; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SUSPENSION;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; DOGS; MALE; NANOPARTICLES; PARTICLE SIZE; POWDERS; SOLUBILITY; SUSPENSIONS; WATER; X-RAY DIFFRACTION;

EID: 84861355531     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2012.04.020     Document Type: Article

References (31)

1. W. Abdelwahed, G. Degobert, S. Stainmesse, and H. Fessi Freeze-drying of nanoparticles: Formulation, process and storage considerations Adv. Drug Deliv. Rev. 58 2006 1688 1713
2. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability Pharm. Res. 12 3 1995 413 420
3. S.I.F. Badawy, and M.A. Hussain Effect of starting material particle size on its agglomeration behavior in high shear wet granulation AAPS Pharm. Sci. Technol. 593 2004 1 7
4. S. Basa, T. Muniyappan, P. Karatgi, R. Prabhu, and R. Pillai Production and in vitro characterization of solid dosage form incorporating drug nanoparticles Drug Dev. Ind. Pharm. 34 11 2008 1209 1218
5. J. Beirowski, S. Inghelbrecht, A. Arien, and H. Gieseler Freeze-drying of nanosuspensions, 1. Freezing rate versus formulation design as critical factors to preserve the original particle size distribution J. Pharm. Sci. 100 5 2011 1958 1968
6. J. Bouffard, M. Kaster, and H. Dumont Influence of process variables and physico-chemical properties on the granulation mechanism of mannitol in a fluid bed top spray granulator Drug Dev. Ind. Pharm. 31 2005 923 933
7. M.V. Chaubal, and C. Popescu Conversion of nanosuspensions into dry powders by spray drying: a case study Pharm. Res. 25 10 2008 2302 2308
8. R.N. Duvall, K.T. Koshy, and J.W. Pyles Comparison of reactivity of amphetamine, metamphetamine and dimethylamphetamine with lactose and related compounds J. Pharm. Sci. 54 4 1965 607 611
9. L. Farber, G.I. Tardos, and J.N. Michaels Micro-mechanical properties of drying material bridges of pharmaceutical excipients Int. J. Pharm. 306 2005 41 55
10. A. Flemming, and K.M. Picker-Freyer Compaction of lactose drug mixtures: Quantification of the extent of incompatibility by FT-Raman spectroscopy Eur. J. Pharm. Biopharm. 68 2008 802 810
11. I. Ghosh, S. Bose, R. Vippagunta, and F. Harmon Nanosuspension for improving the bioavailability of a poorly soluble drug and screening agents to inhibit crystal growth Int. J. Pharm. 409 2011 260 268
12. S.M. Iveson, and P. Wauters Growth regime map for liquid-bound granules: further development and experimental validation Powder Technol. 117 2001 83 97
13. J. Jinno, N. Kamada, M. Miyake, K. Yamada, T. Mukai, M. Odomi, H. Toguchi, G.G. Liversidge, K. Higaki, and T. Kimura Effect of particle size reduction on dissolution and oral absorption of a poorly water-soluble drug, cilostazol, in beagle dogs J. Cont. Rel. 111 1-2 2006 56 64
14. J.-U.A.H. Junghanns, and R.H. Muller Nanocrystal technology, drug delivery and clinical applications Int. J. Nanomed. 3 3 2008 295 310
15. P. Kayaert, M. Anne, and G. Van den Mooter Bead layering as a process to stabilize nanosuspensions: influence of drug hydrophobicity on nanocrystal reagglomeration following in-vitro release from sugar beads J. Pharm. Pharmacol. 63 11 2011 1446 1453
16. C.A. Lipinski Poor aqueous solubility - an industry wide problem in drug discovery Am. Pharm. Rev. 5 2002 82 85
17. Y. Liu, C. Sun, Y. Hao, T. Jiang, L. Zheng, and S. Wang Mechanism of dissolution enhancement and bioavailability of poorly water soluble celecoxib by preparing stable amorphous nanoparticles J. Pharm. Pharm. Sci. 13 4 2010 589 606
18. D. Mou, H. Chen, J. Wan, H. Xu, and X. Yang Potent dried drug nanosuspensions for oral bioavailability enhancement of poorly soluble drugs with pH-dependent solubility Int. J. Pharm. 413 1-2 2011 237 244
19. R.H. Muller, and K. Peters Nanosuspensions for the formulation of poorly soluble drugs I. Preparation by a size reduction technique Int. J. Pharm. 160 1998 229 237
20. V. Nekkanti, R. Pillai, V. Venkateshwarlu, and T. Harisudhan Development and characterization of solid oral dosage form incorporating candesartan nanoparticles Pharm. Dev. Technol. 14 3 2009 290 298
21. L. Peltonen, and J. Hirvonen Pharmaceutical nanocrystals by wet media milling: critical process parameters, particle fracturing and stabilization methods J. Pharm. Pharmacol. 62 2010 1569 1579
22. B.E. Rabinow Nanosuspensions in drug delivery Nat. Rev. Drug Discov. 3 2004 785 796
23. B. Van Eerdenbrugh, L. Froyen, J.A. Martens, N. Blaton, P. Augustijns, M. Brewster, and G. Van den Mooter Characterization of physico-chemical properties and pharmaceutical performance of sucrose co-freeze-dried solid nanoparticulate powders of the anti-HIV agent loviride prepared by media milling Int. J. Pharm. 338 1-2 2007 198 206
24. B. Van Eerdenbrugh, S. Vercruysse, J.A. Martens, J. Vermant, L. Froyen, J. Van Humbeeck, G. Van den Mooter, and P. Augustijns Microcrystalline cellulose, a useful alternative for sucrose as a matrix former during freeze-drying of drug nanosuspensions-a case study with itraconazole Eur. J. Pharm. Biopharm. 70 2 2008 590 596
25. B. Van Eerdenbrugh, L. Froyen, J. Van Humbeeck, J.A. Martens, P. Augustijns, and G. Van den Mooter Drying of crystalline drug nanosuspensions- the importance of surface hydrophobicity on dissolution behavior upon redispersion Eur. J. Pharm. Sci. 35 2008 127 135
26. B. Van Eerdenbrugh, J. Vermant, J.A. Martens, L. Froyen, J. Van Humbeeck, P. Augustijns, and G. Van den Mooter A screening study of surface stabilization during the production of drug nanocrystals J. Pharm. Sci. 98 6 2009 2091 2103
27. P. Van Hoogevest, X. Liu, and A. Fahr Drug delivery strategies for poorly water soluble drugs: the industrial perspective Expert Opin. Drug Deliv. 8 11 2011 1481 1500
28. G.M. Venkatesh, M.E. Barnett, C. Owusu-Fordjour, and M. Galop Detection of low levels of the amorphous phase in crystalline pharmaceutical materials by thermally stimulated current spectrometry Pharm. Res. 18 1 2001 98 103
29. B.H. Wang, W.B. Zhang, W. Zhang, A.S. Mujumdar, and L.X. Huang Progress in drying technology for nanomaterials Dry. Technol. 23 2005 7 32
30. Y. Wang, Z. Liu, D. Zhang, X. Gao, X. Zhang, C. Duan, L. Jia, F. Feng, Y. Huang, Y. Shen, and Q. Zhang Development and in vitro evaluation of deacety mycoepoxydiene nanosuspension Colloid. Surf. B 83 2 2011 189 197
31. K. Yamasaki, P.C. Kwok, K. Fukushige, R.K. Prud'homme, and H.K. Chan Enhanced dissolution of inhalable cyclosporine nano-matrix particles with mannitol as matrix former Int. J. Pharm. 420 1 2011 34 42