Potential of the isolated lung technique for the examination of sildenafil absorption from lung-delivered poly(lactide-co-glycolide) microparticles

Journal of Controlled Release

Volumn 226, Issue , 2016, Pages 15-20

  Beck Broichsitter, Moritz ^a,b   Stoisiek, Katharina ^a   Bohr, Adam ^c   Aragão Santiago, Leticia ^d   Gessler, Tobias ^a   Seeger, Werner ^a   Kissel, Thomas ^b  

^a JUSTUS LIEBIG UNIVERSITY   (Germany)

^b PHILIPPS UNIVERSITY MARBURG   (Germany)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d Groupe Hospitalier Pitié Salpêtrière   (France)

Author keywords

Controlled drug delivery; Correlation; Drug absorption; Drug release; Isolated lung; Polymeric microparticles

Indexed keywords

BIOLOGICAL ORGANS; CORRELATION METHODS; GLASS TRANSITION; PARTICLE SIZE; POLYMERS;

CONTROLLED RELEASE; DRUG ABSORPTION; DRUG RELEASE; DRUG-RELEASE RATE; ISOLATED LUNG; POLY LACTIDE-CO-GLYCOLIDE; POLYMERIC MICROPARTICLES; RELEASE BEHAVIORS;

CONTROLLED DRUG DELIVERY;

POLYGLACTIN; SILDENAFIL; DELAYED RELEASE FORMULATION; DRUG CARRIER; VASODILATOR AGENT;

ANIMAL TISSUE; ARTICLE; BIOCOMPATIBILITY; BIODEGRADABILITY; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CORRELATION ANALYSIS; DRUG ABSORPTION; DRUG DELIVERY SYSTEM; DRUG HALF LIFE; DRUG SOLUBILITY; DRY POWDER; EX VIVO STUDY; EXPERIMENTAL RABBIT; GLASS TRANSITION TEMPERATURE; IN VITRO STUDY; ISOLATED LUNG; MEAN DISSOLUTION TIME; MEAN RESIDENCE TIME; MICROENCAPSULATION; MOLECULAR WEIGHT; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SPRAY DRYING; ANIMAL; CHEMISTRY; DELAYED RELEASE FORMULATION; DRUG FORMULATION; DRUG RELEASE; LUNG; METABOLISM; RABBITS AND HARES; TRANSITION TEMPERATURE;

ANIMALS; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; DRUG COMPOUNDING; DRUG LIBERATION; LUNG; PARTICLE SIZE; POLYGLACTIN 910; RABBITS; SILDENAFIL CITRATE; TRANSITION TEMPERATURE; VASODILATOR AGENTS;

EID: 84957575290     PISSN: 01683659     EISSN: 18734995     Source Type: Journal    
DOI: 10.1016/j.jconrel.2016.01.057     Document Type: Article

References (47)

1. J.L. Rau The inhalation of drugs: advantages and problems Respir. Care 50 2005 367 382
2. F. Ichinose, J. Erana-Garcia, J. Hromi, Y. Raveh, R. Jones, L. Krim, M.W.H. Clark, J.D. Winkler, K.D. Bloch, and W.M. Zapol Nebulized sildenafil is a selective pulmonary vasodilator in lambs with acute pulmonary hypertension Crit. Care Med. 29 2001 1000 1005
3. A.J. Hickey Controlled delivery of inhaled therapeutic agents J. Control. Release 190 2014 182 188
4. C. Loira-Pastoriza, J. Todoroff, and R. Vanbever Delivery strategies for sustained drug release in the lungs Adv. Drug Deliv. Rev. 75 2014 81 91
5. Z. Liang, R. Ni, J. Zhou, and S. Mao Recent advances in controlled pulmonary drug delivery Drug Discov. Today 20 2015 380 389
6. D. Cipolla, B. Shekunov, J. Blanchard, and A.J. Hickey Lipid-based carriers for pulmonary products: preclinical development and case studies in humans Adv. Drug Deliv. Rev. 75 2014 53 80
7. C.A. Fernandes, and R. Vanbever Preclinical models for pulmonary drug delivery Expert Opin. Drug Deliv. 6 2009 1231 1245
8. J.G. Weers, J. Bell, H.K. Chan, D. Cipolla, C. Dunbar, A.J. Hickey, and I.J. Smith Pulmonary formulations: what remains to be done? J. Aerosol Med. 23 2010 S5 S23
9. B. Forbes, B. Asgharian, L.A. Dailey, D. Ferguson, P. Gerde, M. Gumbleton, L. Gustavsson, C. Hardy, D. Hassall, R. Jones, R. Lock, J. Maas, T. McGovern, G.R. Pitcairn, G. Somers, and R.K. Wolff Challenges in inhaled product development and opportunities for open innovation Adv. Drug Deliv. Rev. 63 2011 69 87
10. S. Sakagami In vivo, in vitro and ex vivo models to assess pulmonary absorption and disposition of inhaled therapeutics for systemic delivery Adv. Drug Deliv. Rev. 58 2006 1030 1060
11. K. Nahar, N. Gupta, R. Gauvin, S. Absar, B. Patel, V. Gupta, A. Khademhosseini, and F. Ahsan In vitro, in vivo and ex vivo models for studying particle deposition and drug absorption of inhaled pharmaceuticals Eur. J. Pharm. Sci. 49 2013 805 818
12. M. Beck-Broichsitter, M. Rieger, R. Reul, T. Gessler, W. Seeger, and T. Schmehl Correlation of drug release with pulmonary drug absorption profiles for nebulizable liposomal formulations Eur. J. Pharm. Biopharm. 84 2013 106 114
13. H.X. Ong, F. Benaouda, D. Traini, D. Cipolla, I. Gonda, M. Bebawy, B. Forbes, and P.M. Young In vitro and ex vivo methods predict the enhanced lung residence time of liposomal ciprofloxacin formulations for nebulisation Eur. J. Pharm. Biopharm. 86 2014 83 89
14. H.A. Ghofrani, I.H. Osterloh, and F. Grimminger Sildenafil: from angina to erectile dysfunction to pulmonary hypertension and beyond Nat. Rev. Drug Discov. 5 2006 689 702
15. U. Westedt, M. Kalinowski, M. Wittmar, T. Merdan, F. Unger, J. Fuchs, S. Schäller, U. Bakowsky, and T. Kissel Poly (vinyl alcohol)-graft-poly(lactide-co-glycolide) nanoparticles for local delivery of paclitaxel for restenosis treatment J. Control. Release 119 2007 41 51
16. T. Lebhardt, S. Roesler, H.P. Uusitalo, and T. Kissel Surfactant-free redispersible nanoparticles in fast-dissolving composite microcarriers for dry-powder inhalation Eur. J. Pharm. Biopharm. 78 2013 90 96
17. M. Beck-Broichsitter, C. Schweiger, T. Schmehl, T. Gessler, W. Seeger, and T. Kissel Characterization of novel spray-dried polymeric particles for controlled pulmonary drug delivery J. Control. Release 158 2012 329 335
18. N. Bege, T. Renette, T. Endres, M. Beck-Broichsitter, D. Hänggi, and T. Kissel In situ forming nimodipine depot system based on microparticles for the treatment of posthemorrhagic cerebral vasospasm Eur. J. Pharm. Biopharm. 84 2013 99 105
19. M. Beck-Broichsitter, I.E. Paulus, A. Greiner, and T. Kissel Modified vibrating-mesh nozzles for advanced spray-drying applications Eur. J. Pharm. Biopharm. 92 2015 96 101
20. M. Beck-Broichsitter, B. Strehlow, and T. Kissel Direct fractionation of spray-dried sildenafil-loaded polymeric microparticles by inertial impaction Powder Technol. 286 2015 311 317
21. M. Beck-Broichsitter, A. Bohr, L. Aragao Santiago, A. Klingl, K. Bolte, and T. Kissel Formulation and process considerations for the design of sildenafil-loaded polymeric microparticles by vibrational spray-drying Pharm. Dev. Technol. 2015 10.3109/10837450.2015.1098661
22. W. Seeger, D. Walmrath, F. Grimminger, S. Rosseau, H. Schütte, H.J. Krämer, L. Ermert, and L. Kiss Adult respiratory distress syndrome: model systems using isolated perfused rabbit lungs Methods Enzymol. 233 1994 549 584
23. K. Lahnstein, T. Schmehl, U. Rüsch, M. Rieger, W. Seeger, and T. Gessler Pulmonary absorption of aerosolized fluorescent markers in the isolated rabbit lung Int. J. Pharm. 351 2008
24. M. Beck-Broichsitter, J. Gauss, C.B. Packhaeuser, K. Lahnstein, T. Schmehl, W. Seeger, T. Kissel, and T. Gessler Pulmonary drug delivery with aerosolizable nanoparticles in an ex vivo lung model Int. J. Pharm. 367 2009 169 178
25. M. Beck-Broichsitter, J. Gauss, T. Gessler, W. Seeger, T. Kissel, and T. Schmehl Pulmonary targeting with biodegradable salbutamol-loaded nanoparticles J. Aerosol Med. 23 2010 47 57
26. M. Beck-Broichsitter, T. Schmehl, W. Seeger, and T. Gessler Evaluating the controlled release properties of inhaled nanoparticles using isolated, perfused, and ventilated lung models J. Nanomater. 2011 163791
27. C.A. Ruge, A. Bohr, M. Beck-Broichsitter, V. Nicolas, N. Tsapis, and E. Fattal Disintegration of nano-embedded microparticles on mucus: a mechanistic study Colloids Surf. B Bibliographic information 139 2016 219 227
28. A.C. Dalla-Bona, K. Stoisiek, N. Oesterheld, T. Schmehl, T. Gessler, W. Seeger, and M. Beck-Broichsitter Characterization of lung-delivered in-situ forming controlled release formulations J. Pharm. Pharmacol. 67 2015 1349 1354
29. M. Beck-Broichsitter, J. Gauss, C. Schweiger, S. Roesler, T. Schmehl, M. Kampschulte, A.C. Langheinrich, and W. Seeger Micro-computed tomography imaging of composite nanoparticle distribution in the lung Int. J. Pharm. 439 2012 230 233
30. M.T. Sheu, A.B. Wu, G.C. Yeh, A. Hsia, and H.O. Ho Development of a liquid chromatographic method for bioanalytical applications with sildenafil J. Chromatogr. B 791 2003 255 262
31. W. Hofmann Modelling inhaled particle deposition in the human lung - a review J. Aerosol Sci. 42 2011 693 724
32. J.S. Patton, J.D. Brain, L.A. Davies, J. Fiegel, M. Gumbleton, K.J. Kim, S. Sakagami, R. Vanbever, and C. Ehrhardt The particle has landed-characterizing the fate of inhaled pharmaceuticals J. Aerosol Med. 23 2010 S71 S87
33. A. Tronde, B. Norden, A.B. Jeppsson, P. Brunmark, E. Nilsson, H. Lennernäs, and U.H. Bengtsson Drug absorption from the isolated perfused rat lung-correlations with drug physicochemical properties and epithelial permeability J. Drug Target. 11 2003 61 74
34. R.A. Brown Jr., and L.S. Schanker Absorption of aerosolized drugs from the rat lung Drug Metab. Dispos. 11 1983 355 360
35. A. Tronde, B. Norden, H. Marchner, A.K. Wendel, H. Lennernäs, and U.H. Bengtsson Pulmonary absorption rate and bioavailability of drugs in vivo in rats: structure-absorption relationships and physicochemical profiling of inhaled drugs J. Pharm. Sci. 92 2003 1216 1233
36. J. Shen, and D.J. Burgess In vitro-in vivo correlation for complex non-oral drug products: where do we stand? J. Control. Release 219 2015 644 651
37. H.K. Makadia, and S.J. Siegel Poly lactic-co-glycolic acid (PLGA) as biodegradable controlled drug delivery carrier Polymers 3 2011 1377 1397
38. N. Schafroth, C. Arpagaus, U.Y. Jadhav, S. Makne, and D. Douroumis Nano and microparticle engineering of water insoluble drugs using a novel spray-drying process Colloids Surf. B 90 2012 8 15
39. M.C. Fontana, T.L. Durli, A.R. Pohlmann, S.S. Guterres, and R.C.R. beck Polymeric controlled release inhalable powder produced by vibrational spray-drying: one-step preparation and in vitro lung deposition Powder Technol. 258 2014 49 59
40. D. Voegele, D. Brockmeyer, H.M. von Hattingberg, and B.C. Lippold Die mittlere Auflösezeit - ein Parameter zur Prüfung von Liberationsbedingungen auf Vergleichbarkeit Acta Pharm. Technol. 29 1983 167 174
41. S. Fredenberg, M. Wahlgren, M. Reslow, and A. Axelsson The mechanisms of drug release in poly(lactic-co-glycolic acid)-based drug delivery systems - a review Int. J. Pharm. 415 2011 34 52
42. G. Schliecker, C. Schmidt, S. Fuchs, and T. Kissel Characterization of a homologous series of d,l-lactic acid oligomers; a mechanistic study on the degradation kinetics in vitro Biomaterials 24 2003 3835 3844
43. W.G. Kreyling, M. Semmler-Behnke, S. Takenaka, and W. Möller Differences in the biokinetics of inhaled nano- versus micrometer-sized particles Acc. Chem. Res. 46 2013 714 722
44. P.R. Byron, N.S. Roberts, and A.R. Clark An isolated perfused rat lung preparation for the study of aerosolized drug deposition and absorption J. Pharm. Sci. 75 1986 168 171
45. Y. Lu, S. Kim, and K. Park In vitro-in vivo correlation: perspectives on model development Int. J. Pharm. 418 2011 142 148
46. A. Ryrfeldt, G. Persson, and E. Nilsson Pulmonary disposition of the potent glucocorticoid budesonide, evaluated in an isolated perfused rat lung model Biochem. Pharmacol. 38 1989 17 22
47. X. Liu, J.Y. Wang, A.M. Khlentzos, F. Fontaine, J. Nikolovski, L.A. Goh, and M.S. Roberts Influence of perfusate composition on drug disposition in the in-situ perfused rat lung Int. J. Pharm. 382 2009 192 197