Cell and tissue-based in vitro models for improving the development of oral inhalation drug products

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 118, Issue , 2017, Pages 73-78

  Hittinger, Marius ^a,b   Schneider Daum, Nicole ^b   Lehr, Claus Michael ^a,b,c  

^a PharmBioTec GmbH   (Germany)

^b SAARLAND UNIVERSITY   (Germany)

^c SAARLAND UNIVERSITY   (Germany)

Author keywords

3R; Animal replacement; Inhalation toxicity; Lung model; Respiratory tract

Indexed keywords

AEROSOL; CELL CULTURE; DRUG CYTOTOXICITY; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG EFFICACY; DRUG SAFETY; IN VITRO STUDY; INHALATION; LUNG MODEL; RESPIRATORY SYSTEM; REVIEW; RISK ASSESSMENT; TISSUE CULTURE; TOXICOLOGY; ADMINISTRATION AND DOSAGE; ANIMAL; CELL CULTURE TECHNIQUE; CYTOLOGY; HUMAN; INHALATIONAL DRUG ADMINISTRATION; LUNG; MEDICINAL CHEMISTRY; METABOLISM; PRACTICE GUIDELINE; PROCEDURES; STANDARDS; TISSUE CULTURE TECHNIQUE;

ADMINISTRATION, INHALATION; AEROSOLS; ANIMALS; CELL CULTURE TECHNIQUES; CELLS, CULTURED; CHEMISTRY, PHARMACEUTICAL; DRUG DELIVERY SYSTEMS; GUIDELINES AS TOPIC; HUMANS; LUNG; RISK ASSESSMENT; TISSUE CULTURE TECHNIQUES;

EID: 85014849896     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2017.02.019     Document Type: Review

References (49)

1. OECD, Guidance Document on Acute Inhalation Toxicity Testing – Environment, Health and Safety Publications Series on Testing and Assessment No. 39, 2009.
2. OECD, Guideline for the Testing of Chemicals – Draft Updated Subchronic Inhalation Toxicity: 90-day Study, 2015.
3. OECD, Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials – Series on the Safety of Manufactured Nanomaterials No. 36, 2012.
4. EMA, Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, 2006.
5. FDA, Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls Documentation, 2002.
6. EMA, Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Asthma, 2015.
7. EMA, Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease (COPD), 2012.
8. EMA, Guideline on Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome, 2006.
9. EMA, Guideline on the Clinical Development of Medicinal Products for the Treatment of Cystic Fibrosis, 2009.
10. A.J. Roi, B. Grune, The European Centre for the Validation of Alternative Methods Search Guide Basic Principles, 2011.
11. European Parliament and the council of the European Union, Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes, Off. J. Eur. Union, 2010, pp. 33–79.
12. Bundesministerium für Risikobewertung (BfR), AnimAlt-ZEBET – Datenbank für Alternativmethoden zu Tierversuchen, < http://www.bfr.bund.de/de/animalt_zebet___datenbank_fuer_alternativmethoden_zu_tierversuchen-59741.html>, 2017.
13. European Commission Joint Research Centre, EURL ECVAM DataBase service on Alterative Methods to animal experimentation (DB-ALM), < https://ecvam-dbalm.jrc.ec.europa.eu/>, 2017.
14. OECD, Guidance Document for Describing Non-guideline In Vitro Test Methods – Series on Testing and Assessment No. 211, 2014.
15. Marks, J., Mason, M.A., A quantitative technique for studying the effect of dust on phagocytic cells in vitro. Br. J. Indust. Med., 192–195, 1956.
16. Hess, A., Wang-Lauenstein, L., Braun, A., Kolle, S.N., Landsiedel, R., Liebsch, M., Ma-Hock, L., Pirow, R., Schneider, X., Steinfath, M., Vogel, S., Martin, C., Sewald, K., Prevalidation of the ex-vivo model PCLS for prediction of respiratory toxicity. Toxicol. In Vitro, 2016, 10.1016/j.tiv.2016.01.006.
17. Sauer, U.G., Vogel, S., Hess, A., Kolle, S.N., Ma-Hock, L., van Ravenzwaay, B., Landsiedel, R., In vivo-in vitro comparison of acute respiratory tract toxicity using human 3D airway epithelial models and human A549 and murine 3T3 monolayer cell systems. Toxicol. In Vitro 27 (2013), 174–190, 10.1016/j.tiv.2012.10.007.
18. Sauer, U.G., Vogel, S., Aumann, A., Hess, A., Kolle, S.N., Ma-Hock, L., Wohlleben, W., Dammann, M., Strauss, V., Treumann, S., Gröters, S., Wiench, K., Van Ravenzwaay, B., Landsiedel, R., Applicability of rat precision-cut lung slices in evaluating nanomaterial cytotoxicity, apoptosis, oxidative stress, and inflammation. Toxicol. Appl. Pharmacol. 276 (2014), 1–20, 10.1016/j.taap.2013.12.017.
19. Wohlleben, W., Driessen, M.D., Raesch, S., Schaefer, U.F., Schulze, C., Von Vacano, B., Vennemann, A., Wiemann, M., Ruge, C.A., Platsch, H., Mues, S., Ossig, R., Tomm, J.M., Schnekenburger, J., Kuhlbusch, T.A.J., Luch, A., Lehr, C., Haase, A., Influence of agglomeration and specific lung lining lipid/protein interaction on short-term inhalation toxicity. Nanotoxicology 10 (2016), 970–980, 10.3109/17435390.2016.1155671.
20. Sorli, J.B., Hansen, J.S., Nørgaard, A.W., Levin, M., Larsen, S.T., An in vitro method for predicting inhalation toxicity of impregnation spray products. Altex 32 (2015), 101–111, 10.14573/altex.1408191.
21. Soldatow, V.V.Y., Lecluyse, E.E.L., Griffith, L.L.G., Rusyn, I., In vitro models for liver toxicity testing. Toxicol. Res. 2 (2013), 23–39, 10.1039/C2TX20051A.In.
22. Castell, J.V., Donato, M.T., Gómez-Lechón, M.J., Metabolism and bioactivation of toxicants in the lung. The in vitro cellular approach. Exp. Toxicol. Pathol. 57 (2005), 189–204, 10.1016/j.etp.2005.05.008.
23. Warsinske, H.C., Wheaton, A.K., Kim, K.K., Linderman, J.J., Moore, B.B., Kirschner, D.E., Computational modeling predicts simultaneous targeting of fibroblasts and epithelial cells is necessary for treatment of pulmonary fibrosis. Front. Pharmacol., 7, 2016, 10.3389/fphar.2016.00183.
24. Murgia, X., Pawelzyk, P., Schaefer, U.F., Wagner, C., Willenbacher, N., Lehr, C.-M., Size-limited penetration of nanoparticles into porcine respiratory mucus after aerosol deposition. Biomacromolecules, 2016, 10.1021/acs.biomac.6b00164.
25. Ong, H.X., Benaouda, F., Traini, D., Cipolla, D., Gonda, I., Bebawy, M., Forbes, B., Young, P.M., 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, 10.1016/j.ejpb.2013.06.024.
26. Thorley, A.J., Ruenraroengsak, P., Potter, T.E., Tetley, T.D., Critical determinants of uptake and translocation of nanoparticles by the human pulmonary alveolar epithelium. ACS Nano 8 (2014), 11778–11789, 10.1021/nn505399e.
27. Salomon, J.J., Muchitsch, V.E., Gausterer, J.C., Schwagerus, E., Huwer, H., Daum, N., Lehr, C.M., Ehrhardt, C., The cell line NCl-H441 is a useful in vitro model for transport studies of human distal lung epithelial barrier. Mol. Pharm. 11 (2014), 995–1006, 10.1021/mp4006535.
28. Kuehn, A., Kletting, S., de Souza Carvalho-Wodarz, C., Repnik, U., Griffiths, G., Fischer, U., Meese, E., Huwer, H., Wirth, D., May, T., Schneider-Daum, N., Lehr, C.-M., Human alveolar epithelial cells expressing tight junctions to model the air-blood barrier. ALTEX, 2016, 1–20, 10.14573/altex.1511131.
29. Hittinger, M., Juntke, J., Kletting, S., Schneider-Daum, N., de Souza Carvalho, C., Lehr, C.-M., Preclinical safety and efficacy models for pulmonary drug delivery of antimicrobials with focus on in vitro models. Adv. Drug Delivery Rev. 85 (2015), 44–56, 10.1016/j.addr.2014.10.011.
30. Herzog, F., Loza, K., Balog, S., Clift, M.J., Epple, M., Gehr, P., Petri-Fink, A., Rothen-Rutishauser, B., Mimicking exposures to acute and lifetime concentrations of inhaled silver nanoparticles by two different in vitro approaches. Beilstein J. Nanotechnol. 5 (2014), 1357–1370, 10.3762/bjnano.5.149.
31. Hein, S., Bur, M., Kolb, T., Muellinger, B., Schaefer, U.F., Lehr, C.-M., The pharmaceutical aerosol deposition device on cell cultures (PADDOCC) in vitro system: design and experimental protocol. Alternatives Lab. Animals: ATLA 38 (2010), 285–295 .
32. Stucki, A.O., Stucki, J.D., Hall, S.R., Felder, M., Mermoud, Y., Schmid, R.A., Geiser, T., Guenat, O.T., A lung-on-a-chip array with an integrated bio-inspired respiration mechanism. Lab Chip., 2014, 10.1039/c4lc01252f.
33. Benam, K.H., Dauth, S., Hassell, B., Herland, A., Jain, A., Jang, K.J., Karalis, K., Kim, H.J., MacQueen, L., Mahmoodian, R., Musah, S., Torisawa, Y.S., van der Meer, A.D., Villenave, R., Yadid, M., Parker, K.K., Ingber, D.E., Engineered in vitro disease models. Annu. Rev. Pathol. 10 (2015), 195–262, 10.1146/annurev-pathol-012414-040418.
34. Collan, Y., Kosma, V.-M., Anttonen, H., Kulju, T., Toxicity of Richterite in hemolysis test and macrophage cultures. Arch. Toxicol. Suppl., 1986, 292–295, 10.1007/978-3-642-71248-7_48.
35. Barile, F.A., Cardona, M., Acute cytotoxicity testing with cultured human lung and dermal cells. In Vitro Cell. Dev. Biol. – Animal 34 (1998), 631–635, 10.1007/s11626-996-0011-0.
36. Zamora, P.O., Benson, J.M., Marshall, T.C., Mokier, B.V., Li, A.P., Dahl, A.R., Brooks, A.L., McClellan, R.O., Cytotoxicity and mutagenicity of vapor-phase pollutants in rat lung epithelial cells and Chinese hamster ovary cells grown on collagen gels. J. Toxicol. Environ. Health 12 (1983), 27–38, 10.1080/15287398309530405.
37. Huh, D., Matthews, B.D., Mammoto, A., Montoya-Zavala, M., Hsin, H.Y., Ingber, D.E., Reconstituting organ-level lung functions on a chip. Science 328 (2010), 1662–1668, 10.1126/science.1188302.
38. Frank, J.A., Briot, R., Lee, J.W., Ishizaka, A., Uchida, T., Matthay, M.a., Physiological and biochemical markers of alveolar epithelial barrier dysfunction in perfused human lungs. AJP: Lung Cell. Mol. Physiol. 293 (2007), L52–L59, 10.1152/ajplung.00256.2006.
39. Bion, A., Fall, M., Gouriou, F., Le Prieur, E., Dionnet, F., Morin, J.P., Biphasic culture of rat lung slices for pharmacotoxicological evaluation of complex atmospheres. Cell Biol. Toxicol., 2002, 301–314, 10.1023/A:1019544416969.
40. Le Prieur, E., Vaz, E., Bion, A., Dionnet, F., Morin, J.P., Toxicity of diesel engine exhausts in an in vitro model of lung slices in biphasic organotypic culture: induction of a proinflammatory and apoptotic response. Arch. Toxicol. 74 (2000), 460–466, 10.1007/s002040000138.
41. Monteil, C., Le Prieur, E., Buisson, S., Morin, J.P., Guerbet, M., Jouany, J.M., Acrolein toxicity: comparative in vitro study with lung slices and pneumocytes type II cell line from rats. Toxicology 133 (1999), 129–138, 10.1016/S0300-483X(99)00015-3.
42. Aufderheide, M., Knebel, J.W., Ritter, D., Novel approaches for studying pulmonary toxicity in vitro. Toxicol. Lett., 2003, 205–211, 10.1016/S0378-4274(02)00512-X.
43. Schuster, B.S., Suk, J.S., Woodworth, G.F., Hanes, J., Nanoparticle diffusion in respiratory mucus from humans without lung disease. Biomaterials 34 (2013), 3439–3446, 10.1016/j.biomaterials.2013.01.064.
44. Wohlsen, A., Martin, C., Vollmer, E., Branscheid, D., Magnussen, H., Becker, W.M., Lepp, U., Uhlig, S., The early allergic response in small airways of human precision-cut lung slices. Eur. Respir. J. 21 (2003), 1024–1032.
45. Ruge, C.A., Schaefer, U.F., Herrmann, J., Kirch, J., Canadas, O., Echaide, M., Perez-Gil, J., Casals, C., Muller, R., Lehr, C.M., The interplay of lung surfactant proteins and lipids assimilates the macrophage clearance of nanoparticles. PLoS One, 7, 2012, e40775, 10.1371/journal.pone.0040775.
46. Larsen, S.T., Dallot, C., Larsen, S.W., Rose, F., Poulsen, S.S., Norgaard, A.W., Hansen, J.S., Sorli, J.B., Nielsen, G.D., Foged, C., Mechanism of action of lung damage caused by a nanofilm spray product. Toxicol. Sci. 140 (2014), 436–444, 10.1093/toxsci/kfu098.
47. Gasser, M., Wick, P., Clift, M.J., Blank, F., Diener, L., Yan, B., Gehr, P., Krug, H.F., Rothen-Rutishauser, B., Pulmonary surfactant coating of multi-walled carbon nanotubes (MWCNTs) influences their oxidative and pro-inflammatory potential in vitro. Part Fibre Toxicol., 9, 2012, 17, 10.1186/1743-8977-9-17.
48. Clift, M.J., Endes, C., Vanhecke, D., Wick, P., Gehr, P., Schins, R.P., Petri-Fink, A., Rothen-Rutishauser, B., A comparative study of different in vitro lung cell culture systems to assess the most beneficial tool for screening the potential adverse effects of carbon nanotubes. Toxicol. Sci. 137 (2014), 55–64, 10.1093/toxsci/kft216.
49. Lauenstein, L., Switalla, S., Prenzler, F., Seehase, S., Pfennig, O., Förster, C., Fieguth, H., Braun, A., Sewald, K., Assessment of immunotoxicity induced by chemicals in human precision-cut lung slices (PCLS). Toxicol. In Vitro 28 (2014), 588–599, 10.1016/j.tiv.2013.12.016.