Establishment and validation of an ex vivo human cervical tissue model for local delivery studies

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 68, Issue 2, 2008, Pages 390-399

  Hiller, Christian ^a   Bock, Udo ^b   Balser, Sigrid ^a   Haltner Ukomadu, Eleonore ^b   Dahm, Michael ^a  

^a Sandoz Biopharmaceuticals   (Germany)

^b ACROSS BARRIERS GMBH   (Germany)

Author keywords

Cervix; Macromolecules; Morphology; Permeability; Uptake

Indexed keywords

BIOLOGICAL MARKER; DEXTRAN 40; FLUORESCEIN ISOTHIOCYANATE DEXTRAN; MANNITOL; PROPRANOLOL DERIVATIVE;

ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG PENETRATION; EX VIVO STUDY; FEMALE; HUMAN; HUMAN TISSUE; HYSTERECTOMY; STATISTICAL SIGNIFICANCE; UTERINE CERVIX; UTERINE CERVIX BIOPSY; VALIDATION STUDY;

FEMALE; HUMANS; MOLECULAR WEIGHT; NUCLEIC ACIDS; PERMEABILITY; UTERINE CERVICAL NEOPLASMS;

EID: 37849026655     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2007.06.014     Document Type: Article

References (34)

1. Walboomers J.M.M., Jacobs M.V., Manos M.M., Bosch F.X., Kummer J.A., Shah K.V., Snijders P.J.F., Peto J., Meijer C.J.L.M., and Munoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worlwide. J. Pathol. 189 (1999) 12-19
2. Bosch F.X., Manos M.M., Munoz N., Sherman M., Jansen A.M., Peto J., Schiffmann M.H., Moreno V., Kurman R., and Shah K.V. Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J. Natl. Cancer Inst. 87 (1995) 796-802
3. zur Hausen H., and de Villiers E.M. Human papillomaviruses. Annu. Rev. Microbiol. 48 (1994) 427-447
4. Larsson G., Gullberg B., and Grundsell H. A comparison of complications of laser and cold knife conization. Obstet. Gynecol. 62 (1983) 213-217
5. Acharya G., Kjeldberg I., Hansen S.M., Sorheim N., Jacobsen B.K., and Maltau J.M. Pregnancy outcome after loop electrosurgical excision procedure for the management of cervical intraepithelial neoplasia. Arch. Gynecol. Obstet. 272 (2005) 109-112
6. Alvarez-Salas L.M., Benitez-Hess M.L., and Di Paolo J.A. Advances in the development of ribozymes and antisense oligonucleotides as antiviral agents for human papillomaviruses. Antivir. Ther. 8 (2003) 265-278
7. Jansen B., and Zangemeister-Wittke U. Antisense therapy for cancer - the time of truth. Lancet Oncol. 3 (2002) 672-683
8. Crooke S.T. Treatment of retinitis induced by cytomegalovirus using intravitreal formivirsen (ISIS 2922). In: Wickstrom E. (Ed). Clinical trials of genetic therapy with antisense DNA and DNA vectors (1998), Marcel Dekker Inc., New York 353-361
9. Wang H., Prasad G., Buolamwini J.K., and Zhang R. Antisense anticancer oligonucleotide therapeutics. Curr. Cancer Drug Targets 1 (2001) 177-196
10. Crooke S.T. Molecular mechanism of antisense drugs: RNase H. Antisense Nucleic Acid Drug Dev. 8 (1998) 133-134
11. Sassi A.B., Mccullough K.D., Cost M.R., Hillier S.L., and Rohan L.C. Permeability of tritiated water through cervical and vaginal tissue. J. Pharm. Sci. 93 (2004) 2009-2016
12. Woolfson A.D., McCafferty D.F., McCarron P.A., and Price J.H. Liquid scintillation spectrometry of 5-fluorouracil in cervical tissue following in vitro surface application of a bioadhesive cervical patch. Pharm. Res. 11 (1994) 1315-1319
13. Gorodeski G.I. Aging and estrogen effects on transcervical-transvaginal epithelial permeability. J. Clin. Endocrinol. Metab. 90 (2005) 345-351
14. Pitkanen L., Ranta V.P., Moilanen H., and Urtti A. Permeability of retinal pigment epithelium: effects of permeant molecular weight and lipophilicity. Invest. Ophthalmol. Vis. Sci. 46 (2005) 46641-46646
15. OECD, The Application of the Principles of GLP to in vitro Studies number 14, OECD series on principles of good laboratory practice and compliance monitoring, 2004.
16. Hartung T., Bremer S., Casati S., Coecke S., Corvi R., Fortaner S., Gribaldo L., Halder M., Hoffmann S., Roi A.J., Prieto S., Sabbioni E., Scott L., Worth A., and Zuang V. A modular approach to the ECVAM principles on test validity. Altern. Lab. Anim. 32 (2004) 467-472
17. Moench T.R., Chipato T., and Padian N.S. Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barriers devices. AIDS 15 (2001) 1595-1602
18. Harrison P.F. Microbicides: forging scientific and political alliances. AIDS Patient Care and STDS 14 (2000) 199-205
19. Morrow K., Rosen R., Richter L., Emans A., Forbes A., Day J., Morar N., Maslankowski L., Profy A.T., Kelly C., Abdool Karim S.S., and Mayer K.H. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among woman in a phase I clinical trial. J. Womens Health (Larchmt) 12 (2003) 655-666
20. Buck C.B., Day P.M., Thompson C.D., Lubkowski J., Lu W., Lowy D.R., and Schiller J.T. Human alpha-defensins block papillomavirus infection. Proc. Natl. Acad. Sci. USA 103 (2006) 1516-1521
21. Meyskens F.L., Surwit E., Moon T.E., Childers J.M., Davis J.R., Dorr R.T., Johnson C.S., and Alberts D.S. Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J. Natl. Cancer Inst. 86 (1994) 539-543
22. Shillitoe E.J. Papillomaviruses for cancer gene therapy. Cancer gene ther. 13 (2006) 445-450
23. Niu X.Y., Peng Z.L., Duan W.Q., Wang H., and Wang P. Inhibition of HPV 16 E6 oncogene expression by RNA interference in vitro and in vivo. Int. J. Gynecol. Cancer 16 (2006) 743-751
24. Clawson G.A., Miranda G.Q., Sivarajah A., Xin P., Pan W., Thiboutot D., and Christensen N.D. Inhibition of papilloma progression by antisense oligonucleotides targeted to HPV11 E6/E7 RNA. Gene Ther. 11 (2004) 1331-1341
25. Uhlmann E., Ryte A., and Peyman A. Studies on the mechanism of stabilization of partially phosphorothioated oligonucleotides against nucleolytic degradation. Antisense Nucleic Acid. Drug Dev. 7 (1997) 345-350
26. Choung S., Kim Y.J., Kim S., Park H.O., and Choi Y.C. Chemical modification of siRNAs to improve serum stability without loss of efficacy. Biochem. Biophys. Res. Commun. 342 (2006) 919-927
27. Lysik M.A., and Wu-Pong S. Innovations in oligonucleotide drug delivery. J. Pharm. Sci. 92 (2003) 1559-1573
28. Hoogstraate A.J., Cullander C., Nagelkerke J.F., Senel S., Verhoef J.C., Junginger H.E., and Bodde H.E. Diffusion rates and transport pathways of fluorescein isothiocyanate (FITC)-labeled model compounds through buccal epithelium. Pharm. Res. 11 (1994) 83-89
29. van der Bijl P., and van Eyk A.D. Human vaginal mucosa as a model of buccal mucosa for in vitro permeability studies: an overview. Curr. Drug Deliv. 1 (2004) 129-135
30. van Eyk A.D., and van der Bijl P. Comparative permeability of various chemical markers through human vaginal and buccal mucosa as well as porcine buccal and mouth floor mucosa. Arch. Oral. Biol. 49 (2004) 387-392
31. Bock U., Floetotto T., and Haltner E. Validation of cell culture models for the intestine and the blood-brain barrier and comparison of drug permeation. ALTEX 21 (2004) 57-64
32. van der Bijl P., and van Eyk A.D. Comparative in vitro permeability of human vaginal, small intestinal and colonic mucosa. Int. J. Pharm. 261 (2003) 147-152
33. Sakai M., Imai T., Ohtake H., Azuma H., and Otagiri M. Effects of absorption enhancers on the transport of model compounds in Caco-2 cell monolayers: assessment by confocal laser scanning microscopy. J. Pharm. Sci. 86 (1997) 779-785
34. Mazzobre M.F., Roman M.V., Mourelle A.F., and Corti H.R. Octanol-water partition coefficient of glucose, sucrose, and trehalose. Carbohydr. Res. 340 (2005) 1207-1211