A novel cyclosporin a aqueous formulation for dry eye treatment: In vitro and in vivo evaluation

Investigative Ophthalmology and Visual Science

Volumn 53, Issue 4, 2012, Pages 2292-2299

  di Tommaso, Claudia ^a   Valamanesh, Fatemeh ^b,c   Miller, Florence ^a   Furrer, Pascal ^a   Rodriguez Aller, Marta ^a   Behar Cohen, Francine ^b,d   Gurny, Robert ^a   Möller, Michael ^a  

^a UNIVERSITY OF GENEVA   (Switzerland)

^b CENTRE DE RECHERCHE DES CORDELIERS   (France)

^c FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD   (France)

^d UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN A;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG FORMULATION; DRUG HALF LIFE; DRY EYE; EMULSION; FEMALE; FLUORESCENCE MICROSCOPY; IMMUNOCYTOCHEMISTRY; LACRIMAL FLUID; MAXIMUM PLASMA CONCENTRATION; MICELLE FORMULATION; NONHUMAN; OSMOLARITY; PRIORITY JOURNAL; RABBIT; RAT; SCHIRMER TEST;

ADMINISTRATION, TOPICAL; ANIMALS; CORNEA; CYCLOSPORINE; FEMALE; IMMUNOSUPPRESSIVE AGENTS; MICELLES; MICROSCOPY, FLUORESCENCE; OPHTHALMIC SOLUTIONS; RABBITS; RATS; RATS, INBRED LEW; TEARS;

EID: 84861141902     PISSN: 01460404     EISSN: 15525783     Source Type: Journal    
DOI: 10.1167/iovs.11-8829     Document Type: Article

References (45)

1. Gaffney EA, Tiffany JM, Yokoi N, Bron AJ. A mass and solute balance model for tear volume and osmolarity in the normal and the dry eye. Prog Retin Eye Res. 2010;29:59-78.
2. Lemp MA. Report of the National Eye Institute/industry workshop on clinical trials in dry eye. CLAO J. 1995;21:221-232.
3. Rao SN. Topical Cyclosporine 0.05% for the prevention of dry eye disease progression. J Ocul Pharm Ther. 2010;26:157-164.
4. Survase SA, Kagliwal LD, Annapure US, Singhal RS. Cyclosporin A. - A review on fermentative production, downstream processing and pharmacological applications. Biotechnol Adv. 2011;29:418-435.
5. Italia JI, Bhardwaj V. Kumar MN. Disease, destination, dose and delivery aspects of ciclosporin: the state of the art. Drug Discov Today. 2006;11:846-854.
6. Rubin M, Rao SN. Efficacy of topical cyclosporin 0.05% in the treatment of posterior blepharitis. J Ocul Pharmacol Ther. 2006;22(1):47-53.
7. Hingorani M, Calder VL, Buckley RJ, Lightman S. The immunomodulatory effect of topical cyclosporin A in atopic keratoconjunctivitis. Invest Ophthalmol Vis Sci. 1999;40:392-399.
8. Yoon KC, Heo H, Kang IS, et al. Effect of topical cyclosporin A on herpetic stromal keratitis in a mouse model. Cornea. 2008; 27:454-460.
9. Kaswan RL. Intraocular penetration of topically applied cyclosporine. Transplant Proc. 1988;2:650-655.
10. Mondon K, Zeisser-Labouèbe M, Gurny R, Möller M. Novel Cyclosporin A formulations using MPEG-hexyl-substituted polylactide micelles: a suitability study. Eur J Pharm Biopharm. 2011;77:56-65.
11. Kunert KS, Tisdale AS, Stern ME, Smith JA, Gipson IK. Analysis of cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol. 2000; 118:1489-1496.
12. Sheppard JD, Scoper SV, Samudre S. Topical loteprednol pretreatment reduces cyclosporine stinging in chronic dry eye disease. J Ocul Pharmacol Ther. 2011;27:23-27.
13. Di Tommaso C, Behar-Cohen F, Gurny R, Möller M. Colloidal systems for the delivery of Cyclosporin A to the anterior segment of the eye. Ann Pharm Fr. 2011;69:116-123.
14. Gokce EH, Sandri G, Bonferoni MC, et al. Cyclosporine A loaded SLNs: evaluation of cellular uptake and corneal cytotoxicity. Int J Pharm. 2008;364:76-86.
15. Yenice I, Mocan MC, Palaska E, et al. Hyaluronic acid coated poly-epsilon-caprolactone nanospheres deliver high concentrations of cyclosporine A into the cornea. Exp Eye Res. 2008; 87:162-167.
16. Di Tommaso C, Torriglia A, Furrer P, Gurny R, Möller M. Ocular biocompatibility of novel Cyclosporin A formulations based on methoxy poly(ethylene glycol)-hexylsubstituted poly(lactide) micelle carriers. Int J Pharm. 2011;416:515-524.
17. Barabino S Dana MR. Animal models of dry eye: a critical assessment of opportunities and limitations. Invest Ophthalmol Vis Sci. 2004;45:1641-1646.
18. Lemp MA, Baudouin C, Baum J, et al. The definition and the classification of dry eye disease: report of the definition and classification subcommittee of the International Dry Eye Workshop (2007). Ocul Surf. 2007;5:75-92.
19. Trimaille T, Mondon K, Gurny R, Möller M. Novel polymeric micelles for hydrophobic drug delivery based on biodegradable poly(hexyl-substituted lactides). Int J Pharm. 2006;319: 147-154.
20. Trimaille T, Möller M, Gurny R. Synthesis and ring-opening polymerization of new monoalkyl-substituted lactides. J Polym Sci Part A:Polym Chem. 2004;42:4379-4391.
21. ARVO. Statement for the use of animals in ophthalmic and vision research. Invest Ophthalmol Vis Sci. 1994;35:2-5.
22. Di Tommaso C, Como C, Gurny R, Möller M. Investigations on the lyophilisation of MPEG-hexPLA micelle based pharmaceutical formulations. Eur J Pharm Sci. 2010;40:38-47.
23. Rodriguez-Aller M, Kaufmann B, Guillarme D, et al. In vivo characterisation of a novel water-soluble cyclosporine A prodrug for the treatment of dry eye disease. Eur J Pharm Biopharm. 2011;80:544-552.
24. Alonso MJ. Nanomedicines for overcoming biological barriers. Biomed Pharmacother. 2004;58:168-172.
25. Calvo P, Thomas C, Alonso MJ, Vila Jato JL, Robinson J. Study of the mechanisms of interaction of poly-E-caprolactone nanocapsules with the cornea by confocal laser scanning microscopy. Int J Pharm. 1994;103:283-291.
26. Suri SS, Fenniri H, Singh B. Nanotechnology-based drug delivery systems. J Occup Med Toxicol. 2007;2:16.
27. Aráujo J, Gonzalez E, Egea MA, Garcia ML, Souto EB. Nanomedicine for ocular NSAIDs: safety on drug delivery. Nanomedicine. 2009;5:394-401.
28. Sahoo SK, Dilnawaz F, Krishnakumar S. Nanotechnology in ocular drug delivery. Drug Discov Today. 2008;13:144-151.
29. Schaeffer HE, Krohn DL. Liposomes in topical drug delivery. Invest Ophthalmol Vis Sci. 1982;22:220-227.
30. Gupta H, Aqil M, Khar RK, Ali A, Bhatnagar A, Mittal G. Sparfloxacin-loaded PLGA nanoparticles for sustained ocular drug delivery. Nanomedicine. 2010;6:324-333.
31. Gokce EH, Sandri G, Bonferoni MC, et al. Cyclosporine A loaded SLNs: evaluation of cellular uptake and corneal cytotoxicity. Int J Pharm. 2008;364:76-86.
32. Ding S, Olejnik O, Reis B, inventors; Allergan, Inc., assignee. Emulsion eye drop for alleviation of dry eye related symptoms in dry eye patients and/or contact lens wearers. US patent no. 5,981,607. November 9, 1999.
33. Sall K, Stevenson OD, Mundorf TK, Reis BL. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CyA Phase 3 Study Group. Ophthalmology. 2000;107:631-639.
34. McCabe E, Narayanan S. Advances in anti-inflammatory therapy for dry eye syndrome. Optometry. 2009;80:555-566.
35. Wan ACA, Ying JY. Nanomaterials for in situ cell delivery and tissue regeneration. Adv Drug Del Rev. 2010;62:731-740.
36. Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;12:348-360.
37. Johnson ME, Murphy PJ. Changes in the tear film and ocular surface from dry eye syndrome. Prog Retin Eye Res. 2004;23: 449-474.
38. Kaur IP, Smitha R. Penetration enhancers and ocular bioadhesives: two new avenues for ophthalmic drug delivery. Drug Dev Ind Pharm. 2002;28:353-369.
39. Gaudana R, Jwala J, Boddu SH, Mitra AK. Recent perspectives in ocular drug delivery. Pharm Res. 2009;26:1197-1216.
40. Chrai SS, Patton TF, Mehta A, Robinson JR. Lacrimal and instilled fluid dynamics in rabbit eye. J Pharm Sci. 1973;62: 1112-1121.
41. Järvinen K, Järvinen T, Urtti A. Ocular absorption following topical delivery. Adv Drug Deliv Rev. 1995;16:3-19.
42. De Paiva CS, Volpe EA, Gandhi NB, et al. Disruption of TGF-b signaling improves ocular surface epithelial disease in experimental autoimmune keratoconjunctivitis sicca. PloS One. 2011;6:e29017.
43. Kuwano M, Ibuki H, Morikawa N, Ota A, Kawashima Y. Cyclosporine A formulation affects its ocular distribution in rabbits. Pharm Res. 2002;19:108-111.
44. Furrer P, Plazonnet B, Mayer JM, Gurny R. Application of in vivo confocal microscopy to the objective evaluation of ocular irritation induced by surfactants. Int J Pharm. 2000;207:89-98.
45. Kaelin P. "Contribution à la validation d'un test de tolérance oculaire sur la souris." Université de Lausanne, 1994;119.