Ocular pharmacokinetics of azasite Xtra2 azithromycin formulated in a durasite delivery system

Current Eye Research

Volumn 34, Issue 6, 2009, Pages 485-491

  Si, Erwin C ^a   Cheung, Paul S ^a   Bowman, Lyle ^a   Hosseini, Kamran ^b  

^a InSite Vision ^*  (United States)

^b InSite Vision   (United States)

Author keywords

Azithromycin; Conjunctivitis; Pharmacokinetics; Rabbit; Topical

Indexed keywords

AZITHROMYCIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BACTERIAL CONJUNCTIVITIS; CLINICAL EVALUATION; CONCENTRATION RESPONSE; CONJUNCTIVA; CONJUNCTIVITIS; CONTROLLED STUDY; CORNEA; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LACRIMAL FLUID; MALE; MASS SPECTROMETRY; NONHUMAN; PRIORITY JOURNAL; RABBIT;

ANIMALS; ANTI-BACTERIAL AGENTS; AZITHROMYCIN; BIOLOGICAL AVAILABILITY; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CONJUNCTIVITIS, BACTERIAL; DRUG DELIVERY SYSTEMS; MALE; MICROBIAL SENSITIVITY TESTS; RABBITS; TANDEM MASS SPECTROMETRY;

EID: 70350624992     PISSN: 02713683     EISSN: 14602202     Source Type: Journal    
DOI: 10.1080/02713680902919532     Document Type: Article

References (28)

1. Hoepelman IM, Schneider MME. Azithromycin: The first of tissue-selective azalides. Int J Antimicrob Agents 1995;5:145-167
2. West SK. Azithromycin for control of trachoma. Commun Eye Health 1999;12(32):55-56
3. Ianaro A, Ialenti A, Maffia P, Sautebin L, Rombola L, Carnuccio R, et al. Anti-inflammatory activity of macrolide antibiotics. J Pharmacol Exp Ther 2000;292;156-163
4. Scaglione F, Rossoni G. Comparative anti-inflammatory effects of roxithromycin, azithromycin, and clarithromycin. J Antimicrob Chemother 1998;41(suppl B):47-50
5. Tkalcevic VI, Bosnjak B, Hrvacic B, Bosnar M, Marjanovic N, Ferencic Z, et al. Anti-inflammatory activity of azithromycin attenuates the effects of lipopolysaccharide administration in mice. Eur J Pharmacol 2006;539:131-138
6. Bowman LM, Si E, Pang J, Friedlaender M. Development of a commercial eye drop formulation of azithromycin. E-abstract 772. Presented at The Association for Research in Vision and Ophthalmology Annual Meeting, Fort Lauderdale, FL, May 5-10, 2007
7. Protzko E, Bowman L, Shapiro A, et al. Phase 3 safety comparisons for 1.0% azithromycin in a polymeric mucoadhesive eye drop vs. 0.3% tobramycin eye drops for bacterial conjunctivitis in AzaSite Study Group. Invest Ophthalmol Vis Sci 2007;48:3427-3431
8. Abelson MB, Heller WH, Shapiro A, et al. Clinical cure of bacterial conjunctivitis with azithromycin 1% eye drops: Doublemasked randomized clinical trial of safety and efficacy. Am J Ophthalmol 2008;145:959-965
9. Cochereau I, Meddeb-Ouertani A, Khairallah M, et al. 3-day treatmentwith azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: Multicentre, randomized, and controlled trial in adults and children. Br J Ophthalmol 2007;91:465-469
10. Denis F, Chaumeil C, Goldschmidt P, Delval L, Pouliquen P, et al. Microbiological efficacy of 3-day treatment with azithromycin 1.5% eye-drops for purulent bacterial conjunctivitis. Eur J Ophthalmol 2008;18(6):858-868
11. Association for Research in Vision and Ophthalmology. Handbook for the Use of Animals in Biomedical Research, 2nd ed. Rockville, MD: Association for Research in Vision and Ophthalmology; 1993
12. Gigliotti F, Williams WT, Hayden FG, Hendley JO. Etiology of acute conjunctivitis in children. J Pediatr 1981;98(4):531-536
13. Seal DV, Barrett SP, McGill JI. Aetiology and treatment of acute bacterial infection of the external eye. Br J Ophthalmol 1982;66:357-360
14. Centers for Disease Control and Prevention. Pneumococcal conjunctivitis at an elementary cchool-Maine, September 20- December 6, 2002. MMWR Morb Mortal Wkly Rep 2003;52:64-66
15. American Academy of Ophthalmology. Conjunctivitis, Preferred Practice Pattern. San Francisco, CA: American Academy of Ophthalmology; 2003. Available at www.aao.org/ppp
16. Hwang DG, Schanzlin, Rotberg MH, Foulks G, Raizman MB. Levofloxacin Bacterial Conjunctivitis Place-Controlled Study Group. A phase III, placebo controlled clinical trial of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Br J Ophthalmol 2003;87:1004-1009
17. Fluoroquinolone antimicrobial drugs. MedWatch 070808. Accessed at http://www.fda.gov/medwatch/ on 071808
18. Asbell PA, Colby KA, Deng S, McDonnell P, Meisler DM, et al. Ocular TRUST: Nationwide antimicrobial susceptibility patterns in ocular isolates. Am J Ophthalmol 2008;145(6):951-958
19. Craig WA. Does the dose matter? Clin Infect Dis 2001;33(Suppl 3):S233-237
20. Jacobs MR.How canwe predict bacterial eradication? Int J Infect Dis 2003;7:S13-S20
21. A4mar T, Gaillaud T, Elena PP. Ocular pharmacokinetic study following single and multiple azithromycin administrations in pigmented rabbits. Curr Eye Res 2008;33:149-158
22. Arquedas A, Loaiza C, Soley C. Single dose azithromycin for the treatment of uncomplicated otitis media. Pediatr Infect Dis J 2004;23:S108-S114
23. Jenkins SG, Brown SD, Farrell DJ. Trends in antibacterial resistance among Streptococcus pneumoniae isolated in the USA: Update from PROTEKT U.S. years 1-4. Ann Clin Microbiol Antimicrob 2008;7:1-11
24. Blumer JL. Evolution of a new drug formulation: The rastionale for high-dose, short-course therapywith azithromycin. Int J Antimicrob Agents 2005;26(Suppl 3):S143-S147
25. Granet DB, Lichtenstein SJ, Onofrey B, et al. An assessment of the tolerability of moxifloxacin 0.5% compared to azithromycin 1.0% in DuraSite. Clin Ophthalmol 2007;1(4):519-525
26. Si EC, BowmanLM, Roy SD. Ocular bioavailability and systemic levels of an ophthalmic formulation of azithromycin, ISV-401. E-Abstract 1461. Presented at The Association for Research in Vision and Ophthalmology Annual Meeting, Fort Lauderdale, FL, May 4-8, 2003
27. Amsden GW, Nafziger AN, Foulds G. Pharmacokinetics in serum and leukocyte exposures of azithromycin, 1500 milligrams, given over a 3- or 5-day period in health subjects. Antimicrob Agents Chemother 1999;43(1):163-165
28. Dunn CJ, Barradell LB. Azithromycin. A review of its pharmacological properties and use as 3-day therapy in respiratory tract infections. Drugs 1996;51(3):483-505