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Review

Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop

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Pages 299-312 | Published online: 13 Feb 2013

References

  • GessiSMerighiSBoreaPAGlucocorticoid’s pharmacology: past, present and futureCurr Pharm Des2010163540355320977419
  • StahnCBButtgereitFGenomic and nongenomic effects of glucocorticoidsNat Clin Pract Rheumatol200841052553318762788
  • CidlowskiJAGlucocorticoids and their actions in cellsRetina2009296S21S2319553792
  • RhenTCidlowskiJAAntiinflammatory action of glucocorticoids – new mechanisms for old drugsN Engl J Med2005353161711172316236742
  • StahnCLöwenbergMHommesDWButtgereitFMolecular mechanisms of glucocorticoid action and selective glucocorticoid receptor agonistsMol Cell Endocrinol20072751–2717817630118
  • AnanthulaHKVaishyaRDBarotMMitraAKBioavailabilityTasmanWJaegerEADuane’s OphthalmologyPhiladelphiaLippincott Williams and Wilkins2011
  • RupenthalIDAlanyRGOcular drug deliveryGadSCPharmaceutical Sciences Encyclopedia: Drug Discovery, Development and ManufacturingJohn Wiley and Sons, Inc2010139Published online 315201010.1002/9780470571224Accessed October 19, 2012
  • MishimaSGassetAKlyceSDBaumJLDetermination of tear volume and tear flowInvest Ophthalmol1966532642765947945
  • TomlinsonAKhanalSAssessment of tear film dynamics: quantification approachOcul Surf200532819517131012
  • GaudanaRAnanthulaHKParenkyAMitraAKOcular drug deliveryAAPS J201012334836020437123
  • Van OoteghemMMFactors influencing the retention of ophthalmic solutions on the eye surfaceSaettoneMSBucciMSpeiserPOphthalmic Drug Delivery: Biopharmaceutical, Technological and Clinical AspectsFidia Research Series.Padova, ItalyLiviana Press198711717
  • ConradJMReayWAPolcynRERobinsonJRInfluence of tonicity and pH on lacrimation and ocular drug bioavailabilityJ Parenteral Drug Assoc1978324149161
  • LudwigAThe use of mucoadhesive polymers in ocular drug deliveryAdv Drug Del Rev20055715951639
  • BronAJTiffanyJMThe meibomian glands and tear film lipids: structure, function, and controlSullivanDADarttDAMenerayMMLacrimal Gland, Tear Film, and Dry Eye Syndromes 2: Basic Science and Clinical RelevanceNew YorkPlenum Press1998281295
  • GilbardJPHuman tear film electrolyte concentrations in health and dry-eye diseaseProceedings of the Annual Meeting of the Association for Research and Vision in OphthalmologyMay 3–8, 1992Sarasota, FL
  • LentnerCGeigy Scientific Tables: Units of Measurement, Body Fluids, Composition of the Body, and NutritionBaselCiba Pharmaceutical Co1981178184
  • ZhangWPrausnitzMREdwardsAModel of transient drug diffusion across corneaJ Control Release200499224125815380634
  • HuangH-SSchoenwaldRDLachJLCorneal penetration of beta-blocking agents II: assessment of barrier contributionJ Pharm Sci198372127212796139472
  • WatskyMAJablonskiMMEdelhauserH FComparison of conjunctival and corneal surface areas in rabbit and humanCurr Eye Res1988754834863409715
  • KimSHLutzRJWangNSRobinsonMRTransport barriers in transscleral drug delivery for retinal diseasesOphthalmic Res200739524425417851264
  • BodorNLoftssonTWuW-MMetabolism, distribution, and transdermal permeation of a soft corticosteroid, loteprednol etabonatePharm Res1992910127512781448425
  • BodorNBuchwaldPSoft drug design: general principles and recent applicationsMed Res Rev20002015810110608921
  • McGheeCNJDeanSDanesh-MeyerHLocally administered ocular corticosteroids: benefits and risksDrug Saf2002251335511820911
  • ClarkA FSteelyH TDickersonJEJrGlucocorticoid induction of the glaucoma gene MYOC in human and monkey trabecular meshwork cells and tissuesInvest Ophthalmol Vis Sci20014281769178011431441
  • ClarkA FWordingerRJThe role of steroids in outflow resistanceExp Eye Res20098875275918977348
  • ManabeSBucalaRCeramiANonenzymatic addition of glucocorticoids to lens proteins in steroid-induced cataractsJ Clin Invest1984745180318106501572
  • AlberthMWuW-MWinwoodDBodorNLipophilicity, solubility, and permeability of loteprednol etabonate: a novel, soft, anti-inflammatory steroidJ Biopharm Sci199122115125
  • DruzgalaPWuWMBodorNOcular absorption and distribution of loteprendol etabonate, a soft steroid, in rabbit eyesCurr Eye Res199110109339371959381
  • GlogowskiSProkschJWOcular pharmacokinetics of loteprednol etabonate following ocular administration of a novel ointment formulation or a suspension (Lotemax®) in rabbits with corneal inflammationProceedings of the Annual Meeting of the Association for Research and Vision in OphthalmologyMay 2–6, 2010Fort Lauderdale, FL
  • DruzgalaPHochhausGBodorNSoft drugs – 10. Blanching activity and receptor binding affinity of a new type of glucocorticoid: loteprednol etabonateJ Steroid Biochem Mol Biol19913821491542004037
  • DellSJLowryGMNorthcuttJAHowesJNovackGDHartKA randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitisJ Allergy Clin Immunol199810222512559723669
  • Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. Loteprednol Etabonate US Uveitis Study GroupAm J Ophthalmol1999127553754410334346
  • ShulmanDGLothringerLLRubinJMA randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitisOphthalmology199910623623699951491
  • IlyasHSlonimCBBraswellGRFavettaJRSchulmanMLong-term safety of loteprednol etabonate 0.2% in the treatment of seasonal and perennial allergic conjunctivitisEye Contact Lens2004301101314722462
  • FriedlaenderMHHowesJA double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. The Loteprednol Etabonate Giant Papillary Conjunctivitis Study Group IAm J Ophthalmol199712344554649124242
  • StewartRHorwitzBHowesJNovackGDHartKDouble-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation. Loteprednol Etabonate Post-operative Infammation Study Group 1J Cataract Refract Surg19982411148014899818338
  • A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. The Loteprednol Etabonate Postoperative Infammation Study Group 2Ophthalmology19981059178017869754192
  • ComstockTLPaternoMRSinghAErbTDavisESafety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgeryClin Ophthalmol2011517718621383946
  • NovackGDHowesJCrockettRSSherwoodMBChange in intraocular pressure during long-term use of loteprednol etabonateJ Glaucoma1998742662699713785
  • ComstockTLDeCoryHHAdvances in corticosteroid therapy for ocular inflammation: loteprendol etabonateInt J Inflam2012201278962310.1155/2012/78962322536546
  • BartlettJDHorwitzBLaibovitzRHowesJFIntraocular pressure response to loteprednol etabonate in known steroid respondersJ Ocul Pharmacol1993921571658345288
  • HollandEJBartlettJDPaternoMRUsnerDWComstockTLEffects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteersCornea2008271505518245967
  • HollandEJDjalilianARSandersonJPAttenuation of ocular hypertension with the use of topical loteprednol etabonate 0.5% in steroid responders after corneal transplantationCornea200928101139114319770719
  • ChenMGongLSunXA multicenter, randomized, parallel-group clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitisCurr Med Res Opin2012283110
  • AmonMBusinMLoteprednol etabonate ophthalmic suspension 0.5%: efficacy and safety for postoperative anti-inflammatory useInt Ophthalmol201232550751722707339
  • CFR – Code of Federal Regulations Title 21Part 349.12 Ophthalmic demulcents, and Part 349.60 Labeling of ophthalmic demulcent drug productsRevised April 1, 2012. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cficfr/CFRSearch.cfm?CFRPart=349Accessed November 12, 2012
  • AptLHenrickASilvermanLMPatient compliance with use of topical ophthalmic corticosteroid suspensionsAm J Ophthalmol1979872210214434075
  • FiscellaRGOphthalmic drug formulationsBartlettJDJaanusSDClinical Ocular Pharmacology5th edSt Louis, MOButterworth-Heinemann2008
  • CoffeyMJDavioSRViscoelastic and sedimentation characterization of loteprednol etabonate ophthalmic gel, 0.5%Proceedings of the Annual Meeting of the Association for Research and Vision in OphthalmologyMay 10, 2012Fort Lauderdale, FL
  • PiauJMCarbopol gels: elastoviscoplastic and slippery glasses made of individual swollen sponges. Meso- and macroscopic properties, constitutive equations and scaling lawsJ Nonnewton Fluid Mech2007144129
  • KaurIPLalSRanaCKakkarSSinghHOcular perservatives: associated risks and newer optionsCutan Ocul Toxicol20092839310319505226
  • EpsteinSPAhdootMMarcusEAsbellPAComparative toxicity of preservatives on immortalized corneal and conjunctival epithelial cellsJ Ocul Pharmacol Ther200925211311919284328
  • United States Pharmacopoeia (USP 35 – NF 30)The United States Pharmacopeia Convention: United States Pharmacopeia/National FormularyRockville, MDUS Pharmacopeia2012
  • Ykuji Nippo Ltd: Japanese Pharmacopoeia15th edTokyoMaruzen Co, Ltd2006
  • European Pharmacopoeia7th ed2012(7.5). European Directorate for the Quality of Medicines and Health Care: efficacy of antimicrobial preservationStrasbourgEuropean Directorate for the Quality of Medicines200651295130
  • HuZDenickJBausch and Lomb Incorporated, assignee. Ophthalmic compositions including glycerin and propylene glycolUnited States patent US 5800807911998
  • GlogowskiSJiangSOcular and systemic pharmacokinetics of loteprednol etabonate gel (0.5%) following topical ocular administration to rabbitsPaper presented at: Annual Meeting of the Association for Research and Vision in OphthalmologyMay 6–10, 2012Fort Lauderdale, FL
  • ChraiSSPattonTFMehtaARobinsonJRLacrimal and instilled fluid dynamics in rabbit eyesJ Pharm Sci1973627111211214576801
  • SaettoneM FGiannacciniBBarattiniFTelliniNThe validity of rabbits for investigations on ophthalmic vehicles: a comparison of four different vehicles containing tropicamide in humans and rabbitsPharm Acta Helv198257247557071067
  • ZakiIFitzgeraldPHardyJGWilsonCGA comparison of the effect of viscosity on the precorneal residence of solutions in rabbit and manJ Pharm Pharmacol19863864634662873224
  • RajpalRKRoelLSiou-MermetRErbTEvaluation of the efficacy and safety of loteprednol etabonate gel 0.5% in the treatment of ocular inflammation and pain after cataract surgeryJ Cataract Refract Surg2012
  • FongRLeitritzMSiou-MermetRErbTLoteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trialClin Ophthalmol201261113112422888209
  • El-HaraziSMFeldmanRMControl of intra-ocular inflammation associated with cataract surgeryCurr Opin Ophthalmol20011214811150074
  • MohammadpourMJafarinasabMRJavadiMAOutcomes of acute postoperative inflammation after cataract surgeryEur J Ophthalmol2007171202817294379
  • WittpennJRSilversteinSHeierJA randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patientsAm J Ophthalmol2008146455456018599019
  • ParekhJGNewsomTHNielsenSSafety of besifoxacin ophthalmic suspension 0.6% in cataract surgery patientsJ Cataract Refract Surg201238101864186722999608
  • RaizmanMBDonnenfeldEDWeinsteinAJClinical comparison of two topical prednisolone acetate 1% formulations in reducing inflammation after cataract surgeryCurr Med Res Opin200723102325233117697456
  • LaneSSHollandEJA randomized, multicenter, masked evaluation of 0.5% loteprednol etabonate versus 1.0% prednisolone acetate for the treatment of inflammation following cataract surgeryJ Cataract Refract Surg2012