Methods and devices to test diffusion rates of ocular drug delivery systems

Abstract

Methods of detecting the discharge and uptake rates of ophthalmic lenses containing pharmaceutical agents are disclosed herein.

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         19 . A method of measuring the discharge rate of a pharmaceutical agent from an ophthalmic lens, wherein the method comprises the steps of
 (a) placing said ophthalmic lens comprising said pharmaceutical agent a testing apparatus, wherein said testing apparatus is sized to enclose said ophthalmic lens and to permit solutions to contact said ophthalmic lens,   (b) placing said enclosed ophthalmic lens into a sufficient amount of solutions,   (c) monitoring sufficient amount of solution to determine the presence or absence of said pharmaceutical agent in said solution   
     
     
         20 . The method of  claim 19  wherein the sufficient amount of solution is about 25 mL. 
     
     
         21 . The method of  claim 19  wherein the pharmaceutical agent is selected from the group consisting of ketotifen, ketotifen, nor ketotifen, 11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde, olapatadine, and pharmaceutically acceptable salts and mixtures thereof. 
     
     
         22 . The method of  claim 19  wherein the ophthalmic lens is selected from the group consisting of acofilcon A, alofilcon A, alphafilcon A, amifilcon A, astifilcon A, atalafilcon A, balafilcon A, bisfilcon A, bufilcon A, comfilcon, crofilcon A, cyclofilcon A, darfilcon A, deltafilcon A, deltafilcon B, dimefilcon A, drooxifilcon A, epsifilcon A, esterifilcon A, etafilcon A, focofilcon A, galfilcon A, genfilcon A, govafilcon A, hefilcon A, hefilcon B, hefilcon D, hilafilcon A, hilafilcon B, hioxifilcon B, hioxifilcon C, hixoifilcon A, hydrofilcon A, lenefilcon A, licryfilcon A, licryfilcon B, lidofilcon A, lidofilcon B, lotrafilcon A, lotrafilcon B, mafilcon A, mesifilcon A, methafilcon B, mipafilcon A, nelfilcon A, netrafilcon A, ocufilcon A, ocufilcon B, ocufilcon C, ocufilcon D, ocufilcon E, ofilcon A, omafilcon A, oxyfilcon A, pentafilcon A, perfilcon A, pevafilcon A, phemfilcon A, polymacon, senofilcon A, silafilcon A, siloxyfilcon A, tefilcon A, tetrafilcon A, trifilcon A, vifilcon, and xylofilcon A. 
     
     
         23 . The method of  claim 19  wherein monitoring comprises analyzing the solution by UV Visible Spectroscopy. 
     
     
         24 . The method of  claim 23  wherein the ophthalmic lens is etafilcon A and the pharmaceutical agent is selected from the group consisting of ketotifen, ketotifen, nor ketotifen, 11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde, olapatadine, and pharmaceutically acceptable salts and mixtures thereof.