US20090126318A1 - Packaging Solutions - Google Patents
Packaging Solutions Download PDFInfo
- Publication number
- US20090126318A1 US20090126318A1 US12/258,938 US25893808A US2009126318A1 US 20090126318 A1 US20090126318 A1 US 20090126318A1 US 25893808 A US25893808 A US 25893808A US 2009126318 A1 US2009126318 A1 US 2009126318A1
- Authority
- US
- United States
- Prior art keywords
- solution
- contact lens
- hydroxypropyl methylcellulose
- weight percent
- range
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 238000004806 packaging method and process Methods 0.000 title abstract description 41
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 36
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 36
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 36
- 239000000017 hydrogel Substances 0.000 claims abstract description 19
- 239000007864 aqueous solution Substances 0.000 claims abstract description 10
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims abstract 12
- 239000000243 solution Substances 0.000 claims description 75
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 34
- 229920001296 polysiloxane Polymers 0.000 claims description 26
- 238000000034 method Methods 0.000 claims description 24
- 239000000872 buffer Substances 0.000 claims description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 239000011780 sodium chloride Substances 0.000 claims description 18
- 230000001954 sterilising effect Effects 0.000 claims description 8
- BTBUEUYNUDRHOZ-UHFFFAOYSA-N Borate Chemical compound [O-]B([O-])[O-] BTBUEUYNUDRHOZ-UHFFFAOYSA-N 0.000 claims description 7
- 239000002738 chelating agent Substances 0.000 claims description 7
- 238000007789 sealing Methods 0.000 claims description 6
- 150000001875 compounds Chemical class 0.000 claims description 2
- 239000000645 desinfectant Substances 0.000 claims description 2
- 230000000249 desinfective effect Effects 0.000 claims description 2
- 230000002070 germicidal effect Effects 0.000 claims description 2
- 238000003860 storage Methods 0.000 abstract description 4
- 239000000178 monomer Substances 0.000 description 35
- HSHXDCVZWHOWCS-UHFFFAOYSA-N N'-hexadecylthiophene-2-carbohydrazide Chemical compound CCCCCCCCCCCCCCCCNNC(=O)c1cccs1 HSHXDCVZWHOWCS-UHFFFAOYSA-N 0.000 description 24
- 239000000203 mixture Substances 0.000 description 17
- 239000000463 material Substances 0.000 description 15
- 125000004432 carbon atom Chemical group C* 0.000 description 8
- -1 cyclic lactams Chemical class 0.000 description 8
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 4
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
- SEQKRHFRPICQDD-UHFFFAOYSA-N N-tris(hydroxymethyl)methylglycine Chemical compound OCC(CO)(CO)[NH2+]CC([O-])=O SEQKRHFRPICQDD-UHFFFAOYSA-N 0.000 description 4
- 0 [1*]C(=C)C(=O)CC[Si](O[Si]([2*])([2*])[2*])(O[Si]([2*])([2*])[2*])O[Si]([2*])([2*])[2*] Chemical compound [1*]C(=C)C(=O)CC[Si](O[Si]([2*])([2*])[2*])(O[Si]([2*])([2*])[2*])O[Si]([2*])([2*])[2*] 0.000 description 4
- 125000000217 alkyl group Chemical group 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 230000004304 visual acuity Effects 0.000 description 4
- UURVHRGPGCBHIC-UHFFFAOYSA-N 3-(ethenoxycarbonylamino)propanoic acid 4-[[[[[[[[[[[[[[[[[[[[[[[[[[[4-ethenoxycarbonyloxybutyl(dimethyl)silyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]oxy-dimethylsilyl]butyl ethenyl carbonate 1-ethenylpyrrolidin-2-one ethenyl N-[3-tris(trimethylsilyloxy)silylpropyl]carbamate Chemical compound C=CN1CCCC1=O.OC(=O)CCNC(=O)OC=C.C[Si](C)(C)O[Si](CCCNC(=O)OC=C)(O[Si](C)(C)C)O[Si](C)(C)C.C[Si](C)(CCCCOC(=O)OC=C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)CCCCOC(=O)OC=C UURVHRGPGCBHIC-UHFFFAOYSA-N 0.000 description 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 3
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 description 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 239000002585 base Substances 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 229910021538 borax Inorganic materials 0.000 description 3
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 3
- 239000004327 boric acid Substances 0.000 description 3
- 239000006172 buffering agent Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000004132 cross linking Methods 0.000 description 3
- 239000003431 cross linking reagent Substances 0.000 description 3
- 229910052739 hydrogen Inorganic materials 0.000 description 3
- 239000001257 hydrogen Substances 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 229920001451 polypropylene glycol Polymers 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- 235000010339 sodium tetraborate Nutrition 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 3
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 3
- BESKSSIEODQWBP-UHFFFAOYSA-N 3-tris(trimethylsilyloxy)silylpropyl 2-methylprop-2-enoate Chemical compound CC(=C)C(=O)OCCC[Si](O[Si](C)(C)C)(O[Si](C)(C)C)O[Si](C)(C)C BESKSSIEODQWBP-UHFFFAOYSA-N 0.000 description 2
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 description 2
- WOBHKFSMXKNTIM-UHFFFAOYSA-N Hydroxyethyl methacrylate Chemical compound CC(=C)C(=O)OCCO WOBHKFSMXKNTIM-UHFFFAOYSA-N 0.000 description 2
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 description 2
- DBXNUXBLKRLWFA-UHFFFAOYSA-N N-(2-acetamido)-2-aminoethanesulfonic acid Chemical compound NC(=O)CNCCS(O)(=O)=O DBXNUXBLKRLWFA-UHFFFAOYSA-N 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 206010047513 Vision blurred Diseases 0.000 description 2
- CIUQDSCDWFSTQR-UHFFFAOYSA-N [C]1=CC=CC=C1 Chemical compound [C]1=CC=CC=C1 CIUQDSCDWFSTQR-UHFFFAOYSA-N 0.000 description 2
- 150000007513 acids Chemical class 0.000 description 2
- 238000013019 agitation Methods 0.000 description 2
- 125000002877 alkyl aryl group Chemical group 0.000 description 2
- 125000005119 alkyl cycloalkyl group Chemical group 0.000 description 2
- 125000003118 aryl group Chemical group 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 229920001400 block copolymer Polymers 0.000 description 2
- 125000002091 cationic group Chemical group 0.000 description 2
- 125000000753 cycloalkyl group Chemical group 0.000 description 2
- 230000001627 detrimental effect Effects 0.000 description 2
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 description 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 229920001987 poloxamine Polymers 0.000 description 2
- 230000000379 polymerizing effect Effects 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- SJHPCNCNNSSLPL-CSKARUKUSA-N (4e)-4-(ethoxymethylidene)-2-phenyl-1,3-oxazol-5-one Chemical compound O1C(=O)C(=C/OCC)\N=C1C1=CC=CC=C1 SJHPCNCNNSSLPL-CSKARUKUSA-N 0.000 description 1
- VAYTZRYEBVHVLE-UHFFFAOYSA-N 1,3-dioxol-2-one Chemical compound O=C1OC=CO1 VAYTZRYEBVHVLE-UHFFFAOYSA-N 0.000 description 1
- CWWYEELVMRNKHZ-UHFFFAOYSA-N 2,3-dimethylbut-2-enamide Chemical compound CC(C)=C(C)C(N)=O CWWYEELVMRNKHZ-UHFFFAOYSA-N 0.000 description 1
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- NPPNUGUVBUJRAB-UHFFFAOYSA-N 2-[tert-butyl(dimethyl)silyl]oxyethyl ethenyl carbonate Chemical compound CC(C)(C)[Si](C)(C)OCCOC(=O)OC=C NPPNUGUVBUJRAB-UHFFFAOYSA-N 0.000 description 1
- 125000000954 2-hydroxyethyl group Chemical group [H]C([*])([H])C([H])([H])O[H] 0.000 description 1
- WHNPOQXWAMXPTA-UHFFFAOYSA-N 3-methylbut-2-enamide Chemical compound CC(C)=CC(N)=O WHNPOQXWAMXPTA-UHFFFAOYSA-N 0.000 description 1
- 239000004255 Butylated hydroxyanisole Substances 0.000 description 1
- 239000004322 Butylated hydroxytoluene Substances 0.000 description 1
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 1
- NHARPDSAXCBDDR-UHFFFAOYSA-N C=C(C)C(=O)OCCC Chemical compound C=C(C)C(=O)OCCC NHARPDSAXCBDDR-UHFFFAOYSA-N 0.000 description 1
- XODWWDLLPURTOQ-UHFFFAOYSA-N CC[Si](C)(C)O[Si](C)(C)CC Chemical compound CC[Si](C)(C)O[Si](C)(C)CC XODWWDLLPURTOQ-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 239000004971 Cross linker Substances 0.000 description 1
- 206010015946 Eye irritation Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 239000005058 Isophorone diisocyanate Substances 0.000 description 1
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 description 1
- 239000007993 MOPS buffer Substances 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
- 229920003100 Methocel™ E15 LV Polymers 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- UZMAPBJVXOGOFT-UHFFFAOYSA-N Syringetin Natural products COC1=C(O)C(OC)=CC(C2=C(C(=O)C3=C(O)C=C(O)C=C3O2)O)=C1 UZMAPBJVXOGOFT-UHFFFAOYSA-N 0.000 description 1
- 239000007997 Tricine buffer Substances 0.000 description 1
- 229920006311 Urethane elastomer Polymers 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 229960004308 acetylcysteine Drugs 0.000 description 1
- 229910052783 alkali metal Inorganic materials 0.000 description 1
- 150000001340 alkali metals Chemical class 0.000 description 1
- 150000001408 amides Chemical class 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 150000003862 amino acid derivatives Chemical class 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 150000001414 amino alcohols Chemical class 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- OWMVSZAMULFTJU-UHFFFAOYSA-N bis-tris Chemical compound OCCN(CCO)C(CO)(CO)CO OWMVSZAMULFTJU-UHFFFAOYSA-N 0.000 description 1
- 239000007975 buffered saline Substances 0.000 description 1
- 235000019282 butylated hydroxyanisole Nutrition 0.000 description 1
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 description 1
- 229940043253 butylated hydroxyanisole Drugs 0.000 description 1
- 235000010354 butylated hydroxytoluene Nutrition 0.000 description 1
- 229940095259 butylated hydroxytoluene Drugs 0.000 description 1
- 239000001110 calcium chloride Substances 0.000 description 1
- 229910001628 calcium chloride Inorganic materials 0.000 description 1
- 125000001951 carbamoylamino group Chemical group C(N)(=O)N* 0.000 description 1
- 150000001732 carboxylic acid derivatives Chemical class 0.000 description 1
- 150000001735 carboxylic acids Chemical class 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 239000000882 contact lens solution Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- 238000000151 deposition Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- KCFYHBSOLOXZIF-UHFFFAOYSA-N dihydrochrysin Natural products COC1=C(O)C(OC)=CC(C2OC3=CC(O)=CC(O)=C3C(=O)C2)=C1 KCFYHBSOLOXZIF-UHFFFAOYSA-N 0.000 description 1
- 125000005442 diisocyanate group Chemical group 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- WBZKQQHYRPRKNJ-UHFFFAOYSA-L disulfite Chemical compound [O-]S(=O)S([O-])(=O)=O WBZKQQHYRPRKNJ-UHFFFAOYSA-L 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- KZJNAICCMJTRKF-UHFFFAOYSA-N ethenyl 2-trimethylsilylethyl carbonate Chemical compound C[Si](C)(C)CCOC(=O)OC=C KZJNAICCMJTRKF-UHFFFAOYSA-N 0.000 description 1
- RWEUKWCZWYHIQA-UHFFFAOYSA-N ethenyl 3-trimethylsilylpropyl carbonate Chemical compound C[Si](C)(C)CCCOC(=O)OC=C RWEUKWCZWYHIQA-UHFFFAOYSA-N 0.000 description 1
- NDXTZJDCEOXFOP-UHFFFAOYSA-N ethenyl 3-tris(trimethylsilyloxy)silylpropyl carbonate Chemical compound C[Si](C)(C)O[Si](O[Si](C)(C)C)(O[Si](C)(C)C)CCCOC(=O)OC=C NDXTZJDCEOXFOP-UHFFFAOYSA-N 0.000 description 1
- BHBDVHVTNOYHLK-UHFFFAOYSA-N ethenyl 3-tris(trimethylsilyloxy)silylpropylsulfanylformate Chemical compound C[Si](C)(C)O[Si](O[Si](C)(C)C)(O[Si](C)(C)C)CCCSC(=O)OC=C BHBDVHVTNOYHLK-UHFFFAOYSA-N 0.000 description 1
- ILHMPZFVDISGNP-UHFFFAOYSA-N ethenyl n-[3-tris(trimethylsilyloxy)silylpropyl]carbamate Chemical compound C[Si](C)(C)O[Si](O[Si](C)(C)C)(O[Si](C)(C)C)CCCNC(=O)OC=C ILHMPZFVDISGNP-UHFFFAOYSA-N 0.000 description 1
- KRAZQXAPJAYYJI-UHFFFAOYSA-N ethenyl trimethylsilylmethyl carbonate Chemical compound C[Si](C)(C)COC(=O)OC=C KRAZQXAPJAYYJI-UHFFFAOYSA-N 0.000 description 1
- 231100000013 eye irritation Toxicity 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 229940005740 hexametaphosphate Drugs 0.000 description 1
- 150000002431 hydrogen Chemical group 0.000 description 1
- 125000004435 hydrogen atom Chemical group [H]* 0.000 description 1
- 125000002768 hydroxyalkyl group Chemical group 0.000 description 1
- IQPQWNKOIGAROB-UHFFFAOYSA-N isocyanate group Chemical group [N-]=C=O IQPQWNKOIGAROB-UHFFFAOYSA-N 0.000 description 1
- NIMLQBUJDJZYEJ-UHFFFAOYSA-N isophorone diisocyanate Chemical compound CC1(C)CC(N=C=O)CC(C)(CN=C=O)C1 NIMLQBUJDJZYEJ-UHFFFAOYSA-N 0.000 description 1
- 229910001629 magnesium chloride Inorganic materials 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 239000012569 microbial contaminant Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 125000004108 n-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 231100000065 noncytotoxic Toxicity 0.000 description 1
- 230000002020 noncytotoxic effect Effects 0.000 description 1
- 239000002736 nonionic surfactant Substances 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920001281 polyalkylene Polymers 0.000 description 1
- 229920001515 polyalkylene glycol Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
- 229940001474 sodium thiosulfate Drugs 0.000 description 1
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- 238000004528 spin coating Methods 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 125000000446 sulfanediyl group Chemical group *S* 0.000 description 1
- 239000012929 tonicity agent Substances 0.000 description 1
- UHUUYVZLXJHWDV-UHFFFAOYSA-N trimethyl(methylsilyloxy)silane Chemical compound C[SiH2]O[Si](C)(C)C UHUUYVZLXJHWDV-UHFFFAOYSA-N 0.000 description 1
- 150000003673 urethanes Chemical class 0.000 description 1
- LVLANIHJQRZTPY-UHFFFAOYSA-N vinyl carbamate Chemical compound NC(=O)OC=C LVLANIHJQRZTPY-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B25/00—Packaging other articles presenting special problems
- B65B25/008—Packaging other articles presenting special problems packaging of contact lenses
-
- A—HUMAN NECESSITIES
- A45—HAND OR TRAVELLING ARTICLES
- A45C—PURSES; LUGGAGE; HAND CARRIED BAGS
- A45C11/00—Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
- A45C11/005—Contact lens cases
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
- C08L1/08—Cellulose derivatives
- C08L1/26—Cellulose ethers
- C08L1/28—Alkyl ethers
- C08L1/284—Alkyl ethers with hydroxylated hydrocarbon radicals
Definitions
- the present invention generally relates to packaging solutions for contact lenses.
- Blister-packs and glass vials are typically used to individually package each soft contact lens for sale to a customer.
- Saline or deionized water is commonly used to store the lens in the blister-packs, as mentioned in various patents related to the packaging or manufacturing of contact lenses.
- packaging solutions for blister-packs have sometimes been formulated to reduce or eliminate lens folding and sticking.
- polymeric components have been included in packaging solutions to improve comfort of a contact lens when worn.
- polyvinyl alcohol (PVA) has been used in contact lens packaging solutions, and U.S. Pat. No. 6,440,366 discloses contact lens packaging solutions comprising polyethylene oxide (PEO)/polypropylene oxide (PPO) block copolymers, especially poloxamers or poloxamines.
- contact lenses be as comfortable as possible for wearers. Some contact lens wearers experience dryness or eye irritation throughout the day and particularly towards the end of the day. Some contact lens wearers experience discomfort when the lens is initially inserted in the eye.
- a drawback to some polymeric components for contact lens packaging solutions is that the polymeric component may affect visual acuity. For example, especially at initial insertion of the lens, a wearer may experience blurred vision.
- the packaging solution comprises hydroxypropyl methylcellulose (HPMC) and has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 8.
- HPMC hydroxypropyl methylcellulose
- This invention also provides a method comprising: (a) immersing a contact lens in a package with the aqueous solution comprising hydroxypropyl methylcellulose; (b) sealing the solution and the contact lens within the package; and (c) sterilizing the packaged solution and device.
- the method may include hermetically sealing the contact lens and the solution in the package and heat sterilizing the package contents.
- this invention provides a combination comprising a contact lens and an aqueous solution in a sealed container, wherein the solution comprises hydroxypropyl methylcellulose and the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of 6 to 8.
- the contact lens is preferably a silicone hydrogel contact lens, and may be made of an ionic copolymeric material, including a Group III or IV contact lens.
- the solution preferably has a viscosity in the range of 0.5 to 5 cps. According to preferred embodiments, the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and/or a viscosity in the range of 1 to 3 cps.
- the concentration of HPMC is 0.05 to 5 weight percent, more preferably 0.1 to 0.4 weight percent.
- the hydroxypropyl methylcellulose has a viscosity (at 20oC and at 2 weight % in water) of no greater than 50 cps, more preferably no greater than 25 cps.
- the solution may further comprise a buffer, such as a borate buffer, and NaCl.
- a buffer such as a borate buffer, and NaCl.
- the solution preferably does not contain an effective disinfecting amount of a disinfecting agent or a germicide compound.
- the solution may consist essentially of hydroxypropyl methylcellulose, a borate buffer and NaCl.
- the solution may consist of hydroxypropyl methylcellulose, a buffer, NaCl, water, and an optional chelating agent.
- a preferred embodiment is a solution consisting of: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; 0.01 to 2.5 weight percent NaCl; 0 to 1 weight percent chelating agent; and water.
- Another preferred embodiment is a solution comprising: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; and 0.01 to 2.5 weight percent NaCl; and the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and a viscosity in the range of 1 to 3 cps.
- the present invention provides a packaging system for the storage of contact lenses. These lenses can provide optical correction, wound care, drug delivery, diagnostic functionality or cosmetic enhancement or effect or a combination of these properties.
- the invention is applicable to soft, hydrogel contact lenses. As is understood by one skilled in the art, a lens is considered to be “soft” if it can be folded back upon itself without breaking.
- the invention is applicable to all hydrogel contact lenses, and especially contact lenses made of an ionic material in US FDA Group III or IV.
- Group IV contact lenses are composed of at least 50 weight percent water when hydrated and are made of an ionic material.
- Group III contact lenses have a lower water content but are also made of an ionic material.
- Group I and II contact lenses in contrast, are made of a non-ionic material.
- the invention is especially applicable to silicone hydrogel contact lenses, especially silicone hydrogel contact lenses in Group III or IV.
- Hydrogels in general are a well-known class of materials that comprise hydrated, cross-linked polymeric systems containing water in an equilibrium state. Hydrogels generally have a water content greater than about 5 weight percent and more commonly between about 10 to about 80 weight percent. Hydrogels are generally prepared by polymerizing a monomeric mixture including at least one hydrophilic monomer; either one of the hydrophilic monomers functions as a crosslinking agent, or a separate crosslinking monomer may be employed in this monomeric mixture.
- a crosslinker, crosslinking agent or crosslinking monomer is defined as a monomer having multiple polymerizable functionalities.
- the initial monomeric mixture includes at least one ionic lens-forming monomer.
- Silicone hydrogels are specific class of hydrogel materials which are usually prepared by polymerizing a monomeric mixture containing at least one silicone-containing monomer and at least one hydrophilic monomer; either the silicone-containing monomer or the hydrophilic monomer functions as a crosslinking agent, or a separate crosslinking monomer may be employed.
- Suitable hydrophilic monomers include: amides such as dimethylacrylamide and dimethylmethacrylamide; cyclic lactams such as n-vinyl-2-pyrrolidone; poly(alkylene glycols) functionalized with polymerizable groups; carboxylic acids such as methacrylic acid, acrylic acid and N-vinyloxycarbonylanaline; and hydroxyalkyl monomers, such as 2-hydroxyethyl methacrylate; and oxazolone monomers, including those disclosed in U.S. Pat. No. 4,910,277.
- Other suitable hydrophilic monomers will be apparent to one skilled in the art.
- the carboxylic acid-containing monomers are examples of ionic, hydrophilic lens-forming monomers.
- silicone-containing monomeric units include bulky polysiloxanylalkyl(meth)acrylic monomers.
- An example of a bulky polysiloxanylalkyl(meth)acrylic monomer is represented by the structure of Formula I:
- X denotes —O— or —NR—; each R 1 independently denotes hydrogen or methyl; each R 2 independently denotes a lower alkyl radical, phenyl radical or a group represented by
- each R 2 independently denotes a lower alkyl or phenyl radical; and h is 1 to 10.
- Examples of bulky monomers are methacryloxypropyl tris(trimethyl-siloxy)silane or tris(trimethylsiloxy)silylpropyl methacrylate, sometimes referred to as TRIS and tris(trimethylsiloxy)silylpropyl vinyl carbamate, sometimes referred to as TRIS-VC and the like.
- Such bulky monomers may be copolymerized with a silicone macromonomer, which is a poly(organosiloxane) capped with an unsaturated group at two or more ends of the molecule.
- a silicone macromonomer which is a poly(organosiloxane) capped with an unsaturated group at two or more ends of the molecule.
- U.S. Pat. No. 4,153,641 discloses, for example, various unsaturated groups such as acryloxy or methacryloxy groups.
- silicone-containing monomers includes, but is not limited to, silicone-containing vinyl carbonate or vinyl carbamate monomers such as, for example, 1,3-bis[4-vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane; 3-(trimethylsilyl)propyl vinyl carbonate; 3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane]; 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate; 3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate; 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbonate; t-butyldimethylsiloxyethyl vinyl carbonate; trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinyl carbonate and the like and mixtures thereof.
- silicone-containing vinyl carbonate or vinyl carbamate monomers such as, for example, 1,3
- silicone-containing monomers includes polyurethane-polysiloxane macromonomers (also sometimes referred to as prepolymers), which may have hard-soft-hard blocks like traditional urethane elastomers. They may be end-capped with a hydrophilic monomer such as 2-hydroxyethyl methacrylate (HEMA).
- HEMA 2-hydroxyethyl methacrylate
- Examples of such silicone urethanes are disclosed in a variety or publications, including U.S. Pat. No. 6,858,218 and PCT Published application Ser. No. WO 96/31792, which disclosures are hereby incorporated by reference in their entirety. Further examples of silicone urethane monomers are represented by Formulae II and III:
- D independently denotes an alkyl diradical, an alkyl cycloalkyl diradical, a cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 6 to about 30 carbon atoms;
- G independently denotes an alkyl diradical, a cycloalkyl diradical, an alkyl cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 1 to about 40 carbon atoms and which may contain ether, thio or amine linkages in the main chain;
- a is at least 1;
- A independently denotes a divalent polymeric radical of Formula IV:
- each R S independently denotes an alkyl or fluoro-substituted alkyl group having 1 to about 10 carbon atoms which may contain ether linkages between the carbon atoms; m′ is at least 1; and p is a number that provides a moiety weight of about 400 to about 10,000;
- each of E and E′ independently denotes a polymerizable unsaturated organic radical represented by Formula V:
- R 3 is hydrogen or methyl
- R 4 is hydrogen, an alkyl radical having 1 to 6 carbon atoms, or a —CO—Y—R 6 radical wherein Y is —O—, —S— or —NH—
- R 5 is a divalent alkylene radical having 1 to about 10 carbon atoms
- R 6 is a alkyl radical having 1 to about 12 carbon atoms
- X denotes —CO— or —OCO—
- Z denotes —O— or —NH—
- Ar denotes an aromatic radical having about 6 to about 30 carbon atoms
- w is 0 to 6
- x is 0 or 1
- y is 0 or 1
- z is 0 or 1.
- m is at least 1 and is preferably 3 or 4
- a is at least 1 and preferably is 1
- p is a number which provides a moiety weight of about 400 to about 10,000 and is preferably at least about 30
- R 7 is a diradical of a diisocyanate after removal of the isocyanate group, such as the diradical of isophorone diisocyanate
- each E′′ is a group represented by:
- a silicone hydrogel material comprises (in bulk, that is, in the monomer mixture that is copolymerized) about 5 to about 50 percent, and preferably about 10 to about 25, by weight of one or more silicone macromonomers, about 5 to about 75 percent, and preferably about 30 to about 60 percent, by weight of one or more polysiloxanylalkyl (meth)acrylic monomers, and about 10 to about 50 percent, and preferably about 20 to about 40 percent, by weight of a hydrophilic monomer, wherein at least one of the hydrophilic monomers is an ionic monomer.
- an ophthalmic lens for use herein can be a cationic lens such as a cationic contact lens or fluorinated silicone-containing monomers.
- a cationic lens such as a cationic contact lens or fluorinated silicone-containing monomers.
- Such monomers have been used in the formation of fluorosilicone hydrogels to reduce the accumulation of deposits on contact lenses made therefrom, as disclosed in, for example, U.S. Pat. Nos. 4,954,587; 5,010,141 and 5,079,319.
- silicone-containing monomers having certain fluorinated side groups i.e., —(CF 2 )—HH, have been found to improve compatibility between the hydrophilic and silicone-containing monomeric units. See, e.g., U.S. Pat. Nos. 5,321,108 and 5,387,662.
- Contact lenses for application of the present invention can be manufactured employing various conventional techniques, to yield a shaped article having the desired posterior and anterior lens surfaces.
- Spincasting methods are disclosed in U.S. Pat. Nos. 3,408,429 and 3,660,545; static casting methods are disclosed in U.S. Pat. Nos. 4,113,224, 4,197,266, and 5,271,875.
- a packaging system for the storage of a contact lens according to the present invention includes at least a sealed container containing an unused contact lenses immersed in an aqueous lens packaging solution.
- the sealed container is a hermetically sealed blister-pack, in which a concave well containing a contact lens is covered by a metal or plastic sheet adapted for peeling in order to open the blister-pack.
- the sealed container may be any suitable generally inert packaging material providing a reasonable degree of protection to the lens, preferably a plastic material such as polyalkylene (e.g., polyethylene or polypropylene), PVC, polyamide, and the like.
- the HPMC-containing packaging solution enhances initial and/or extended comfort when a contact lens, packaged in the solution and then removed from the packaging system, is placed on the eye for wearing.
- Any suitable HPMC may be employed in the packaging solution of this invention provided that it functions as described herein and has no substantial detrimental effect on the contact lens being stored or on the wearer of the contact lens.
- the HPMC and all other components of the packaging solution must be stable, soluble in aqueous solution, and compatible with one another, not only at room temperature, but also at temperatures of at least 120° C. for autoclaving conditions.
- the packaging solutions of this invention have a pH in the range of 6 to 8 (at 25° C.), more preferably in the range of 7.0 to 7.5.
- the solutions have an osmolality of at least 200 mOsm/kg, more preferably in the range of 250 to 400 mOsm/kg, and most preferably in the range of 300 to 370 mOsm/kg.
- the packaging solutions have a viscosity within the range of 0.5 to 5 cps (or, mPa ⁇ s), more preferably in the range of 1 to 3 cps. It was found that if the packaging solution has too high viscosity, blurred vision may result when the contact lens coated with the solution is inserted in the eye. It was found that if the packaging solution has too low viscosity, no improvement in comfort results when the contact lens is inserted in the eye.
- the HPMC is included in the solution at 0.05 to 0.5 weight percent, more preferably at 0.1 to 0.4 weight percent.
- the HPMC used in the packaging solution has a viscosity (at 20° C., and a concentration of 2 weight percent in water) of no greater than 50 cps, and preferably no greater than 25 cps. Accordingly, HPMC frequently marketed as “low viscosity” grades are preferred for this invention. These grades of HPMC typically having Mn no greater 20,000. It was found that relatively low viscosity HPMC, in amounts no greater than 0.5 weight percent, provided solutions with the desired improvement in comfort for initial insertion of the contact lens, but without deleteriously affecting visual acuity, contact lens dimensions, or stability of the packaging solution. In contrast, higher viscosity HPMC, in amounts necessary to improve comfort of the contact lens packaged therein, may tend to gel when autoclaved for sterilization, or may be difficult to filter in the sterile environment required for contact lens packaging.
- the packaging solutions include a buffer, in an amount to maintain the pH of the solution in the desired range.
- Suitable buffers include: phosphate; borate; citrate; carbonate; tris-(hydroxymethyl)aminomethane (TRIS); bis(2-hydroxyethyl)-imino-tris-(hydroxymethyl)aminoalcohol (bis-tris); zwitterionic buffers such as N-[2-Hydroxy-1,1-bis(hydroxymethyl)ethyl]glycine (Tricine)and N-[2-Hydroxy-1,1-bis(hydroxymethyl)ethyl]glycine, MOPS; N-(Carbamoylmethyl)taurine (ACES); amino acids and amino acid derivatives; and mixtures thereof.
- Tricine tris-(hydroxymethyl)aminomethane
- bis-tris bis(2-hydroxyethyl)-imino-tris-(hydroxymethyl)aminoalcohol
- zwitterionic buffers such as
- buffers will be used in amounts ranging from about 0.05 to about 2.5 percent by weight, and preferably from about 0.1 to about 1.5 percent by weight of the solution.
- a preferred buffer is borate buffer, comprising sodium borate and/or boric acid as the buffering agent.
- minor amounts of a base (such as NaOH) or an acid (such as HCl) may be included, if necessary, to make minor adjustments to the pH.
- bases such as NaOH
- an acid such as HCl
- these acids and bases are included within the term “buffer” and like terms.
- the solutions include a tonicity agent, in an amount to maintain the osmotic pressure in the desired range.
- the solutions are made substantially isotonic with physiological saline, used alone or in combination with other tonicity adjusting agents.
- suitable tonicity adjusting agents include: sodium and potassium chloride, dextrose, calcium and magnesium chloride and the like and mixtures thereof. These agents are typically used individually in amounts ranging from about 0.01 to about 2.5 percent by weight, and preferably from about 0.2 to about 1.5%.
- Various other materials may be included in the packaging system.
- a surfactant may be included in the aqueous solution.
- This class includes poloxamers and poloxamines, including those disclosed in U.S. Pat. No. 6,440,366.
- the surfactant is employed at a concentration from about 0.01 to about 10% w/w and preferably from about 0.5 to about 1.5% w/w.
- a chelating agent may be included in the aqueous solution.
- Agents include disodium ethylene diamine tetraacetate, alkali metal hexametaphosphate, citric acid, sodium citrate, 1-hydroxyethylidene-1,1,-diphosphonic acid, and the like, and mixtures thereof.
- the chelating agent is preferably used in an amount of 0.001 to 10% w/w, more preferably 0.03 to 1% w/w.
- An antioxidant may be included in the aqueous solution.
- Agents includesodium metabisulfite, sodium thiosulfate, N-acetylcysteine, butylated hydroxyanisole, butylated hydroxytoluene and the like and mixtures thereof.
- the packaging solutions according to the present invention are physiologically compatible.
- the solution must be “ophthalmically safe” for use with a lens such as a contact lens, meaning that a contact lens treated with the solution is generally suitable and safe for direct placement on the eye without rinsing, that is, the solution is safe and comfortable for daily contact with the eye via a contact lens that has been wetted with the solution.
- An ophthalmically safe solution has a tonicity and pH that is compatible with the eye and includes materials, and amounts thereof, that are non-cytotoxic according to ISO standards and U.S. Food & Drug Administration (FDA) regulations.
- the solution should be sterile in that the absence of microbial contaminants in the product prior to release must be statistically demonstrated to the degree necessary for such products.
- the liquid media useful in the present invention are selected to have no substantial detrimental effect on the lens being treated or cared for and to allow or even facilitate the present lens treatment or treatments.
- the liquid media are aqueous-based.
- a particularly useful aqueous liquid medium is that derived from saline, for example, a conventional saline solution or a conventional buffered saline solution.
- the method of packaging and storing an ophthalmic lens according to the present invention includes at least packaging the ophthalmic lens immersed in the aqueous contact lens packaging solution described above.
- the method may include immersing the ophthalmic lens in an aqueous contact lens solution prior to delivery to the customer/wearer, directly following manufacture of the contact lens.
- the packaging and storing in the solution of the present invention may occur at an intermediate point before delivery to the ultimate customer (wearer) but following manufacture and transportation of the lens in a dry state, wherein the dry lens is hydrated by immersing the lens in the contact lens packaging solution. Consequently, a package for delivery to a customer may include a sealed container containing one or more unused contact lenses immersed in an aqueous contact lens packaging solution according to the present invention.
- the steps leading to the present ophthalmic device packaging system include (1) molding an ophthalmic device in a mold comprising at least a first and second mold portion, (2) removing the lens from the mold portions; (3) introducing the packing solution of this invention and the ophthalmic lens into the container, and (4) sealing the container.
- the method also includes the step of sterilizing the contents of the container. Sterilization may take place prior to, or most conveniently after, sealing of the container and may be effected by any suitable method known in the art, e.g., by balanced autoclaving of the sealed container at temperatures of about 120° C. or higher.
- Preferred packages are plastic blister packages, including a recess for receiving a contact lens and the package solution, where the recess is sealed with lidstock prior to sterilization of the package contents.
- the packaging solutions in Table 1 are prepared by the following general procedure. Purified water is heated to at least 70° C. NaCl and buffering agents are added with agitation. The HPMC is added in increments with agitation. After complete dissolution, the solution is brought to room temperature, and at this point, minor amounts of NaCl or NaOH may be added for final pH adjustment. Additional water is added to final volume (Q.S.).
- the HPMC is Table 1 is Methocel E15LV (trademark Dow Chemical), having a viscosity (as measured at 20° C., 2% concentration in water) of about 12.
- Composition 1 Composition 2 (% w/w) (% w/w) Boric acid 1.080 1.148 Sodium borate 0.125 0.125 Sodium chloride 0.459 0.459 HPMC 0.300 0.300 Purified water QS to 100% w/w QS to 100% w/w
- Balafilcon A is a Group III, silicone hydrogel contact lens.
- Composition 1 or Composition 2 is added to the package so as to immerse the contact lens therein, and the package is sealed with lidstock. The sealed packages are sterilized by autoclaving at 121° C.
- balafilcon A contact lenses were provided, packaged in borate buffer saline, at a similar pH and osmolality, but lacking HPMC.
- the control lenses, and the test lenses packaged in Composition 1 of this Example were tested in a one day dispensing clinical.
- the test lens eyes exhibited statistically significant better forced choice preference for comfort at insertion compared to the control lens eyes. Forced choice denotes the wearer is asked to state a preference for either the control or the test lens.
- test and control lenses There were no statistically significant differences noted between the test and control lenses with respect to movement, inferior overlap, horizontal decentration, comfort, sting/burn, handling, normalized visual acuity, deposition, wettability, normalized corneal and conjunctival staining severity, and forced choice preference for comfort at end of day.
- Packaging solutions in Table 2 include a chelating agent, and may be prepared according to the general procedure, supra.
- HAP denotes 1-hydroxyethylidene-1,1,-diphosphonic acid
- EDTA denotes disodium ethylene diamine tetraacetate.
- Composition 1 Composition 2 (% w/w) (% w/w) Boric acid 1.080 1.148 Sodium borate 0.125 0.125 Sodium chloride 0.459 0.459 HPMC 0.300 0.300 HAP 0.05 — EDTA — 0.05 Purified water QS to 100% w/w QS to 100% w/w
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Abstract
A packaging system for the storage of a hydrogel contact lens employs an aqueous solution including hydroxypropyl methylcellulose.
Description
- This application claims benefit of Provisional Patent Application No. 60/989,485 filed Nov. 21, 2007 which is incorporated by reference herein.
- 1. Technical Field
- The present invention generally relates to packaging solutions for contact lenses.
- 2. Description of Related Art
- Blister-packs and glass vials are typically used to individually package each soft contact lens for sale to a customer. Saline or deionized water is commonly used to store the lens in the blister-packs, as mentioned in various patents related to the packaging or manufacturing of contact lenses. Because lens material may tend to stick to itself and/or to the lens package, packaging solutions for blister-packs have sometimes been formulated to reduce or eliminate lens folding and sticking. Additionally, polymeric components have been included in packaging solutions to improve comfort of a contact lens when worn. As examples, polyvinyl alcohol (PVA) has been used in contact lens packaging solutions, and U.S. Pat. No. 6,440,366 discloses contact lens packaging solutions comprising polyethylene oxide (PEO)/polypropylene oxide (PPO) block copolymers, especially poloxamers or poloxamines.
- It is highly desirable that contact lenses be as comfortable as possible for wearers. Some contact lens wearers experience dryness or eye irritation throughout the day and particularly towards the end of the day. Some contact lens wearers experience discomfort when the lens is initially inserted in the eye.
- A drawback to some polymeric components for contact lens packaging solutions is that the polymeric component may affect visual acuity. For example, especially at initial insertion of the lens, a wearer may experience blurred vision.
- Accordingly, it would be desirable to provide a packaging system for contact lenses such that the lenses would be more comfortable to wear, without compromising visual acuity.
- This invention provides an aqueous solution for the packaging and storage of a contact lens. The packaging solution comprises hydroxypropyl methylcellulose (HPMC) and has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 8.
- This invention also provides a method comprising: (a) immersing a contact lens in a package with the aqueous solution comprising hydroxypropyl methylcellulose; (b) sealing the solution and the contact lens within the package; and (c) sterilizing the packaged solution and device. The method may include hermetically sealing the contact lens and the solution in the package and heat sterilizing the package contents.
- Additionally, this invention provides a combination comprising a contact lens and an aqueous solution in a sealed container, wherein the solution comprises hydroxypropyl methylcellulose and the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of 6 to 8.
- The contact lens is preferably a silicone hydrogel contact lens, and may be made of an ionic copolymeric material, including a Group III or IV contact lens.
- The solution preferably has a viscosity in the range of 0.5 to 5 cps. According to preferred embodiments, the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and/or a viscosity in the range of 1 to 3 cps.
- According to preferred embodiments, the concentration of HPMC is 0.05 to 5 weight percent, more preferably 0.1 to 0.4 weight percent. According to preferred embodiments, the hydroxypropyl methylcellulose has a viscosity (at 20oC and at 2 weight % in water) of no greater than 50 cps, more preferably no greater than 25 cps.
- The solution may further comprise a buffer, such as a borate buffer, and NaCl. The solution preferably does not contain an effective disinfecting amount of a disinfecting agent or a germicide compound.
- The solution may consist essentially of hydroxypropyl methylcellulose, a borate buffer and NaCl.
- The solution may consist of hydroxypropyl methylcellulose, a buffer, NaCl, water, and an optional chelating agent. A preferred embodiment is a solution consisting of: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; 0.01 to 2.5 weight percent NaCl; 0 to 1 weight percent chelating agent; and water.
- Another preferred embodiment is a solution comprising: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; and 0.01 to 2.5 weight percent NaCl; and the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and a viscosity in the range of 1 to 3 cps.
- The present invention provides a packaging system for the storage of contact lenses. These lenses can provide optical correction, wound care, drug delivery, diagnostic functionality or cosmetic enhancement or effect or a combination of these properties. The invention is applicable to soft, hydrogel contact lenses. As is understood by one skilled in the art, a lens is considered to be “soft” if it can be folded back upon itself without breaking. The invention is applicable to all hydrogel contact lenses, and especially contact lenses made of an ionic material in US FDA Group III or IV. Group IV contact lenses are composed of at least 50 weight percent water when hydrated and are made of an ionic material. Group III contact lenses have a lower water content but are also made of an ionic material. Group I and II contact lenses, in contrast, are made of a non-ionic material. Additionally, the invention is especially applicable to silicone hydrogel contact lenses, especially silicone hydrogel contact lenses in Group III or IV.
- Any hydrogel material known to produce contact lenses can be used herein. Hydrogels in general are a well-known class of materials that comprise hydrated, cross-linked polymeric systems containing water in an equilibrium state. Hydrogels generally have a water content greater than about 5 weight percent and more commonly between about 10 to about 80 weight percent. Hydrogels are generally prepared by polymerizing a monomeric mixture including at least one hydrophilic monomer; either one of the hydrophilic monomers functions as a crosslinking agent, or a separate crosslinking monomer may be employed in this monomeric mixture. (A crosslinker, crosslinking agent or crosslinking monomer is defined as a monomer having multiple polymerizable functionalities.) For ionic hydrogels, the initial monomeric mixture includes at least one ionic lens-forming monomer. Silicone hydrogels are specific class of hydrogel materials which are usually prepared by polymerizing a monomeric mixture containing at least one silicone-containing monomer and at least one hydrophilic monomer; either the silicone-containing monomer or the hydrophilic monomer functions as a crosslinking agent, or a separate crosslinking monomer may be employed.
- Suitable hydrophilic monomers include: amides such as dimethylacrylamide and dimethylmethacrylamide; cyclic lactams such as n-vinyl-2-pyrrolidone; poly(alkylene glycols) functionalized with polymerizable groups; carboxylic acids such as methacrylic acid, acrylic acid and N-vinyloxycarbonylanaline; and hydroxyalkyl monomers, such as 2-hydroxyethyl methacrylate; and oxazolone monomers, including those disclosed in U.S. Pat. No. 4,910,277. Other suitable hydrophilic monomers will be apparent to one skilled in the art. The carboxylic acid-containing monomers are examples of ionic, hydrophilic lens-forming monomers.
- Applicable silicone-containing monomeric units for use in the formation of silicone hydrogels are well known in the art and numerous examples are provided in U.S. Pat. Nos. 4,136,250; 4,153,641; 4,740,533; 5,034,461; 5,070,215; 5,260,000; 5,310,779, and 5,358,995.
- Representative examples of applicable silicone-containing monomeric units include bulky polysiloxanylalkyl(meth)acrylic monomers. An example of a bulky polysiloxanylalkyl(meth)acrylic monomer is represented by the structure of Formula I:
- wherein X denotes —O— or —NR—; each R1 independently denotes hydrogen or methyl; each R2 independently denotes a lower alkyl radical, phenyl radical or a group represented by
- wherein each R2 independently denotes a lower alkyl or phenyl radical; and h is 1 to 10.
- Examples of bulky monomers are methacryloxypropyl tris(trimethyl-siloxy)silane or tris(trimethylsiloxy)silylpropyl methacrylate, sometimes referred to as TRIS and tris(trimethylsiloxy)silylpropyl vinyl carbamate, sometimes referred to as TRIS-VC and the like.
- Such bulky monomers may be copolymerized with a silicone macromonomer, which is a poly(organosiloxane) capped with an unsaturated group at two or more ends of the molecule. U.S. Pat. No. 4,153,641 discloses, for example, various unsaturated groups such as acryloxy or methacryloxy groups.
- Another class of representative silicone-containing monomers includes, but is not limited to, silicone-containing vinyl carbonate or vinyl carbamate monomers such as, for example, 1,3-bis[4-vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane; 3-(trimethylsilyl)propyl vinyl carbonate; 3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane]; 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate; 3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate; 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbonate; t-butyldimethylsiloxyethyl vinyl carbonate; trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinyl carbonate and the like and mixtures thereof.
- Another class of silicone-containing monomers includes polyurethane-polysiloxane macromonomers (also sometimes referred to as prepolymers), which may have hard-soft-hard blocks like traditional urethane elastomers. They may be end-capped with a hydrophilic monomer such as 2-hydroxyethyl methacrylate (HEMA). Examples of such silicone urethanes are disclosed in a variety or publications, including U.S. Pat. No. 6,858,218 and PCT Published application Ser. No. WO 96/31792, which disclosures are hereby incorporated by reference in their entirety. Further examples of silicone urethane monomers are represented by Formulae II and III:
-
E(*D*A*D*G)a*D*A*D*E′; or (II) -
E(*D*G*D*A)a*D*A*D*E′; or (III) - wherein:
- D independently denotes an alkyl diradical, an alkyl cycloalkyl diradical, a cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 6 to about 30 carbon atoms;
- G independently denotes an alkyl diradical, a cycloalkyl diradical, an alkyl cycloalkyl diradical, an aryl diradical or an alkylaryl diradical having 1 to about 40 carbon atoms and which may contain ether, thio or amine linkages in the main chain;
- * denotes a urethane or ureido linkage;
- a is at least 1;
- A independently denotes a divalent polymeric radical of Formula IV:
- wherein each RS independently denotes an alkyl or fluoro-substituted alkyl group having 1 to about 10 carbon atoms which may contain ether linkages between the carbon atoms; m′ is at least 1; and p is a number that provides a moiety weight of about 400 to about 10,000;
- each of E and E′ independently denotes a polymerizable unsaturated organic radical represented by Formula V:
- wherein: R3 is hydrogen or methyl;
R4 is hydrogen, an alkyl radical having 1 to 6 carbon atoms, or a —CO—Y—R6 radical wherein Y is —O—, —S— or —NH—;
R5 is a divalent alkylene radical having 1 to about 10 carbon atoms;
R6 is a alkyl radical having 1 to about 12 carbon atoms;
X denotes —CO— or —OCO—;
Z denotes —O— or —NH—;
Ar denotes an aromatic radical having about 6 to about 30 carbon atoms;
w is 0 to 6; x is 0 or 1; y is 0 or 1; and z is 0 or 1. - A specific example of a silicone-containing urethane monomer is represented by Formula VI:
- wherein m is at least 1 and is preferably 3 or 4, a is at least 1 and preferably is 1, p is a number which provides a moiety weight of about 400 to about 10,000 and is preferably at least about 30, R7 is a diradical of a diisocyanate after removal of the isocyanate group, such as the diradical of isophorone diisocyanate, and each E″ is a group represented by:
- In another embodiment of the present invention, a silicone hydrogel material comprises (in bulk, that is, in the monomer mixture that is copolymerized) about 5 to about 50 percent, and preferably about 10 to about 25, by weight of one or more silicone macromonomers, about 5 to about 75 percent, and preferably about 30 to about 60 percent, by weight of one or more polysiloxanylalkyl (meth)acrylic monomers, and about 10 to about 50 percent, and preferably about 20 to about 40 percent, by weight of a hydrophilic monomer, wherein at least one of the hydrophilic monomers is an ionic monomer.
- The above silicone materials are merely exemplary, and other materials for use as substrates that can benefit by being packaged in the packaging solution according to the present invention and have been disclosed in various publications and are being continuously developed for use in contact lenses and other medical devices can also be used. For example, an ophthalmic lens for use herein can be a cationic lens such as a cationic contact lens or fluorinated silicone-containing monomers. Such monomers have been used in the formation of fluorosilicone hydrogels to reduce the accumulation of deposits on contact lenses made therefrom, as disclosed in, for example, U.S. Pat. Nos. 4,954,587; 5,010,141 and 5,079,319. The use of silicone-containing monomers having certain fluorinated side groups, i.e., —(CF2)—HH, have been found to improve compatibility between the hydrophilic and silicone-containing monomeric units. See, e.g., U.S. Pat. Nos. 5,321,108 and 5,387,662.
- Contact lenses for application of the present invention can be manufactured employing various conventional techniques, to yield a shaped article having the desired posterior and anterior lens surfaces. Spincasting methods are disclosed in U.S. Pat. Nos. 3,408,429 and 3,660,545; static casting methods are disclosed in U.S. Pat. Nos. 4,113,224, 4,197,266, and 5,271,875.
- Next, the lens will be immersed in a packaging solution and stored in a packaging system according to the present invention. Generally, a packaging system for the storage of a contact lens according to the present invention includes at least a sealed container containing an unused contact lenses immersed in an aqueous lens packaging solution. Preferably, the sealed container is a hermetically sealed blister-pack, in which a concave well containing a contact lens is covered by a metal or plastic sheet adapted for peeling in order to open the blister-pack. The sealed container may be any suitable generally inert packaging material providing a reasonable degree of protection to the lens, preferably a plastic material such as polyalkylene (e.g., polyethylene or polypropylene), PVC, polyamide, and the like.
- The HPMC-containing packaging solution enhances initial and/or extended comfort when a contact lens, packaged in the solution and then removed from the packaging system, is placed on the eye for wearing. Any suitable HPMC may be employed in the packaging solution of this invention provided that it functions as described herein and has no substantial detrimental effect on the contact lens being stored or on the wearer of the contact lens. The HPMC and all other components of the packaging solution must be stable, soluble in aqueous solution, and compatible with one another, not only at room temperature, but also at temperatures of at least 120° C. for autoclaving conditions.
- The packaging solutions of this invention have a pH in the range of 6 to 8 (at 25° C.), more preferably in the range of 7.0 to 7.5. The solutions have an osmolality of at least 200 mOsm/kg, more preferably in the range of 250 to 400 mOsm/kg, and most preferably in the range of 300 to 370 mOsm/kg. The packaging solutions have a viscosity within the range of 0.5 to 5 cps (or, mPa·s), more preferably in the range of 1 to 3 cps. It was found that if the packaging solution has too high viscosity, blurred vision may result when the contact lens coated with the solution is inserted in the eye. It was found that if the packaging solution has too low viscosity, no improvement in comfort results when the contact lens is inserted in the eye.
- The HPMC is included in the solution at 0.05 to 0.5 weight percent, more preferably at 0.1 to 0.4 weight percent. The HPMC used in the packaging solution has a viscosity (at 20° C., and a concentration of 2 weight percent in water) of no greater than 50 cps, and preferably no greater than 25 cps. Accordingly, HPMC frequently marketed as “low viscosity” grades are preferred for this invention. These grades of HPMC typically having Mn no greater 20,000. It was found that relatively low viscosity HPMC, in amounts no greater than 0.5 weight percent, provided solutions with the desired improvement in comfort for initial insertion of the contact lens, but without deleteriously affecting visual acuity, contact lens dimensions, or stability of the packaging solution. In contrast, higher viscosity HPMC, in amounts necessary to improve comfort of the contact lens packaged therein, may tend to gel when autoclaved for sterilization, or may be difficult to filter in the sterile environment required for contact lens packaging.
- The packaging solutions include a buffer, in an amount to maintain the pH of the solution in the desired range. Suitable buffers include: phosphate; borate; citrate; carbonate; tris-(hydroxymethyl)aminomethane (TRIS); bis(2-hydroxyethyl)-imino-tris-(hydroxymethyl)aminoalcohol (bis-tris); zwitterionic buffers such as N-[2-Hydroxy-1,1-bis(hydroxymethyl)ethyl]glycine (Tricine)and N-[2-Hydroxy-1,1-bis(hydroxymethyl)ethyl]glycine, MOPS; N-(Carbamoylmethyl)taurine (ACES); amino acids and amino acid derivatives; and mixtures thereof. Generally, buffers will be used in amounts ranging from about 0.05 to about 2.5 percent by weight, and preferably from about 0.1 to about 1.5 percent by weight of the solution. A preferred buffer is borate buffer, comprising sodium borate and/or boric acid as the buffering agent. Optionally, minor amounts of a base (such as NaOH) or an acid (such as HCl) may be included, if necessary, to make minor adjustments to the pH. To the extent such acids or bases are used in conjunction with the aforementioned buffering agents to adjust pH, these acids and bases are included within the term “buffer” and like terms.
- The solutions include a tonicity agent, in an amount to maintain the osmotic pressure in the desired range. The solutions are made substantially isotonic with physiological saline, used alone or in combination with other tonicity adjusting agents. Examples of suitable tonicity adjusting agents include: sodium and potassium chloride, dextrose, calcium and magnesium chloride and the like and mixtures thereof. These agents are typically used individually in amounts ranging from about 0.01 to about 2.5 percent by weight, and preferably from about 0.2 to about 1.5%.
- Various other materials may be included in the packaging system.
- A surfactant may be included in the aqueous solution. Preferred are non-ionic surfactants, especially block copolymers of PEO and PPO. This class includes poloxamers and poloxamines, including those disclosed in U.S. Pat. No. 6,440,366. When present, the surfactant is employed at a concentration from about 0.01 to about 10% w/w and preferably from about 0.5 to about 1.5% w/w.
- A chelating agent may be included in the aqueous solution. Agents include disodium ethylene diamine tetraacetate, alkali metal hexametaphosphate, citric acid, sodium citrate, 1-hydroxyethylidene-1,1,-diphosphonic acid, and the like, and mixtures thereof. When present, the chelating agent is preferably used in an amount of 0.001 to 10% w/w, more preferably 0.03 to 1% w/w.
- An antioxidant may be included in the aqueous solution. Agents includesodium metabisulfite, sodium thiosulfate, N-acetylcysteine, butylated hydroxyanisole, butylated hydroxytoluene and the like and mixtures thereof.
- The packaging solutions according to the present invention are physiologically compatible. Specifically, the solution must be “ophthalmically safe” for use with a lens such as a contact lens, meaning that a contact lens treated with the solution is generally suitable and safe for direct placement on the eye without rinsing, that is, the solution is safe and comfortable for daily contact with the eye via a contact lens that has been wetted with the solution. An ophthalmically safe solution has a tonicity and pH that is compatible with the eye and includes materials, and amounts thereof, that are non-cytotoxic according to ISO standards and U.S. Food & Drug Administration (FDA) regulations. The solution should be sterile in that the absence of microbial contaminants in the product prior to release must be statistically demonstrated to the degree necessary for such products. The liquid media useful in the present invention are selected to have no substantial detrimental effect on the lens being treated or cared for and to allow or even facilitate the present lens treatment or treatments. The liquid media are aqueous-based. A particularly useful aqueous liquid medium is that derived from saline, for example, a conventional saline solution or a conventional buffered saline solution.
- The method of packaging and storing an ophthalmic lens according to the present invention includes at least packaging the ophthalmic lens immersed in the aqueous contact lens packaging solution described above. The method may include immersing the ophthalmic lens in an aqueous contact lens solution prior to delivery to the customer/wearer, directly following manufacture of the contact lens. Alternately, the packaging and storing in the solution of the present invention may occur at an intermediate point before delivery to the ultimate customer (wearer) but following manufacture and transportation of the lens in a dry state, wherein the dry lens is hydrated by immersing the lens in the contact lens packaging solution. Consequently, a package for delivery to a customer may include a sealed container containing one or more unused contact lenses immersed in an aqueous contact lens packaging solution according to the present invention.
- In one embodiment, the steps leading to the present ophthalmic device packaging system include (1) molding an ophthalmic device in a mold comprising at least a first and second mold portion, (2) removing the lens from the mold portions; (3) introducing the packing solution of this invention and the ophthalmic lens into the container, and (4) sealing the container. Preferably, the method also includes the step of sterilizing the contents of the container. Sterilization may take place prior to, or most conveniently after, sealing of the container and may be effected by any suitable method known in the art, e.g., by balanced autoclaving of the sealed container at temperatures of about 120° C. or higher. Preferred packages are plastic blister packages, including a recess for receiving a contact lens and the package solution, where the recess is sealed with lidstock prior to sterilization of the package contents.
- The following examples are provided to enable one skilled in the art to practice the invention and are merely illustrative of the invention. The examples should not be read as limiting the scope of the invention as defined in the claims.
- The packaging solutions in Table 1 are prepared by the following general procedure. Purified water is heated to at least 70° C. NaCl and buffering agents are added with agitation. The HPMC is added in increments with agitation. After complete dissolution, the solution is brought to room temperature, and at this point, minor amounts of NaCl or NaOH may be added for final pH adjustment. Additional water is added to final volume (Q.S.). The HPMC is Table 1 is Methocel E15LV (trademark Dow Chemical), having a viscosity (as measured at 20° C., 2% concentration in water) of about 12.
-
TABLE 1 Composition 1 Composition 2 (% w/w) (% w/w) Boric acid 1.080 1.148 Sodium borate 0.125 0.125 Sodium chloride 0.459 0.459 HPMC 0.300 0.300 Purified water QS to 100% w/w QS to 100% w/w - Contact lens blister packages, each containing a balafilcon A contact lens (sold under the trademark PureVision, Bausch & Lomb Incorporated), are provided. Balafilcon A is a Group III, silicone hydrogel contact lens. Composition 1 or Composition 2 is added to the package so as to immerse the contact lens therein, and the package is sealed with lidstock. The sealed packages are sterilized by autoclaving at 121° C.
- As a control, balafilcon A contact lenses were provided, packaged in borate buffer saline, at a similar pH and osmolality, but lacking HPMC. The control lenses, and the test lenses packaged in Composition 1 of this Example, were tested in a one day dispensing clinical. The test lens eyes exhibited statistically significant better forced choice preference for comfort at insertion compared to the control lens eyes. Forced choice denotes the wearer is asked to state a preference for either the control or the test lens. There were no statistically significant differences noted between the test and control lenses with respect to movement, inferior overlap, horizontal decentration, comfort, sting/burn, handling, normalized visual acuity, deposition, wettability, normalized corneal and conjunctival staining severity, and forced choice preference for comfort at end of day.
- Packaging solutions in Table 2 include a chelating agent, and may be prepared according to the general procedure, supra. HAP denotes 1-hydroxyethylidene-1,1,-diphosphonic acid, and EDTA denotes disodium ethylene diamine tetraacetate.
-
TABLE 2 Composition 1 Composition 2 (% w/w) (% w/w) Boric acid 1.080 1.148 Sodium borate 0.125 0.125 Sodium chloride 0.459 0.459 HPMC 0.300 0.300 HAP 0.05 — EDTA — 0.05 Purified water QS to 100% w/w QS to 100% w/w - It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. For example, the functions described above and implemented as the best mode for operating the present invention are for illustration purposes only. Other arrangements and methods may be implemented by those skilled in the art without departing from the scope and spirit of this invention. Moreover, those skilled in the art will envision other modifications within the scope and spirit of the features and advantages appended hereto.
Claims (20)
1. A method comprising:
(a) immersing a contact lens in a package with an aqueous solution comprising hydroxypropyl methylcellulose, wherein the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of 6 to 8;
(b) sealing the solution and the contact lens within the package; and
(c) sterilizing the packaged solution and device.
2. The method of claim 1 , wherein the contact lens is a silicone hydrogel contact lens.
3. The method of claim 1 , wherein the contact lens is a Group III or IV contact lens.
4. The method of claim 1 , wherein the solution has a viscosity in the range of 0.5 to 5 cps.
5. The method of claim 1 , wherein the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and a viscosity in the range of 1 to 3 cps.
6. The method of claim 1 , wherein the concentration of hydroxypropyl methylcellulose is 0.05 to 5 weight percent.
7. The method of claim 1 , wherein the concentration of hydroxypropyl methylcellulose is 0.1 to 0.4 weight percent.
8. The method of claim 1 , wherein the hydroxypropyl methylcellulose has a viscosity (at 20 oC and at 2 weight % in water) of no greater than 50 cps.
9. The method of claim 1 , wherein the hydroxypropyl methylcellulose has a viscosity (at 20 oC and at 2 weight % in water) of no greater than 25 cps.
10. The method of claim 1 , wherein the solution comprises a buffer and NaCl.
11. The method of claim 10 , wherein the solution comprises a borate buffer.
12. The method of claim 1 , including hermetically sealing the contact lens and the solution in the package and heat sterilizing the package contents.
13. The method of claim 1 , wherein the solution does not contain an effective disinfecting amount of a disinfecting agent or a germicide compound.
14. A combination comprising a contact lens and an aqueous solution in a sealed container, wherein the solution comprises hydroxypropyl methylcellulose and the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of 6 to 8.
15. The combination of claim 14 , wherein the contact lens is a silicone hydrogel contact lens.
16. The combination of claim 14 , wherein the solution consists essentially of hydroxypropyl methylcellulose, a borate buffer and NaCl.
17. The combination of claim 14 , wherein the solution consists of hydroxypropyl methylcellulose, a buffer, NaCl, water, and an optional chelating agent.
18. The combination of claim 14 , wherein the solution consists of: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; 0.01 to 2.5 weight percent NaCl; 0 to 1 weight percent chelating agent; and water.
19. The combination of claim 15 , wherein the solution comprises: 0.05 to 0.5 weight percent hydroxypropyl methylcellulose; 0.05 to 2.5 weight percent buffer; and 0.01 to 2.5 weight percent NaCl; and the solution has an osmolality in the range of 250 to 400 mOsm/kg, a pH in the range of 7.0 to 7.5, and a viscosity in the range of 1 to 3 cps.
20. The combination of claim 19 , wherein the hydroxypropyl methylcellulose has a viscosity (at 20 oC and at 2 weight % in water) of no greater than 25 cps.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12/258,938 US20090126318A1 (en) | 2007-11-21 | 2008-10-27 | Packaging Solutions |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US98948507P | 2007-11-21 | 2007-11-21 | |
| US12/258,938 US20090126318A1 (en) | 2007-11-21 | 2008-10-27 | Packaging Solutions |
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| US12/258,938 Abandoned US20090126318A1 (en) | 2007-11-21 | 2008-10-27 | Packaging Solutions |
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| WO (1) | WO2009067313A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2023166315A (en) * | 2022-05-09 | 2023-11-21 | ロート製薬株式会社 | Ophthalmic composition |
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| US4983585A (en) * | 1987-05-04 | 1991-01-08 | Mdr Group, Inc. | Viscoelastic fluid for use in surgery and other therapies and method of using same |
| US5422029A (en) * | 1993-06-18 | 1995-06-06 | Potini; Chimpiramma | Composition for cleaning contact lenses |
| US5882687A (en) * | 1997-01-10 | 1999-03-16 | Allergan | Compositions and methods for storing contact lenses |
| US6634748B1 (en) * | 2000-11-15 | 2003-10-21 | Johnson & Johnson Vision Care, Inc. | Methods of stabilizing silicone hydrogels against hydrolytic degradation |
| US20040186028A1 (en) * | 2003-03-19 | 2004-09-23 | Zhenze Hu | Method and composition for reducing contact lens swelling |
| US20080307751A1 (en) * | 2004-10-01 | 2008-12-18 | Newman Stephen D | Contact Lens Package Solution |
-
2008
- 2008-10-21 WO PCT/US2008/080633 patent/WO2009067313A1/en not_active Ceased
- 2008-10-27 US US12/258,938 patent/US20090126318A1/en not_active Abandoned
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4808239A (en) * | 1984-12-28 | 1989-02-28 | Alcon Laboratories, Inc. | Method of cleaning contact lens using compositions containing polyether carboxylic acid surfactant |
| US4983585A (en) * | 1987-05-04 | 1991-01-08 | Mdr Group, Inc. | Viscoelastic fluid for use in surgery and other therapies and method of using same |
| US5422029A (en) * | 1993-06-18 | 1995-06-06 | Potini; Chimpiramma | Composition for cleaning contact lenses |
| US5882687A (en) * | 1997-01-10 | 1999-03-16 | Allergan | Compositions and methods for storing contact lenses |
| US6634748B1 (en) * | 2000-11-15 | 2003-10-21 | Johnson & Johnson Vision Care, Inc. | Methods of stabilizing silicone hydrogels against hydrolytic degradation |
| US20040186028A1 (en) * | 2003-03-19 | 2004-09-23 | Zhenze Hu | Method and composition for reducing contact lens swelling |
| US20080307751A1 (en) * | 2004-10-01 | 2008-12-18 | Newman Stephen D | Contact Lens Package Solution |
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| JP2023166315A (en) * | 2022-05-09 | 2023-11-21 | ロート製薬株式会社 | Ophthalmic composition |
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