DK2185951T3 - Kontaktlinseprodukter - Google Patents
Kontaktlinseprodukter Download PDFInfo
- Publication number
- DK2185951T3 DK2185951T3 DK08795634.8T DK08795634T DK2185951T3 DK 2185951 T3 DK2185951 T3 DK 2185951T3 DK 08795634 T DK08795634 T DK 08795634T DK 2185951 T3 DK2185951 T3 DK 2185951T3
- Authority
- DK
- Denmark
- Prior art keywords
- acid
- polymer
- packaging solution
- contact lens
- lens
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
-
- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B1/00—Optical elements characterised by the material of which they are made; Optical coatings for optical elements
- G02B1/04—Optical elements characterised by the material of which they are made; Optical coatings for optical elements made of organic materials, e.g. plastics
- G02B1/041—Lenses
- G02B1/043—Contact lenses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L12/00—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor
- A61L12/02—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using physical phenomena, e.g. electricity, ultrasonics or ultrafiltration
- A61L12/04—Heat
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D11/00—Producing optical elements, e.g. lenses or prisms
- B29D11/00009—Production of simple or compound lenses
- B29D11/00038—Production of contact lenses
- B29D11/00067—Hydrating contact lenses
-
- G—PHYSICS
- G02—OPTICS
- G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
- G02B1/00—Optical elements characterised by the material of which they are made; Optical coatings for optical elements
- G02B1/04—Optical elements characterised by the material of which they are made; Optical coatings for optical elements made of organic materials, e.g. plastics
-
- G—PHYSICS
- G02—OPTICS
- G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
- G02C7/00—Optical parts
- G02C7/02—Lenses; Lens systems ; Methods of designing lenses
- G02C7/04—Contact lenses for the eyes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
Claims (15)
1. Ophthalmisk produkt omfattende: en forseglet og steriliseret pakning, der indeholder en forpakningsopløsning og en blød hydrogelkontaktlinse nedsænket i forpakningsopløsningen, idet hydrogelkontaktlinsen omfatter en polymermatrix, et første udvaskeligt polymert smøremiddel og et andet udvaskeligt polymert smøremiddel, idet det andet udvaskelige polymere smøremiddel er forskelligt fra det første udvaskelige polymere smøremiddel med hensyn til molvægt eller polymersammensætning, idet forpakningsopløsningen indeholder en ikke-ionisk hydroxylholdig viskositetsforøgende polymer i en tilstrækkelig mængde til at bibringe forpakningsopløsningen en viskositet fra ca. 1,5 centipoise til ca. 20 centipoise ved 25°C, en polyethylenglycol med en molvægt på 2000 eller derunder, en a-oxo-multisyre eller et salt deraf i en tilstrækkelig mængde til at nedsætte modtageligheden for oxidativ nedbrydning af polyethylenglycolen i forpakningsopløsningen, og ét eller flere puffermidler i en tilstrækkelig mængde til at bibringe opløsningen en pH-vædi fra ca. 6,0 til 8,0, og idet pakningsopløsningen har en osmolalitet fra ca. 200 til ca. 450 mOsm/kg.
2. Ophthalmisk produkt ifølge krav 1, hvori a-oxo-multisyren er valgt fra gruppen bestående af citronsyre, 2-ketoglutarsyre og æblesyre.
3. Ophthalmisk produkt ifølge krav 2, hvori α-oxo-multisyren er citronsyre.
4. Ophthalmisk produkt ifølge krav 1, hvori det første og det andet udvaskelige smøremiddel indbyrdes uafhængigt er ikke-tværbindelige hydrofile polymere valgt fra gruppen bestående af polyvinylalkoholer, polyamider, polyimider, polylacton, homopolymere af en vinyllactam, copolymere af mindst én vinyllactam og mindst én hydrofil vinylisk monomer, alkylerede polyvinylpyrrolidoner, homopolymere af acrylamid, homopolymere af methacrylamid, copolymere af acrylamid og mindst én hydrofil vinylisk monomer, copolymere af methacrylamid med mindst én hydrofil vinylisk monomer, polyethylenoxid, et polyoxyethylenderivat, poly-N,N-dimethylacrylamid, poly-2-ethyl-oxazolin, heparinpolysaccharider, polysaccharider og blandinger deraf.
5. Ophthalmisk produkt ifølge krav 1, hvori den viskositetsforøgende polymere er valgt fra gruppen bestående af polyvinylalcohol, methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydro xypropyl-methylcellulose, et poly(ethylenoxid) med en molvægt, der er højere end 2000 dalton, og en blanding deraf.
6. Ophthalmisk produkt ifølge krav 1, hvori polyethylenglycolen har en molvægt på ca. 600 dalton eller mindre.
7. Ophthalmisk produkt ifølge krav 1, hvori forpakningsopløsningen har en viskositet fra ca. 2,0 centipoise til ca. 8 centipoise ved 25°C.
8. Ophthalmisk produkt ifølge krav 1, hvori forpakningsopløsningen indeholder mindst ét puffermiddel valgt fra gruppen bestående af borsyre, phosphorsyre, TRIS (2-amino-2-hydroxymethyl-1,3-propandiol), bis-tris (bis-(2-hydroxyethyl)-imino-tris-(hydroxy-methyl)-methan), en bis-aminopolyol, triethanolamin, ACES (N-(2-hydroxyethyl)-2-aminoethansulfonsyre), BES (N,N-bis-(2-hydroxyethyl)-2-aminoethansulfonsyre), HEPES (4-(2-hydroxyethyl)-1-piperazinethansulfonsyre), MES (2-(N-morpholino)ethan-sulfonsyre), MOPS (3-[N-morpholino]-propansulfonsyre), PIPES (piperazin-N,N'-bis-(2-ethansulfonsyre), TES (N-[Tris(hydroxymethyl)methyl]-2-aminoethansulfonsyre) og salte deraf.
9. Ophthalmisk produkt ifølge krav 1, hvori forpakningsopløsningen indeholder et ophthalmisk acceptabelt overfladeaktivt middel valgt fra gruppen bestående af en poloxamer, en polyamin, en polyethylenglycolester af en fedtsyre, en polyoxyethylen-eller polyoxypropylenether af Ci2-Ci8-alkaner, polyoxyethylenstearat, polyoxyethylen-propylenglycolstearat og en blanding deraf.
10. Fremgangsmåde til fremstilling af en blød kontaktlinse omfattende følgende trin: a) hærdning af en hydrogellinsedannende sammensætning i en form til dannelse af en hydrogelkontaktlinse, idet linsepræparatet omfatter et første udvaskeligt polymert smøremiddel og et andet udvaskeligt polymert smøremiddel, idet det første og det andet udvaskelige polymere smøremiddel er indarbejdet ikke-covalent og fordelt i kontaltlinsens matrix, idet det andet udvaskelige polymere smøremiddel er forskelligt fra det første udvaskelige polymere smøremiddel med hensyn til molvægt eller polymersammensætning; b) emballering af hydrogelkontaktlinsen i en beholder, der indeholder en forpakningsopløsning, idet forpakningsopløsningen omfatter en viskositetsforøgende polymer, idet den viskositetsforøgende polymere er en ikke-ionisk hydroxylholdig polymer, i en tilstrækkelig mængde til at bibringe forpakningsopløsningen en viskositet fra ca. 1,5 centipoise til ca. 20 centipoise ved 25°C, og et polymert overfladeaktivt middel, hvor det polymere overfladeaktive middel er polyethylenglycol med en molvægt mindre end ca. 2000 dalton; og idet forpakningsopløsningen omfatter en a-oxo-multisyre eller et salt deraf i en mængde, der er tilstrækkelig til at nedsætte modtageligheden over for oxidativ nedbrydning af polyethylenglycolen i forpakningsopløsningen, og ét eller flere puffermidler i en mængde, der er tilstrækkelig til at bibringe opløsningen en pH-værdi fra ca. 6,0 til 8,0, og idet forpakningsopløsningen har en osmolalitet fra ca. 200 til ca. 450 mOsm/kg; og c) sterilisation af hydrogelkontaktlinsen i emballagen for at opnå den bløde kontaktlinse.
11. Fremgangsmåde ifølge krav 10, ved hvilken a-oxo-multisyren er valgt fra den gruppe, der består af citronsyre, 2-ketoglutarsyre og æblesyre.
12. Fremgangsmåde ifølge krav 11, ved hvilken α-oxo-multisyren er citronsyre.
13. Fremgangsmåde ifølge krav 10, ved hvilken det første og det andet udvaskelige smøremiddel indbyrdes uafhængigt er ikke-tværbindelige og ikke-ladede hydrofile polymere valgt fra gruppen bestående af polyvinylalkoholer, polyamider, polyimider, polylacton, homopolymere af en vinyllactam, copolymere af mindst én vinyllactam og mindst én hydrofil vinylisk monomer, alkylerede polyvinylpyrrolidoner, homopolymere af acrylamid, homopolymere af methacrylamid, copolymere af acrylamid og mindst én hydrofil vinylisk monomer, copolymere af methacrylamid med mindst én hydrofil vinylisk monomer, polyethylenoxid, et polyoxyethylenderivat, poly-N,N-dimethylacrylamid, poly-2-ethyloxazolin, heparinpolysaccharider, polysaccharider og blandinger deraf.
14. Fremgangsmåde ifølge krav 10, ved hvilken den viskositetsforøgende polymere er valgt fra gruppen bestående af polyvinylalcohol, methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl-methylcellulose, et poly(ethylenoxid) med en molvægt, der er højere end 2000 dalton, og en blanding deraf.
15. Fremgangsmåde ifølge krav 10, ved hvilken polyethylenglycolen har en molvægt på 600 dalton.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US96933907P | 2007-08-31 | 2007-08-31 | |
PCT/US2008/010159 WO2009032132A1 (en) | 2007-08-31 | 2008-08-27 | Contact lens products |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2185951T3 true DK2185951T3 (da) | 2016-01-04 |
Family
ID=40242570
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK08795634.8T DK2185951T3 (da) | 2007-08-31 | 2008-08-27 | Kontaktlinseprodukter |
Country Status (20)
Country | Link |
---|---|
US (2) | US8647658B2 (da) |
EP (2) | EP2990837B1 (da) |
JP (2) | JP5520224B2 (da) |
KR (1) | KR101548391B1 (da) |
CN (2) | CN104758974A (da) |
AR (2) | AR068123A1 (da) |
AU (1) | AU2008295493B2 (da) |
BR (1) | BRPI0816104B8 (da) |
CA (1) | CA2692778C (da) |
DK (1) | DK2185951T3 (da) |
ES (1) | ES2553411T3 (da) |
HU (1) | HUE026360T2 (da) |
MX (1) | MX2010002342A (da) |
PL (1) | PL2185951T3 (da) |
PT (1) | PT2185951E (da) |
RU (1) | RU2486920C2 (da) |
SG (2) | SG10201500807PA (da) |
TW (2) | TWI551305B (da) |
WO (1) | WO2009032132A1 (da) |
ZA (1) | ZA200908849B (da) |
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