EP0252974B1 - Erhöhung von enzymatischer wirksamkeit bei der reinigung von kontaktlinsen durch verwendung von hypotonischen lösungen - Google Patents

Erhöhung von enzymatischer wirksamkeit bei der reinigung von kontaktlinsen durch verwendung von hypotonischen lösungen Download PDF

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Publication number
EP0252974B1
EP0252974B1 EP87900942A EP87900942A EP0252974B1 EP 0252974 B1 EP0252974 B1 EP 0252974B1 EP 87900942 A EP87900942 A EP 87900942A EP 87900942 A EP87900942 A EP 87900942A EP 0252974 B1 EP0252974 B1 EP 0252974B1
Authority
EP
European Patent Office
Prior art keywords
enzyme
solution
contact lenses
cleaning
lenses
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.)
Expired - Lifetime
Application number
EP87900942A
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English (en)
French (fr)
Other versions
EP0252974A1 (de
EP0252974A4 (de
Inventor
Stanley W. Huth
Sam W. Lam
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson Surgical Vision Inc
Original Assignee
Allergan Inc
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Filing date
Publication date
Application filed by Allergan Inc filed Critical Allergan Inc
Priority to AT87900942T priority Critical patent/ATE83179T1/de
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Publication of EP0252974A4 publication Critical patent/EP0252974A4/de
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/0005—Other compounding ingredients characterised by their effect
    • C11D3/0078—Compositions for cleaning contact lenses, spectacles or lenses
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/38—Products with no well-defined composition, e.g. natural products
    • C11D3/386—Preparations containing enzymes, e.g. protease or amylase
    • C11D3/38618—Protease or amylase in liquid compositions only

Definitions

  • This invention relates to the potentiation of the enzymatic activity in cleaning contact lenses. More specifically, this invention is a method for potentiating the proteolytic activity of the proteases pancreatin and subtilisin in the cleaning of contact lenses by carrying out the cleaning in a hypotonic solution.
  • Contact lenses particularly those with a hydrophilic surface such as the hydrogel lenses and the hard, gas permeable lenses with a treated surface, encounter protein accretions during normal wear. It is beneficial, if not often times necessary, to remove these accretions in order to maintain visual acuity, prevent eye irritation and to prevent the development of giant papillary conjunctivitis.
  • proteolytic enzymes has been developed to remove such deposits. See, for example, U.S. Patent 3,910,296, and 4,285,738.
  • the '296 disclosure makes no comment on the effect of tonicity value on enzyme activity.
  • the '738 patent discloses in the specification and stipulates in the claim, that the solution must be hypertonic. Hypertonic is not specifically defined, but the urea concentration is specified as being between 5% through saturation (weight/volume).
  • the normal tonicity value is that of a physiological solution as illustrated by the 0.9% by weight/volume concentration of aqueous saline.
  • This invention covers a method for enhancing the activity of an enzyme used in the cleaning of contact lenses, said enzyme being pancreatin or subtilisin, which method comprises carrying out the cleaning regimen in a solution having an osmolality value up to about 275 milliosmoles/kilogram.
  • Tonicity values may range from 0 up to about 275 mOsm/kg.
  • the enzyme itself will be active at tonicity values close to 0, but as a practical matter it is difficult to prepare such solutions because of the solutes normally present in diluents, including purified water. Tests have been carried out where the osmolality was as low as 6 mOsm/kg. A more preferred lower limit is about 50 mOsm/kg. which number allows for the addition of small amounts of salts, stabilizers, enzyme co-factors or other excipients which may be useful and beneficial to solution stability, enzyme activity or the like.
  • the upper limit will be between 175 and 200 mOsm/kg.
  • tonicity value can be made with any number of excipients and constituents well known in the art. If an enzyme co-factor is critical or essential to the cleaning process, obviously its presence must be given primary consideration in adding materials to the formulation. Salts of any sort including salts which are necessary co-factors for enzymatic activity such as calcium should be accounted for in formulating these hypotonic solutions. The hypotonic value is determined, that is measured, after addition of the enzyme.
  • the ability of a given solution and enzyme to remove protein from a contact lens was determined by essentially the same procedure each time. Generically, the procedure was to take a contact lens and coat it with heat denatured lysozyme by placing the lens in a phosphate buffered saline solution to which was then added sufficient lysozyme to make a 0.1% solution by weight. The lysozyme was from egg white. These solutions were then heated for 30 minutes at about 95 C. The lenses were removed, cooled and rinsed with distilled water and viewed to determine what type of lysozyme accretion was on the lens at time zero.
  • Protein deposit classification as a means for quantifying the proteolytic activity of enzymes in removing absorbed protein from the lenses, a system was developed whereby the protein on the lenses was visually quantified before and after enzyme treatment.
  • the lens After a lens had been heated for 30 minutes in the lysozyme solution, the lens was wetted with distilled water, rubbed between the thumb and finger, then grasped by the edge with plastic tweezers and rinsed with distilled water again. The convex side of the lens was viewed under a microscope at 100X magnification. A film or deposit detected under these conditions was classified according to the percentage of the lens surface covered by the deposit. The protein removal efficacy of an enzyme solution is expressed in terms of the percentage of the lens surface which has been cleaned. This number is derived by subtracting the percentage of the lens surface covered by the protein deposit from 100%.
  • a subtilisin enzyme containing solution was prepared as follows: cysteine hydrochloride monohydrate (1.001g), sodium borate dihydrate (1.911 g), sodium carbonate anhydrous (3.106g), polyethylene glycol 3350 (0.403g), tartaric acid (2.002g), S .
  • carlsberg (0.041g), obtained from Novo Industries of Denmark, was dissolved in 300 ml of purified water, the pH adjusted to 8.4 with sodium hydroxide or hydrochloric acid, and then water added in a quantity sufficient to make 1000 ml. Three 200 ml portions were removed and the osmolality adjusted with sodium chloride and the pH with NaOH or HCl as needed to obtain the figures given in table I.
  • Hydrogel-type lenses (Hydrocurve II®, 55% water, sold by Barnes-Hind, Inc.) were treated with heat-denatured lysozyme as described above.
  • a subtilisin-A-containing solution was prepared (0.04 mg/ml of water without excipients, activity: 0.0012 Au/ml) in such a manner as to have pH values between approximately 5.0 and 10.0.
  • the osmolality value was then adjusted to 6, 133 and 264 mOsm/kg with NaCl for each of these solutions, each of the tonicity values being tested at pH 9.0.
  • Lenses were then soaked in these solutions (five in each) for 2 hours at room temperature, rinsed, and analyzed for percentage residual protein deposit as described above. Results are given in Table II. Table II Effect of pH vs.
  • Lenses with lysozyme protein deposits covering at least 98% of the lens surface were cut in half, one half being soaked in one enzyme solution and the other in another enzyme solution in the first comparison (pancreatin data); whole lenses were used in the other studies.
  • the enzyme solutions were comprised of enzyme and excipients as indicated in Table III.
  • Lenses were bufilcon-A sold by Barnes-Hind, Inc. under the name Hydrocurve II®. Results from each of the several formulations are listed in the following table. The abbreviation DI is used for deionized water.
  • a subtilisin enzyme tablet was dissolved in either 10ml of DI water or saline. Each enzyme tablet contained: 30mg N-acetylcysteine, 34mg sodium carbonate, 7mg tartaric acid, 4mg polyethylene glycol 3350, 4mg subtilisin-A (subtilisin carlsberg from NOVO Industries of Denmark), and 50mg of lactose. 5. Allergan HydrocareTM Preserved Saline. It can be seen from the data presented in Table III that for both pancreatin and Subtilisin carlsberg , the solutions with the lowest tonicity produced the highest cleaning efficacy.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Detergent Compositions (AREA)
  • Eyeglasses (AREA)

Claims (2)

  1. Eine Methode zur Verbesserung der Aktivität eines zur Reinigung von Kontaktlinsen verwendeten, aus Pankreatin und Subtilisin ausgewählten Enzyms, welche die Durchführung der Reinigungsroutine in einer Lösung mit einem Osmolalitätswert bis zu 275 mOsm/kg umfaßt.
  2. Die in Anspruch 1 beschriebene Methode, wobei die Osmolalität zwischen 100 und 200 mOsm/kg beträgt.
EP87900942A 1986-01-06 1987-01-05 Erhöhung von enzymatischer wirksamkeit bei der reinigung von kontaktlinsen durch verwendung von hypotonischen lösungen Expired - Lifetime EP0252974B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT87900942T ATE83179T1 (de) 1986-01-06 1987-01-05 Erhoehung von enzymatischer wirksamkeit bei der reinigung von kontaktlinsen durch verwendung von hypotonischen loesungen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US81651886A 1986-01-06 1986-01-06
US816518 1986-01-06

Publications (3)

Publication Number Publication Date
EP0252974A1 EP0252974A1 (de) 1988-01-20
EP0252974A4 EP0252974A4 (de) 1988-05-03
EP0252974B1 true EP0252974B1 (de) 1992-12-09

Family

ID=25220860

Family Applications (1)

Application Number Title Priority Date Filing Date
EP87900942A Expired - Lifetime EP0252974B1 (de) 1986-01-06 1987-01-05 Erhöhung von enzymatischer wirksamkeit bei der reinigung von kontaktlinsen durch verwendung von hypotonischen lösungen

Country Status (6)

Country Link
EP (1) EP0252974B1 (de)
AT (1) ATE83179T1 (de)
AU (1) AU6898887A (de)
DE (1) DE3782981T2 (de)
HK (1) HK113995A (de)
WO (1) WO1987004091A1 (de)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5037647A (en) * 1988-09-15 1991-08-06 Alcon Laboratories, Inc. Aqueous antimicrobial opthalmic solutions comprised of quaternary ammonium compound, citric acid, citrate and sodium chloride
CA2009118C (en) * 1989-02-21 1996-02-27 Mary F. Mowrey-Mckee Method and composition for cleaning and disinfecting contact lenses
US5783532A (en) * 1993-06-17 1998-07-21 Allergan Enzyme compositions and methods for contact lens cleaning
IL109705A (en) * 1993-06-17 1998-07-15 Allergan Inc Enzyme compositions and methods for contact lens cleaning

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3240709A (en) * 1962-05-16 1966-03-15 Burton Parsons Chemicals Inc Method of cleansing contact lenses
US3910296A (en) * 1973-04-20 1975-10-07 Allergan Pharma Method of removing proteinaceous deposits from contact lenses
US4048122A (en) * 1976-01-23 1977-09-13 Barnes-Hind Pharmaceuticals, Inc. Cleaning agents for contact lenses
JPS54140553A (en) * 1978-04-24 1979-10-31 Senju Pharma Co Contact lens washing liquid
US4263054A (en) * 1979-02-23 1981-04-21 George D. Weaver Contact lens cleaning and rinsing method
GB2088581A (en) * 1980-10-02 1982-06-09 Smith & Nephew Associated Cie Papain and lactose containing tablet for cleaning contact lenses
US4521254A (en) * 1981-02-09 1985-06-04 Anderson Ronald L Cleaning contact lenses with solution of bromelain and carboxypeptidase
GB2117534B (en) * 1982-03-31 1986-02-19 Smith & Nephew Ass Papain containing tablet for cleaning contact lenses
US4626292A (en) * 1982-06-01 1986-12-02 Sherman Laboratories, Inc. Soft contact lens wetting and preservation method
US4613380A (en) * 1985-04-01 1986-09-23 Dow Corning Corporation Method for removing lipid deposits from contact lenses
US4670178A (en) * 1985-09-09 1987-06-02 Allergan Pharmaceuticals, Inc. Method for the simultaneous cleaning and disinfecting of contact lenses

Also Published As

Publication number Publication date
EP0252974A1 (de) 1988-01-20
DE3782981T2 (de) 1993-04-08
WO1987004091A1 (en) 1987-07-16
ATE83179T1 (de) 1992-12-15
HK113995A (en) 1995-07-21
EP0252974A4 (de) 1988-05-03
AU6898887A (en) 1987-07-28
DE3782981D1 (de) 1993-01-21

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