Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
  • A61K35/08—Mineral waters; Sea water
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P27/00—Drugs for disorders of the senses
  • A61P27/02—Ophthalmic agents
  • A61P27/04—Artificial tears; Irrigation solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
  • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Definitions

• the invention relates to aqueous ionic solutions of the type obtained in particular from seawater and their uses in particular in ophthalmology.
• the subject of the invention is therefore the use, for treating and cleaning the eye and its appendages, of the aqueous ionic solutions obtained from seawater and whose ionic composition, pH and osmolality have been consequently adjusted.
• the ionic composition of the solutions used in accordance with the invention is that of seawater.
• the ionic composition of the solutions in question obtained from seawater, is chosen such that their pH is from 4 to 9, preferably from 7 to 8, and that their osmolality is from 150 to 700, preferably from 250 to 350 mOsm/kg.
• aqueous ionic solutions in accordance with the invention which constitute novel industrial products and which are in particular obtained from seawater, are characterized by:
• a pH value preferably less than or at most equal to the lowest pH values of seawater
• compositions from the ionic point of view, which is qualitatively and quantitatively that of seawater, with the exception from the quantitative point of view, on the one hand, of the potassium concentration which is greater than that of seawater and, on the other hand, of the Na, Mg, Ca and Cl concentrations which are less than those of seawater, said concentrations being
• Na + from 1 300 to 1 500, preferably from 500 to 1 000 mg/l,
• K + from 4 500 to 6 500, preferably from 5 000 to 6 000 mg/l,
• Mg ++ for Mg ++ , from 50 to 1 300, preferably from 100 to 500 mg/l,
• Cl ⁇ from 4 000 to 6 000, preferably from 4 500 to 5 000 mg/l.
• novel aqueous ionic solutions in accordance with the invention are particularly appropriate for treating and cleaning the eye and its appendages.
• seawater was used which was taken off Saint-Malo and collected at a depth of 5 to 10 meters in a zone with strong movements of current; this water is characterized by a salt content greater than 32 g/l; it is naturally rich in calcium, magnesium and trace elements.
• This water is subjected to selective electrodialysis; in a first instance, only sodium chloride is removed in order to reach the desired osmolality, then the ionic concentrations are adjusted depending on the therapeutic use; the desired pH is preferably obtained by exchanging the Na + ions against protons.
• the Draize test makes it possible to evaluate eye irritation after multiple applications; it can be carried out on the eye of albino rabbits.
• the reference solution used in this test consists, as indicated above, of physiological saline, that is to say a solution of sodium chloride (0.9% NaCl); physiological saline is traditionally used to rinse the eyes in the event of an accidental chemical spillage, to clean the eyes of unweaned babies and also as solvent for artificial tears, as collyrium or as ophthalmic washing solution; it is the reference solution in ophthalmology for the French Agency for the Safety of Health Products.
• the treated eyes of the rabbits are examined using a slit lamp (Slit lamp AIT-20, Topcon, Topcon France—F-92300 Levallois-Perret), before instillation, and then 1 hour after the 1st and 6th instillations, respectively, and then 1, 2 and 3 days after the sixth instillation.
• a slit lamp Slit lamp AIT-20, Topcon, Topcon France—F-92300 Levallois-Perret
• the intensity (e) of the opaqueness knowing that the score 0 is awarded for the absence of opaqueness and the score 4 for complete corneal opaqueness with an invisible iris, and, on the other hand, the area of opaqueness (f), the scores ranging from 0 to 4, the latter score corresponding to an opacification of more than 3 ⁇ 4 of the total area.
• the arithmetic mean of the values found for the 6 rabbits represents the mean ocular irritation index (MOI).
• MOI max The maximum ocular irritation index
• Day 1/1 denotes the measurement made 1 hour after the 1st instillation
• Day 1/6 denotes the measurement made 1 hour after the 6th instillation
• Day 2 denotes the measurement made 24 hours after the last instillation
• Day 3 denotes the measurement made 48 hours after the last instillation
• Day 4 denotes the measurement made 72 hours after the last instillation. TABLE I (solution in accordance with the invention) Day 1/0 Day 1/1 Day 1/6 Day 2 Day 3 Day 4 MOI 0.00 0.67 0.00 0.00 0.00 MOI max 0 4 0 0 0 0
• the products, in particular the ophthalmic products, prepared using the aqueous ionic solutions in accordance with the invention or more generally any aqueous ionic solutions obtained from seawater may be provided, for example, in the form of lotions intended for washing the eye, in the form of collyria, ophthalmological gels, or to replace the water in ocular inserts.
• composition of such a lotion may be as follows: aqueous ionic solution: qsp 100% salicylic acid: 0.1% distilled water of hamamelis 0.4%
• the lotions in question may be administered using, more preferably, devices of the type according to the French patent application filed in the name of the applicant on Oct. 13, 1999 under No. 99 12782 under the title “Device for washing and bathing the eye”.

Landscapes

• Health & Medical Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medicinal Chemistry (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• General Chemical & Material Sciences (AREA)
• Organic Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Engineering & Computer Science (AREA)
• Ophthalmology & Optometry (AREA)
• Epidemiology (AREA)
• Hematology (AREA)
• Diabetes (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Detergent Compositions (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)

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• 1999
  • 1999-12-31 FR FR9916814A patent/FR2803205B1/fr not_active Expired - Fee Related
• 2000
  • 2000-12-28 JP JP2001549672A patent/JP2003519190A/ja active Pending
  • 2000-12-28 DE DE60035799T patent/DE60035799T2/de not_active Expired - Lifetime
  • 2000-12-28 CA CA2396045A patent/CA2396045C/fr not_active Expired - Fee Related
  • 2000-12-28 EP EP00990830A patent/EP1242098B1/fr not_active Expired - Lifetime
  • 2000-12-28 WO PCT/FR2000/003709 patent/WO2001049304A2/fr active IP Right Grant
  • 2000-12-28 PT PT00990830T patent/PT1242098E/pt unknown
  • 2000-12-28 AU AU30295/01A patent/AU3029501A/en not_active Abandoned
  • 2000-12-28 US US10/169,284 patent/US20030152645A1/en not_active Abandoned
  • 2000-12-28 AT AT00990830T patent/ATE368468T1/de not_active IP Right Cessation
• 2005
  • 2005-05-23 US US11/135,113 patent/US7700077B2/en not_active Expired - Fee Related

Patent Citations (1)

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