EP0362277A1 - Pommades ophtalmiques sans conservateurs - Google Patents

Pommades ophtalmiques sans conservateurs

Info

Publication number
EP0362277A1
EP0362277A1 EP88905291A EP88905291A EP0362277A1 EP 0362277 A1 EP0362277 A1 EP 0362277A1 EP 88905291 A EP88905291 A EP 88905291A EP 88905291 A EP88905291 A EP 88905291A EP 0362277 A1 EP0362277 A1 EP 0362277A1
Authority
EP
European Patent Office
Prior art keywords
ointment
ointments
salt
ophthalmic
weight
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.)
Ceased
Application number
EP88905291A
Other languages
German (de)
English (en)
Other versions
EP0362277A4 (en
Inventor
Donald S. Clark
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.)
Allergan Inc
Original Assignee
Allergan Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Allergan Inc filed Critical Allergan Inc
Publication of EP0362277A1 publication Critical patent/EP0362277A1/fr
Publication of EP0362277A4 publication Critical patent/EP0362277A4/en
Ceased legal-status Critical Current

Links

Classifications

    • 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

Definitions

  • Ophthalmic ointments roust meet certain U.S. preservative efficacy testing standards in order to be marketed.
  • ophthalmic ointment preservation has been achieved by organic-based chemical preservatives such as chlorobutanol, methylparaben and propylparaben.
  • organic preservatives irritate ocular tissu and are discomforting.
  • Ointments by nature are not particularly susciptable to single dose packaging because of the difficulty in expressing material from such a small package. Ointment materials are inherently not self-preserving so some preservative means is needed to meet most health agency preservative standards. ""
  • High salt concentration ophthalmic ointments are known (5% sodium chloride formulations) .
  • a hypertonic ointment of sodium chloride 5% in a base of mineral oil, lanolin, white petrolatum and water is marketed by Muro Pharmaceuticals, Inc.
  • a similar sodium chloride 5% ointment is also produced by Akorn, Inc.
  • This high level of salt in these ointments is used to provide temporary relief of corneal swelling or edema by dehydrating the tissue. So though these ointments are non-preserved, no one has previously determined that low levels of salt could be used to effect preservation of ointments.
  • Salts at low concentrations are non-irritating and non-discomforting. Nor do they cause adverse reaction which is particularly useful for ocular preparations. It has now been found that using between about 0.01% and 0.9% (w/w) salt in ointments provides a composition which meets USP PET standards and does not involve a chemical preservative which may be irritating or discomforting to ocular tissue. Such means for preserving ointments is particularly useful for ophthalmic ointments where the greatest likelyhood of reaction to organic preservatives is encountered.
  • This invention relates to an improved ointment which does not require use of an organic preservative, particularly an ophthalmic ointment, wherein the improvement comprises adding 0.01%-0.9% weight/weight of a pharmaceutically acceptable inorganic salt to an ointment formulation.
  • this invention relates to a method for preparing preservative free ointments which method comprises adding between 0.01%-0.9% w/w of a pharmaceutically acceptable inorganic salt to an ointment formulation.
  • a pharmaceutically acceptable inorganic salt is any salt derived from the reaction of an inorganic acid and base, which at the concentrations recited herein does not have deleterious or untoward effect when administered to mammal.
  • Preferred salts are those derived from lithium, sodium, potassium, calcium, magnesium, or iron (the cation) and chloride, bromide, iodide, sulfate, carbonate and phosphate in its various forms (anions). Borate salt may also be used.
  • Particularly preferred salts are sodiu - chloride, potassium chloride, calcium chloride, magnesium chloride, sodium or potassium salts of phosphates and sulfates, calcium sulfate, magnesium sulfate and sodium o potassium carbonate.
  • Salt concentrations may vary between 0.1 and 0.9% by weight. Concentrations between 0.05 and 0.3% are preferred.
  • Salts may be introduced into ointment bases by any means so long as a intimate and even distribution of the salt is effected.
  • Salt, in powder form, or in a concentrated aqueous solution are the two primary forms - ⁇ -
  • Esarople 1 Five ointment samples were prepared containing a range of sodium chloride concentration. The formulation is as follows:
  • USP sodium chloride

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

Des pommades opthalmiques n'exigeant pas de conservateurs peuvent être préparées avec 0,01-0,9% (en poids) de sels.
EP19880905291 1987-06-01 1988-05-18 Preservative free ophthalmic ointments Ceased EP0362277A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5741787A 1987-06-01 1987-06-01
US57417 1987-06-01

Publications (2)

Publication Number Publication Date
EP0362277A1 true EP0362277A1 (fr) 1990-04-11
EP0362277A4 EP0362277A4 (en) 1990-11-28

Family

ID=22010462

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19880905291 Ceased EP0362277A4 (en) 1987-06-01 1988-05-18 Preservative free ophthalmic ointments

Country Status (3)

Country Link
EP (1) EP0362277A4 (fr)
AU (1) AU1936788A (fr)
WO (1) WO1988009665A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6267962B1 (en) 1990-12-21 2001-07-31 C-P Technology Limited Partnership Compositions and methods of treatment using peat derivatives
WO1996037207A2 (fr) * 1995-05-25 1996-11-28 Biofrontiers, Inc. Compositions pharmaceutiques contenant du sulfate de calcium
US5683725A (en) * 1995-05-25 1997-11-04 Biofrontiers, Inc. Modulation of substance P by compounds containing calcium sulfate and methods relating thereto
TW201010727A (en) * 2008-09-03 2010-03-16 Alcon Res Ltd Pharmaceutical composition having relatively low ionic strength
IT201800010796A1 (it) * 2018-12-04 2020-06-04 Vincenzo Orfeo Unguenti oftalmici ipertonici stabili contenenti una fase idrofila satura di sodio cloruro

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2703777A (en) * 1950-05-02 1955-03-08 Iso Sol Company Inc Ophthalmological preparations and vehicles and method of making the same
US3767788A (en) * 1970-06-08 1973-10-23 Burton Parsons Chemicals Inc Ophthalmic solution
US3843782A (en) * 1971-07-26 1974-10-22 Flow Pharma Inc Eye solution and method of using same
US4005191A (en) * 1974-06-04 1977-01-25 Clark Mary G Topical ointment composition
US4039662A (en) * 1975-12-04 1977-08-02 Alcon Laboratories, Inc. Ophthalmic solution
FR2361904A1 (fr) * 1976-04-27 1978-03-17 Culibrk Djura Procede pour l'obtention d'un medicament antiphlogistique et astringent contenant du chlorure de potassium
US4409205A (en) * 1979-03-05 1983-10-11 Cooper Laboratories, Inc. Ophthalmic solution
US4271144A (en) * 1979-06-06 1981-06-02 Holles Laboratories, Inc. Dextran composition for controlling corneal hydration
US4550022A (en) * 1981-10-05 1985-10-29 Alcon Laboratories, Inc. Tissue irrigating solution
US4540568A (en) * 1982-10-14 1985-09-10 Trager Seymour F Injectionable viscoelastic ophthalmic gel
CA1263606A (fr) * 1985-05-29 1989-12-05 Jeffrey P. Gilbard Preparations ophtalmiques non toxiques

Also Published As

Publication number Publication date
EP0362277A4 (en) 1990-11-28
WO1988009665A1 (fr) 1988-12-15
AU1936788A (en) 1989-01-04

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