WO1988009665A1 - Preservative free ophthalmic ointments - Google Patents
Preservative free ophthalmic ointments Download PDFInfo
- Publication number
- WO1988009665A1 WO1988009665A1 PCT/US1988/001708 US8801708W WO8809665A1 WO 1988009665 A1 WO1988009665 A1 WO 1988009665A1 US 8801708 W US8801708 W US 8801708W WO 8809665 A1 WO8809665 A1 WO 8809665A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- ointment
- ointments
- salt
- ophthalmic
- preservative
- Prior art date
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
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US5741787A | 1987-06-01 | 1987-06-01 | |
US057,417 | 1987-06-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1988009665A1 true WO1988009665A1 (en) | 1988-12-15 |
Family
ID=22010462
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1988/001708 WO1988009665A1 (en) | 1987-06-01 | 1988-05-18 | Preservative free ophthalmic ointments |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP0362277A4 (en) |
AU (1) | AU1936788A (en) |
WO (1) | WO1988009665A1 (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1996037207A2 (en) * | 1995-05-25 | 1996-11-28 | Biofrontiers, Inc. | Pharmaceutical compositions containing calcium sulfate |
US5683725A (en) * | 1995-05-25 | 1997-11-04 | Biofrontiers, Inc. | Modulation of substance P by compounds containing calcium sulfate and methods relating thereto |
US6267962B1 (en) | 1990-12-21 | 2001-07-31 | C-P Technology Limited Partnership | Compositions and methods of treatment using peat derivatives |
US20100056537A1 (en) * | 2008-09-03 | 2010-03-04 | Malay Ghosh | Pharmaceutical composition having relatively low ionic strength |
Citations (9)
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 (en) * | 1976-04-27 | 1978-03-17 | Culibrk Djura | Antiphlogistic, astringent medicaments contg. potassium chloride - i.e. in lotions, ointments, soaps and tooth-pastes |
US4271144A (en) * | 1979-06-06 | 1981-06-02 | Holles Laboratories, Inc. | Dextran composition for controlling corneal hydration |
US4540568A (en) * | 1982-10-14 | 1985-09-10 | Trager Seymour F | Injectionable viscoelastic ophthalmic gel |
US4550022A (en) * | 1981-10-05 | 1985-10-29 | Alcon Laboratories, Inc. | Tissue irrigating solution |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4409205A (en) * | 1979-03-05 | 1983-10-11 | Cooper Laboratories, Inc. | Ophthalmic solution |
CA1263606A (en) * | 1985-05-29 | 1989-12-05 | Jeffrey P. Gilbard | Non-toxic opthalmic preparations |
-
1988
- 1988-05-18 EP EP19880905291 patent/EP0362277A4/en not_active Ceased
- 1988-05-18 WO PCT/US1988/001708 patent/WO1988009665A1/en not_active Application Discontinuation
- 1988-05-18 AU AU19367/88A patent/AU1936788A/en not_active Abandoned
Patent Citations (9)
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 (en) * | 1976-04-27 | 1978-03-17 | Culibrk Djura | Antiphlogistic, astringent medicaments contg. potassium chloride - i.e. in lotions, ointments, soaps and tooth-pastes |
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 |
Non-Patent Citations (1)
Title |
---|
See also references of EP0362277A4 * |
Cited By (5)
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 (en) * | 1995-05-25 | 1996-11-28 | Biofrontiers, Inc. | Pharmaceutical compositions containing calcium sulfate |
WO1996037207A3 (en) * | 1995-05-25 | 1997-02-27 | Biofrontiers Inc | Pharmaceutical compositions containing calcium sulfate |
US5683725A (en) * | 1995-05-25 | 1997-11-04 | Biofrontiers, Inc. | Modulation of substance P by compounds containing calcium sulfate and methods relating thereto |
US20100056537A1 (en) * | 2008-09-03 | 2010-03-04 | Malay Ghosh | Pharmaceutical composition having relatively low ionic strength |
Also Published As
Publication number | Publication date |
---|---|
EP0362277A4 (en) | 1990-11-28 |
AU1936788A (en) | 1989-01-04 |
EP0362277A1 (en) | 1990-04-11 |
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