Compositions and methods for reducing ocular hypertension
AssigneeNovartis AG
InventorsKenneth Warren Reed, Shau Fong Yen, Mary Sou, Regina Flinn Peacock
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Abstract
An improved ophthalmic composition, including docosanoid active agents, which is especially useful in lowering intraocular pressure associated with glaucoma. Improvements in IOP reduction efficacy, preservative efficacy and reduced additive concentrations are achieved by utilizing the disclosed compositions which include a docosanoid active agent (e.g., isopropyl unoprostone), in conjunction with selected non-ionic surfactants, preservatives, and non-ionic tonicity adjusting agents.
Claims31
A composition, comprising:
- (a) a docosanoid active agent which is selected from the group consisting of docosanoids, metabolites thereof, derivatives thereof, salts thereof, and mixtures thereof;
- (b) an ophthalmic preservative;
- (c) a non-ionic toncity adjusting agent, wherein said non-ionic tonicity adjusting agent is present in a concentration sufficient to:
- (i) adjust the tonicity of the composition and
- (ii) increase the preservative effectiveness;
- and
- (d) an ophthalmically acceptable carrier.
A composition comprising:
- (1) a docosanoid active agent;
- (2) a first non-ionic surfactant;
- and
- (3) a second non-ionic surfactant;
- and
- (4) an ophthalmically acceptable carrier, wherein the total surfactant concentration is lower than the surfactant concentration which would be required to solubilize the docosanoid active agent for either individual non-ionic surfactant
A composition comprising:
- (1) a docosanoid active agent;
- (2) a strong preservative;
- (3) a non-ionic surfactant which increases solubility of the docosanoid active agent but decreases the preservative effectiveness of the strong preservative;
- (4) a preservative enhancer which increases the effectiveness of the strong preservative;
- and
- (5) an ophthalmically acceptable carrier.
A method of reducing ocular hypertension, which comprises administering to the ocular fluids or ocular tissue an ophthalmic composition comprising:
- (a) a docosanoid active agent which is selected from the group consisting of docosanoids, metabolites thereof, derivatives thereof, salts thereof, and mixtures thereof;
- (b) an ophthalmic preservative;
- and
- (c) a non-ionic tonicity adjusting agent, wherein said non-ionic tonicity adjusting agent is present in a concentration sufficient to:
- (i) adjust the tonicity of the composition and
- (ii) increase the preservative effectiveness;
- and
- (d) an ophthalmically acceptable carrier, wherein said composition is effective in lowering intraocular pressure when administered to a patient in need of a reduction in intraocular pressure.
A method of reducing ocular hypertension, which comprises administering to the ocular fluids or ocular tissue an ophthalmic composition comprising:
- (1) a docosanoid active agent;
- (2) a first non-ionic surfactant;
- and
- (3) a second non-ionic surfactant;
- and
- (4) an ophthalmically acceptable carrier, wherein the total surfactant concentration is lower than the surfactant concentration which would be required to solubilize the docosanoid active agent for either individual non-ionic surfactant
A method of reducing ocular hypertension, which comprises administering to the ocular fluids or ocular tissue an ophthalmic composition comprising:
- (1) a docosanoid active agent;
- (2) a strong preservative;
- (3) a non-ionic surfactant which increases solubility of the docosanoid active agent but decreases the preservative effectiveness of the strong preservative;
- (4) a preservative enhancer which increases the effectiveness of the strong preservative;
- and
- (5) an ophthalmically acceptable carrier.
An ophthalmic composition, comprising:
- (a) about 0.06 to about 0.24 weight percent of a docosanoid active agent which is selected from the group consisting of docosanoids, metabolites thereof, derivatives thereof, salts thereof, and mixtures thereof;
- (b) an ophthalmic preservative;
- (c) a non-ionic toncity adjusting agent;
- (d) a non-ionic surfactant;
- and
- (e) an ophthalmically acceptable carrier.
Dependencies are inferred from the claim text.