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Publication Number
US-12263119-B2
Publication Date
2025-04-01
Expiration Date
Abstract
The present invention is directed to a dispensing device comprising: an ophthalmic liquid composition comprising a prostaglandin analogue; a container with the ophthalmic liquid composition comprising a prostaglandin analogue packaged therein; a dropper; and a gasket, wherein the gasket is made of a polymer substantially free of ethylene-vinyl acetate or plasticiser. The present invention further refers to a dropper and a gasket for the dispensing device and to a preservative-free aqueous ophthalmic composition of latanoprost.
Core Innovation
The invention relates to an ophthalmic dispensing device comprising an ophthalmic liquid composition comprising a prostaglandin analogue, packaged in a container, and dispensed via a dropper and a gasket. The ophthalmic liquid composition is preservative-free and aqueous, and includes prostaglandin analogues such as latanoprost, optionally with timolol. The device is characterized by a gasket design intended to control interactions between the prostaglandin analogue and the packaging component.
A core aspect is that the gasket is substantially free of plasticizer, or comprises 2% or less of plasticizer, while the gasket polymer is selected from polyethylene, polypropylene, polytetrafluoroethylene, and mixtures thereof. The use of a gasket polymer substantially free of ethylene-vinyl acetate (EVA) or plasticisers is described as reducing adsorption of the prostaglandin analogue.
The disclosed examples include preservative-free aqueous ophthalmic solution formulations with specified ranges for latanoprost and optional timolol, together with polysorbate 80 and disodium edetate, and tonicity/osmolality and optionally pH targets. Stability testing is described using HPLC assays (DAD) and reporting low impurity levels, with improved active ingredient retention relative to devices using PE/EVA. Tightness of the device is described as maintained despite removal of plasticiser, with water loss rates meeting USP/EMA-style tightness requirements.
Claims Coverage
The partial claim set includes three independent claims covering a dispensing device structure with a plasticizer-free gasket polymer limitation, a preservative-free aqueous ophthalmic solution formulation with defined concentration ranges and physicochemical targets, and a dispensing device with a tighter plasticizer constraint on the gasket and a specified polymer group.
Plasticizer-free gasket polymer dispensing device
An ophthalmic liquid composition comprising a prostaglandin analogue packaged in a container and dispensed with a dropper and a gasket, wherein the gasket is substantially free of plasticizer and the gasket comprises a polymer selected from the group consisting of polyethylene, polypropylene, polytetrafluoroethylene and mixtures thereof.
Preservative-free aqueous ophthalmic solution formulation
A preservative-free aqueous ophthalmic solution comprising latanoprost in a concentration comprised in the range 0.010-0.100 mg/ml; optionally timolol or a pharmaceutically acceptable salt thereof in a concentration comprised in the range 1-10 mg/ml; polysorbate 80 in a concentration comprised in the range 0.2-1.0 mg/ml; disodium edetate in a concentration comprised in the range 0.1-0.5 mg/ml; a tonicity agent sufficient to adjust the osmolality to a value comprised in the range 250-320 mOsmol/kg; an ophthalmically-acceptable buffering agent; optionally a pH adjusting agent to adjust the pH to a value in the range 5.5-6.5; and water, as solvent.
Low-plasticizer gasket dispensing device with restricted polymer group
An ophthalmic liquid composition comprising a prostaglandin analogue packaged in a container and dispensed with a dropper and a gasket, wherein the gasket comprises 2% or less of plasticizer and the gasket comprises a polymer selected from the group consisting of polyethylene, polypropylene, polytetrafluoroethylene and mixtures thereof.
Across the independent claims, the inventive coverage centers on preservative-free aqueous ophthalmic compositions containing prostaglandin analogues, with optional timolol, and dispensing devices in which the gasket polymer is selected from polyethylene, polypropylene, and polytetrafluoroethylene, while the gasket plasticizer content is substantially eliminated or limited to 2% or less.
Stated Advantages
Reduced adsorption of the prostaglandin analogue versus devices using PE/EVA (Evatane®).
Improved active ingredient retention with low impurity levels based on HPLC assay (DAD) stability testing.
Maintained tightness despite removing plasticiser, with water loss rates meeting USP/EMA-style tightness requirements.
Documented Applications
Dispensing preservative-free aqueous ophthalmic solutions containing prostaglandin analogues, including latanoprost and optionally timolol, for ophthalmic use using a container and dropper with a gasket.
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