Preservative free pharmaceutical compositions for ophthalmic administration
Inventors
Karavas, Evangelos • Koutris, Efthimios • SAMARA, VASILIKI • Koutri, Ioanna • Kalaskani, Anastasia • KAKOURIS, ANDREAS • GOTZAMANIS, GEORGE
Assignees
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Publication Number
US-10772830-B1
Publication Date
2020-09-15
Expiration Date
Abstract
The present invention relates to a preservative-free, aqueous solution in the form of eye drops packed in a container that ensures stability of the product, ideal eye drop volume and reduced drop volume variability and provides efficient dispensing.
Core Innovation
The invention relates to a multi-use ophthalmic kit in which a container has an integral bacterial protection system and a dispensing tip, and an ophthalmic composition is contained within the container and configured to be dispensed as drops from an orifice of the dispensing tip into an eye of a patient. The ophthalmic composition comprises a preservative-free aqueous solution with an active ingredient selected from travoprost or bimatoprost, together with pharmaceutically acceptable excipients configured to provide specified physical properties.
The ophthalmic composition is specified to have physical-property targets measured according to European pharmacopoeia requirements, including viscosity of less than 200 cP at 25° C, surface tension of less than 22 mN/m and more than 10 mN/m at 25° C, and osmolality of 250 to 300 mOsm/Kg. The composition is free of viscosity increasing agents.
The dispensing tip and container are integrated with an integral bacterial protection system that prevents bacterial contamination using mechanical tip-seal technology. The mechanical tip-seal technology uses a spring-loaded valve located directly below the dispensing tip orifice, and the container is configured to dispense drops having a volume of between 22 μL and 31 μL when the dispensing tip is oriented at an angle of 45° relative to a horizontal axis, with variability between each drop dispensed of +7 μL.
The dispensing-tip orifice geometry is defined through an inner diameter to outer diameter ratio from 1:1 to 1:6, with the inner diameter more than 0.3 mm and less than 2 mm and the outer diameter more than 1 mm and less than 4 mm.
Claims Coverage
Two independent claims are identified: clm-00001 and clm-00006. The claims cover five inventive features in a multi-use ophthalmic kit combining defined dispensing-tip geometry, a preservative-free aqueous active-drug solution with specified physical properties and no viscosity increasing agents, an integral bacterial protection system using mechanical tip-seal technology with a spring-loaded valve below the orifice, and defined drop volume behavior at a 45° orientation.
Multi-use ophthalmic kit with integral bacterial protection system and dispensing tip
A container comprising an integral bacterial protection system and a dispensing tip, wherein the ophthalmic composition contained within the container is configured to be dispensed as drops from an orifice of the dispensing tip into an eye of a patient.
Defined dispensing-tip orifice geometry for drop exit
A dispensing tip orifice geometry having a ratio of an inner diameter to an outer diameter from 1:1 to 1:6, wherein the inner diameter is more than 0.3 mm and less than 2 mm and the outer diameter is more than 1 mm and less than 4 mm.
Preservative-free aqueous solution with specified physical properties and no viscosity increasing agents
The ophthalmic composition comprises a preservative-free aqueous solution of an active ingredient selected from travoprost or bimatoprost and pharmaceutically acceptable excipients selected to provide viscosity of less than 200 cP at 25° C, surface tension of less than 22 mN/m and more than 10 mN/m at 25° C, and osmolality of 250 to 300 mOsm/Kg, wherein the ophthalmic composition is free of viscosity increasing agents.
Mechanical tip-seal bacterial contamination prevention with spring-loaded valve below orifice
The integral bacterial protection system uses mechanical tip-seal technology to prevent bacterial contamination, wherein the mechanical tip-seal technology comprises a spring-loaded valve located directly below the dispensing tip orifice.
Drop volume range and variability at 45° dispensing orientation
The container is configured to dispense drops of the ophthalmic composition having a volume of between 22 μL and 31 μL when the dispensing tip is oriented at an angle of 45° relative to a horizontal axis, with variability between each drop dispensed of +7 μL.
Across both independent claims, the inventive combination is a multi-use ophthalmic kit that integrates a dispensing tip with defined orifice geometry, a preservative-free aqueous active-drug solution with specified viscosity, surface tension, and osmolality, and an integral bacterial protection system based on mechanical tip-seal technology with a spring-loaded valve located directly below the dispensing tip orifice, achieving specified drop volume and drop-to-drop variability at a 45° orientation.
Stated Advantages
Provides dispensable preservative-free aqueous ophthalmic solutions as drops from a multiple-use container with an integral bacterial protection system.
Prevents bacterial contamination using mechanical tip-seal technology with a spring-loaded valve located directly below the dispensing tip orifice.
Dispensing is configured to achieve controlled drop volume between 22 μL and 31 μL and variability between each drop dispensed of +7 μL at a 45° dispensing orientation.
Documented Applications
Ophthalmic drop dispensing into an eye of a patient using a multi-use ophthalmic kit.
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