TOPICAL ADMINISTRATION METHOD

• US 20190321218A1
• Filed: 06/21/2017
• Published: 10/24/2019
• Est. Priority Date: 06/23/2016
• Status: Active Grant

• Current Assignee: Novaliq GmbH
• Original Assignee: Novaliq GmbH
• Inventors: GRAF, Gesche, AHMED, Yasin, LEGNER, Stephanie, KEMP, Philip, HOPPMANN, Eike, LOSCHER, Frank, MAUDEN, Jorg Martin, BURKHARDT, Sybille, LOSSL, Veronika
• Granted Patent: US 10,507,132 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61K 31/02 Halogenated hydrocarbons
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/04 Artificial tears; Irrigation solutions

Abstract

The present invention relates to a method for topical administration of ophthalmic compositions in a dropwise manner, preferably for topical administration of ophthalmic compositions comprising semifluorinated alkanes (SFAs). Further, the present invention relates to the use of said methods in the prevention or treatment of ocular diseases or disorders or any symptoms or conditions associated therewith. In a further aspect, the present invention relates to a kit comprising a drop dispenser at least partially filled with a liquid composition for the use in such a method and directions for use of said drop dispenser.

Claims

1. A method for dropwise topical administration of a liquid composition (2), comprising the steps of:

a) providing a drop dispenser (1), comprising;

a container part (1B) with an interior volume partially filled with the liquid composition (2) and a gaseous phase (3) filling the remainder of the interior volume at ambient pressure, the container part (1B) having a displaceable section (1C) and optionally a substantially stationary section, and

a dropper part (1A) in physical connection and in fluid communication with the interior volume of the container part (1B), comprising an outflow channel (5), connecting the interior volume of the container part (1B) to the environment;

b) exerting a first force to the displaceable section (1C) of the container part (1B) of the drop dispenser (1) while holding the drop dispenser (1) in an upright position in which the outflow channel (5) is not in contact with the liquid composition (2), thereby reducing the interior volume of the container part (1B) and forcing the gaseous phase (3) of the interior volume at least partially out of the drop dispenser (1) into the environment;

c) inverting the drop dispenser (1) to an inverted position in which the liquid composition (2) is in contact with the outflow channel (5);

d) releasing said first force from the displaceable section (1C) of the container part (1B) at least partly, thereby reducing the pressure inside the container part (1B) below ambient pressure; and

e) exerting a second force to the displaceable section (1C) of the container part (1B), while still holding the drop dispenser in the inverted position in which the liquid composition (2) is in contact with the outflow channel (5), thereby raising the pressure inside the interior volume of the container part (1B) above ambient pressure and releasing the liquid composition (2) dropwise from the dropper part (1A) of the drop dispenser (1).

2. The method according to claim 1, wherein the drop dispenser (1) is a dropper bottle with a dropper part (1A) and a container part (1B), the container part (1B) comprising the displaceable section (1C).

3. The method according to claim 1, wherein the inversion of the drop dispenser (1) to the inverted position according to step (c) and the release of the first force according to step (d) is performed at least partly simultaneously.

4. The method according to claim 1, wherein the liquid composition (2) is an ophthalmic composition.

5. The method according to claim 1, wherein the liquid composition (2) comprises a liquid semifluorinated alkane.

6. The method according to claim 1, wherein the liquid composition (2) further comprises water.

7. The method according to claim 1, wherein the reduced pressure generated inside the interior volume of the container part (1B) prevents unintended release of the liquid composition (2).

8. The method according to claim 1, wherein the liquid composition (2) has a density measured at 25°

C. in the range of 1.0 to 1.7 g/cm³.

9. The method according to claim 1, wherein the liquid composition (2) has a viscosity measured at 25°

C. in air in the range of 0.9 to 4.0 mPa s.

10. The method according to claim 1, wherein the liquid composition (2) has a surface tension in air measured at 25°

C. in the range of 15 to 30 mN/m.

11. The method according to claim 1, wherein the liquid composition (2) comprises a liquid linear or branched semifluorinated alkane having one perfluorinated segment and one non-fluorinated hydrocarbon segment, preferably each segment independently having a number of carbon atoms selected from the range of 3 to 10.

12. The method according to claim 1, wherein the liquid composition (2) further comprises one or more pharmaceutical active ingredients.

13. The method according to claim 1, further comprising the step:

f) dropwise administering the composition to the eye, eye lid, eye sac or an ophthalmic tissue of a subject in need thereof.

14. A kit comprising:

a drop dispenser (1) at least partially filled with a liquid composition (2) and a gaseous phase (3) for the use in a method according to claim 1; and

directions for use of the drop dispenser (1) in a method according to claim 1.

15. A method of treating an ocular disease or disorder, or any symptoms or conditions associated therewith, comprising dropwise administration of a liquid ophthalmic composition according to the method of claim 1.

16. The method according to claim 15, wherein the ocular disease or disorder is dry eye disease (keratoconjunctivitis sicca).

17. The method according to claim 15, wherein the ocular disease or disorder is a disease or disorder of the eyelid, lacrimal system, orbit, conjunctiva, sclera, cornea, iris, ciliary body, lens, choroid and/or retina.