Ophthalmic compositions comprising tafluprost for the treatment of glaucoma

A technology of tafluprost and composition, applied in the field of drug therapy, can solve the problems of limited volume and capacity of lacrimal sac, adverse drug effect and the like

Pending Publication Date: 2020-12-29
NOVALIQ GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Considering the drug in eye drops that is actually administered into the eye, only a small part produces an effect due to the limited volumetric capacity of the lacrimal sac: a significant part of the administered fluid volume is expelled by the blinking of the eyelids, and another A small amount is absorbed systemically via the nasolacrimal duct, which may lead to adverse drug effects

Method used

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  • Ophthalmic compositions comprising tafluprost for the treatment of glaucoma
  • Ophthalmic compositions comprising tafluprost for the treatment of glaucoma
  • Ophthalmic compositions comprising tafluprost for the treatment of glaucoma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0098] CLAIMS 1. A pharmaceutical composition comprising tafluprost and a semifluorinated alkane for use in a method of treatment of glaucoma, increased intraocular pressure, ocular hypertension and / or symptoms associated therewith.

[0099] 2. The pharmaceutical composition for said use according to clause 1, wherein said semifluorinated alkane is selected from 1-perfluorohexyloctane or 1-perfluorobutylpentane, preferably 1-perfluorohexyl octane.

[0100] 3. The pharmaceutical composition for said use according to any one of the preceding clauses, wherein said tafluprost target dose per eye is in the range of about 0.20 μg to 0.55 μg, preferably about In the range of 0.30 μg to 0.50 μg, more preferably in the range of 0.30 μg to 0.45 μg.

[0101] 4. The pharmaceutical composition for said use according to any one of the preceding clauses, wherein the concentration of said tafluprost is in the range of about 0.002% w / v to 0.005% w / v.

[0102] 5. The pharmaceutical compositio...

Embodiment 1

[0145] The study described below was carried out to evaluate the pharmacodynamics of tafluprost in normotensive dogs following repeated administration of topical ocular doses of tafluprost in 1-perfluorohexyloctane (F6H8) ( intraocular pressure (IOP), and evaluate the pharmacokinetics of tafluprost in aqueous humor. The dog is a suitable species for evaluating the ocular distribution and pharmacodynamics of prostaglandin analogs; this model can also provide quantitative pharmacokinetic data.

[0146] Study settings:

[0147] Animals for the study were selected based on general health, body weight, ophthalmic examination results, response to IOP stimulation, and the following criteria:

[0148] - Healthy, normal ocular surface;

[0149] - Have not had invasive eye surgery for at least one month prior to the study; in particular no surgery involving the cornea or anterior segment;

[0150] - No topical or systemic corticosteroid therapy for at least one month;

[0151] - T...

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Abstract

The invention provides a pharmaceutical composition for use in the prevention or therapy of glaucoma, increased intraocular pressure, ocular hypertension and / or a symptom associated therewith, whereinthe composition comprises tafluprost and a semifluorinated alkane.

Description

[0001] field of invention [0002] The present invention relates to the field of drug therapy. More specifically, the present invention relates to the treatment of diseases and conditions affecting the eye such as glaucoma, increased intraocular pressure, ocular hypertension and / or symptoms related thereto. Background technique [0003] Increased intraocular pressure is a common eye disorder often associated with damage to the optic nerve, in this case glaucoma. In the absence of optic nerve damage, the condition is called ocular hypertension. Normal intraocular pressure is usually defined as being in the range of 10 mmHg to 21 mmHg. Pressure is primarily generated by the balance between the rate of production and the rate of outflow of aqueous humor in the eye. In addition, it is also affected by the thickness and stiffness of the cornea. Intraocular pressure usually fluctuates around about 15mmHg to 16mmHg, with amplitudes up to 6mmHg. For example, intraocular pressure ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K47/06A61K9/00A61P27/06
CPCA61K9/0048A61K31/5575A61P27/06A61K47/10A61K47/24A61K2300/00A61F9/0008A61K31/02
Inventor F·勒舍尔D·斯特雷尔K·艾克霍夫
Owner NOVALIQ GMBH
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