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Ophthalmic compositions comprising prostaglandin f2α derivatives and hyaluronic acid

一种透明质酸、前列腺素的技术，应用在治疗高眼压症和青光眼领域，能够解决没有销售前列腺素类似物组合物等问题

Active Publication Date: 2018-02-06
UNITHER PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] However, to the applicant's knowledge, there is currently no commercially available prostaglandin analog composition that is free or substantially free of preservatives and wherein the prostaglandin analog remains dissolved, stable and bioavailable

Method used

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  • Ophthalmic compositions comprising prostaglandin f2α derivatives and hyaluronic acid
  • Ophthalmic compositions comprising prostaglandin f2α derivatives and hyaluronic acid
  • Ophthalmic compositions comprising prostaglandin f2α derivatives and hyaluronic acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0181] Embodiment 1: Eye Drops for Eyes

[0182] Various ophthalmic eye drops are the preferred compositions described herein. However, such examples should in no way be construed in a limiting sense, but rather, as far as possible, are recognized as means by which eventual modifications can be made without departing from the principles of the invention.

[0183] Example of a protocol for preparing a solution comprising a prostaglandin analogue:

[0184] Add disodium hydrogen phosphate anhydrate and sodium dihydrogen phosphate dihydrate to the solution of sodium chloride. After stirring for 10 minutes, the pH of the solution referred to as "Solution 1" was measured and adjusted to 6.3-7.1 using 10% disodium hydrogen phosphate solution or 10% sodium dihydrogen phosphate solution. Then, hyaluronic acid was added to the 10% solution 1. The resulting mixture was stirred for 30 minutes or until completely dissolved, yielding "Solution 2", and cooled at least at 4-8°C. Thereaf...

Embodiment 2

[0203] Example 2: Chemical Stability Study

[0204] In order to measure the intrinsic stability of the prostaglandin analogues in the compositions of the present invention, the applicant carried out a stability test in which the compositions of the present invention were subjected to a specific temperature (up to 40° C.) for a specific period of time. Stabilize the samples at different temperatures: refrigerated at 2-4°C (long-term stability test), 25°C (accelerated stability test), 30°C (stress stability test 1) and 40°C (stress stability test 2) sex studies.

[0205] Evaluation of recovery of latanoprost, travoprost and bimatoprost was performed using high pressure liquid chromatography (HPLC) with LC9 pump. In short, samples are kept in glass containers. The content of latanoprost, travoprost and bimatoprost was determined using HPLC equipped with a UV detector and using a mixture of two mobile phases and using Shimadzu Type-VP software.

[0206] The results are presen...

Embodiment 3

[0213] Example 3: Chemical Stability of Prostaglandins in the Presence of a Range of Molecular Weight Hyaluronic Acid

[0214] Prostaglandin stability was studied using a range of hyaluronic acid molecular weights (60 to 3 million Daltons (MDa)). The test composition contained prostaglandin (0.005% latanoprost or 0.004% travoprost or 0.03% bimatoprost) and 0.15% (w / v) hyaluronic acid in phosphate buffered saline. The recovery of latanoprost, travoprost and bimatoprost was evaluated by high pressure liquid chromatography (HPLC). Briefly, samples were stored in glass containers at 40 °C for 3 months. The content of latanoprost, travoprost and bimatoprost was determined using HPLC equipped with UV detector and using a mixture of two mobile phases and using Shimadzu Type-VP software.

[0215] Results are expressed as the percentage of prostaglandin recovery at 3 months (t=3 months) compared to the initial concentration of prostaglandin (ie, the percentage of prostaglandin reco...

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Abstract

The present invention relates to a composition comprising at least one prostaglandin analogue as active compound and a stable amount of at least one hyaluronic acid or a salt thereof, said composition being free from preservatives; and to its use in the treatment of Use for ocular hypertension and / or glaucoma in a subject in need thereof.

Description

technical field [0001] The present invention relates to the treatment of ocular hypertension and glaucoma. More specifically, the present invention relates to a preservative-free composition for the treatment of ocular hypertension and glaucoma, wherein said composition comprises at least one prostaglandin analogue and at least one hyaluronic acid polymer. Background technique [0002] Glaucoma is an eye disease characterized by damage to the optic nerve head and associated visual field defects, often accompanied by elevated intraocular pressure (IOP). Glaucoma is characterized by slow and progressive degeneration of retinal ganglion cells and optic nerve axons. Worldwide, the disease affects more than 66 million people and causes 6.8 million blindness in both eyes. [0003] One can divide glaucoma into primary glaucoma (with no known prior cause) and secondary glaucoma. Primary glaucoma may be genetically determined. The term secondary glaucoma refers to glaucoma caused...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/5575A61K47/36A61P27/06
CPCA61K9/0048A61K31/5575A61K47/02A61K31/5377A61K31/728A61K47/36A61P27/02A61P27/06A61K2300/00A61K31/165A61K31/216
Inventor R·哈德-斯利梅恩
Owner UNITHER PHARMA INC
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