Composition comprising prostaglandin derivatives and ophthalmic liquid formulation comprising the composition

A technology of prostaglandins and derivatives, applied in the field of medicine, can solve problems such as adverse reactions, hair loss, liver toxicity, etc., and achieve the effect of avoiding the use of co-solvents and improving safety characteristics

Active Publication Date: 2019-01-11
ZHONGSHAN WANHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in this clinical trial, valproic acid was used in an oral dosage form, and the single oral dose was higher than the single oral dose of sodium valproate in the treatment of epilepsy described in "New Pharmacology", so there will also be Adverse reactions that occur during the treatment of epilepsy include gastrointestinal adverse reactions, and a very small number of patients may also have adverse reactions such as lymphocytosis, thrombocytopenia, hair loss, lethargy, weakness, ataxia, and even liver toxicity. Significantly reduced risk-benefit profile of oral valproic acid for glaucoma
[0005] At present, there is no combination of prostaglandin derivatives and sodium valproate for ocular administration in the prior art, and achieve a synergistic effect of lowering intraocular pressure, thereby reducing the therapeutic dose of prostaglandin derivatives and reducing systemic adverse effects of sodium valproate Response to Technical Inspiration

Method used

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  • Composition comprising prostaglandin derivatives and ophthalmic liquid formulation comprising the composition
  • Composition comprising prostaglandin derivatives and ophthalmic liquid formulation comprising the composition
  • Composition comprising prostaglandin derivatives and ophthalmic liquid formulation comprising the composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Example 1 Preparation of Ophthalmic Liquid Preparation Containing Latanoprost and Valproic Acid (1:16)

[0060] prescription

[0061]

[0062] Preparation

[0063] Mix and dissolve the prescribed amount of latanoprost, valproic acid, sodium chloride, edetate disodium, glycerin and benzalkonium chloride in 800mL water for injection, add the remaining amount of water for injection, sterilize, and pack , that is.

Embodiment 2

[0064] Example 2 Preparation of Ophthalmic Liquid Preparation Containing Bimatoprost and Sodium Valproate (1:6)

[0065] prescription

[0066]

[0067]

[0068] Preparation

[0069] Take the prescribed amount of travoprost, sodium valproate, sodium chloride, polyvinyl alcohol, benzalkonium chloride and carmellose sodium, mix and dissolve in 800mL water for injection, then add the remaining water for injection, and sterilize , sub-package, that is.

Embodiment 3

[0070] Example 3 Preparation of an ophthalmic liquid preparation comprising travoprost and divalproex sodium (1:15)

[0071] prescription

[0072]

[0073] Preparation

[0074] Take the prescribed amount of travoprost, divalproex sodium, sodium bisulfite, sodium chloride, glycerin and ethyl paraben, mix and dissolve in 800mL water for injection, then add the remaining amount of water for injection, sterilize, Subpackage, that is.

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PUM

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Abstract

The invention provides a composition comprising prostaglandin derivatives and valproic acid or a pharmaceutically acceptable salt thereof and an ophthalmic liquid formulation comprising the composition, wherein the prostaglandin derivative is preferably one of latanoprost, bemeprost, travoprost, taflurane, unoprost and latanoprostene, and valproic acid or a pharmaceutically acceptable salt thereofis preferably one of valproic acid, sodium valproate, sodium divalproate and magnesium valproate. The composition provided by the invention can synergistically reduce intraocular pressure, avoid theuse of cosolvent, and improve the safety of medicament.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a composition containing prostaglandin derivatives and an ophthalmic liquid preparation containing the composition. Background technique [0002] Glaucoma is currently the main blinding eye disease with a high and irreversible blinding rate, and has been listed as the second leading blinding eye disease by the World Health Organization (WHO). The important pathological factor leading to glaucomatous optic nerve damage is high intraocular pressure, and controlling intraocular pressure is currently the only clinically proven effective treatment for glaucoma. In addition to controlling the high intraocular pressure of patients, some studies in recent years have also confirmed that fluctuations in intraocular pressure are one of the important factors for the progression of glaucoma. At present, there are many kinds of drugs for controlling intraocular pressure on the market, and th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K31/20A61K31/19A61K9/08A61P27/02A61P27/06
CPCA61K9/0048A61K9/08A61K31/19A61K31/20A61K31/5575A61P27/02A61P27/06A61K2300/00
Inventor 向飞杜志博彭韪
Owner ZHONGSHAN WANHAN PHARM CO LTD
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