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Ophthalmic pharmaceutical composition with improved preservative effectiveness or light stability

A technology of composition and medicine, which is applied in the field of enhancing the antiseptic effect of catiolol, can solve the problems of cost and stability of storage facilities unsuitable for long-term continuous application, and achieve the goal of enhancing antiseptic effect or antibacterial effect and improving photostability Effect

Active Publication Date: 2019-04-16
OTSUKA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such unit dose eye drops require a single-use disposable container for each administration, and may not be suitable for long-term continuous administration in terms of cost and security of storage facilities, etc.

Method used

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  • Ophthalmic pharmaceutical composition with improved preservative effectiveness or light stability
  • Ophthalmic pharmaceutical composition with improved preservative effectiveness or light stability
  • Ophthalmic pharmaceutical composition with improved preservative effectiveness or light stability

Examples

Experimental program
Comparison scheme
Effect test

example 19 and 20

[0166]

[0167] The components of the test solutions of Comparative Examples 19 and 20 are shown in Table 12. Carteolol hydrochloride, disodium hydrogen phosphate anhydrous and sodium dihydrogen phosphate dihydrate were mixed to prepare the compositions shown in Table 12. Add sterile purified water to the mixture to dissolve it. The pH of these solutions was adjusted to 6.7 by adding 5N sodium hydroxide, and sterile purified water was added to these solutions to obtain the prescribed volume. These solutions were filtered through a 0.22-μm membrane filter, and 5 mL of each solution was loaded into sterile glass containers to be used as test solutions.

[0168] [Table 11]

[0169]

[0170] [Table 12]

[0171] Quantity (g / 100mL)

Comparative Example 19

Comparative Example 20

Carteolol Hydrochloride

1.0

2.0

Edetate Disodium Hydrate

-

-

Na 2 HPO 4

0.04

0.04

NaH 2 PO 4· 2H 2 o

0.04

0.04

NaOH...

example 1

[0203] : Formulation example of a formulation comprising a prostaglandin F2α derivative

[0204] Examples 30 to 39 and Comparative Example 29 were prepared according to the following methods.

example 30

[0206] Latanoprost (0.005 g), polysorbate 80 (0.1 g) and purified water (80 g) were measured and mixed, and the mixture was warmed to 60° C. to dissolve it. Then, the mixture was cooled to room temperature. To this solution were added carteolol hydrochloride (2.0 g), alginic acid (1.0 g), boric acid (1.0 g) and edetate disodium hydrate (0.1 g). The mixture was dissolved by adding sodium hydroxide, and the pH of the mixture was adjusted to 6.5. Then, purified water was added to the mixture so that the total amount was 100 g. The solution was filtered through a membrane filter with a pore size of 0.2 μm to prepare Example 30.

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Abstract

A problem to be solved by the present invention is the provision of an ophthalmic pharmaceutical composition with enhanced preservative effectiveness and / or improved light stability of carteolol. Theproblem may be solved by combining carteolol or a pharmaceutically acceptable salt thereof with edetic acid or a pharmaceutically acceptable salt thereof.

Description

technical field [0001] The present invention relates to an ophthalmic pharmaceutical composition comprising carteolol as a beta blocker, a process for the preparation of the ophthalmic pharmaceutical composition and its medical use. The present invention also relates to methods for enhancing the preservative efficacy of carteolol, improving its photostability, and / or reducing its breakdown. Background technique [0002] Carteolol is known as a beta blocker and its chemical name is 5-[3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]-3,4-dihydro Quinolin-2(1H)-one, and known for ophthalmic use, is therapeutically effective in glaucoma and ocular hypertension. Eye drops usually need to contain preservatives or preservatives to avoid contamination by microorganisms during use. Such preservatives or preservatives typically include benzalkonium chloride, benzethonium chloride, chlorhexidine gluconate, parabens, chlorobutanol and sorbates. However, these preservatives and preserva...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/00A61K9/08A61K31/4704A61K31/5575
CPCA61K31/4704A61K47/36A61K47/183A61K9/08A61K9/0048A61P27/06A61P27/02A61K45/06A61K9/10A61K47/00A61K31/5575A61K2300/00
Inventor 长滨良治近藤文雄大八木优平田雄树
Owner OTSUKA PHARM CO LTD
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