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Stable aqueous solution

A water-based liquid and stabilizer technology, which is applied in the direction of medical preparations containing non-active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., to achieve the effect of improving solubility and stability

Inactive Publication Date: 2015-10-28
SENJU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, so far, there are no reports on the stability of compound A to light and heat and its stabilization
[0005] Generally speaking, since the stabilization of a drug is not only affected by the inherent physical and chemical properties of the drug, but also by the properties of the drug, the physical and chemical properties of the additives used, and their combination, it is not easy to Its preparation method is summarized

Method used

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  • Stable aqueous solution
  • Stable aqueous solution
  • Stable aqueous solution

Examples

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Effect test

preparation example Construction

[0088] The eye drops of the present invention can be produced according to a production method known per se (for example, methods described in Japanese Pharmacopoeia 16th Edition, General Rules for Preparations, Eye Drops, etc.). For example, the eye drops of the present invention can be prepared by dissolving other additives such as solubilizers, buffers, isotonic agents, and preservatives in distilled or purified water, then dissolving Compound A, adding alcohol, and adjusting to a given The osmotic pressure and pH, in a sterile environment, filter-sterilized, and aseptically filled into cleaned and sterilized containers.

[0089] When formulated as eye drops, the aqueous liquid preparation is preferably accommodated in an eye drop container having a small-diameter liquid injection hole that can control the amount of liquid droplets that can be easily instilled into the eyes. The material of the container is not particularly limited, and is preferably a container with low mo...

Embodiment

[0093] The present invention will be described in detail with reference to the following test examples and preparation examples, but the present invention is not limited to these examples, and the present invention can be adjusted without departing from the scope of the present invention. In the following test examples and formulation examples, (3-{2-[4-isopropyl-2-(4-trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl -1,2-benzisoxazol-6-yl)glycolic acid as compound A. Meanwhile, all formulations of the following test examples and formulation examples are clear aqueous liquid formulations with a light transmittance of 98.0% or more at a wavelength of 600 nm.

[0094] In the following test examples, HCO-60 represents polyoxyethylene hydrogenated castor oil 60, and MYS-40 represents polyethylene glycol stearate 40.

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Abstract

Provided is an aqueous solution with high stability to light and heat, characterized by containing (3-{2-[4-isopropyl-2-(4-trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl-1,2-benzisoxazole-6-yl)oxyacetic acid or a pharmaceutically acceptable salt thereof, and tyloxapol or octoxynol.

Description

technical field [0001] The present invention relates to a kind of (3-{2-[4-isopropyl-2-(4-trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl-1,2-benzene A method for stabilizing isoxazol-6-yl) glycolic acid or a pharmaceutically acceptable salt thereof, and a stabilized (3-{2-[4-isopropyl-2-(4 - an aqueous liquid formulation of trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl-1,2-benzisoxazol-6-yl)glycolic acid. Background technique [0002] It has been reported that (3-{2-[4-isopropyl-2-(4-trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl-1,2-benzo Isoxazol-6-yl)glycolic acid is an agent having a peroxisome proliferator-activated receptor (Peroxisome Proliferator-Activated Receptor, hereinafter referred to as "PPAR") delta agonist action (see Patent Document 1). In addition, it has been reported that (3-{2-[4-isopropyl-2-(4-trifluoromethyl)phenyl-5-thiazolyl]ethyl}-5-methyl-1,2- Benzisoxazol-6-yl) glycolic acid or a pharmaceutically acceptable salt thereof (hereinafte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/427A61K9/08A61K47/10A61K47/34A61P27/02
CPCA61K9/0048A61K31/427A61P27/02A61P43/00A61K9/08A61K47/10A61K47/34
Inventor 鹿村悠子东村由佳
Owner SENJU PHARMA CO LTD