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Pharmaceutical composition with improved storage stability and method for preparing the same

A composition and drug technology, applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., can solve problems such as residual metal salts, complicated steps, etc., and achieve the effect of improving storage stability

Inactive Publication Date: 2017-04-05
SAMYANG BIOPHARMLS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method involves complicated steps, requires additional steps to remove alkali metal salts and salts for salting out (sodium chloride or potassium chloride), and may have residual metal salts even after they are removed

Method used

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  • Pharmaceutical composition with improved storage stability and method for preparing the same
  • Pharmaceutical composition with improved storage stability and method for preparing the same
  • Pharmaceutical composition with improved storage stability and method for preparing the same

Examples

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preparation example Construction

[0075] In the method for preparing a pharmaceutical composition according to the embodiment of the present invention, for example, a water-miscible organic solvent selected from the group consisting of alcohol (such as ethanol), acetone, tetrahydrofuran, acetic acid, acetonitrile, and dioxane and combinations thereof can be used as the organic solvent, But it is not limited to this. In addition, one selected from regular water, distilled water, distilled water for injection, physiological saline, 5% glucose, buffer, and combinations thereof may be used as the aqueous solvent, but is not limited thereto.

[0076] The method for preparing a pharmaceutical composition according to the embodiment of the present invention may further include removing the organic solvent after the step (a).

[0077] In embodiments, the method may further comprise adding a lyophilization aid to lyophilize the micellar composition. A lyophilization aid may be added to the lyophilized composition to m...

preparation example 1

[0080] Preparation 1: Synthesis and purification of a diblock copolymer (mPEG-PDLLA) consisting of monomethoxypolyethylene glycol and D,L-lactide

[0081] 150 g of monomethoxypolyethylene glycol (mPEG, number average molecular weight = 2,000) was added to a 500 ml round bottom flask equipped with a stirrer, and stirred under vacuum at 120° C. for 2 hours to remove moisture. 0.15 g of tin octoate (Sn(Oct)) dissolved in 200 μl of toluene 2 ) was added to the reaction flask and stirred under vacuum for an additional 1 hour to distill and remove the toluene. Then 150 g of D,L-lactide was added and stirred under nitrogen atmosphere to dissolve. After the D,L-lactide was completely dissolved, the reactor was tightly sealed, and a polymerization reaction was performed at 120° C. for 10 hours. After the reaction was terminated, the reactor was connected to a vacuum pump under magnetic bar stirring, and the product was purified by a sublimation method at a pressure of 1 torr or lower...

preparation example 2

[0082] Preparation 2: Purification of Diblock Copolymer (mPEG-PDLLA) by Sublimation Method

[0083] 30 g of mPEG-PDLLA obtained during the polymerization reaction of Preparation Example 1 before the purification process was charged into the single-necked flask and dissolved at 80°C. Under magnetic bar stirring, the reactor was connected to a vacuum pump, and the product was purified by sublimation method at a pressure of 1 Torr or lower for 24 hours and 48 hours.

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Abstract

A pharmaceutical composition containing a specific related compound within a specified limit and a method for preparing the same are provided.

Description

technical field [0001] The present invention relates to pharmaceutical compositions having improved storage stability and methods for their preparation, and more particularly to pharmaceutical compositions comprising poorly water-soluble drugs comprising amphiphilic block copolymers, wherein the content of specific related compounds is kept within prescribed limits within; and a method of preparation thereof. Background technique [0002] Dissolution of poorly water-soluble drugs is a key technology for drug delivery into the body via oral or parenteral administration. Such a dissolution method includes a method in which a surfactant is added to an aqueous solution to form micelles, and then a poorly water-soluble drug is entrapped therein. Amphiphilic block copolymers useful as surfactants comprise hydrophilic polymer blocks and hydrophobic polymer blocks. Since the hydrophilic polymer block directly contacts blood proteins and cell membranes in vivo, biocompatible polyet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/337A61K47/32A61K47/34A61K47/10
CPCA61K9/1075A61K31/337A61K47/34C08G63/90C08G63/664C08G63/78C08G63/823C08G63/85A61K2300/00A61K9/19A61K31/122A61K47/30A61K47/32
Inventor 金峰五闵范赞金志英金寭林徐敏孝李思元李一雄赵重雄崔仁子
Owner SAMYANG BIOPHARMLS CORP
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