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Esmolol formulation

The technology of esmolol hydrochloride and buffering agent is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, inorganic non-active ingredients, etc. It can solve the problems of product microbial contamination and achieve stable preparation Effect of suitable shelf life

Inactive Publication Date: 2003-11-12
BAXTER INT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, during dilution / aseptic handling, there is a risk of microbial contamination of the product, whether in vials or ampoules

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] All mixing, filtering and filling equipment and glassware are lightly washed and dried. Filter units, fill tube units, and other parts and equipment are sanitized.

[0026] 80% of the final product volume of cold water for injection is added to a calibrated mixing tank. Add sodium chloride to the tank and stir the solution until the sodium chloride dissolves. Glacial acetic acid and sodium acetate were then added. The solution was further stirred until the added excipients were dissolved. Add water for injection to 90% of the final volume, and then mix and stir. About 2 liters of this solution (buffer solution) was used to prepare the slurry solution. Weigh esmolol hydrochloride and add 2 liters of buffer solution to form a slurry solution. This slurry is then added to the mixing tank for mixing. The solution was adjusted to pH 5.0 with 1N sodium hydroxide or hydrochloric acid. Add water for injection to the volume of the final product and mix.

[0027] T...

Embodiment 2

[0033] components

[0034] components

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PUM

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Abstract

An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy] phenylpropionate hydrochloride (esmolol hydrochloride), a buffering agent and an osmotic-adjusting agent, as well as a method for its manufacture, are disclosed.

Description

Background of the invention [0001] Esmolol hydrochloride is a short-acting beta-receptor blocker used in the treatment or prevention of cardiac diseases in mammals. Most currently effective beta-blockers are stable drugs administered to cardiac patients over a relatively long period of time. However, in the treatment of critically ill patients it is often necessary to rapidly reduce the cardiac load or improve the rhythm of the heart during critical periods, for example, at or shortly after a myocardial infarction. Conventional beta-blockers can be used in the above treatments, but their long duration of action can cause undesirable side effects. [0002] Esmolol hydrochloride contains an ester functional group and has typical beta-adrenergic blocking activity. However, unlike conventional β-receptor blocking compounds, esmolol HCl has a shorter duration of action in vivo due to the presence of an ester functional group. Thus, esmolol hydrochloride has advantages over tradi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/00A61K31/215A61K31/216A61K31/24A61K47/02A61K47/12A61K47/18A61K47/24A61K47/26A61P9/00A61P9/10A61P43/00
CPCA61K47/02A61K31/215A61K47/12A61K47/26A61K31/24A61K9/0019A61P43/00A61P9/00A61P9/10
Inventor 刘婕萨蒂什·K·佩亚娃尔乔治·奥沃
Owner BAXTER INT INC
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