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Rocuronium bromide formulations

A preparation and solvent technology, applied in the field of rocuronium bromide preparations, can solve problems such as damage, achieve sufficient stability, excellent practicability, and ensure stability

Pending Publication Date: 2022-05-31
MARUISHI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, in the technique of this document, a sulfoalkyl ether-β-cyclodextrin derivative or a pharmaceutically acceptable salt thereof is required, and it has been reported that its use causes kidney damage, etc.

Method used

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  • Rocuronium bromide formulations
  • Rocuronium bromide formulations
  • Rocuronium bromide formulations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0128] Rocuronium bromide (rocuronium bromide), 1M hydrochloric acid, and sodium chloride were added to water for injection to obtain a solution (preparation) at pH 3.0. The solution was passed through a filter (filter) with a pore size of 0.2 μm to perform filter sterilization.

[0129] In addition, in the solution, the concentration of rocuronium bromide is 10 mg / mL, the concentration of hydrogen chloride is 16.8 mM, the concentration of sodium chloride is 9 mg / mL, the concentration of the whole component is 1.96 mass %, and the concentration of hydrogen chloride and sodium chloride is 0.96 mass % .

[0130] In addition, the osmotic pressure ratio of the solution to physiological saline is about 1.

[0131] The obtained solution (preparation) was filled into a glass vial, subjected to high-temperature treatment (treatment with high-pressure steam at 121°C for 20 minutes), and then stored (preserved) at 60°C, and the pH and the value of analogue C were measured over time. g...

Embodiment 2

[0133] In the same manner as in Example 1 except that the high-temperature treatment was not performed in Example 1, pH and the production rate of analogue C were measured over time.

reference example 1

[0135] Except having used the solution obtained in the following manner in Example 1, it carried out similarly to Example 1, and measured pH and the production rate of analog C over time.

[0136] Rocuronium bromide (rocuronium bromide), glycine, 1M hydrochloric acid, and sodium chloride were added to water for injection to obtain a solution (preparation) at pH 3.0.

[0137] In addition, in the solution, the concentration of rocuronium bromide is 10 mg / mL, the concentration of glycine is 73 mM, the concentration of hydrogen chloride is 30 mM, the concentration of sodium chloride is 5 mg / mL, and the concentration of the whole component is 2.16% by mass. Glycine, hydrogen chloride and sodium chloride The concentration is 1.16% by mass.

[0138] In addition, the osmotic pressure ratio of the solution to physiological saline is about 1.

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Abstract

The invention provides a novel rocuronium bromide preparation. The rocuronium bromide preparation contains rocuronium bromide, has a pH of 4 or less, and does not contain a buffering agent.

Description

technical field [0001] The invention relates to rocuronium bromide preparations and the like. Background technique [0002] Rocuronium bromide (rocuronium bromide) is known as an active ingredient of a muscle relaxant for anesthesia and the like (Non-Patent Document 1). [0003] This rocuronium bromide is relatively unstable to heat in aqueous solution, and its preservation and transportation take effort and cost. For example, ESLAX, which is known as a commercial product of rocuronium bromide preparation, is a preparation containing an acetate buffer and requires refrigeration at 2 to 8° C. to ensure stability (Non-Patent Document 1). [0004] Therefore, attempts are being made to improve the stability of rocuronium bromide in formulations. For example, WO2008 / 065142 (Patent Document 1) discloses a technique in which a sulfoalkyl ether-β-ring Dextrin derivatives, or pharmaceutically acceptable salts thereof, stabilize aqueous solutions. [0005] However, in the techniqu...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K47/04A61K47/12A61K47/20A61P21/02A61P23/00
CPCA61K31/58A61K47/02A61K47/12A61K47/20A61P21/02A61P23/00
Inventor 王咏井辻裕
Owner MARUISHI PHARMACEUTICAL CO LTD
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