Formulations including amiodarone and salts thereof and methods of their manufacture and use

A kind of technology of amiodarone and injection preparation, applied in the field of ready-to-use liquid preparation

Inactive Publication Date: 2013-05-01
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prior art does not disclose or suggest the invention claimed herein

Method used

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  • Formulations including amiodarone and salts thereof and methods of their manufacture and use
  • Formulations including amiodarone and salts thereof and methods of their manufacture and use
  • Formulations including amiodarone and salts thereof and methods of their manufacture and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0325] Example 1: Solubilization of Amiodarone HCl Using Sulfobutyl Ether β-Cyclodextrin

[0326] A volume of deionized water was added to the composite vessel and brought to the desired temperature, which was maintained throughout the study. The cyclodextrin and, if present, citric acid were added and dissolved using agitation provided by the overhead mixer. Amiodarone HCl was added slowly with continued stirring and the contents of the vessel were visually inspected for the presence of gel. Continue stirring until the amiodarone dissolves. Batch parameters and results are in the table below.

[0327]

[0328]

[0329] Formulations containing a cyclodextrin:amiodarone molar ratio of about 1.4:1 form a gel when prepared at a temperature of about 40°C to 57°C.

Embodiment 2

[0330] Example 2: Solubilization of Amiodarone HCl in the Presence of Dextrose

[0331] Formulations were prepared in deionized water according to the following recipe:

[0332]

[0333]

[0334] Add the initial volume of deionized water to the dosing container and bring to set temperature. Add dextrose, citric acid, SBECD and sodium citrate separately and dissolve with mixing. The pH of the solution was measured and amiodarone was added slowly with vigorous stirring. The solution was observed for the presence of gel formation. If no gel formation was observed, the solutions were brought to room temperature and made up to their final volume with deionized water as needed. The formulation parameters and results are shown in the table below.

[0335]

[0336] Formulations containing a molar ratio of cyclodextrin:amiodarone of about 1.4:1 which, when prepared at an initial volume of less than about 17.5% (corresponding to a SBECD concentration of greater than about 4...

Embodiment 3

[0337] Example 3: Solubilization of Amiodarone HCl Using Different Orders of Addition

[0338] The formulation was prepared as described in Example 2, except that sodium citrate was added after the amiodarone had dissolved. The formulation parameters and results are shown in the table below.

[0339]

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Abstract

The invention encompasses ready to administer liquid formulations including amiodarone and a substituted cyclodextrin. The invention also encompasses methods of making the liquid formulations to provide acceptable concentrations of amiodarone suitable for parenteral administration. The liquid formulations of the invention are formulations included, for example, in a ready to use intravenous bag, bottle or syringe.

Description

technical field [0001] The invention encompasses ready-to-use liquid formulations comprising amiodarone or a salt thereof and a substituted cyclodextrin. The invention also encompasses methods of manufacturing said liquid formulations to provide acceptable concentrations of amiodarone for parenteral administration while avoiding the formation of gels or particulate matter. The liquid preparation of the present invention is a preparation contained in, for example, an intravenous infusion bag or bottle. Background technique [0002] Amiodarone is approved for the treatment of life-threatening ventricular tachyarrhythmias. Amiodarone is also used to treat less severe ventricular arrhythmias and many supraventricular arrhythmias, including atrial fibrillation and reentry tachyarrhythmias involving accessory tracts. Since amiodarone exhibits significant inter-individual variability, close monitoring of the individual is necessary to adjust the amount of drug delivered. The mos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K47/48A61K9/08
CPCA61K9/0019A61K47/40A61K47/48969A61K47/26B82Y5/00A61K31/343A61K47/6951A61P9/06
Inventor 格罗尔德·L·莫舍尔斯特芬·马查塔丹尼尔·卡欣布什拉·阿格哈
Owner BAXTER INT INC
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