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Infusion preparation containing (2r)-2-propyloctanoic acid as the active ingredient

A technology of propyl caprylic acid and preparations, applied in anhydride/acid/halide active ingredients, inorganic non-active ingredients, drug delivery, etc.

Inactive Publication Date: 2007-01-03
ONO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there has been no specific report on an infusion solution formulation for continuous intravenous administration comprising (2R)-2-propyloctanoic acid or a salt thereof dissolved in advance in an infusion solution so far.

Method used

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  • Infusion preparation containing (2r)-2-propyloctanoic acid as the active ingredient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-1

[0099] Trisodium phosphate dodecahydrate (7.08kg), sodium chloride (18kg) and (2R)-2-propyl octanoic acid (4.0kg) were added to water for injection, and water for injection was added to obtain a total volume of 2000L. The mixture was made into a homogeneous solution, then filtered on a sterilizing filter (0.22 μm membrane, manufactured by Durapore), and the resulting solution was filled into fluid bags (100 mL, 250 mL, and 500 mL). These filled containers were capped and then autoclaved (123°C, 15 minutes) to prepare the infusion formulations described in Table 1 below. The dissolved state of each formulation is transparent and colorless, and the pH is in the range of 5.0-9.0.

[0100] formula

Embodiment 1-2

[0102] Trisodium phosphate·dodecahydrate (14.16 kg) and (2R)-2-propyloctanoic acid (8.0 kg) were added to water for injection and dissolved therein. Sodium chloride (18 kg) was added to the resulting solution, followed by water for injection to obtain a total volume of 2000 L. The mixture was made into a homogeneous solution, then filtered on a sterilizing filter (0.22 μm membrane, manufactured by Durapore), and the resulting solution was filled into fluid bags (100 mL, 250 mL, and 500 mL). These filled containers were capped and then autoclaved (123°C, 15 minutes) to prepare the infusion formulations described in Table 2 below. The dissolved state of each formulation is transparent and colorless, and the pH is in the range of 5.0-9.0.

[0103] formula

Embodiment 2-1

[0105] Add disodium phosphate dodecahydrate (6.4kg), sodium chloride (18kg) and (2R)-2-propyl octanoic acid (4.0kg) to the water for injection, and then add water for injection to obtain a total volume of 2000L. The mixture was made into a homogeneous solution, then filtered on a sterilizing filter (0.22 μm membrane, manufactured by Durapore), and the resulting solution was filled into fluid bags (100 mL, 250 mL, and 500 mL). These filled containers were capped and then autoclaved (123°C, 15 minutes) to prepare the infusion formulations described in Table 3 below. The dissolved state of each formulation is transparent and colorless, and the pH is in the range of 5.0-9.0.

[0106] formula

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Abstract

An infusion preparation which contains (2R)-2-propyloctanoic acid or its salt useful in treating neurodegenerative diseases and a basic metal ion supplied from a metal salt of a weak acid or a metal hydroxide preferably in an amount of about 1 to 5 equivalents per equivalent of the (2R)-2-propyloctanoic acid or its salt optionally together with other infusion component(s). This infusion preparation has a pH value suitable for intravenous administration and is useful in continuous intravenous administration without a need for any pretreatment such as dissolution or dilution before using.

Description

technical field [0001] The present invention relates to an infusion solution preparation for continuous intravenous administration comprising (2R)-2-propyloctanoic acid or a salt thereof, which can be used as a drug for treating and / or preventing neurodegenerative diseases including cerebral infarction, and relates to a process for producing the infusion solution preparation method. Background technique [0002] Stroke patients are usually brought to the hospital only after being unconscious due to cerebral infarction or cerebral hemorrhage, and such stroke patients inevitably receive treatment while remaining unconscious. Therefore, the drug administered for the treatment of this disease is preferably a preparation suitable for parenteral administration such as an injection. Injections for intravenous administration are preferred especially when rapid expression of action is desired. Currently, both Radicut (edaravone) and t-PA, which are used as drugs for treating cerebr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/20A61K9/08A61K47/02A61P25/28A61K9/00
CPCA61K31/20A61K47/02A61K9/0019A61P25/00A61P25/28
Inventor 须藤真生谷川诚一
Owner ONO PHARMA CO LTD
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