Alcohol free formulation of argatroban

A technology of argatroban and preparation, applied in the field of argatroban and related compounds, can solve the problems of material waste and the like

Inactive Publication Date: 2009-08-26
SCIDOSE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, each supplied vial provides 250 ml of dosable diluent, resulting in significant material waste during almost most ex...

Method used

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  • Alcohol free formulation of argatroban
  • Alcohol free formulation of argatroban
  • Alcohol free formulation of argatroban

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] (2R, 4R)-1-[N 2 -(3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl]-4-methyl-2-piperidinecarboxylic acid (argatroban) was Dissolve (to a concentration of 5 mg / ml) in an aqueous system containing 50 mg / ml arginine and adjust the pH of the final solution to 9.0 using acetic acid. Dissolution of argatroban was performed at 25°C.

Embodiment 2

[0069] Argatroban was dissolved (to a concentration of 5 mg / ml) in an aqueous system containing 50 mg / ml arginine and the pH was adjusted to 9.0 using acetic acid. Dissolution of argatroban was performed at 50°C.

Embodiment 3

[0071] Argatroban was dissolved (up to a concentration of 5 mg / ml) in an aqueous system containing 50 mg / ml arginine and the pH was adjusted to 9.0 using tartaric acid. Dissolution of argatroban was performed at 25°C.

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PUM

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Abstract

The invention provides an aqueous formulation of argatroban and of related compounds along with a reconstitutable formulation, each of which is substantially, if not totally alcohol free. The formulations are also substantially free, if not totally free, of mono-, di-, and oligo- saccharides. An especially preferred embodiment is a ready-to-use 1 mg/ml injectable dosage form having argatroban, lactobionic acid, and methionine.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application 60 / 850,725, filed October 11, 2006, and US Provisional Application 60 / 847,556, filed September 27, 2006. See also a co-owned US application filed contemporaneously with the same title and inventor as this application and claiming priority from the two identical provisional applications above. These applications, as well as each of these applications and each of the patents and patent applications mentioned in this specification, are incorporated herein by reference in their entirety. [0003] Statement Regarding Federally Sponsored Research or Development [0004] Not applicable technical field [0005] The present invention relates to argatroban and related compounds, and to the solubilization of argatroban and related compounds without the need for alcohol or other solvents and / or without the use of sugars to obtain injectable solutions having desired con...

Claims

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Application Information

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IPC IPC(8): A61K31/47
Inventor N·R·帕勒普
Owner SCIDOSE
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