Pharmaceutical Compositions And Methods For Producing Low Impurity Concentrations Of The Same

a technology of compositions and pharmaceutical compositions, applied in the field of pharmaceutical compositions, to achieve the effect of reducing or minimizing the level of certain impurities

Inactive Publication Date: 2010-05-06
HOSPIRA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]The third aspect of the present invention describes pharmaceutical compositions prepared or stored using the methods described herein wherein the level of certain impurities is minimized or reduced,

Problems solved by technology

For example, some impurities arise from the process used in making clevidipine, while others are due to gradual degradation of the active ingredient.

Method used

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  • Pharmaceutical Compositions And Methods For Producing Low Impurity Concentrations Of The Same
  • Pharmaceutical Compositions And Methods For Producing Low Impurity Concentrations Of The Same
  • Pharmaceutical Compositions And Methods For Producing Low Impurity Concentrations Of The Same

Examples

Experimental program
Comparison scheme
Effect test

example 1

HPLC Procedure

[0035]Clevidipine assay and related substances were tested at each time point by a stability indicating method. This method is an isocratic, normal phase HPLC method with peak detection at 220 nm wavelength.

Column temperature: 35-40 degrees C.

Injection volume: 20 μl.

Flow rate: 1.0 ml / min.

Run time about 25 minutes.

Mobile phase of Heptane:ethanol (90:10) is employed and used for the assay of clevidipine and the degradation products with the exception of Substance 24.

Condition column with clevidipine mobile phase at 1.0 mL / min for 4 hours.

New column should be conditioned overnight at 0.2 mL / min.

When a degradation product is eluted, column can be washed with filtered ethanol for about 2 hours at 1.0 mL / min, then proceed with equilibration.

Examples of Column: PVA silica column 4.6 mm×150 mm, 5 micron PV12s051546WT or equivalent.

example 2

HPLC Procedure Substance 24

[0036]This method is an isocratic, normal phase HPLC method with peak detection at 220 nm wavelength.

Column temperature: 35-40 degrees C.

Injection volume: 20 μl to 100 μl.

Run time about 60 minutes.

Mobile phase of Heptane:Isopropyl Alcohol (95:5) is employed is used for the assay of Substance 24.

Condition column with Heptane:Isopropyl Alcohol 95:5 mobile phase at 1.0 ml / min until the blank injection baseline is stable. New column should be conditioned overnight at 0.2 mL / min.

Examples of Column: Two PVA silica columns 4.6 mm×150 mm, 5 micron PV12s051546WT or equivalent.

Flow rate 1.0 mL / min.

[0037]Calculation of percent impurity based on total peak area:

impurityPeakArea(100)(totalpeakareaofdegradationproducts+H324 / 38peakarea(clevidipinepeakarea))

[0038]Calculation of percent impurity based on total peak area using H168 / 79 as the impurity example:

H168 / 79PeakArea(100)(totalpeakareaofdegradationproducts+H324 / 38peakarea(clevidipinepeakarea))

[0039]When a standard of...

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Abstract

A composition having clevidipine as an active ingredient is described. The composition includes clevidipine as an active ingredient and an amount of the impurity H168/79 that is no greater than about 1.5%, or where the ratio between clevidipine and H168/79 is equal or above 60 to 1.

Description

[0001]This application claims priority from U.S. Provisional Application No. 61 / 085,597 filed on Aug. 1, 2008 and U.S. Provisional Application No. 61 / 093,772 filed on Sep. 3, 2008. The above mentioned applications are incorporated herein by reference.FIELD OF THE INVENTION[0002]The instant invention relates to pharmaceutical compositions, and in particular to compositions of clevidipine having a reduced level of impurities, and a method of maintaining the stability of such pharmaceutical compositions.BACKGROUND OF THE INVENTION[0003]Clevidipine, which is also known as Cleviprex™, is a short-acting, vascular selective calcium antagonist that has been shown to reduce arterial blood pressure with a fast termination of effect due to metabolism by blood and tissue esterases. As an arterial-selective vasodilator, clevidipine reduces peripheral vascular resistance directly, without dilating the venous capacitance bed.[0004]The chemical name of clevidipine is butyroxymethyl methyl 4-(2′,3′-...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/4418G01N30/02
CPCA61K31/519G01N30/02A61K31/4422A61P9/00A61P9/12A61K31/4418A61K31/436
Inventor MOTHERAM, RAJESHWARKRISHNA, GOPALDING, MINFLOOD, KEITHRAMAKRISHNA, KORNEPATI
Owner HOSPIRA
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