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Metal complex-containing pharmaceutical agents

a technology of complex compounds and pharmaceutical agents, applied in the field of improved agents based on metal-containing complex compounds, can solve problems such as unobjectionably tolerable complexes

Inactive Publication Date: 2006-07-27
GRIES HEINZ +4
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The invention is about a new pharmaceutical agent and a process for its production. The new pharmaceutical agent contains a complexing agent and a weaker metal complex. The complexing agent can be added in various amounts to the pharmaceutical agent. The weaker metal complex can be added in a similar amount to the complexing agent. The complexing agents can be selected from a wide variety of chelating agents. The metal complex used as an additive should have a lower stability constant than the active metal complex. The complexing agents and metal complexes can be used in the form of physiologically acceptable salts. The production of the additives is described in the patent text. The technical effect of this invention is to provide a new pharmaceutical agent with improved tolerability and stability."

Problems solved by technology

It has been found that adding one or more free complexing agent(s) and / or one or more weak metal complex(es) or their mixtures to pharmaceutical agents based on metal complexes surprisingly yields unobjectionably tolerable complexes.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 2

[0067] Production of a solution of the di-N-methylglucamine salt of the gadolinium(III) complex of diethylenetriaminepentaacetic acid (DTPA) with the penta-N-methylglucamine salt of DTPA as additive.

[0068] 97.6 g (0.05 mol) of N-methylglucamine is dissolved sterile in 500 ml of water. After addition of 196.6 g (0.5 mol) of DTPA and 90.6 g (0.25 mol) of gadolinium oxide, Gd2O3, the batch is refluxed for 2 hours and the clear solution is brought to pH 7.2 by adding another 97.6 g (0.5 mol) of N-methylglucamine. Next, another solution of 197 mg (0.5 mmol) of DTPA and 488 mg (2.5 mmol) of N-methylglucamine in 100 ml of water is added sterile and water is added sterile to produce 1000 ml. The solution is finally ultrafiltered, placed in an ampule and heat sterilized, and is ready for parenteral use.

example 3

[0069] Production of a solution of the sodium salt of the gadolinium(III) complex of 1,4,7,10-tetraazacyclododecane-N,N′,N″,N′″-tetraacetic acid (DOTA) with the calcium disodium salt of DOTA as additive.

[0070] 290.3 g (0.5 mol) of the complex salt described in example 11 of DE 3401052 is dissolved sterile in 700 ml of water. After addition of 7.44 g (30 mmol) of the calcium disodium salt of DOTA, water is added sterile to the neutral solution to produce 1000 ml, it is ultrafiltered, placed in an ampule and heat sterilized.

example 4

[0071] Production of a solution of the lysine salt of the gadolinium(III) complex of DOTA with the zinc disodium salt of DOTA as additive.

[0072] 80.80 g (0.2 mol) of DOTA (Parish Chemical Comp.) is introduced sterile into a suspension of 36.26 g (0.1 mol) of gadolinium oxide, Gd2O3, in 700 ml of water. It is heated with stirring for 20 hours to 70° C. and the solution is neutralized by adding an aqueous 20% by weight solution of lysine. Then 10.24 g (20 mmol) of the zinc disodium salt of DOTA is added and water is added sterile to the solution to produce 1000 ml. The solution is ultrafiltered, placed in an ampule and heat sterilized.

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PUM

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Abstract

Improved metal complex-containing pharmaceutical agents are described which, as an additive, contain one or more complexing agents and / or one or more weak metal complex(es) or mixtures thereof.

Description

BACKGROUND OF THE INVENTION [0001] This invention relates, e.g., to improved agents based metal-containing complex compounds suitable for NMR, X-ray, ultrasound and radiodiagnosis and therapy and a process for their production. [0002] Soon after the discovery of X-rays the most varied substances were experimentally tested as “contrast media” to boost the insufficient contrast of body fluids and soft tissues (Barke, R. Roentgenkontrastmittel [X-ray Contrast Media]; Chemie, Physiologie, Klinik VEB Georg Thieme Leipzig, 1970). Heavy elements were suitable as the X-ray absorbing elements of such contrast media. In the course of a long selection and optimization process, finally only contrast media based on iodine (in a stable organic bond) or barium (as a nearly insoluble sulfate) remained. Barium sulfate is used exclusively for visualization of the gastro-intestinal tract and it does not penetrate the body. [0003] With the development of nuclear medicine, e.g., the use of radioactive e...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K51/00A61K49/10A61K31/28A61K47/48A61K49/00A61K49/04A61P43/00
CPCA61K47/48076A61K47/48707Y10T436/24Y10S424/90A61K49/0002A61K47/547A61K47/6887A61P43/00
Inventor GRIES, HEINZSPECK, ULRICHWEINMANN, HANNS-JOACHIMNIENDORF, HANS PETERSEIFERT, WOLFGANG
Owner GRIES HEINZ
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