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Liquid pharmaceutical formulations containing 3.7-diazabicyclo[3,3,1]nonane compounds and methods of treatment relating to arrhythmic events

a technology of diazabicyclo[3,3,1]nonane and liquid pharmaceutical formulations, which is applied in the direction of biocide, drug compositions, cardiovascular disorders, etc., can solve the problems of significant mortality and morbidity of afib, limited technique, and significant impact on quality of life, so as to improve the effect

Inactive Publication Date: 2005-11-24
SOLVAY PHARMA GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009] Another object of the invention is to provide new anti-arrhythmic pharmaceutical formulations having an improved effect in human patients in need of treatment

Problems solved by technology

AFib is associated with significant mortality and morbidity and impacts significantly on quality of life.
Although this may be achieved using DC cardioversion, the technique has limitations such as the need for general anesthesia and hospitalization.
However, many of these agents have important side effects such as the potential for pro-arrhythmia, impairment of LV function, or extracardiac unwanted effects.

Method used

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  • Liquid pharmaceutical formulations containing 3.7-diazabicyclo[3,3,1]nonane compounds and methods of treatment relating to arrhythmic events
  • Liquid pharmaceutical formulations containing 3.7-diazabicyclo[3,3,1]nonane compounds and methods of treatment relating to arrhythmic events
  • Liquid pharmaceutical formulations containing 3.7-diazabicyclo[3,3,1]nonane compounds and methods of treatment relating to arrhythmic events

Examples

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examples

[0233] The following Example describes a liquid pharmaceutical formulation which contains an active substance of Formula I according to the invention, and also the production of such pharmaceutical preparations. The following example explains the production of a liquid pharmaceutical preparation containing tedisamil dihydrochloride. Liquid pharmaceutical preparations containing tedisamil sesquifumarate may be obtained in an analogous manner.

example

Ampules Composition (per Ampule)

[0234] 5 mg N,N′-dicyclopropylmethyl-9,9-tetramethylen-3,7-diazabicyclo[3,3,1]nonane dihydrochloride [0235] 16 mg Sodium chloride

Water for injection purposes to make up to 2.0 ml

Preparation Method

[0236] Sodium chloride was dissolved in water for injection purposes. The active substance was added and dissolved while stirring. Sufficient water for injection purposes was added to make up the final volume. The mixture was passed through a 0.1 μm membrane filter. 2.15 ml aliquots were filled into brown glass ampules, and the ampules were hermetically closed. The ampules were sterilized with steam for 30 minutes at 121° C. 2 ml of the resulting injection solution contained 5 mg of the active substance.

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Abstract

A method of using 3,7-diazabicyclo[3,3,1]nonane compounds, preferably of 9,9-alkylene-3,7-diazabicyclo[3,3,1]nonane compounds, and most preferably to the use of tedisamil, and the physiologically acceptable acid addition salts and / or solvates thereof, in the form of a liquid pharmaceutical preparation for the treatment and / or inhibition of arrhythmic events in human patients, preferably in conversion of recent onset of atrial fibrillation or flutter to normal sinus rhythm in humans, as well as related methods and pharmaceutical products or packages.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of co-pending U.S. patent application Ser. No. 10 / 715,130, filed Nov. 18, 2003, now U.S. Patent No. ______, which in turn claims priority from U.S. Provisional Application No. 60 / 426,795, filed Nov. 18, 2002, the entire disclosure of which is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention relates to the use of 3,7-diazabicyclo[3,3,1]nonane compounds, preferably of 9,9-alkylene-3,7-diazabicyclo[3,3,1]nonane compounds, and most preferably to the use of tedisamil, and the physiologically acceptable acid addition salts and / or solvates thereof, in the form of a liquid pharmaceutical preparation for the treatment and / or inhibition of arrhythmic events in human patients, preferably in conversion of recent onset of atrial fibrillation (Afib) or flutter to normal sinus rhythm (NSR) in human patients. Furthermore, the invention relates to method of treatments and to pharmace...

Claims

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Application Information

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IPC IPC(8): A61K31/439A61K31/4747A61P9/06
CPCA61K31/4747A61K31/439A61P9/06A61K9/08
Inventor STRAUB, MATTHIASJANSEN, JOHANNES WILHELMUS CATHARINE MARIADE VRIES, MICHIEL HENRICUSSTEINBORN, CLAUS RUDOLFCAUTREELS, WERNER
Owner SOLVAY PHARMA GMBH
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