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Combination composition, comprising as active ingredients L-carnitine or propionyl L-carnitine, for the prevention or treatment of chronic venous insufficiency

Inactive Publication Date: 2011-08-04
SIGMA TAU IND FARMACEUTICHE RIUNITE SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0055]Their procurement therefore is very easy, inasmuch as these are products which have been on the market now for a long time and are of a grade suitable for human administration.

Problems solved by technology

But when patient sit or stand, especially for a long time, the blood in the leg veins can pool and increase the venous blood pressure.
However, sitting or standing for a long time can stretch vein walls because they are flexible.
Over time, in susceptible individuals, this can weaken the walls of the veins and damage the vein valves, causing CVI.
The legs may also feel heavy, tired, restless, or achy.
Patient may feel pain while walking or shortly after stopping.
Large varicose veins can lead to skin changes like rashes, redness, and sores.
CVI can also cause problems with leg swelling because of the pressure of the blood pooling in the veins.
Human leg tissues may then absorb some of this fluid, which can increase the tendency for the legs to swell.
In severe cases, CVI and the leg swelling can cause ulcers to form on the lower parts of the leg.
The blood trying to pass through the blocked veins can increase the blood pressure in the vein, which, in turn, overloads our valves.
Vein valves that do not work properly are called incompetent because they stretch and no longer work efficiently, and incompetent valves contribute to CVI.
DVT is a potentially serious condition that causes leg swelling and requires immediate medical attention because sometimes the blood clots in the veins can break off and travel to the lungs.
This inflammation causes a blood clot to form, which can also lead to DVT.
Factors that can increase the risk for CVI include a family history of varicose veins, being overweight, being pregnant, not exercising enough, smoking, and standing or sitting for long periods of time.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0060]Reduction of the swelling of the recto-anus, in croton oil-induced hemorrhoid model in rats.

[0061]Male SD rats (6 weeks old, approximately 140 g) were purchased from Harlan Sprague Dawley and allowed to acclimate for 1 week. The rats were maintained in a pathogen-free facility in accordance with the National Research Council of Laboratory Animal care and use guidelines. Each experiment was preformed with age-matched rats 7-8 weeks old. The croton oil-induced hemorrhoid model in rats was performed according to the method published by Nishiki (Nishiki et al. (1988) Folia Pharmacology Japan 92:215-225; Nishiki et al. (1988) Folia Pharmacol. Japan 92:227-240). Briefly, a cotton swab with a diameter of 4 mm soaked with 0.16 mL of inducer (deionized water: pyridine: ethyl ether: 6% croton oil / ethyl ether (1:4:5:10) was applied to the rat's anus for 12 seconds. The final concentration of croton oil was 3%. The edema developed linearly until 7-8 hours after application and the severit...

example 2

Relaxant Effect on Aortic Rings of the Compounds Tested

[0068]The objective of this study was to investigate the vasoarelaxation effects of the compositions of the invention using isolated aorta from spontaneously hypertensive rats.

[0069]Materials and Methods

[0070]The compounds tested were used at a concentration expressed as final concentration in the organ chamber.

[0071]Animals

[0072]Male spontaneously hypertensive rats (SHR) 10-12 weeks old, weighing 250-300 g, were housed at 24±2° C. with 60±20% relative humidity, on a 12-h light-dark cycle. Rats were given free access to a diet of standard food and water. All experiments were performed according to the guidelines for the ethical treatment of animals of the European Union. The rats were killed by cervical dislocation and the aortae were rapidly dissected.

[0073]Aortic Ring Preparation

[0074]The descending thoracic aorta was placed in a modified Krebs-Henseleit solution (PSS) containing (mM): NaCl 118, KCl 4.75, NaHCO3 25, MgSO4 1.2,...

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Abstract

A combination composition comprising as active ingredients L-carnitine or propionyl L-carnitine, troxerutine, diosmine and hesperidine, useful for the prevention and / or treatment of chronic venous diseases.

Description

RELATED APPLICATIONS[0001]This application claims priority to and benefit of U.S. Provisional Application No. 61 / 322,532 filed Apr. 9, 2010, the contents of which are herein incorporated by reference.FIELD OF THE INVENTION[0002]The present invention relates to a combination composition comprising as active ingredients L-carnitine or a derivative thereof, or a salt thereof, troxerutine, diosmine and hesperidine, useful for the prevention and / or treatment of chronic venous insufficiency (CVI).BACKGROUND OF THE INVENTION[0003]In humans, arteries bring oxygen-rich blood from the heart to the rest of the body and veins return oxygen-poor blood back to the heart. When human leg veins cannot pump enough blood back to heart, there is the onset of chronic venous insufficiency (CVI). CVI is also sometimes called chronic venous disease, or CVD.[0004]Humans have three kinds of veins: superficial veins, which lie close to the skin, deep veins, which lie in groups of muscles, and perforating vein...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61P9/00A61P9/12A61P7/10A61P29/00A61P17/00A61P9/14A61P3/02A61P39/06A61P7/02
CPCA61K31/205A61K31/221A61K31/7048A61K45/06A61K2300/00A61P17/00A61P29/00A61P3/02A61P39/06A61P7/02A61P7/10A61P9/00A61P9/12A61P9/14
Inventor VIRMANI, MOHAMED ASHRAFKOVERECH, ALEARDO
Owner SIGMA TAU IND FARMACEUTICHE RIUNITE SPA
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