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Medical composition containing low-dosage desmopressin

A technology for desmopressin and composition, which is applied in the directions of drug combination, medical preparation containing active ingredients, medical formula, etc., can solve problems such as adverse side effects, fluid restriction and the like

Inactive Publication Date: 2013-07-24
ALLERGAN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, tablets usually need to be taken with a glass of water or other beverage. The problem with desmopressin therapy is that fluid intake is restricted. The patient message is clearer when no water is ingested at all
Furthermore, while the above doses and plasma / plasma / serum concentrations are effective in the treatment of CDI and PNE, standard doses of desmopressin have been shown to cause adverse side effects, including a high incidence of hyponatremia

Method used

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  • Medical composition containing low-dosage desmopressin
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0120] Example 1 Orodispersible dosage form of 200 μg desmopressin

[0121] Spray-dried fish gelatin (4 g) and mannitol (3 g) were added to a glass beaker. Purified water (93 g) was then added and the solution was stirred using a magnetic follower. Check the pH and adjust to 4.8 with citric acid if necessary. A Gilson pipette can then be used to deliver 500 mg of this solution into a series of pre-formed individual blister wells having a well diameter of approximately 16 mm. The blister laminate may comprise PVdC coated PVC. The dosing unit was then frozen in a freezing tunnel at -110°C for a residence time of 3.2 minutes, and then placed in an upright freezer at -25°C (±5°C) for more than 1.5 hours. The units were then lyophilized overnight at a pressure of 0.5 mbar with an initial storage temperature of 10°C raised to +20°C. The unit can be checked for moisture by drying the trace and passing a pressurized moisture check before removing the load.

[0122] In this m...

Embodiment 2

[0124] Example 2 Orodispersible dosage form of 400 μg desmopressin

[0125] The procedure of Example 1 herein was followed except that the amount of desmopressin per unit dosage form was 400 μg.

Embodiment 3

[0126] Example 3 Orodispersible dosage form of 800 μg desmopressin

[0127] The procedure of Example 1 herein was followed except that the amount of desmopressin per unit dosage form was 800 [mu]g.

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Abstract

The invention relates to a medical composition containing 0.5-20 microgrammes of desmopressin and a pharmaceutically acceptable carrier. The invention further relates to a medical composition containing desmopressin the pharmaceutically acceptable carrier, wherein the medical composition can effectively establish stable blood plasma / blood serum desmopressin concentration from 0.1 micromicrograms of desmopressin / mL blood plasma / blood serum to 10.0 micromicrograms of desmopressin / mL blood plasma / blood serum. The invention further discloses a product made from the medical composition and the preparation method of the product.

Description

[0001] This application is a divisional application of an invention patent application with an application date of November 10, 2003, an application number of 200380110675.1, and an invention title of "Pharmaceutical Composition Containing Low-Dose Desmopressin". technical field [0002] The present invention relates to pharmaceutical compositions comprising desmopressin, and more particularly to pharmaceutical compositions comprising low doses of desmopressin for the treatment of specific human diseases. Background technique [0003] Desmopressin (1-deamino-8-D-arginine vasopressin, dDAVP) is an analog of vasopressin. Desmopressin has decreased vasopressor activity and increased urostatic activity compared to vasopressin. This pharmacological property allows desmopressin to be clinically used for urinary control without causing a significant increase in blood pressure. Desmopressin acetate is commercially available in tablet and nasal spray forms and is commonly used for d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/11A61P7/04A61P7/12A61P13/00A61K38/095
Inventor 西摩·H·费恩
Owner ALLERGAN INC
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