Pharmaceutical compositions including low dosages of desmopressin

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

Inactive Publication Date: 2006-12-13
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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  • Pharmaceutical compositions including low dosages of desmopressin
  • Pharmaceutical compositions including low dosages of desmopressin
  • Pharmaceutical compositions including low dosages of desmopressin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Example 1 Orodispersible dosage form of 200 μg desmopressin

[0118] 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.

[0119] In this manne...

Embodiment 2

[0125] Example 2 Orodispersible dosage form of 400 μg desmopressin

[0126] The procedure of Example 1 herein was followed except that the amount of desmopressin per unit dosage form was 400 μg.

Embodiment 3

[0127] Example 3 Orodispersible dosage form of 800 μg desmopressin

[0128] 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 present invention is directed to a pharmaceutical composition comprising 0.5 ng to 20 g desmopressin and a pharmaceutically acceptable carrier. The present invention is also directed to a pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is effective to establish a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL plasma/serum. Articles of manufacture and methods of using the above invention are also disclosed.

Description

technical field [0001] 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 [0002] 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 delayed voiding, incontinence, primary nocturnal enuresis (PNE) and nocturia, among other indications, including central Prescription for diabetes insipidus. [0003] Desmopressin has been administered intravenously, subcutaneously, intranasally...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61K38/095A61K9/00A61K9/20
CPCA61K9/0019A61K9/2018A61K38/11A61K9/0056A61K38/095A61P7/04A61P13/00A61P13/02A61P13/10
Inventor 西摩·H·费恩
Owner ALLERGAN INC
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