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Stabilized desmopressin

A desmopressin and stabilizer technology, which is applied in the field of stabilized desmopressin, and can solve problems such as instability of desmopressin

Active Publication Date: 2017-02-22
FERRING BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, due to its tendency to denature, especially due to heat denaturation, desmopressin is prone to instability during and / or after drug manufacture

Method used

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  • Stabilized desmopressin
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  • Stabilized desmopressin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1、2

[0051] Total impurities (embodiment 1,2,3) and determination (embodiment 1)

[0052] test solution – Examples 1, 2, 3

[0053] Put 1 mg desmopressin acetate equivalent of the membrane prepared according to the preparation example into a 10 ml volumetric flask. This was mixed with the mobile phase as listed below for the HPLC conditions until the solution reached the 10 ml mark. Put the solution into a centrifuge tube and centrifuge for 20 minutes. The solution was filtered with a 0.2 μm filter (hydrophilic polytetrafluoroethylene (PTFE)). Completion of these steps yielded test solutions (0.1 mg / ml).

[0054] Excipient solution – Example 2, 3

[0055] Each excipient (HPC, TiO 2 , gum) into a 10ml volumetric flask. The mobile phase as listed below for the HPLC conditions was poured into the bottle until the solution reached the 10 ml mark. Place the solution in a centrifuge tube and centrifuge for 20 minutes. The solution was filtered using a 0.2 μm filter (hydroph...

Embodiment 1

[0085] LOD (Example 1, 2)

[0086] 0.5 g of the film prepared as described in the preparation above was tested as follows:

[0087] - Dry the glass bottle in a 105° C. chamber for 1 chamber, then cool in a desiccator (room temperature) for 30 minutes.

[0088] - Weigh the cooled glass bottle from the desiccator. The film samples were then rolled or folded and, without undue delay, placed into standing glass jars. The glass bottle with the sample is accurately weighed.

[0089] - Incubate the glass vials with the membrane samples in a chamber at 105°C for 4 hours.

[0090] - After 4 hours, the glass bottle was cooled in a desiccator (room temperature) for 30 minutes.

[0091] - The cooled glass jars are then weighed without undue delay.

[0092] - To calculate the LOD value, divide the reduced weight of the film sample by the weight of the first film sample.

[0093] Example 1

[0094] Determining Conditions for Membrane Drying

[0095] Membrane preparation soluti...

Embodiment 2

[0109] The stabilizing effect of gum

[0110] Membranes were prepared according to the method as described in the preparation, wherein the components and amounts are given in Table 4. The membrane was dried at 80°C for 30 minutes.

[0111] Table 4

[0112]

[0113] The viscosity of the solution was measured using a Brookfield viscometer. The results of the stability measurements are shown as total impurities (%). Total Impurities (%) Determine the total amount of impurities of desmopressin measured after 2-4 weeks under accelerated conditions (40±2° C., relative humidity 75±5%).

[0114] The standard deviation of the LOD values ​​was ±0.5% and there were no significant differences between the test groups.

[0115] As a result, as can be seen in Table 4, over the entire weight ratio range of desmopressin acetate to gum from 10:1 to 1:50, compared to the same composition without any gum (control), A gum (in this example xanthan gum) as a stabilizer resulted in a sign...

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Abstract

The invention is related to a pharmaceutical composition comprising an active ingredient and a stabilizing agent, wherein the active ingredient is desmopressin or a pharmaceutical acceptable salt thereof, and the stabilizing agent is at least one gum. The invention relates to uses of one or more gums to increase the stability of a pharmaceutical composition comprising desmopressin or a pharmaceutical acceptable salt thereof as an active ingredient against denaturation, a method for preparing an orally disintegrating film comprising desmopressin or a pharmaceutically acceptable salt thereof as well as the orally disintegrating film obtainable thereby.

Description

[0001] field of invention [0002] The present invention relates to a pharmaceutical composition comprising desmopressin or a pharmaceutically acceptable salt thereof as an active ingredient, wherein the desmopressin or a pharmaceutically acceptable salt thereof is stabilized in the pharmaceutical composition, and relates to a Method for stabilizing desmopressin or a pharmaceutically acceptable salt thereof in a composition, relates to a process for the preparation of an orally disintegrating film comprising desmopressin or a pharmaceutically acceptable salt thereof and to a method obtainable thereby orally disintegrating membrane. [0003] Background of the invention [0004] Desmopressin is a synthetic analog of the natural antidiuretic hormone vasopressin. [0005] Unlike vasopressin, desmopressin does not have vasopressor activity, but only antidiuretic activity. This selective antidiuretic activity is due to its ability to bind only V-2 receptors and not V-1 receptors. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/11A61K47/36A61K9/70A61P7/12A61P13/00
CPCA61K38/095A61K9/006A61K47/36A61K9/0056A61K9/7007A61P13/00A61P13/02A61P43/00A61P7/12
Inventor 李凤相朴秀晙韩知姈吉明哲金敏燮
Owner FERRING BV
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