Method for improving aging resistance of film-controlled sustained-release pellet coated with aqueous dispersion

A technology of sustained-release pellets and dispersions, which can be used in pharmaceutical formulations, medical preparations of non-active ingredients, block delivery, etc., and can solve the problems of decreased release performance and other issues

Active Publication Date: 2013-04-03
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if the currently commonly used aqueous dispersion coating materials are used, such as Kollicoat SR 30D, Eudragit RS / RL 30D, Eudragit NE 30D, Surelease (Surelease, ethylcellulose aqueous dispersion), etc., the preparation of film-controlled sustained-release microparticles The release performance of pills is good for a period of time just after preparation, but after storage for a period of time, the release performance begins to decline, the longer the storage time, the more obvious the decline, and it is often within the specified expiration date of the drug (generally about two years) In the second half period, the release performance decreased significantly

Method used

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  • Method for improving aging resistance of film-controlled sustained-release pellet coated with aqueous dispersion
  • Method for improving aging resistance of film-controlled sustained-release pellet coated with aqueous dispersion
  • Method for improving aging resistance of film-controlled sustained-release pellet coated with aqueous dispersion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The metoprolol tartrate slow-release pellet capsule of embodiment 1 common ball core

[0038] 1. Prescription

[0039] 1. Pill core prescription (1000 capsules)

[0040]

[0041] 2. Prescription of sustained-release film coating solution

[0042]

[0043] 3. No. 0 ordinary stomach-soluble gelatin capsule shell 1000 capsules

[0044] Second, the preparation process:

[0045] 1. Ball core preparation process:

[0046] (1) take by weighing metoprolol tartrate, microcrystalline cellulose PH101 of recipe quantity, put in wet granulator and mix homogeneously;

[0047] (2) make soft material with 1% sodium carboxymethylcellulose 10% ethanol solution;

[0048] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0049] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0050] (5) Sieve, get the ball core between 16-30 mesh.

[0051] 2. Preparation process of sustained-release fil...

Embodiment 2

[0074] Example 2 Containing low-substituted hydroxypropyl cellulose as swelling material of metoprolol tartrate sustained-release pellet capsules

[0075] 1. Prescription

[0076] 1. Pill core prescription (1000 capsules)

[0077]

[0078] 2. Prescription of sustained-release film coating solution and capsule shell: same as in Example 1

[0079] 2. Preparation process

[0080] 1. Ball core preparation process:

[0081] The prescribed amount of metoprolol tartrate, microcrystalline cellulose PH101, and low-substituted hydroxypropyl cellulose were weighed, and other operations were the same as in Example 1.

[0082] 2. Preparation process of sustained-release film coating solution: same as in Example 1

[0083] 3. Coating (sustained release film):

[0084] The ball core is placed in the fluidized bed for coating, and the weight gain of the coating film is controlled. For the ball core with a low-substituted hydroxypropyl cellulose content of 4.9%, the coating weight gain...

Embodiment 3

[0098] Example 3 Containing sodium carboxymethyl starch as expansion material of metoprolol tartrate sustained-release pellet capsules

[0099] 1. Prescription

[0100] 1. Pill core prescription (1000 capsules)

[0101]

[0102] 2. Prescription of sustained-release film coating solution and capsule shell: same as in Example 1

[0103] 2. Preparation process

[0104] 1. Ball core preparation process:

[0105] Take by weighing metoprolol tartrate, microcrystalline cellulose PH101, sodium carboxymethyl starch of recipe quantity, other operations are with embodiment 1.

[0106] 2. Preparation process of sustained-release film coating solution: same as in Example 1

[0107] 3. Coating (sustained release film):

[0108] The ball core is placed in the fluidized bed coating, and the weight gain of the coating film is controlled. The ball core with a sodium carboxymethyl starch content of 4.9%, the coating weight gain of 11.5%, and the ball core with a sodium carboxymethyl star...

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PUM

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Abstract

The invention relates to a method for improving aging resistance of a film-controlled sustained-release pellet coated with an aqueous dispersion. The method realizes improvement of the aging resistance of the film-controlled sustained-release pellet coated with an aqueous dispersion by a high-expansion core, wherein the core contains high-expansion auxiliary materials. Through the method, the film-controlled sustained-release pellet which can be not limited by storage time and always keep stable release performance in the shelf life can be prepared. The invention further provides a use of a polymer expanding agent in improvement of the aging resistance of the film-controlled sustained-release pellet coated with an aqueous dispersion. In addition, the invention provides the film-controlled sustained-release pellet coated with an aqueous dispersion having aging resistance, wherein the core contains the high polymer expanding agent.

Description

technical field [0001] The invention relates to a method for improving the anti-aging performance of membrane-controlled sustained-release pellets coated with water dispersion, in particular, to a method for improving the membrane-controlled sustained-release pellets coated with water dispersion by adopting high-swellability pellet cores. The invention discloses a method for the anti-aging performance of sustained-release pellets. The pellet core contains high-swellability auxiliary materials, and belongs to the field of pharmaceutical preparations. Background technique [0002] Membrane-controlled sustained-release pellets are usually composed of a pellet core and an outer polymer coating. Various coating structures can be designed by using the principle of osmotic pressure or the properties of the coating material, and different functional properties of polymer materials can also be used. , to prepare pellets with different release patterns, such as ordinary sustained-rele...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/32A61K47/36A61K47/38
Inventor 姜庆伟刘全志杨文斌衣伟峰狄媛吕玉珠葛振中李帅唐亚坤刘俊轶孔利平
Owner 北京天衡药物研究院有限公司
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