Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent

A technology of pharmaceutical excipients and sustained-release agents, applied in the field of carbomer hot-melt granulation, can solve problems such as poor fluidity, small particle size, and strong electrostatic interaction

Active Publication Date: 2016-06-29
张秋野
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problems of light and loose carbomer materials of various specifications, small particle size, strong electrostatic effect, strong adhesion and poor fluidity, the purpose of this invention is to provide a new type of carbomer hot-melt granulation method

Method used

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  • Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent
  • Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent
  • Hot-melt granulation method of pharmaceutical adjuvant of controlled/slow-released agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 120 grams of Carbopol 971P was placed in a pot of a wet granulator, and Carbopol 971P was heated with an 85 degree water bath through the interlayer of the pot. Under the stirring of a stirring paddle at 50 rpm, Carbopol971P will gradually heat up. When the temperature reaches 65-70 degrees, 120 grams of polyethylene glycol 8000 (PEG8000) particles with an average particle size of 100 μm are slowly poured into the wet granulator. inside the pot, then increase the paddle speed to 60 rpm and keep the water bath heated at 85 degrees. After about 10-20 minutes, the carbomer will evenly adhere to the surface of the polyethylene glycol 8000 wax particles, forming denser particles. After the granulation is completed, the material is poured out, slightly cooled, and passed through a 20-mesh sieve, which is the final product with an average particle size of 72 μm.

[0023] 32.9 grams of theophylline anhydrous, 50 grams of Carbopol971P and PEG8000 above-mentioned granular produc...

Embodiment 2

[0025] 120 grams of Carbopol 971P was placed in a pot of a wet granulator, and Carbopol 971P was heated with an 80-degree water bath through the interlayer of the pot. Under the stirring of a stirring paddle at 50 rpm, Carbopol971P will gradually heat up. When the temperature reaches 60-65 degrees, 120 grams of glycerol monostearate (GMS) particles with an average particle size of 100 μm are slowly poured into wet granulation. Then increase the speed of the stirring paddle to 60 rpm and keep the water bath heated at 80 degrees. After about 10-20 minutes, the carbomer will evenly adhere to the surface of the glycerol monostearate wax particles to form denser particles. After the granulation is completed, the material is poured out, cooled a little, and passed through a 20-mesh sieve, which is the final product. Its average particle size is 69 μm.

[0026] Mix 32.9 grams of anhydrous theophylline, 50 grams of Carbopol 971P and glycerol monostearate into granules, 16.6 grams of...

Embodiment 3

[0028] 120 grams of Carbopol 974P was placed in a pot of a wet granulator, and Carbopol 974P was heated with an 85 degree water bath through the interlayer of the pot. Under the stirring of the stirring paddle at 50 rpm, the temperature of Carbopol974P will gradually increase. When the temperature reaches 65-70 degrees, 120 grams of polyethylene glycol 8000 (PEG8000) particles with an average particle size of 100 μm are slowly poured into the wet granulator. inside the pot, then increase the paddle speed to 60 rpm and keep the water bath heated at 85 degrees. After about 10-20 minutes, the carbomer will evenly adhere to the surface of the polyethylene glycol 8000 wax particles, forming denser particles. After the granulation is completed, the material is poured out, cooled a little, and passed through a 20-mesh sieve, which is the final product. Its average particle size is 78 μm.

[0029] 32.9 grams of theophylline anhydrous, 50 grams of Carbopol974P and the above-mentioned...

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Abstract

The invention relates to a hot-melt granulation method of pharmaceutical adjuvant of a controlled / slow-released agent, in particular a hot-melt granulation method of carbomer. The method comprises the following steps: heating powdery carbomer until the temperature of the powdery carbomer is between the melting points of wax granules and the glass transition temperature of the carbomer; and then, adding the wax granules with predetermined grain size, and stirring at a low speed, so that the carbomer is gradually uniformly attached on the surfaces of the wax material granules, and the novel pharmaceutical adjuvant, namely carbomer, of the controlled / slow-released agent is obtained. Since the grain size of the granules formed by the carbomer and wax materials is associated with the grain size of the wax materials and since the grain size of the wax materials is controllable, the grain size of the finally prepared carbomer granules is controllable as well.

Description

technical field [0001] The invention relates to a hot-melt granulation technology for a new type of pharmaceutical excipients for controlled-release agents, in particular to a method for hot-melt granulation of carbomer. The pharmaceutical excipients for controlled-release agents can be used in pharmaceuticals, cosmetics and daily necessities. Background technique [0002] Carbomer, also known as carbopol, chemical name: CarboxyvinylPolymer (CP), is a high molecular polymer cross-linked by acrylic acid and propylene-based sucrose or propylene-based pentaerythritol. As a new type of polymer material and an excellent pharmaceutical excipient, carbomer is widely used in the fields of pharmaceuticals, cosmetics and daily necessities. Carbomer is mainly used as thickening agent, suspending agent, adhesive, matrix of gel and skeleton material of controlled and sustained-release preparations in pharmaceuticals. [0003] Depending on the materials used in polymerization and the de...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/32A61K9/51A61K8/02A61K8/81A61K9/22A61K47/34
Inventor 张秋野
Owner 张秋野
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