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Preparation of ibuprofen orally-disintegrating pellet coated by compound essence powder and capable of hierarchically releasing drug

A technology of powder coating and orally disintegrating pellets, applied in the field of pharmaceutical preparations, can solve the problems of difficulty in achieving gastric targeting effect and the like

Inactive Publication Date: 2014-02-12
南京亿华药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ordinary oral solid preparations (tablets, capsules) reach the bottom of the stomach and are quickly emptied, making it difficult to achieve the targeted effect of the stomach

Method used

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  • Preparation of ibuprofen orally-disintegrating pellet coated by compound essence powder and capable of hierarchically releasing drug
  • Preparation of ibuprofen orally-disintegrating pellet coated by compound essence powder and capable of hierarchically releasing drug
  • Preparation of ibuprofen orally-disintegrating pellet coated by compound essence powder and capable of hierarchically releasing drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029]

[0030]

[0031] The preparation method: the ibuprofen is subjected to jet milling and micronization, and the particle size is controlled to be less than 200 μm. Divide the micronized ibuprofen into three parts and carry out powder coating respectively, the steps are as follows:

[0032] (1) Composite essence powder coating, 20g micronized ibuprofen is placed in fluidized bed, sweet orange essence and lemon essence are dispersed in acrylic resin E100 coating material (the ratio of composite essence and coating material is 1: 3) In the process, increase the main ingredient by 10% to obtain 35-50 mesh orally disintegrating pellets (I);

[0033] (2) gastric soluble coating material powder coating, 15g micronized ibuprofen is placed in the fluidized bed, with acrylic resin No. IV as the coating material, the main ingredient is increased by 90%, and the oral cavity of 30~45 objects is obtained Disintegrating pellets (II);

[0034] (3) enteric coating material powder c...

Embodiment 2

[0037]

[0038]

[0039] Preparation method: The ibuprofen is pulverized by ball milling to control its particle size to be less than 200 μm. Divide the micronized ibuprofen into three parts and carry out powder coating respectively, the steps are as follows:

[0040] (1) Composite essence powder coating, 20g micronized ibuprofen is placed in fluidized bed, sweet orange essence and mandarin orange essence are dispersed in acrylic resin E100 and acrylic resin NE30D mixed coating material (composite essence and coating material In the ratio of 1:4), the main ingredient is increased by 10% to obtain 35 to 50 mesh orally disintegrating pellets (I);

[0041] (2) gastric soluble coating material powder coating, 15g micronized ibuprofen is placed in the fluidized bed, with acrylic resin No. IV as the coating material, the main ingredient is increased by 90%, and the oral cavity of 30~45 objects is obtained Disintegrating pellets (II);

[0042] (3) enteric coating material pow...

Embodiment 3

[0045]

[0046] Preparation method: The ibuprofen is pulverized by ball milling to control its particle size to be less than 200 μm. Divide the micronized ibuprofen into three parts and carry out powder coating respectively, the steps are as follows:

[0047] (1) Composite essence powder coating, 20g micronized ibuprofen is placed in fluidized bed, sweet orange essence and mandarin orange essence are dispersed in acrylic resin E100 coating material (the ratio of composite essence and coating material is 1: 7) In the process, increase the main ingredient by 8% to obtain 35-50 mesh orally disintegrating pellets (I);

[0048] (2) gastric soluble coating material powder coating, 15g micronized ibuprofen is placed in the fluidized bed, with acrylic resin No. IV as the coating material, the main ingredient is increased by 100%, and the oral cavity of 30~45 orders is obtained Disintegrating pellets (II);

[0049] (3) enteric coating material powder coating, 15g micronized ibupro...

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Abstract

The invention relates to an ibuprofen orally-disintegrating pellet coated by compound essence powder and capable of hierarchically releasing drug. The pellet can cover the spicy taste in the mouth and hierarchically release drug. The preparation method of the ibuprofen orally-disintegrating pellet comprises the following steps: pulverizing ibuprofen micro-particles until the particle size is less than 200 [mu]m; then carrying out three coating processes with three kinds of powder: (1) drug releasing in the mouth: coating part of ibuprofen with compound essence powder so as to obtain orally-disintegrating pellets (I); (2) drug releasing in the stomach: coating part of ibuprofen with gastric soluble powder so as to obtain orally-disintegrating pellets (II); (3) drug releasing in the intestine: coating part of ibuprofen with enteric powder so as to obtain orally-disintegrating pellets (III); evenly mixing the orally-disintegrating pellets (I), (II) and (III) with a vertical press filling agent, a compound disintegrating agent, a flow aid, a lubricant, and a taste modifying agent, and then pressing the mixture into tablets. In the preparation method three orally-disintegrating pellets are prepared, besides the spicy taste of ibuprofen in the mouth is covered, hierarchical releasing of drug in the mouth, stomach, and intestine is achieved, and no prominent grit feeling exists.

Description

1. Technical field: [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, it relates to drug release in layers, and compound essence powder coating to prepare ibuprofen orally disintegrating pellets, which are then directly compressed into tablets. 2. Background technology: [0002] Ibuprofen is a phenylpropionic acid non-steroidal anti-inflammatory drug with strong anti-inflammatory, analgesic and antipyretic effects. Together with paracetamol, aspirin and diclofenac, it has become the four pillar products in the antipyretic and analgesic drug market in my country . But ibuprofen has its own advantages in clinical application. Both are safe and effective antipyretics. When the body temperature is higher than 39.2°C, ibuprofen is more effective than paracetamol at the same dose, and the antipyretic time is longer. Pharmacodynamic studies have proved that the analgesic and antipyretic effects of ibuprofen are 28 times and 20 times...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/192A61K47/46A61P29/00
Inventor 杨鹏辉靳静丁峰张霞陈广宇
Owner 南京亿华药业有限公司
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