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Enteric omeprazole micropill and its preparing method

A technology of omeprazole intestines and omeprazole, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of the amount and release rate affecting the release of active ingredients. Uniformity of drug release, adverse health effects of patients taking the drug, electrostatic adsorption of particles, etc., to achieve the effects of low cost, dense coating, rapid and stable release

Active Publication Date: 2007-06-27
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the relatively large application of these substances brings adverse effects on the health of patients taking medicine, and affects the amount, release rate and uniformity of drug release of active ingredients from omeprazole pellets, affecting the curative effect
[0011] The preparation process disclosed in the existing literature still has the following problems: ① blank pellet core is required, which increases the amount of auxiliary materials; ② the main material cannot be directly mixed with auxiliary materials to make pellets; ③ pharmaceutical polymer materials are prone to produce particles when they are enteric coated Electrostatic adsorption; ④The batch of one-time production is small, the production cycle is long, and the production cost is high

Method used

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  • Enteric omeprazole micropill and its preparing method

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Comparison scheme
Effect test

Embodiment 1

[0028] The present embodiment omeprazole enteric-coated pellets constitute the following table:

[0029] ingredients

Content (wt%)

Inner active ball core

Omeprazole

sucrose

starch

magnesium oxide

8.0

58.0

3.2

1.6

HPMC (viscosity 4)

0.08

Intermediate isolation layer

HPMC (viscosity 4)

PEG-6000

Titanium dioxide

8.8

1.8

1.7

outer enteric coating layer

Eudragit L100-55

PEG-6000

Talc powder (800 mesh)

12.4

1.0

3.42

[0030] Preparation:

[0031](1) prepare 1% HPMC solution: soak HPMC with 70 ℃ hot water 45min, then stir well, make 1% solution; Mix the magnesium oxide evenly, divide it into 2 parts, spray one part into 1% HPMC solution to prepare pellets with a diameter of 0.2-0.3mm, and the other part for later use; In the machine, continue to spray 1% HPMC solution, and at the same time, add the r...

Embodiment 2

[0037] The present embodiment omeprazole enteric-coated pellets constitute the following table:

[0038] ingredients

Content (wt%)

Inner active ball core

Omeprazole

sucrose

starch

magnesium oxide

8.0

49.0

9.6

3.2

HPMC (viscosity 4.5)

0.05

Intermediate isolation layer

HPMC (viscosity 4.5)

PEG-6000

Titanium dioxide

8.5

0.8

1.8

outer enteric coating layer

Eudragit L100-55

PEG-6000

Talc powder

14.9

1.3

2.85

[0039] Preparation:

[0040] With embodiment 1.

[0041] The seven graphs shown in Figure 2 represent the release of different batches of omeprazole enteric-coated pellets and capsules of Example 2. The graph shows the release at different times in an alkaline environment, and the release curve with the average of 6 batches of release. This figure further proves that the method of the presen...

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Abstract

The present invention discloses a kind of enteric omeprazole micropill preparation and its preparation process. The enteric omeprazole micropill preparation has core of omeprazole or its single antimer subsalt as the active component and excipient and middle isolating coating and enteric protecting layer to coat the core. The enteric omeprazole micropill preparation is prepared directly with the main medicine component and supplementary materials including magnesia as the stabilizer, hydroxypropylmethyl cellulose and talcum powder.

Description

technical field [0001] The invention relates to a chemical drug preparation for treating diseases such as gastric and duodenal ulcers and a preparation method thereof, in particular to an omeprazole enteric-coated pellet preparation and a preparation method thereof. Background technique [0002] Omeprazole (chemical name 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1-benzimidazole ) is a potent inhibitor of acidic gastrointestinal secretion (Swedish Patent No. 7804231), which can be used to treat gastric and duodenal ulcers. European patent EP-Al-0005129 discloses the active compound of the proton pump inhibitor omeprazole. Omeprazole and pharmaceutically acceptable salts thereof are described in EP5129; EP124495 and WH95 / 01977 disclose some specific basic salts of omeprazole; WO94 / 27988 discloses certain omeprazole single enantiomers salts and their preparations. [0003] Omeprazole or its single enantiomer or alkali salt thereof is hereinafter simply...

Claims

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Application Information

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IPC IPC(8): A61K31/4439A61K9/16A61K47/02A61K47/32A61K47/34A61P1/04A61J3/06A61K47/10
Inventor 吴健民
Owner KAMP PHARMA
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