Preparation method of omeprazole enteric capsule

A technology of omeprazole enteric capsules, which is applied in the field of preparation of omeprazole enteric-coated capsules, can solve problems such as unevenness, narrow particle size distribution, and influence on drug efficacy, and achieve good toughness, handling, and water retention Effect, good drug release effect

Inactive Publication Date: 2020-05-15
SHOUGUANG FUKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If pellets with a wider particle size are used, problems of capsule filling weight and uneven release will occur
If the roundness of the pellets is poor, it will easily lead to deviations in the subsequent enteric coating process. If the enteric coating is incomplete or uneven, the product may not be able to effectively control the enteric coating mechanism or cause the pellets to be resistant to gastric acid. Insufficient sex will directly affect the curative effect of the drug in the human body
[0010] The micropills in the prior art belong to the matrix type micropills, and blank pellet cores with narrow particle size distribution and good roundness can be selected to solve the problem of roundness, but there are higher requirements for the hardness of the micropills, and the flow rate in the process The chemical damage will stick to the isolation layer when the isolation layer is coated, which will affect the stability. In addition, in order to maintain stability, some layers of packaging are added for isolation, resulting in the release rate being affected by the surface area of ​​the pellets. If the roundness reproducibility between product batches is poor, it may cause large differences in in vitro dissolution rate and in vivo efficacy between batches, making it difficult for generic products to have good consistency evaluation results

Method used

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  • Preparation method of omeprazole enteric capsule
  • Preparation method of omeprazole enteric capsule
  • Preparation method of omeprazole enteric capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1: Alkalinizing agent uses disodium hydrogen phosphate instead of sodium hydroxide, because of its compatibility difference with cellulose, disodium hydrogen phosphate is prepared separately with high concentration, and added in the mixed powder in turn, both to ensure It not only improves the compatibility, but also realizes the requirement of basicity of raw materials and the viscosity of soft materials for extrusion.

[0058] The formula is as follows:

[0059]

[0060]

[0061] Preparation:

[0062] (1) Preparation of raw and auxiliary materials: weigh omeprazole, microcrystalline cellulose, mannitol, anhydrous lactose, and sodium lauryl sulfate according to the prescription amount, mix and pass through a 40-mesh sieve;

[0063] (2) Preparation of adhesive: dissolve hypromellose in purified water of the prescribed amount until the solution is clear and transparent; then add disodium hydrogen phosphate until completely dissolved;

[0064] (3) Premixin...

Embodiment 2

[0079]Example 2: The enteric-coated layer plasticizer is replaced by triethyl citrate, matched with glyceryl monostearate and Tween 80. This classic combination can solve the impact of polyethylene glycols on the later release, and realize A perfect substitute, reducing the adhesion of the coating.

[0080] The formula is as follows:

[0081]

[0082] Preparation:

[0083] (1) Preparation of raw and auxiliary materials: weigh omeprazole, microcrystalline cellulose, mannitol, anhydrous lactose, and sodium lauryl sulfate according to the prescription amount, mix and pass through a 40-mesh sieve;

[0084] (2) Preparation of adhesive: dissolve hypromellose in purified water of the prescribed amount until the solution is clear and transparent; then add sodium hydroxide until completely dissolved;

[0085] (3) Premixing: put the materials in step 1 into a wet granulator for premixing, set the stirring speed of the wet granulator to 60 rpm, and mix for 5 minutes;

[0086] (4) S...

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Abstract

The invention discloses a preparation method of an omeprazole enteric capsule. The preparation method has the advantages of high stability and good in vitro dissolution curve, and can realize the consistency with original drug through human body bioequivalence tests.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of omeprazole enteric-coated capsules. Background technique [0002] The compound omeprazole was patented in 1978 and approved for medical use in 1988. It is listed on the World Health Organization's list of essential medicines as the most effective and safest medicine needed in the health system. It can be used not only for adults, but also for infants and young children. Although it is now a generic drug, as of 2014, the wholesale price in developing countries is US$0.01 to US$0.07 per dose. In the United States, the average price per pill is $0.50. In 2016, it was the seventh most prescribed drug in the United States, with prescriptions totaling more than $70 million. [0003] Omeprazole (Omeprazole) belongs to a kind of proton pump inhibitor (proton pumpinhibitor; PPI) in pharmacological action, and is used to treat gastroesophage...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/58A61K9/62A61K47/38A61K47/26A61K31/4439A61P1/04
CPCA61K9/5026A61K9/5031A61K9/5042A61K9/5073A61K31/4439A61P1/04
Inventor 郝学伟杨会顺魏明超孙英豪辛兵
Owner SHOUGUANG FUKANG PHARMA
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