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Solid dispersion method of celecoxib and preparation method of celecoxib capsules

A technology for celecoxib and solid dispersion, which is applied in capsule delivery, medical preparations containing non-active ingredients, and medical preparations containing active ingredients, etc. Problems such as agglomeration, to achieve the effect of fast and convenient detection, consistent dissolution, and increased particle density

Active Publication Date: 2019-12-24
SHANDONG CHUANGXIN PHARMA RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the deficiencies in the prior art, the object of the present disclosure is to provide a solid dispersion method of celecoxib and a preparation method of celecoxib capsules, so as to overcome the serious wall sticking, agglomeration, Astringent materials, difficult crushing, difficult to clean up

Method used

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  • Solid dispersion method of celecoxib and preparation method of celecoxib capsules
  • Solid dispersion method of celecoxib and preparation method of celecoxib capsules
  • Solid dispersion method of celecoxib and preparation method of celecoxib capsules

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preparation example Construction

[0034] The preparation method of the present disclosure not only solves the problems that celecoxib is easy to agglomerate into agglomerates, has serious wall adhesion and is difficult to crush, but also solves the problem of slow dissolution.

[0035] In one or more examples of this embodiment, the particle size D of the pulverized solid material 90 ≤20μm.

[0036] In one or more examples of this embodiment, the pharmaceutical excipients include polyvinylpyrrolidone and croscarmellose sodium.

[0037] In this series of examples, the mass ratio of celecoxib, lactose monohydrate, sodium lauryl sulfate, polyvinylpyrrolidone, and croscarmellose sodium is 30~40:50~60:1~5: 1~5: 0.5~5.

[0038]During the powder mixing process of raw materials and excipients in the present disclosure, a part of the selected drug excipients can be added in part or in whole. For example, when lactose monohydrate and sodium lauryl sulfate are selected to be mixed with celecoxib, the It can be: lactos...

Embodiment 1

[0049] Celecoxib, lactose monohydrate and sodium lauryl sulfate ultrafine airflow pulverization solid dispersion process: weigh celecoxib, lactose monohydrate and sodium lauryl sulfate according to the prescription ratio and mix them for later use; Excipients are mixed with powder for ultra-fine airflow pulverization and solid dispersion to control particle size D 90 ≤20μm, then wet granulate with polyvinylpyrrolidone and croscarmellose sodium in the prescription ratio, dry, and granulate; mix the obtained granules with magnesium stearate in the prescription ratio, and fill it to obtain the plug Lecoxib capsules.

Embodiment 2

[0051] Mechanical pulverization of celecoxib, lactose monohydrate and sodium lauryl sulfate solid dispersion process: weigh celecoxib, lactose monohydrate and sodium lauryl sulfate according to the prescription ratio and mix them for later use; mix the raw and auxiliary materials The powder is mechanically pulverized and solid dispersed to control the particle size D 90 ≤20μm, then wet granulate with polyvinylpyrrolidone and croscarmellose sodium in the prescription ratio, dry, and granulate; mix the obtained granules with magnesium stearate in the prescription ratio, and fill it to obtain the plug Lecoxib capsules.

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Abstract

The invention provides a solid dispersion method of celecoxib and a preparation method of celecoxib capsules, and the solid dispersion method comprises the following steps: mixing the celecoxib with pharmaceutical adjuvants to obtain raw and auxiliary material mixed powder, and carrying out ultramicro jet milling and / or mechanical milling on the raw and auxiliary material mixed powder, wherein thepharmaceutical adjuvants at least comprise lactose monohydrate and lauryl sodium sulfate. The solid dispersion method disclosed by the invention not only overcomes the characteristic of poor preparation of a celecoxib preparation, but also solves the problem of slow dissolution of the celecoxib, and the preparation is good in stability, so that the preparation is consistent with an original developed preparation (Celebrex) in prescription and dissolution, and the quality consistency and bioequivalence of the celecoxib preparation and the original developed preparation (Celebrex) are ensured.

Description

technical field [0001] The disclosure relates to a solid dispersion method of celecoxib and a preparation method of celecoxib capsules, belonging to the technical field of pharmaceutical preparations. Background technique [0002] The statements herein merely provide background information related to the present disclosure and may not necessarily constitute prior art. [0003] Celecoxib was originally developed by G.D. Searle & Co, which was later acquired by Pharmacia. In 2002, Pfizer acquired Pharmacia for $60 billion, making Celecoxib a patented product of Pfizer. In January 2001, Celecoxib was approved by CFDA to be launched in China. As the only COX-2 inhibitor in China, it is widely used in the pain and treatment of acute and chronic osteoarthritis and rheumatoid arthritis. Celecoxib, a "COX-2 specific inhibitor" based on the design of the target structure, became the world's first selective non-steroidal anti-inflammatory analgesics (NSAIDs, Non-Steroid Anti-Inflamma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/48A61K47/26A61K47/20A61K47/32A61K47/38A61K31/635A61P29/00A61P19/02
CPCA61K9/145A61K9/1635A61K9/1652A61K31/635A61P19/02A61P29/00
Inventor 江鸿赵利军吕传涛刘玉芹陈立叶郭艺
Owner SHANDONG CHUANGXIN PHARMA RES & DEV
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