Celecoxib new formulation and preparation method thereof

A technology of celecoxib and preparation, which is applied to the new dosage form of celecoxib and its preparation field, can solve the problems of easy agglomeration, low solubility of celecoxib, and cannot be directly compressed, and achieves increased drug efficacy , good release reproducibility, small difference in loading

Inactive Publication Date: 2013-07-10
GUIZHOU LIANSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Celecoxib has extremely low solubility in water, and it is easy to agglomerate into lumps, so it cannot be directly compressed into tablets

Method used

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  • Celecoxib new formulation and preparation method thereof
  • Celecoxib new formulation and preparation method thereof
  • Celecoxib new formulation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 (sustained-release pellets)

[0039] The prescription is as follows

[0040]

[0041]

[0042] A. Prepare the solution according to the prescription

[0043] A-1 preparation of drug-loading solution

[0044]Weigh the celecoxib raw material and sodium lauryl sulfate in a beaker according to the prescription, then add 95% ethanol in the prescribed amount, and stir until the celecoxib raw material is completely dissolved. Remove the beaker from the water bath, let it stand, and cool to room temperature. Finally, slowly add pvpK30 according to the prescription, stir and let stand until pvpK30 is completely dissolved.

[0045] A-2 Preparation of isolation coating solution

[0046] Weigh 50% hydroxypropyl methylcellulose HPMC (5mPa.s) according to the prescription, take an appropriate amount of purified water, slowly add HPMC to the water, stir while adding, and let it stand until the HPMC is completely swollen.

[0047] A-3 preparation of sustained-re...

Embodiment 2

[0077] Embodiment 2 (enteric-coated pellets)

[0078] Prescription sees embodiment 1 form, and processing step is with embodiment 1, and difference is:

[0079] A-3 preparation of enteric coating solution

[0080] Swell the remaining HPMC (5mPa.s) in an appropriate amount of purified water and set aside;

[0081] Weigh triethyl citrate (TEC) according to the prescription, add an appropriate amount of purified water, stir, then add the prescribed amount of talc powder (Talc, 800 mesh), stir, and undergo high-speed shear (10000rpm) for 10 minutes to obtain A;

[0082] Weigh L30D-55 according to the prescription, slowly add to A, stir while adding, and get B;

[0083] Mix the previously prepared HPMC solution into B, stir and mix well, and add the remaining purified water to obtain C;

[0084] Stir slowly with a paddle agitator C, pass through a 40-mesh sieve just before coating, keep stirring for no less than 40 minutes before coating, and keep stirring the coating solution d...

Embodiment 3

[0089] Embodiment 3 (sustained-release pellets+enteric-coated pellets)

[0090] The sustained-release coated pellets prepared in Examples 1 and 2 were uniformly mixed with the enteric coated pellets at a ratio of 3:1, and packed into No. 2 capsules (200 mg specification).

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Abstract

The invention discloses a celecoxib pellet preparation, which is used for treating rheumatic arthritis, osteoarthritis and ankylosing spondylitis, and also can be used for treating acute pain, dysmenorrheal, colorectal polyps, post-operation analgesia, low back pain, periarthritis of shoulder and tenosynovitis. According to the celecoxib new formulation and the preparation method thereof, the pellet preparation technology and the controlled-release pellet upper covering technology are adopted and microcrystalline cellulose pills are selected for dissolving the celecoxib material medicines in adhesive povidone solution, the medicine materials are uniformly sprayed on the surface of the pills and covered with isolating layers, so that the pellet is pressed and capsule. When the disintegration time limit of the celecoxib pellet preparation is remarkably shortened and the bioavailability is remarkably improved.

Description

[technical field] [0001] The invention relates to a new dosage form of celecoxib and a preparation method thereof. Specifically, it relates to a slow-release or enteric-coated pellet preparation of celecoxib and a preparation method thereof. [Background technique] [0002] Celecoxib is a blockbuster drug developed and marketed by Pfizer. It is mainly used to treat rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. It is also used to treat acute pain, dysmenorrhea, colorectal polyps and postoperative sedation. Pain etc. In 2007, celecoxib was approved for low back pain, frozen shoulder and tenosynovitis. Celecoxib is in phase III clinical trials for traumatic pain and tooth extraction pain, and it is also being studied for the treatment of various tumors including breast cancer, lung cancer and pancreatic cancer. The latest domestic and foreign epidemiological, clinical and experimental studies have shown that celecoxib also has the effect of preventing and i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/635A61K47/38A61K47/32A61K9/54A61P29/00A61P19/02A61P19/08A61P19/04A61P35/00
Inventor 王超志
Owner GUIZHOU LIANSHENG PHARMA
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