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Celecoxib chewable tablet and preparation method thereof

A technology for celecoxib and chewable tablets, applied in the field of celecoxib chewable tablets and preparation thereof, can solve the problems of poor bioavailability, small degree of disintegration, inconvenience in taking and the like, and achieves smooth and beautiful tablet surface , The effect of promoting fluidity and large adsorption force

Inactive Publication Date: 2013-02-13
SHANDONG PROVINCIAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Celebrex is more than 9 yuan per tablet (200mg), which is expensive
And because celecoxib is an insoluble compound, it is light in weight and easy to bond. With the general process and dosage form, the bioavailability of celecoxib raw materials with D90 greater than 200 μm is used to prepare solid preparations, and the bioavailability is very poor.
In order to further improve the absorption of celecoxib, a lot of researches have been done on celecoxib. The Chinese patent with the authorized announcement number CN1154490C discloses a pharmaceutical composition comprising one or more orally releasable Dosage units, each dosage unit comprising an intimate mixture of 10 mg to 1000 mg celecoxib granules with one or more pharmaceutically acceptable excipients, and a particle size distribution of celecoxib such that the D90 of the largest extent of the granules is less than 200 μm The Chinese patent whose publication number is CN102000018A discloses a solid dispersion containing celecoxib and solid polyethylene glycol, and the weight ratio of celecoxib and solid polyethylene glycol in the solid dispersion is 1:0.5~ 10. However, the above-mentioned celecoxib raw materials are mostly made into hard capsules and coated tablets. Capsules and coated tablets are generally fearful for patients who are inconvenient to swallow, such as children and the elderly, and it is inconvenient to take them. , and the degree of disintegration is small, and the onset of action is slow

Method used

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  • Celecoxib chewable tablet and preparation method thereof
  • Celecoxib chewable tablet and preparation method thereof
  • Celecoxib chewable tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020]

[0021] Preparation:

[0022] Pass celecoxib through a 100-mesh sieve, starch, lactose, and cross-linked polyvinylpyrrolidone through a 80-mesh sieve, and set aside; accurately weigh 20 g of celecoxib, 50 g of starch, 40 g of lactose, 25 g of cross-linked polyvinylpyrrolidone, and Mix 3.5g of sodium alkyl sulfate evenly; then add 35g of ethanol with a volume concentration of 30% to make a soft material, pass through a 18-20 mesh sieve to make granules, and dry the granules in an oven at 55°C; pass the dry granules through a 20-mesh sieve for granulation, Add 3.5 g of magnesium stearate and mix well. After inspection of the semi-finished product, it is pressed into tablets. After the finished product is inspected, it is packaged and ready to be obtained.

[0023] The celecoxib chewable tablets prepared in this example were inspected, and its content, properties, identification, disintegration time limit, dissolution rate, dispersion uniformity and other quality ind...

Embodiment 2

[0025]

[0026] Preparation:

[0027] Pass celecoxib through a 100-mesh sieve, starch, cellulose powder, and sodium carboxymethyl cellulose through a 80-mesh sieve, and set aside; accurately weigh 20 g of celecoxib, 50 g of microcrystalline cellulose, and croscarmellose Mix 40g of plain sodium evenly; then add 50g of ethanol with a volume concentration of 30% to make a soft material, pass through a 18-20 mesh sieve to make granules, and dry the granules in an oven at 65°C; pass the dry granules through a 20 mesh sieve for granulation, add stearin Magnesium acid 2.0g and mix well. After inspection of the semi-finished product, it is pressed into tablets. After the finished product is inspected, it is packaged and ready to be obtained.

[0028] The celecoxib chewable tablets prepared in this example, after inspection, its content, character, identification, disintegration time limit, dissolution rate, dispersion uniformity and other quality indicators not only conform to th...

Embodiment 3

[0030]

[0031] Preparation:

[0032] Pass celecoxib through a 100-mesh sieve, starch, microcrystalline cellulose, and croscarmellose sodium through a 80-mesh sieve, and set aside; accurately weigh 20 g of celecoxib, 30 g of microcrystalline cellulose, and cross-linked carboxymethyl cellulose. 40g of sodium methylcellulose, 25.0g of low-substituted hydroxypropyl cellulose, mix evenly; then add 44g of ethanol with a volume concentration of 30% to make a soft material, pass through a 18-20 mesh sieve to make granules, and granules are placed in an oven at 70°C Drying; the dry granules are passed through a 20-mesh sieve for granulation, and 2.0 g of magnesium stearate is added and mixed evenly. After inspection of the semi-finished product, it is pressed into tablets. After the finished product is inspected, it is packaged and ready to be obtained.

[0033] The celecoxib chewable tablets prepared in this example were inspected, and its content, properties, identification, disi...

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Abstract

The invention provides a celecoxib chewable tablet and a preparation method thereof. The celecoxib chewable tablet consists of the following raw materials in percentage by weight: 5-30% of celecoxib, 5-20% of disintegrating agent, 20-80% of filler, 5-30% of adhesive, 0.5-5% of flow aid and 0.5-3% of surfactant. The celecoxib chewable tablet has the advantages of both tablets and fluid preparations and has the characteristics of even dispersion, very short disintegrating time limit, fast medicament dissolution and high bioavailability, and is better convenience to take. The celecoxib chewable tablet is especially suitable for the aged and the patients who have swallowing difficulties. Upon inspection, the celecoxib chewable tablet shows that the quality indexes such as content, characteristics, identification, disintegrating time limit and dissolution accord with the 2010 edition of China Pharmacopoeia and relevant regulations. The bioavailability of the celecoxib chewable tablet is higher than the tablets on sale.

Description

technical field [0001] The invention belongs to the technical field of medicine and pharmacy, and in particular relates to a celecoxib chewable tablet 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. It is currently one of the best-selling drugs for the treatment of arthritis in the world, with annual sales of more than 2.5 billion US dollars. In 2007, celecoxib was approved for low back pain, frozen shoulder and tenosynovitis. The use of celecoxib for traumatic pain and tooth extraction pain is in Phase III clinical trials, and it is also being studied for the treatment of various tumors including breast cancer, lung cancer and pancreatic cancer. The expansion of these indications will bring a larger market...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/635A61P19/02A61P29/00A61P29/02
Inventor 曹艳花
Owner SHANDONG PROVINCIAL HOSPITAL
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