Etoricoxib dispersible tablets and preparation method thereof

A technology for etoricoxib and dispersible tablets, applied in the field of etoricoxib dispersible tablets and preparation thereof, can solve problems such as low dissolution, and achieve the effects of promoting absorption, enhancing medication compliance, and improving bioavailability

Inactive Publication Date: 2015-05-06
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Purpose of the present invention: in order to solve the shortcoming that etoricoxib common tablet is prone to low stripping in the prior art, the present invention proposes a kind of etoricoxib dispersible tablet and preparation method thereof, to improve the dissolution rate of etoricoxib and ensure curative effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] etoricoxib 4.0 g polyethylene glycol 20.0 g Mannitol (bulking agent) 72.0 g Talc (anti-sticking agent) 40.0 g Crospovidone (disintegrant) 35.0 g Microcrystalline Cellulose (Filler) 40.0 g Croscarmellose sodium (disintegrant) 25.0 g Silica (lubricant) 2.0 g

[0025] Its preparation method comprises the following steps:

[0026] (1) Heat and melt polyethylene glycol 4000, then add etoricoxib, stir vigorously to dissolve it into a clear and transparent solution, and obtain etoricoxib solution, and prepare the etoricoxib solution into dry etoricoxib solution by freeze-drying Xi solid dispersion;

[0027] (2) Gradually add diluent, disintegrant, anti-adhesive agent, lubricant, glidant by equal amount incremental method, after repeated sieving and mixing, directly compress into tablets to obtain etoricoxib dispersible tablets.

[0028] test results:

[0029] Compressibility: good

[0030] Friability: in compliance wit...

Embodiment 2

[0035] etoricoxib 4.0 g povidone 28.0 g Lactose (filler) 30.0 g Talc (anti-sticking agent) 50.0 g Sodium carboxymethyl starch (disintegrant) 45.0 g Microcrystalline Cellulose (Filler) 20.0 g Croscarmellose sodium (disintegrant) 41.0 g Silica (lubricant) 4.0 g

[0036] Its preparation method comprises the following steps:

[0037] (1) Take etoricoxib, dissolve it in absolute ethanol, then add povidone, stir vigorously to make it dissolve into a clear and transparent solution, and obtain etoricoxib solution. The etoricoxib solution is prepared into a dry etoricoxib solid dispersion;

[0038] (2) Gradually add diluent, disintegrant, anti-adhesive agent, lubricant, glidant by equal amount incremental method, after repeated sieving and mixing, directly compress into tablets to obtain etoricoxib dispersible tablets.

[0039] test results:

[0040] Compressibility: good

[0041] Friability: in compliance with regulations

[...

Embodiment 3

[0046] etoricoxib 4.0 g povidone 40.0 g Dextrin (thinner) 30.0 g Micronized silica gel (anti-sticking agent) 50.0 g Crospovidone (disintegrant) 45.0 g Microcrystalline Cellulose (thinner) 30.0 g Low-substituted hydroxypropyl cellulose (disintegrant) 20.0 g Magnesium Stearate (Lubricant) 3.0 g

[0047] Its preparation method comprises the following steps:

[0048] (1) Take etoricoxib, dissolve it in absolute ethanol, then add povidone, stir vigorously to make it dissolve into a clear and transparent solution, and obtain etoricoxib solution. The etoricoxib solution is prepared into a dry etoricoxib solid dispersion;

[0049] (2) Gradually add diluent, disintegrant, anti-adhesive agent, lubricant, glidant by equal amount incremental method, after repeated sieving and mixing, directly compress into tablets to obtain etoricoxib dispersible tablets.

[0050] test results:

[0051] Compressibility: good

[0052] Friability: i...

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PUM

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Abstract

The invention discloses etoricoxib dispersible tablets and a preparation method thereof. The etoricoxib dispersible tablets are prepared by the following steps: by adopting etoricoxib as an active pharmaceutical ingredient, dissolving the active pharmaceutical ingredient and carriers in a solvent, adopting a pressure reducing and drying or spraying and drying technology to prepare into solid dispersion bodies, and then using the solid dispersion bodies to prepare into the dispersible tablets. The etoricoxib dispersible tablets disclosed by the invention have the advantages that the etoricoxib and a proper amount of carriers are adopted to be prepared into the solid dispersion bodies, so that the solubility and the dissolving-out speed of medicines are increased, the absorption of the medicines in a body is enhanced, and the bioavailability of the medicines is improved; and simultaneously, the solid dispersion bodies are prepared into the dispersible tablets, so that the compliance of administration of a patient is enhanced.

Description

technical field [0001] The invention relates to a pharmaceutical preparation in the category of oral rapid release, in particular to an etoricoxib dispersible tablet and a preparation method thereof. Background technique [0002] Etoricoxib, chemical name is 5-chloro-6-methyl-3[4-(methylsulfonyl)phenyl]-2,3-bipyridine, molecular formula: C 18 h 15 CIN 2 o 2 S, molecular weight: 358.84, its structure is as follows: [0003] . [0004] Etoricoxib is a new type of highly selective COX-2 inhibitor, and its selective inhibitory effect on COX-2 is 100 times that of COX-1; in vitro studies have shown that etoricoxib has a strong selective effect on COX-2 than any other currently available COX-2 selective inhibitor. Etoricoxib has been approved for the treatment of osteoarthritis by more than 80 countries in Europe, Latin America, and Asia Pacific, and the recommended dose is 30 mg and 60 mg, once a day. A number of clinical studies have shown that the therapeutic effect of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/444A61K47/34A61K47/32A61K47/38A61K47/36
Inventor 李艳莉刁媛媛马苏峰
Owner 万全万特制药江苏有限公司
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