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Sumatriptan succinate rapid disintegrating tablet and preparation thereof

A technology of sumatriptan succinate and succinic acid, which is applied in the field of sumatriptan succinate fast disintegrating tablet and its preparation field, and can solve the problem of inconvenient use of injections, unsatisfactory disintegration time limit and dissolution rate of capsules and tablets, etc. question

Inactive Publication Date: 2009-12-16
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Sumatriptan succinate currently on the market has capsules, injections and tablets, etc., but injections are inconvenient to use, and the existing capsules, tablet disintegration time limit and dissolution rate are not satisfactory, so there are still developments. The need for fast-disintegrating sumatriptan succinate

Method used

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  • Sumatriptan succinate rapid disintegrating tablet and preparation thereof
  • Sumatriptan succinate rapid disintegrating tablet and preparation thereof
  • Sumatriptan succinate rapid disintegrating tablet and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Tablet prescription:

[0092] Sumatriptan succinate 35g (equivalent to sumatriptan 25g)

[0093] Microcrystalline Cellulose 80g

[0094] Anhydrous calcium hydrogen phosphate 20g

[0095] Croscarmellose Sodium 9g

[0096] Sodium bicarbonate 3g

[0097] Magnesium Stearate 1.5g

[0098] Appropriate amount of purified water

[0099]

[0100] Makes 1000 pieces

[0101] Coating solution formula:

[0102] Gastric Dissolving Film Coating Powder 4.5g

[0103] Purified water 25.5g

[0104]

[0105] 30g / 1000 pieces

[0106] The preparation method is

[0107] (1) Weigh the sumatriptan succinate, dibasic calcium phosphate anhydrous, microcrystalline cellulose, and croscarmellose sodium in the prescribed amounts respectively, and mix them evenly.

[0108] (2) Add an appropriate amount of purified water to prepare soft materials, pass through a 24-mesh sieve to granul...

Embodiment 2

[0113] The prescription for every thousand tablet cores is: 20g sumatriptan succinate, 40g microcrystalline cellulose, 100g anhydrous calcium hydrogen phosphate, 2g croscarmellose sodium, 1g sodium bicarbonate, 0.5g magnesium stearate , Appropriate amount of purified water

[0114] The formula of the coating solution per thousand tablets is: 2g of stomach-soluble film coating powder dissolved in 28g of purified water

[0115] The preparation method is:

[0116] (1) Weigh the sumatriptan succinate, dibasic calcium phosphate anhydrous, microcrystalline cellulose, and croscarmellose sodium in the prescribed amounts respectively, and mix them evenly.

[0117] (2) Add an appropriate amount of purified water to prepare soft materials, pass through a 24-mesh sieve to granulate, and dry the wet granules at 60±5°C until the water content is below 3%.

[0118] (3) The dry granules are sized with a 24-mesh sieve, and the prescribed amount of sodium bicarbonate and magnesium stearate is...

Embodiment 3

[0122] The prescription per thousand tablet cores is: sumatriptan succinate 200g, microcrystalline cellulose 200g, calcium hydrogen phosphate anhydrous 10g, croscarmellose sodium 20g, sodium bicarbonate 10g, magnesium stearate 3g, Appropriate amount of purified water

[0123] The formula of coating liquid per thousand tablets is: 10g of stomach-soluble film coating powder dissolved in 50g of purified water

[0124] The preparation method is the same as in Example 2.

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Abstract

The invention provides a sumatriptan succinate fast-disintegrating tablet. The components and contents of the disintegrating agent and diluent in the sumatriptan succinate fast-disintegrating tablet are screened, and the preparation process is improved, so that The product according to the invention has faster onset of action, more complete absorption and less gastrointestinal residue.

Description

technical field [0001] The invention relates to sumatriptan succinate fast-disintegrating tablets and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Sumatriptan succinate, its English name is Sumatriptan Succinate, its chemical name is: 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide succinate Salt, the structural formula is: [0003] [0004] Sumatriptan succinate is very similar to 5-hydroxytryptamine (5-HT), and is a new type of anti-migraine drug developed by GlaxoSmithKline (CSK) in the UK. The trade name is Imigran. [0005] The mechanism of action of sumatriptan succinate is to highly selectively excite vascular 5-HT1D receptors, constrict intracranial arteries, redistribute blood, and improve cerebral blood supply. Vascular 5-HT1D receptors are dominant in the carotid artery circulation, and the contractile effect of the drug is concentrated at the arteriovenous anastomosis i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/404A61P25/06
Inventor 罗韬
Owner HAINAN JINRUI PHARMA CO LTD