Topiramate sustained-release preparation and preparation method thereof

A technology of sustained-release preparations and topiramate, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve problems such as complex preparation processes, reduce side effects, improve adaptability, Seizure Control Effects

Active Publication Date: 2016-03-23
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process is more complicated

Method used

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  • Topiramate sustained-release preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: preparation topiramate sustained-release dry suspension

[0029] Topiramate 200g

[0030] Polysulfonyl styrene sodium ion exchange resin 400g

[0031] Polyethylene glycol 168g

[0032] Ethyl cellulose 76.8g

[0033] Sucrose 2053.2g

[0034] Xanthan gum 24g

[0035] Citric acid 18g

[0036] Micropowder silica gel 30g

[0037] Flavor 30g

[0038] Make 1000 bags

[0039] Preparation Process:

[0040] 1. To prepare the drug-resin complex, add topiramate to a certain amount of water, heat to dissolve, then add polysulfonylstyrene sodium ion exchange resin, continue to stir for 1-12h, let stand, filter, and dry;

[0041] 2. Drug resin complex PEG impregnation treatment, drying;

[0042] 3. Prepare a coating solution, dissolve ethyl cellulose in a certain amount of 95% ethanol, and set aside;

[0043] 4. Coating with a fluidized bed to obtain sustained-release granules;

[0044] 5. Sucrose and citric acid were crushed to 80 mesh respectively, and micr...

Embodiment 2

[0049] Embodiment 2: Preparation of topiramate sustained-release capsules

[0050] Topiramate 200g

[0051] Polysulfonyl styrene sodium ion exchange resin 400g

[0052] Polyethylene glycol 168g

[0053] Ethyl cellulose 76.8g

[0054] Microcrystalline cellulose 80g

[0055] Micropowder silica gel 9.2g

[0056] Make 1000 capsules

[0057] Preparation Process:

[0058] 1. To prepare the drug-resin complex, add topiramate to a certain amount of water, heat to dissolve, then add polysulfonylstyrene sodium ion exchange resin, continue to stir for 1-12h, let stand, filter, and dry;

[0059] 2. Drug resin complex PEG impregnation treatment, drying;

[0060] 3. Prepare a coating solution, dissolve ethyl cellulose in a certain amount of 95% ethanol, and set aside;

[0061] 4. Coating with a fluidized bed to obtain sustained-release granules;

[0062] 5. Mix the slow-release granules with microcrystalline cellulose and micropowder silica gel evenly;

[0063] 6. Fill capsules an...

Embodiment 3

[0064] Embodiment 3: preparation topiramate sustained-release tablet

[0065] Topiramate 200g

[0066] Polysulfonyl styrene sodium ion exchange resin 400g

[0067] Polyethylene glycol 168g

[0068] Ethyl cellulose 76.8g

[0069] Microcrystalline cellulose 80g

[0070] Croscarmellose Sodium 10g

[0071] Magnesium Stearate 9g

[0072] Make 1000 capsules

[0073] Preparation Process:

[0074] 1. To prepare the drug-resin complex, add topiramate to a certain amount of water, heat to dissolve, then add polysulfonylstyrene sodium ion exchange resin, continue to stir for 1-12h, let stand, filter, and dry;

[0075] 2. Drug resin complex PEG impregnation treatment, drying;

[0076]3. Prepare a coating solution, dissolve ethyl cellulose in a certain amount of 95% ethanol, and set aside;

[0077] 4. Coating with a fluidized bed to obtain sustained-release granules;

[0078] 5. Mix the sustained-release granules with microcrystalline cellulose, croscarmellose sodium and magnesiu...

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Abstract

The invention relates to a medicine sustained release preparation, and particularly relates to a topiramate sustained release preparation and a preparation method thereof. The topiramate sustained release preparation is prepared by sustained release particles and pharmaceutical auxiliary materials, wherein the sustained release particles comprise 15-30% of topiramate, 30-60% of an ion-exchange resin, 12-25% of an impregnant and 5-15% of a sustained release coating material. The topiramate sustained release preparation has stable and effective plasma concentration which is lower than the peak concentration of a quick release preparation, reduces incidence rate of side reactions, and can control epileptic seizures well. The topiramate sustained release preparation is taken once every day, and employs the ion ion-exchange resin, so that unpleasant taste of topiramate can be covered; and adaptability for patients is increased. The topiramate sustained release preparation can be well-received by doctors and patients.

Description

technical field [0001] The invention relates to drug sustained-release preparations, in particular to topiramate sustained-release preparations and a preparation method thereof. Background technique [0002] Topiramate is a white crystalline powder with a bitter taste. It is easily soluble in alkaline solutions with a pH value of 9-10 such as sodium hydroxide or sodium phosphate, and easily soluble in acetone, chloroform, dimethyl sulfoxide and ethanol. The solubility in water is 9.8mg / mL, the pH value of its saturated solution is 6.3, and the melting point is 125-126°. [0003] Its chemical name: 2,3:4,5-bis-O-(1-methylethylene)-β-D fructopyranose sulfamate, molecular formula: C 12 h 21 NO 8 S, molecular weight: 339.36. [0004] Its structural formula: [0005] [0006] It is a new broad-spectrum antiepileptic drug, effective for all types of epileptic seizures, especially for primary and secondary generalized tonic-clonic seizures and simple or complex partial seiz...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/22A61K9/32A61K9/36A61K47/34A61K31/7048A61P25/08A61K47/10
Inventor 范敏华姜新东魏巍刘华
Owner HAINAN PULIN PHARMA
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