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Topiramate sustained release preparation and preparation method thereof

A technology of sustained-release preparations and topiramate, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. drug concentration, the effect of improving adaptability

Active Publication Date: 2012-12-19
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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
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Effect test

Embodiment 1

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

[0029] Topiramate 200g

[0030] Sodium Polysulfonyl Styrene Ion Exchange Resin 400g

[0031] Polyethylene glycol 168g

[0032] Ethylcellulose 76.8g

[0033] Sucrose 2053.2g

[0034] Xanthan gum 24g

[0035] Citric acid 18g

[0036] Micronized silica gel 30g

[0037] Flavor 30g

[0038] Make 1000 bags

[0039] making 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 micronized ...

Embodiment 2

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

[0050] Topiramate 200g

[0051] Sodium Polysulfonyl Styrene Ion Exchange Resin 400g

[0052] Polyethylene glycol 168g

[0053] Ethylcellulose 76.8g

[0054] Microcrystalline Cellulose 80g

[0055] Micronized silica gel 9.2g

[0056] Makes 1000 capsules

[0057] making 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 and get...

Embodiment 3

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

[0065] Topiramate 200g

[0066] Sodium Polysulfonyl Styrene Ion Exchange Resin 400g

[0067]Polyethylene glycol 168g

[0068] Ethylcellulose 76.8g

[0069] Microcrystalline Cellulose 80g

[0070] Croscarmellose Sodium 10g

[0071] Magnesium Stearate 9g

[0072] Makes 1000 capsules

[0073] making 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 slow-release granules with microcrystalline cellulose, croscarmellose sodium and magnesium stearat...

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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 9.8 mg / 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 sei...

Claims

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Application Information

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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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