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Oxcarbazepine controlled-release tablet and preparation method thereof

A controlled-release tablet and controlled-release material technology, which is applied in pharmaceutical formulations, drug delivery, nervous system diseases, etc., can solve problems such as inability to provide therapeutically effective concentrations and decreased drug bioavailability

Inactive Publication Date: 2014-07-30
QINGDAO CENT HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This results in decreased bioavailability of the drug, making the dosage form unable to provide therapeutically effective concentrations in the body
This poses a serious challenge to the successful development of sustained-release dosage forms of oxcarbazepine and its derivatives

Method used

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  • Oxcarbazepine controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] prescription:

[0036] Oxcarbazepine 300g

[0037] Hypromellose 200g

[0038] Microcrystalline Cellulose 100g

[0039] Low-substituted hydroxypropyl cellulose 50g

[0040] Povidone 50g

[0041] Magnesium Stearate 3g

[0042] Proper amount of ethanol

[0043] Made in 1000 pieces.

[0044] Preparation process:

[0045] 1. Preparation of adhesive: Dissolve the prescribed amount of povidone in ethanol to make a 10% (w / w) adhesive for later use.

[0046] 2. Granulation: After sieving oxcarbazepine and hypromellose with 80 meshes respectively, put them into a mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and add a binder after they are uniform. Wet granulation, take out the granules and use a 20-mesh sieve for wet granulation, after drying, pass through a 20-mesh sieve for granulation, and set aside.

[0047] 3. Tablet compression: After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test...

Embodiment 2

[0049] Plain Tablet Prescription:

[0050] Oxcarbazepine 300g

[0051] Hypromellose 100g

[0052] Microcrystalline Cellulose 100g

[0053] Mannitol 100g

[0054] Povidone 30g

[0055] Magnesium Stearate 3g

[0056] Proper amount of ethanol

[0057] Made in 1000 pieces.

[0058] Preparation Process:

[0059] 1. Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 10% (w / w) adhesive for subsequent use;

[0060] 2. Granulation: After sieving oxcarbazepine and mannitol with 80 meshes respectively, put them into the mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and then add binders for wet granulation , Take out the granules and carry out wet sizing with a 20 mesh sieve. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0061] 3. Tablet compression. After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determi...

Embodiment 3

[0063] prescription:

[0064] Oxcarbazepine 300g

[0065] Ethylcellulose 150g

[0066] Microcrystalline Cellulose 120g

[0067] Lactose 80g

[0068] Povidone 40g

[0069] Magnesium Stearate 4g

[0070] Proper amount of ethanol

[0071] Made in 1000 pieces.

[0072] Preparation Process

[0073] 1. Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 10% (w / w) adhesive for subsequent use;

[0074] 2. Granulation. After sieving oxcarbazepine and lactose with 80 meshes respectively, put them into the mixing granulator together with ethyl cellulose and microcrystalline cellulose, mix them, and add binders after they are uniform for wet granulation. Take out The granules are wet sized with a 20-mesh sieve, and after drying, pass through a 20-mesh sieve for granulation and set aside.

[0075] 3. Tablet compression After mixing the prepared granules with the prescribed amount of magnesium stearate evenly, test the content to determine t...

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Abstract

The invention aims at providing an oxcarbazepine controlled-release tablet which is capable of releasing medicines at a constant speed, and higher in medicine release stability and medicine use safety. The oxcarbazepine controlled-release tablet is characterized by consisting of curative dose of oxcarbazepine and physiologically acceptable pharmaceutical adjuvant; the medicine can be released at the constant speed in different release media. The controlled-release tablet disclosed by the invention has the characteristics of being convenient to dose, lasting in action, stable in curative effect, small in toxic and side effect, and the like.

Description

field of invention [0001] The invention relates to a pharmaceutical preparation for treating epilepsy and a preparation method thereof, which belongs to medicine for neurosurgery diseases, and in particular to an oxcarbazepine controlled-release tablet and a preparation method thereof. Background of the invention [0002] Oxcarbazepine belongs to the benzodiazepine class of drugs and is registered as an antiepileptic drug worldwide. Oxcarbazepine is approved as an adjunct or monotherapy for the treatment of partial-onset and generalized tonic-clonic seizures in adults and children. Currently, the immediate release (IR) dosage form of oxcarbazepine is sold under the trade name Qulai Sold, administered twice daily to control seizures. This immediate release composition delivers the drug to the patient in such a way that the plasma drug concentration rises rapidly and then falls rapidly. This sharp change in drug concentration can lead to side effects, and the drug must be ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/55A61P25/08
Inventor 赵明媚李敏宁铁英
Owner QINGDAO CENT HOSPITAL
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