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Tablet medicine compound containing levetiracetam

A composition and drug technology, applied in the directions of drug combination, drug delivery, medical preparations containing active ingredients, etc., can solve the problems of affecting and affecting the yield of coated tablets, etc.

Active Publication Date: 2013-01-16
HANGZHOU ZHUYANGXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Levetiracetam is expected to be made into tablets, especially film-coated tablets with less coating material consumption, but the inventors have found that the inherent properties of uncoated plain tablets have an undesirable impact on tablet coating. For example, there may be an impact on the yield of coated tablets

Method used

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  • Tablet medicine compound containing levetiracetam
  • Tablet medicine compound containing levetiracetam
  • Tablet medicine compound containing levetiracetam

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0293] Embodiment 1: prepare pharmaceutical composition (tablet) of the present invention

[0294] prescription:

[0295]

[0296] Opadry is prepared as a 14% aqueous suspension for use, and 3% in the prescription represents the percentage of the weight of the tablet increased due to coating (ie, the weight of the dry coating material) relative to the total weight of the pharmaceutical composition after coating, which is prepared below The same meaning applies to the examples and comparative examples of the composition.

[0297] Preparation method:

[0298] The method includes the steps of:

[0299] i) fully mixing levetiracetam, disintegrating agent, binding agent, glidant, the mixture obtained is compacted;

[0300] ii) pulverizing the compacted mixture obtained in step i); and

[0301] iii) Add a lubricant to the pulverized mixture obtained in step ii), mix it uniformly, and compress it to form a tablet of the pharmaceutical composition of the present invention, wh...

Embodiment 2

[0303] Embodiment 2: prepare pharmaceutical composition (tablet) of the present invention

[0304] Prescription: with embodiment 1.

[0305] Preparation method:

[0306] i) Levetiracetam, disintegrant, binding agent, glidant are fully mixed;

[0307] ii) adding lubricant;

[0308] iii) fully mixing levetiracetam, disintegrant, binder, glidant and lubricant;

[0309] iv) compacting the mixture obtained in step iii) (in a block);

[0310] v) comminuting the compacted mixture from step iv) (to form particles that pass through a 20-mesh sieve);

[0311] vi) compressing the mixture in step v) to form a tablet of the pharmaceutical composition of the present invention, which may be called a tablet core or plain tablet;

[0312] vii) Coating the tablet obtained in the above steps to obtain a tablet of the pharmaceutical composition of the present invention, which is a coated tablet.

Embodiment 3

[0313] Embodiment 3: prepare pharmaceutical composition (tablet) of the present invention

[0314] Prescription: with embodiment 1.

[0315] Preparation method:

[0316] i) Fully mix levetiracetam, disintegrant and glidant, dissolve the binder with 50% ethanol to make a binder solution, use the binder solution to make soft materials, make wet granules, and dry (measure loss on drying to be less than 3% at 105 ℃ to dry granule), get dry granule;

[0317] ii) adding a lubricant to the pulverized mixture obtained in step i), mixing it uniformly, and compressing it to form a tablet of the pharmaceutical composition of the present invention, which may be called a tablet core or a plain tablet;

[0318] iii) Coating the tablet obtained in the above steps to obtain a tablet of the pharmaceutical composition of the present invention, which is a coated tablet.

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Abstract

The invention relates to a tablet medicine compound containing levetiracetam. Specifically, the medicine compound comprises levetiracetam, disintegrant, binder, glidant and lubricant. More specifically, the medicine compound comprises 500 parts by weight of levetiracetam, 10-50 parts by weight of disintegrant, 2 -10 parts by weight of binder, 1-5 parts by weight of glidant, and 1 -5 parts by weight of lubricant. The medicine compound has good pharmaceutical characteristics, and can be used for treating or preventing epilepsy, Parkinson's disease, dyskinesia, migraine, tremor, essential tremor, bipolar disorder, chronic pain, neuropathic pain, bronchia, asthma or allergic diseases.

Description

technical field [0001] The present invention relates to a novel tablet pharmaceutical composition containing levetiracetam and a preparation method thereof. Background technique [0002] European patent EP0162036B discloses a levetiracetam levetiracetam compound, its chemical name is (S)-(-)-[α]-ethyl-2-oxo-1-pyrrolidineacetamide, the drug can be used as Protective agent for the treatment and prevention of hypoxic and ischemic type attacks of the central nervous system. The compound is effective in the treatment of epilepsy and its dextro-enantiomer (R)-(-)-[α]-ethyl-2-oxo-1-pyrrolidineacetamide has been shown to be completely free of Activity (AJ. Gowe et al., Eur. J. Pharmacol., 222, 1992, 193-203). [0003] Levetiracetam is a pyrrolidone derivative whose chemical structure is not related to existing antiepileptic drugs. The antiepileptic effects of levetiracetam have been evaluated in various antiepileptic animal models. Levetiracetam has no inhibitory effect on isola...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/36A61K9/20A61K31/4015A61P25/08A61P25/16A61P25/14A61P25/18A61P25/24A61P25/22A61P25/00A61P25/06A61P29/02A61P9/10A61P9/06A61P21/02A61P25/36A61P37/08A61P11/06A61P11/00A61P11/02
Inventor 李阅东唐建飞沈如杰何海珍刘玉艳赵福斌
Owner HANGZHOU ZHUYANGXIN PHARMA
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