CN101584673A - Levetiracetam tablet and preparation method - Google Patents
Levetiracetam tablet and preparation method Download PDFInfo
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- CN101584673A CN101584673A CNA2009101003788A CN200910100378A CN101584673A CN 101584673 A CN101584673 A CN 101584673A CN A2009101003788 A CNA2009101003788 A CN A2009101003788A CN 200910100378 A CN200910100378 A CN 200910100378A CN 101584673 A CN101584673 A CN 101584673A
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Abstract
The invention discloses a Levetiracetam tablet and preparation method thereof. Levetiracetam is a bolus injection medicine with bad compressibility and proportion of supplementary materials which can be added is small. Quality of Levetiracetam is unstable and it is hard to produce Levetiracetam industrially. The invention comprises components of weight percentage content: 70% to 80% of Levetiracetam as active component, 1.5% to 8.0% of plasticizer, 9% to 17% of disintegrant, 3% to 14% of filler, 0.1% to 0.5% of bond and 0.1% to 3% of fluidizer. Addition of plasticizer is added by inner way of wet granulation. Levetiracetam as active component has bad mechanic compressibility. The invention adds plasticizer to solve tablet compression difficulty in industrial embodiment thoroughly, which realizes the purpose of being suitable for coating with stable quality and easy industrial application.
Description
Technical field
The present invention relates to pharmaceutical field, specifically a kind of levetiracetam tablet and preparation method thereof.
Background technology
Levetiracetam is the antuepileptic of Belgium's associating chemical industry (UCB) company limited exploitation, is sold (trade name Keppra) in 1999 by drugs approved by FDA, is a kind of levo-compound, and structure expression is as follows:
The chemical name of levetiracetam is (S)-2-ethyl-2-oxo-1 pyrrolidine acetamide, and character is extremely yellowish crystallinity powder of white, and is easily molten in water, dissolves in methanol or ethanol.The levetiracetam sheet is a comparatively ideal antuepileptic on the pharmacokinetics, oral easy absorption, the bioavailability height, have the therapeutic index height, do not interact with other antiepileptic, side effect is slight, the characteristics of better tolerance, be used for independent treatment, clinical with it as wide spectrum epilepsy medicine, at present unique antiepileptic with special performance that the prevention epilepsy takes place.Levetiracetam is used to be grown up and the adding with treatment of child epileptic partial seizures more than 4 years old.
The levetiracetam common dosage forms is a tablet, conventional preparation method is a dry granulation, as the bibliographical information of Rote listeService Gmbh " Rote Liste 2003; 2002; ECV-Editio Cantor; Aulentorf; Germany " adopt following prescription to be prepared, it is filler that the label prescription adopts corn starch, 30 POVIDONE K 30 BP/USP 30 is as binding agent, Pulvis Talci, colloid anhydride silica are as fluidizer, and magnesium stearate is as lubricant, and coating material adopts hypromellose, Polyethylene Glycol and titanium dioxide.Yet because levetiracetam is a heavy dose of medicine, compressibility is relatively poor, and the adjuvant ratio that can add is little, and the suitability for industrialized production difficulty has limited the application of this product.Moreover the label prescription only adopts corn starch as filler, do not add more suitably disintegrating agent, levetiracetam tablet may cause active component slower and therefore reduce stability of drug when discharging as time passes, and one of result that this stability reduces can make the product of above-mentioned prescription will be defective before being less than effect duration.
On the other hand, the levetiracetam drug dose is bigger, be subjected to the heavy influence of sheet shape and sheet, tablet must be accomplished suitable weight and shape, the right adjuvant amount that adds is limited, the mechanical compressibility of active component levetiracetam itself is relatively poor, utilizes prior art need use proprietary tabletting pressure apparatus and could extrude the tablet that is fit to hardness, is unfavorable for industrialization promotion.
Summary of the invention
Technical problem to be solved by this invention is to overcome the defective that exists in the above-mentioned existing levetiracetam tablet, and more stable compositions of a kind of easier industrialization promotion and quality is provided.
For this reason, the present invention adopts following technical scheme: a kind of levetiracetam tablet, the component that comprises following quality percentage composition: as the levetiracetam 70～80% of active component, plasticizer 1.5～8.0%, disintegrating agent 9%～17%, filler 3%～14%, binding agent 0.1～0.5% and fluidizer 0.1～3% add adding in when the adding mode of plasticizer is wet granulation.The mechanical compressibility of active component levetiracetam itself is relatively poor, and the present invention adopts the adding plasticizer and thoroughly solved the tabletting difficult problem of running in the industrializing implementation.
Above-mentioned levetiracetam tablet, the component of preferred following quality percentage composition: as the levetiracetam 74～78% of active component, plasticizer 3～5%, disintegrating agent 9%～13%, filler 3%～14%, binding agent 0.2～0.5% and fluidizer 0.1～3%.
Above-mentioned levetiracetam tablet, described disintegrating agent is any or the mixture more than two kinds in starch, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, preferred disintegrating agent is the mixture of pregelatinized Starch and cross-linking sodium carboxymethyl cellulose, and wherein the mass ratio of pregelatinized Starch and cross-linking sodium carboxymethyl cellulose is 3: 1～2: 1; The consumption that described disintegrating agent adds in when humidifying is granulated accounts for 3%～7% of tablet gross mass.Disintegrating agent is meant and can makes tablet split the material that is broken into fine particle rapidly in gastro-intestinal Fluid, thereby makes functional component dissolve absorption rapidly, plays a role.This class material mostly has good water absorption and dilatancy, thereby realizes the disintegrate of tablet.Compared with prior art, adopt among the present invention pregelatinized Starch and cross-linked carboxymethyl fiber sodium share disintegrating agent after, it can remedy the deficiency of other disintegrating agent wonderful discovery, can improve the dissolving out capability of medicine greatly and obtain stable stripping curve.
Above-mentioned levetiracetam tablet, the present invention adopts the plasticizer of Macrogol 4000 as tablet, when carrying out preparation of granules in adding, the hardness of tablet is multiplied, and has reached the purpose that can adapt to coating fully.
Above-mentioned levetiracetam tablet, it is 1～8% hypromellose aqueous solution that binding agent is preferably mass concentration, the apparent viscosity of hypromellose is preferably 3～15cp, 3～6cp more preferably, the binding agent kind is chosen in tabletting indexs such as the compressibility that guarantees tablet and flowability crucial support is provided, after using the hypromellose aqueous solution as binding agent, can improve the compressibility in the tabletting process greatly and keep the good molding and the necessary hardness of tablet, solve the use polyvinylpyrrolidone as the just easy moisture absorption of tablet of binding agent, the levetiracetam active component is degraded, making it curative effect reduces, increase problems such as untoward reaction probability.
Above-mentioned levetiracetam tablet, fluidizer is preferably precipitated silica, fluidizer is to reduce frictional force between the granule, thereby improve the material of powder flowbility, the present invention adopts precipitated silica to efficiently solve the mobile poor tabletting problem that is difficult for of tablet and powder as fluidizer, simultaneously will be well below the colloidal silica anhydrous of present normal use on cost.
Above-mentioned levetiracetam tablet, filler is preferably microcrystalline Cellulose, though microcrystalline Cellulose is a kind of filler commonly used in tablet is made, but share with the active component levetiracetam and tablet to be played in manufacture process assist that tablet is bonding, the function of disintegrate, after using microcrystalline Cellulose, in the tabletting process, can also keep the good flowability of tablet and powder, make tablet have better fragility value simultaneously, make the tablet powder incrust, wear-resistant.
Above-mentioned levetiracetam tablet, it also comprises the gastric solubility coating material, as Opadry (Opadry) 85G60729,85G62984.
Another object of the present invention is to provide the preparation method of above-mentioned levetiracetam tablet, its step is as follows: with levetiracetam and plasticizer, disintegrating agent and filler mix homogeneously, add binding agent and granulate drying, granulate; Disintegrating agent, fluidizer, filler and the lubricant (magnesium stearate) that add Extra Section mix, and tabletting carries out coating promptly with the gastric solubility coating material.
The present invention has following beneficial effect: the present invention adopts the plasticizer of Macrogol 4000 as tablet, adding in when wet granulation, the hardness of tablet is multiplied, thoroughly solved the tabletting difficult problem of running in the industrializing implementation, reach the purpose that can adapt to coating fully, be easy to industrialization promotion; Adopt pregelatinized Starch and cross-linked carboxymethyl fiber sodium share disintegrating agent after, it can remedy the deficiency of other disintegrating agent, has improved the dissolving out capability of medicine greatly and has obtained stable stripping curve, quality is more stable.
Description of drawings
Fig. 1 is the product and the stripping curve figure of commercially available prod in the phosphate solution of PH6.8 of the embodiment of the invention 7 gained.
Fig. 2 is the product and the stripping curve figure of commercially available prod in the phosphate solution of PH6.8 of the embodiment of the invention 8 gained.
The specific embodiment
The present invention is further illustrated below in conjunction with the specific embodiment, but do not limit the present invention in any way.
Embodiment 1
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 5% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G60729 carries out coating promptly with Opadry (Opadry).
Embodiment 2
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, starch, the cross-linking sodium carboxymethyl cellulose, adding 2% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G60729 carries out coating promptly with Opadry (Opadry).
Embodiment 3
Prescription is formed (per 1000 consumptions, specification 500mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 3% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G62984 carries out coating promptly with Opadry (Opadry).
Embodiment 4
Prescription is formed (per 1000 consumptions, specification 500mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 1% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G60729 carries out coating promptly with Opadry (Opadry).
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 3% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G60729 carries out coating promptly with Opadry (Opadry).
Embodiment 6
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 8% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G62984 carries out coating promptly with Opadry (Opadry).
Embodiment 7
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 5% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G60729 carries out coating promptly with Opadry (Opadry).
Embodiment 8
Prescription is formed (per 1000 consumptions, specification 500mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 5% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G62984 carries out coating promptly with Opadry (Opadry).
Embodiment 9
Prescription is formed (per 1000 consumptions, specification 250mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 5% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G62984 carries out coating promptly with Opadry (Opadry).
Prescription is formed (per 1000 consumptions, specification 500mg)
With levetiracetam and Macrogol 4000, add partially mixed even in microcrystalline Cellulose, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose, adding 3% hypromellose aqueous solution granulates, dry, add Extra Section microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose and precipitated silica, magnesium stearate is mixed, with conventional tablet machine tabletting, 85G62984 carries out coating promptly with Opadry (Opadry).
Product and commercially available prod (Kai Pulan) to embodiment 7 and embodiment 8 gained compare influence factor's test, mainly investigate the impurity situation; Product to commercially available prod and embodiment gained carries out stripping curve and the detection of tabletting hardness simultaneously, sees Table 1～table 7, Fig. 1～Fig. 2:
Table 1: 60 ℃ of influence factor results of high temperature of self-control sample
Table 2: 92.5%25 ℃ of influence factor results of high humidity of self-control sample
Table 3: 25 ℃ of influence factor results of illumination 4500LX of self-control sample
Table 4: 60 ℃ of influence factor results of the high temperature of commercially available sample
Table 5: 92.5%25 ℃ of influence factor results of the high humidity of commercially available sample
Table 6: the illumination 4500LX25 ℃ influence factor result of commercially available sample
Table 7: hardness ratio
Can show clearly that from above result every quality index of levetiracetam tablet of the present invention has all realized re-set target, particularly all show concordance with the commercially available prod height in hardness, the impurity stability of stripping curve and tablet.
The above only is preferred embodiment of the present invention.Every foundation technical spirit of the present invention all falls within the scope of protection of the present invention any simple modification, equivalent variations and modification that above embodiment did.
Claims (10)
1, a kind of levetiracetam tablet, the component that comprises following quality percentage composition: as the levetiracetam 70～80% of active component, plasticizer 1.5～8.0%, disintegrating agent 9%～17%, filler 3%～14%, binding agent 0.1～0.5% and fluidizer 0.1～3% add adding in when the adding mode of plasticizer is wet granulation.
2, levetiracetam tablet according to claim 1, it is characterized in that being to comprise the component of following quality percentage composition: as the levetiracetam 74～78% of active component, plasticizer 3～5%, disintegrating agent 9%～13%, filler 3%～14%, binding agent 0.2～0.5% and fluidizer 0.1～3%.
3, levetiracetam tablet according to claim 2 is characterized in that being that described disintegrating agent selects in starch, pregelatinized Starch, the cross-linking sodium carboxymethyl cellulose any or the mixture more than two kinds for use.
4, levetiracetam tablet according to claim 3, it is characterized in that being that described disintegrating agent selects the mixture of pregelatinized Starch and cross-linking sodium carboxymethyl cellulose for use, wherein the mass ratio of pregelatinized Starch and cross-linking sodium carboxymethyl cellulose is 3: 1～2: 1.
5, levetiracetam tablet according to claim 4 is characterized in that being that the consumption that adds in described disintegrating agent is when humidifying is granulated accounts for 3%～7% of tablet gross mass.
6, levetiracetam tablet according to claim 5, it is characterized in that being that described plasticizer selects Macrogol 4000 for use, it is 1～8% hypromellose aqueous solution that binding agent is selected mass concentration for use, and fluidizer is selected precipitated silica for use, and filler is selected microcrystalline Cellulose for use.
7, levetiracetam tablet according to claim 6 is characterized in that the apparent viscosity of described hypromellose is selected 3～15cp for use.
8, levetiracetam tablet according to claim 7 is characterized in that the apparent viscosity of described hypromellose is selected 3～6cp for use.
9, levetiracetam tablet according to claim 1 is characterized in that also comprising the gastric solubility coating material.
10, the preparation method of each described levetiracetam tablet of claim 1-9, its step is as follows: with levetiracetam and plasticizer, disintegrating agent and filler mix homogeneously, add binding agent and granulate drying, granulate; The disintegrating agent, fluidizer, filler and the lubricant that add Extra Section mix, and tabletting carries out coating promptly with the gastric solubility coating material.
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| CNA2009101003788A CN101584673A (en) | 2009-07-13 | 2009-07-13 | Levetiracetam tablet and preparation method |
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| CNA2009101003788A CN101584673A (en) | 2009-07-13 | 2009-07-13 | Levetiracetam tablet and preparation method |
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Cited By (12)
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| CN102379857A (en) * | 2011-05-30 | 2012-03-21 | 深圳信立泰药业股份有限公司 | Levetiracetam slow release medicinal composite and preparation method thereof |
| CN102764254A (en) * | 2012-05-16 | 2012-11-07 | 深圳信立泰药业股份有限公司 | Levetiracetam drug composition and preparation method thereof |
| CN102895214A (en) * | 2012-10-25 | 2013-01-30 | 杭州朱养心药业有限公司 | Solid pharmaceutical composition of levetiracetam tablet |
| CN102949372A (en) * | 2011-08-26 | 2013-03-06 | 山东方明药业集团股份有限公司 | Nicergoline pill and preparation method thereof |
| CN103142583A (en) * | 2011-12-07 | 2013-06-12 | 北大方正集团有限公司 | Levetiracetam-containing pharmaceutical composition and preparation method thereof |
| CN104706640A (en) * | 2015-02-10 | 2015-06-17 | 哈尔滨珍宝制药有限公司 | Irbesartan-containing pharmaceutical composition and preparing process thereof |
| CN105769784A (en) * | 2014-12-24 | 2016-07-20 | 广州朗圣药业有限公司 | Oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN107913258A (en) * | 2016-10-09 | 2018-04-17 | 北京阜康仁生物制药科技有限公司 | A kind of levetiracetam sustained-release tablets and preparation method thereof |
| CN111920778A (en) * | 2020-08-12 | 2020-11-13 | 湖北欣泽霏药业有限公司 | Levetiracetam tablet and preparation method thereof |
| CN114173767A (en) * | 2019-06-27 | 2022-03-11 | 葛兰素史克消费者健康控股(美国)有限责任公司 | Novel combination of ibuprofen and paracetamol |
| CN115350178A (en) * | 2022-08-24 | 2022-11-18 | 浙江京新药业股份有限公司 | Pharmaceutical composition containing levetiracetam |
| CN115350178B (en) * | 2022-08-24 | 2024-04-26 | 浙江京新药业股份有限公司 | Pharmaceutical composition containing levetiracetam |
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2009
- 2009-07-13 CN CNA2009101003788A patent/CN101584673A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102379857A (en) * | 2011-05-30 | 2012-03-21 | 深圳信立泰药业股份有限公司 | Levetiracetam slow release medicinal composite and preparation method thereof |
| CN102949372A (en) * | 2011-08-26 | 2013-03-06 | 山东方明药业集团股份有限公司 | Nicergoline pill and preparation method thereof |
| CN103142583A (en) * | 2011-12-07 | 2013-06-12 | 北大方正集团有限公司 | Levetiracetam-containing pharmaceutical composition and preparation method thereof |
| CN102764254A (en) * | 2012-05-16 | 2012-11-07 | 深圳信立泰药业股份有限公司 | Levetiracetam drug composition and preparation method thereof |
| CN102764254B (en) * | 2012-05-16 | 2016-09-07 | 深圳信立泰药业股份有限公司 | A kind of levetiracetam medicinal composition and preparation method thereof |
| CN102895214A (en) * | 2012-10-25 | 2013-01-30 | 杭州朱养心药业有限公司 | Solid pharmaceutical composition of levetiracetam tablet |
| CN102895214B (en) * | 2012-10-25 | 2014-03-26 | 杭州朱养心药业有限公司 | Solid pharmaceutical composition of levetiracetam tablet |
| CN105769784B (en) * | 2014-12-24 | 2019-01-01 | 广州朗圣药业有限公司 | A kind of oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN105769784A (en) * | 2014-12-24 | 2016-07-20 | 广州朗圣药业有限公司 | Oral tablet of acotiamide hydrochloride trihydrate and preparation method thereof |
| CN104706640A (en) * | 2015-02-10 | 2015-06-17 | 哈尔滨珍宝制药有限公司 | Irbesartan-containing pharmaceutical composition and preparing process thereof |
| CN107913258A (en) * | 2016-10-09 | 2018-04-17 | 北京阜康仁生物制药科技有限公司 | A kind of levetiracetam sustained-release tablets and preparation method thereof |
| CN114173767A (en) * | 2019-06-27 | 2022-03-11 | 葛兰素史克消费者健康控股(美国)有限责任公司 | Novel combination of ibuprofen and paracetamol |
| CN111920778A (en) * | 2020-08-12 | 2020-11-13 | 湖北欣泽霏药业有限公司 | Levetiracetam tablet and preparation method thereof |
| CN115350178A (en) * | 2022-08-24 | 2022-11-18 | 浙江京新药业股份有限公司 | Pharmaceutical composition containing levetiracetam |
| CN115350178B (en) * | 2022-08-24 | 2024-04-26 | 浙江京新药业股份有限公司 | Pharmaceutical composition containing levetiracetam |
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Application publication date: 20091125 |