CN104784134A - Lacosamidesolid preparation and preparation method thereof - Google Patents
Lacosamidesolid preparation and preparation method thereof Download PDFInfo
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- CN104784134A CN104784134A CN201510169440.4A CN201510169440A CN104784134A CN 104784134 A CN104784134 A CN 104784134A CN 201510169440 A CN201510169440 A CN 201510169440A CN 104784134 A CN104784134 A CN 104784134A
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Abstract
The invention discloses a lacosamide solid preparation and a preparation method thereof. The lacosamide solid preparation comprises lacosamide, an internally added disintegrating agent, an externally added disintegrating agent, an internally added attenuant, an externally added attenuant, an adhesive, a glidant and a lubricant. Through adoption of the preparation method, the defects, of the conventional lacosamide fast-release tablet, that raw materials are loose and light to cause high layering possibility after mixing, the conventional preparation is high in fine powder content and low in flowability, the dissolution rate of the conventional preparation is relatively low, special equipment is required due to adoption of the inclusion technology, the process is cumbersome, and commercialized production is inconvenient are overcome.
Description
Technical field
The invention belongs to medical art, particularly relate to a kind of scheme for lacosamide solid preparation and preparation method thereof.
Background technology
Scheme for lacosamide is a kind of novel Glycine site nmda receptor antagonist, belongs to new class functional amino, and research concentrates on its epilepsy and treatment neuralgia effect aspect.External electrophysiologic study display scheme for lacosamide selectivity promotes the activity of slow inactivation Voltage-gated sodium channels, thus the neuronal cell film of permanent anomaly excitement, inhibitory neuron triggers repeatedly, but the normal physiology irritability of the unit that do not affect the nerves, and neuronal excitability reduction is the important molecule mechanism for the treatment of epilepsy and neuropathic pain.In addition, scheme for lacosamide can mediate modulin with collapsin--and 2 (CRMP--2 is mainly distributed in the phosphoprotein in nervous system) combines.Have now found that CRMP--2 functional disorder in epileptic's brain, therefore scheme for lacosamide is as the anticonvulsant drug with brand-new double action mechanism, in treatment epilepsy, have higher curative effect.
The evaluate report of EMEA (European FAD) to scheme for lacosamide shows scheme for lacosamide poor fluidity, and raw material becomes abnormal loose after crushed: bulk density 0.11g/cm
3, tap density 0.35g/cm
3, Hao Senna ratio (Hausner ratio ratio) is 3.18, and (China Medical Science Press's " pharmaceutics " second edition is mentioned Hao Senna ratio and is greater than 1.5, shows material compression formability extreme difference to be greater than 50 ° angle of repose; Be greater than 45 ° angle of repose, show material fluidity extreme difference), easily cause material layering when therefore raw material mixes with adjuvant.
The patent CN201210266439 of Yongguang Pharmaceutical Co., Ltd.'s application discloses a kind of scheme for lacosamide sheet for the treatment of epilepsy and preparation method thereof, and this invention prepares tablet by conventional method after using conventional enclose material to wrap up scheme for lacosamide again.Clathrate process in the method needs to use the special installation such as grinder, and experience is dissolved, the step of grinding and drying, and not only technique is loaded down with trivial details, and consuming time longer, at home under pharmaceutical industry current condition, is difficult to commercialization and applies.Inventor, by special disintegrating agent kind and unique disintegrating agent feed postition, makes the present invention first by the process of scheme for lacosamide raw material enclose, but need not can reach the effect of the dissolution significantly improving preparation.
Summary of the invention
The object of the invention is to solve existing scheme for lacosamide quick-release tablet technology Raw to loosen light weight, mix easy layering; Granulation fine powder is more, poor fluidity; Preparation dissolution is on the low side, and inclusion technique needs special installation, and technique is loaded down with trivial details, is unfavorable for the problem commercially produced.Inventor to be present invention accomplishes in " pharmacopeia " the requirements in solid preparation by test proof and is applicable to the suitability for industrialized production of domestic existing pharmaceutical technology.
Solid preparation of the present invention contains the scheme for lacosamide accounting for said preparation gross weight 10% ~ 60%, and chemical name is: (R), and--2--acetamido--N--benzyl--3--methoxypropionamide, molecular formula is: C
13h
18n
2o
3, its structural formula is:
This solid preparation reaches the necessary disintegrating agent of the object of the invention, diluent, binding agent, fluidizer and lubricant containing promising, and wherein, disintegrating agent and diluent are divided into Nei Jia and additional two parts.
The present invention, by measuring the physical attributes such as the bulk density of raw material and granulation granule and angle of repose, selects the adjuvant of the special type matched with it, and in conjunction with the improvement of preparation technology, reaches and ensure that formulation content improves the object of dissolution all in the lump.Inside adding diluent is to loosen light weight to solve raw material, mixes the problem of easy layering, after raw material is granulated, significantly improves the bulk density of granule; After additional diluent can solve and granulate, fine powder is many, the problem of poor fluidity; It is granule that additional disintegrating agent can make tablet meet fater disintegration after water, promotes the infiltration of moisture; Inside granule interior then can be made to meet the rapid disintegrate of water with disintegrating agent is tiny microgranule.
With disintegrating agent in solid preparation of the present invention contains, consumption is in the formulation 2.5% ~ 15% of total formulation weight amount, can be inside one or more mixture in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and carboxymethylcellulose calcium with disintegrating agent.Be cross-linking sodium carboxymethyl cellulose with disintegrating agent in the present invention is preferred, preferable amount is in the formulation 5% ~ 10% of total formulation weight amount.
Add diluent in solid preparation of the present invention contains, consumption is in the formulation 5% ~ 15% of total formulation weight amount, and inside adding diluent can be one or more mixture in microcrystalline Cellulose, mannitol and dextrin.The microcrystalline Cellulose PH102 that diluent is bulk density close, good fluidity (angle of repose close to 40) relative to raw material is added in the present invention is preferred, so that mix homogeneously with loose raw material, preferable amount is in the formulation 8% ~ 15% of total formulation weight amount.
Pharmaceutical preparation of the present invention contains at least one binding agent, consumption is in the formulation 0.5% ~ 3% of total formulation weight amount, and binding agent can be one or more mixture in hyprolose, hypromellose, polyvidone, Polyethylene Glycol and sodium carboxymethyl cellulose.The preferred binding agent of the present invention is hypromellose, and preferable amount is in the formulation 0.5% ~ 1% of total formulation weight amount.
Solid preparation of the present invention contains additional disintegrating agent, and consumption is in the formulation 2.5% ~ 15% of total formulation weight amount, and additional disintegrating agent and the interior weight ratio with disintegrating agent are 1:1.Additional disintegrating agent can be one or both mixture in polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose.The preferred additional disintegrating agent of the present invention is polyvinylpolypyrrolidone CL (bulk density 0.35g/cm
3left and right, tap density 0.50g/cm
3left and right, mean diameter 110 ~ 130 μm), so that mix with granule, do not affect mobility, preferable amount is in the formulation 5% ~ 10% of total formulation weight amount simultaneously.
Solid preparation of the present invention contains additional diluent, consumption is in the formulation 10% ~ 35% of total formulation weight amount, additional diluent can be optimize microcrystalline Cellulose (German JRS company production, mixture for prepared by silica sol and microcrystalline Cellulose weight ratio 2:98), pregelatinized Starch, (French Roquette Freres produces mannitol/composites of starch, mixture for mannitol is prepared than 80:20 with starch weight) and microcrystalline Cellulose/glyceryl monostearate complex (Irish Kai Airui group produces, mixture for microcrystalline Cellulose and glyceryl monostearate weight ratio 98:2) in one or more mixture.The preferred additional diluent of the present invention is that bulk density and granule are close to (bulk density 0.35g/cm
3left and right, tap density 0.46g/cm
3left and right), the optimization microcrystalline Cellulose of good fluidity (angle of repose is less than 35, mean diameter 110 μm) so that mix homogeneously with granule, improve mobility, preferable amount is in the formulation 20% ~ 30% of total formulation weight amount simultaneously.
Solid preparation of the present invention contains at least one fluidizer, and consumption is in the formulation 0.1% ~ 3% of total formulation weight amount, and fluidizer can be one or more mixture in colloidal silica and Pulvis Talci.The preferred fluidizer of the present invention is colloidal silica, and preferable amount is in the formulation 0.5% ~ 1% of total formulation weight amount.
Pharmaceutical preparation of the present invention contains at least one lubricant, consumption is in the formulation 0.5% ~ 3% of total formulation weight amount, and lubricant can be one or more mixture of magnesium stearate, stearic acid, hydrogenated vegetable oil, sodium stearyl fumarate, Glyceryl Behenate and Polyethylene Glycol apoplexy due to endogenous wind.The preferred lubricant of the present invention is magnesium stearate, and preferable amount is in the formulation 0.5% ~ 1% of total formulation weight amount.
In addition, present invention also offers a kind of preparation method of scheme for lacosamide solid preparation, it is characterized in that, comprise the following steps: (1) by scheme for lacosamide, in disintegrating agent, in add mixing diluents evenly after add that binding agent is granulated, dry mixture one; (2) in mixture one, add additional diluent, additional disintegrating agent, fluidizer and lubricant, always mix, tabletting.
Solid preparation of the present invention is applicable oral immediate release drug formulations, can be general thin garment piece, oral cavity disintegration tablet, capsule etc., preferred tablet, particularly preferably general thin garment piece.Optional coating is carried out to tablet, use the gastric solubility coating material of pharmaceutical field routine, such as, based on the hypromellose of various molecular weight or polyvinyl alcohol.In addition this coating can containing conventional pigment, such as titanium dioxide etc.
Accompanying drawing explanation
(comparative example 2) stripping curve comparison diagram is added in additional in Fig. 1 disintegrating agent (embodiment 1 ~ 3) and disintegrating agent
Additional in Fig. 2 disintegrating agent (embodiment 1 ~ 3) and disintegrating agent additional (comparative example 1) stripping curve comparison diagram
Fig. 3 concrete sample position schematic diagram, in figure, 1--9 is respectively sampling particular location
Detailed description of the invention
By the following examples the present invention is described in further detail, but the present invention is not limited to these embodiments.
Embodiment 1 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH102 24g
Cross-linking sodium carboxymethyl cellulose 24g
Hypromellose 2.4g
Polyvinylpolypyrrolidone CL 24g
Optimize microcrystalline Cellulose 60g
Colloidal silica 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process:
(1) put in wet-mixed machine by recipe quantity scheme for lacosamide, microcrystalline Cellulose PH102, cross-linking sodium carboxymethyl cellulose, in 15min, in mixer upper, middle and lower, three positions sample three parts respectively, measure content, calculate uniformity of dosage units.Granulate, dry mixture one.
(2) in mixture one, add optimization microcrystalline Cellulose, polyvinylpolypyrrolidone CL, colloidal silica and magnesium stearate, always mix.
(3) tabletting, coating, packaging.
Embodiment 2 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH102 36g
Cross-linking sodium carboxymethyl cellulose 12g
Hypromellose 2.4g
Polyvinylpolypyrrolidone CL 12g
Optimize microcrystalline Cellulose 72g
Colloidal silica 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process:
(1) put in wet-mixed machine by recipe quantity scheme for lacosamide, microcrystalline Cellulose PH102, cross-linking sodium carboxymethyl cellulose, in 15min, in mixer upper, middle and lower, three positions sample three parts respectively, measure content, calculate uniformity of dosage units.Granulate, dry mixture one.
(2) in mixture one, add optimization microcrystalline Cellulose, polyvinylpolypyrrolidone CL, colloidal silica and magnesium stearate, always mix.
(3) tabletting, coating, packaging.
Embodiment 3 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH102 30g
Cross-linking sodium carboxymethyl cellulose 18g
Hypromellose 2.4g
Polyvinylpolypyrrolidone CL 18g
Optimize microcrystalline Cellulose 66g
Colloidal silica 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process:
(1) put in wet-mixed machine by recipe quantity scheme for lacosamide, microcrystalline Cellulose PH102, cross-linking sodium carboxymethyl cellulose, in 15min, in mixer upper, middle and lower, three positions sample three parts respectively, measure content, calculate uniformity of dosage units.Granulate, dry mixture one.
(2) in mixture one, add optimization microcrystalline Cellulose, polyvinylpolypyrrolidone CL, colloidal silica and magnesium stearate, always mix.
(3) tabletting, coating, packaging.
For convenience of contrasting with embodiment, spy enumerates following comparative example, carries out comparative study.
Comparative example 1 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH102 24g
Hypromellose 2.4g
Polyvinylpolypyrrolidone CL 48g
Optimize microcrystalline Cellulose 60g
Colloidal silica 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process:
(1) by granulating after recipe quantity scheme for lacosamide, microcrystalline Cellulose PH102 mix homogeneously, dry mixture one.
(2) in mixture one, add optimization microcrystalline Cellulose, polyvinylpolypyrrolidone CL, colloidal silica and magnesium stearate, always mix.
(3) tabletting, coating, packaging.
Comparative example 2 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH102 24g
Cross-linking sodium carboxymethyl cellulose 48g
Hypromellose 2.4g
Optimize microcrystalline Cellulose 60g
Colloidal silica 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process:
(1) by granulating after recipe quantity scheme for lacosamide, microcrystalline Cellulose PH102, cross-linking sodium carboxymethyl cellulose mix homogeneously, dry mixture one.
(2) in mixture one, add optimization microcrystalline Cellulose, colloidal silica and magnesium stearate, always mix.
(3) tabletting, coating, packaging.
Comparative example 3 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline Cellulose PH101 24g
Cross-linking sodium carboxymethyl cellulose 24g
Preparation process:
Put in wet-mixed machine by recipe quantity scheme for lacosamide, microcrystalline Cellulose PH101, cross-linking sodium carboxymethyl cellulose, in 15min, in mixer upper, middle and lower, three positions sample three parts respectively, measure content, calculate uniformity of dosage units.
Evaluate:
Test one: mensuration stripping curve (with reference to foundation: Chinese Pharmacopoeia 2010 editions two annex X C) the respectively tablet of Example 1 ~ 3 and comparative example 1 and comparative example 2 gained carries out stripping curve test, medium is the hydrochloric acid solution 900mL (get 9ml hydrochloric acid add water 1000mL mixing) of pH1.0, rotating speed: 50 revs/min, test solution temperature: 37 ± 0.5 DEG C, UV determined wavelength: 210nm, respectively at 5 minutes, 10 minutes, 15 minutes sampling 10mL test, add synthermal isopyknic dissolution medium simultaneously.The stripping data of result of the test and patent CN201210266439 are contrasted, the results are shown in Figure 1 and Fig. 2 and table 1.
The stripping Data Comparison result of table 1 embodiment 1 ~ 3 and patent CN201210266439
As can be seen from Table 1,5 minutes dissolutions of embodiment of the present invention 1--3 are obviously better than patent CN201210266439 embodiment 1--2; 10 minutes stripping data of patent CN201210266439 embodiment 1 ~ 2 are also not as 10 minutes stripping data of the embodiment of the present invention 1 ~ 3, and 15 minutes stripping data are basically identical, reach a conclusion thus: the present invention can reach the object of Fast Stripping when not using raw material inclusion technique, effect is better than prior art.
From Fig. 1 and Fig. 2, the dissolution of embodiment 1 ~ 3 (additional in disintegrating agent) each time point will apparently higher than comparative example 1 (disintegrating agent is additional) and comparative example 2 (adding in disintegrating agent).
Test two: measure angle of repose (with reference to foundation: " pharmaceutics " the 5th edition--People's Health Publisher)
Gauge: BT--1000 type Powder Determination instrument (Dandong Bai Te Instrument Ltd.)
Measuring process: vibration-free tables device is put in the locating hole of instrument central authorities, then put receiver and angle of repose sample bench.Shut at instrument Qianmen, get out sample, intervalometer is transferred to about 3 minutes, open vibration screen cover, open on and off switch and the vibrosieve switch of instrument, slowly feed in raw material at charge door with little spoon, material is trickled down on sample bench by screen cloth, discharging opening, forms cone.When sample falls full sample bench after cone symmetrically, stop reinforced, close vibrosieve power supply, goniometer to be placed on the left of sample tray and near stockpile, concordant with the inclined-plane of conical stockpile, measure angle of repose.Should measure angle of repose from three diverse locations when measuring angle of repose, then average, this meansigma methods is the angle of repose (θ r) of this sample.Result of the test is in table 2 and table 3.
(embodiment 1 ~ 3) comparing result angle of repose before and after the granulation of table 2 raw material
As shown in Table 2, after raw material is granulated, angle of repose, mobility was obviously improved, but also needs further improvement for suitability for industrialized production close to 40 ° (it is generally acknowledged angle of repose < 40 ° can adapt to suitability for industrialized production).
The additional front and back of table 3 diluent (embodiment 1 ~ 3) comparing result angle of repose
As shown in Table 3, diluent obviously reduces additional rear angle of repose, can meet the requirement of suitability for industrialized production completely.
Test three: measure bulk density (with reference to foundation: " pharmaceutics " the 5th edition--People's Health Publisher)
Get one, 50ml graduated cylinder, put in precision electronic balance, reset.Sample thief is appropriate, slowly adds in above-mentioned graduated cylinder, stops, accurately weighed example weight M1 (g) to during 20ml graduation mark.Put by graduated cylinder on testing stand, up-down vibration several times, no longer change to sample volume, record the volume V1 (ml) of now sample.Result of the test is in table 4.
(embodiment 1 ~ 3) bulk density comparing result before and after the granulation of table 4 raw material
As seen from the above table, after raw material is granulated, the bulk density of granule has remarkable increase.
Test four: uniformity of dosage units sample point, detection and computational methods (with reference to foundation: U.S. FDA " mixing homogeneity guide "-2003 editions)
Get each embodiment and comparative example 3 sample appropriate (being about equivalent to containing scheme for lacosamide 11mg), accurately weighed, put in 100ml volumetric flask, add purified water and dissolve rear standardize solution, be need testing solution.Get above-mentioned need testing solution and measure absorbance in 210nm place, calculate each sample content and uniformity of dosage units (limit: uniformity of dosage units RSD≤3%).Fig. 3 is seen in concrete sample position.Result of the test is in table 5.
Mixed material uniformity of dosage units comparing result is added in the different diluent of table 5.
As shown in Table 5, inside adding diluent adopts the uniformity of dosage units of microcrystalline Cellulose PH102 (embodiment 1 ~ 3) to be about about 1.5%, and use the uniformity of dosage units of microcrystalline Cellulose PH101 (comparative example 3) to be about 4%, can not ensure the homogeneity of mixed material.
Test five: stability test
This test is carried out with reference to Chinese Pharmacopoeia (version in 2010 two annex XIXC) stability test guideline.In accelerated test, sample obtained in embodiment 2 is placed in the environment of temperature 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%, detects when 1 month, 2 months, 3 months and 6 months respectively; In long term test, sample obtained in embodiment 2 is placed in the environment of temperature 25 DEG C ± 2 DEG C, relative humidity 60% ± 10%, detects when 3 months and 6 months, and data and patent CN201210266439 are contrasted.The results are shown in Table 6.
Table 6 embodiment 2 and the stability data comparing result contrasting patent (patent CN201210266439)
As can be seen from Table 6: the embodiment of the present invention 2 is placed 3 months under acceleration and long term test condition, the indexs such as character, dissolution, content and related substance have no significant change, therefore, the present invention does not need to carry out enclose process to raw material and can obtain good stabilizing effect equally.
Claims (10)
1. a scheme for lacosamide solid preparation, comprise scheme for lacosamide, in disintegrating agent, additional disintegrating agent, in add diluent, additional diluent, binding agent, fluidizer and lubricant.
2. solid preparation as claimed in claim 1, is characterized in that scheme for lacosamide content is 10% ~ 60% of described total formulation weight amount.
3. solid preparation as claimed in claim 1, it is characterized in that described in be cross-linking sodium carboxymethyl cellulose with disintegrating agent, consumption is 2.5% ~ 15% of total formulation weight amount.
4. solid preparation as claimed in claim 1, it is characterized in that described in add diluent be microcrystalline Cellulose PH102, consumption is 5% ~ 15% of total formulation weight amount.
5. solid preparation as claimed in claim 1, it is characterized in that described additional disintegrating agent is polyvinylpolypyrrolidone CL, consumption is 2.5% ~ 15% of total formulation weight amount.
6. solid preparation as claimed in claim 1, is characterized in that described additional disintegrating agent and the interior weight ratio with disintegrating agent are 1:1.
7. solid preparation as claimed in claim 1, it is characterized in that described additional diluent is for optimizing microcrystalline Cellulose, consumption is 10% ~ 35% of total formulation weight amount.
8. solid preparation as claimed in claim 1, is characterized in that described binder dosage is 0.5% ~ 3% of total formulation weight amount; Fluidizer consumption is 0.1% ~ 3% of total formulation weight amount; Lubricant quantity is 0.5% ~ 3% of total formulation weight amount.
9. prepare the method for the solid preparation in claim 1 ~ 8 described in any one, it is characterized in that, comprise the following steps: (1) by scheme for lacosamide, in disintegrating agent, in add mixing diluents evenly after add that binding agent is granulated, dry mixture one; (2) in mixture one, add additional diluent, additional disintegrating agent, fluidizer and lubricant, always mix, tabletting.
10. solid preparation as claimed in claim 1, it is characterized in that, can be general thin garment piece, oral cavity disintegration tablet, preferred general thin garment piece.
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| CN201510169440.4A CN104784134B (en) | 2015-04-12 | 2015-04-12 | A kind of scheme for lacosamide solid pharmaceutical preparation and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010301A (en) * | 2018-09-05 | 2018-12-18 | 上海上药第生化药业有限公司 | A kind of lacosamide crystal form II tablet and its preparation method and application |
| CN111000812A (en) * | 2020-01-03 | 2020-04-14 | 石药集团中奇制药技术（石家庄）有限公司 | Preparation method of lacosamide tablets |
| CN114522147A (en) * | 2020-11-23 | 2022-05-24 | 武汉武药科技有限公司 | Carglutamic acid solid preparation and preparation method thereof |
| CN115581676A (en) * | 2022-09-30 | 2023-01-10 | 澳美制药(苏州)有限公司 | Lacosamide tablet and preparation process thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110833528A (en) * | 2018-08-17 | 2020-02-25 | 北京万全德众医药生物技术有限公司 | Lacosamide liposome freeze-dried powder injection and preparation method thereof |
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| CN102885796A (en) * | 2012-07-30 | 2013-01-23 | 永光制药有限公司 | Lacosamide tablet for treating epilepsy and preparation method for lacosamide tablet |
| WO2014163314A1 (en) * | 2013-04-02 | 2014-10-09 | 주식회사 바이오파마티스 | Pharmaceutical composition capable of readily controlling dissolution pattern of lacosamide or pharmaceutically acceptable salt thereof |
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| CN101011362A (en) * | 2007-02-01 | 2007-08-08 | 山东益康药业有限公司 | Dispersible tablet of pidotimod and its preparing process and use |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109010301A (en) * | 2018-09-05 | 2018-12-18 | 上海上药第生化药业有限公司 | A kind of lacosamide crystal form II tablet and its preparation method and application |
| CN109010301B (en) * | 2018-09-05 | 2021-01-26 | 上海上药第一生化药业有限公司 | Lacosamide crystal form II tablet and preparation method and application thereof |
| CN111000812A (en) * | 2020-01-03 | 2020-04-14 | 石药集团中奇制药技术（石家庄）有限公司 | Preparation method of lacosamide tablets |
| CN114522147A (en) * | 2020-11-23 | 2022-05-24 | 武汉武药科技有限公司 | Carglutamic acid solid preparation and preparation method thereof |
| CN114522147B (en) * | 2020-11-23 | 2023-08-04 | 武汉武药科技有限公司 | Solid preparation of carboglutamic acid and preparation method thereof |
| CN115581676A (en) * | 2022-09-30 | 2023-01-10 | 澳美制药(苏州)有限公司 | Lacosamide tablet and preparation process thereof |
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| CN104784134B (en) | 2018-05-29 |
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