CN104784134B - A kind of scheme for lacosamide solid pharmaceutical preparation and preparation method thereof - Google Patents
A kind of scheme for lacosamide solid pharmaceutical preparation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of scheme for lacosamide solid pharmaceutical preparations and preparation method thereof, include scheme for lacosamide, interior plus disintegrant, additional disintegrant, interior plus diluent, additional diluent, adhesive, glidant and lubricant.The present invention solves in existing scheme for lacosamide quick-release tablet technology that raw material is loose light, mixes easily layering；Fine powder of pelletizing is more, poor fluidity；Preparation dissolution rate is relatively low, and inclusion technique needs special installation, and technique is cumbersome, the problem of being unfavorable for commercially producing.
Description
Technical field
The invention belongs to pharmaceutical technology fields more particularly to a kind of scheme for lacosamide solid pharmaceutical preparation and preparation method thereof.
Background technology
Scheme for lacosamide is a kind of new Glycine site nmda receptor antagonist, belongs to new class functional amino, grinds
Study carefully in terms of concentrating on its anti-epileptic and treatment nerve pain effect.External electrophysiologic study shows that scheme for lacosamide selectively promotes slowly
The activity of Voltage-gated sodium channels is inactivated, so as to the neuronal cell film of permanent anomaly excitement, inhibits neuron and touches repeatedly
Hair, but the normal physiology excitability of neuron is had no effect on, and neuronal excitability reduction is treatment epilepsy and neuropathic pain
Important molecule mechanism.In addition, scheme for lacosamide can mediate modulin with collapsin -- 2 (CRMP--2 is mainly distributed on
Phosphoprotein in nervous system) it combines.Have now found that epileptic's intracerebral CRMP--2 functional disturbances, therefore scheme for lacosamide conduct
Anticonvulsant drug with brand-new double action mechanism, in terms for the treatment of epileptic attack have it is higher the effect of.
EMEA (European Drug Administration) shows scheme for lacosamide poor fluidity to the report of evaluating of scheme for lacosamide, and raw material is through powder
Become abnormal loose after broken：Bulk density 0.11g/cm3, tap density 0.35g/cm3, Hao Senna ratios (Hausner ratio ratios) are
3.18, angle of repose is more than 50 ° of (China Medical Science Press《Pharmacy》The second edition mentions Hao Senna ratios more than 1.5, shows object
Expect that compressibility is very poor；Angle of repose is more than 45 °, shows that material fluidity is very poor), thus when raw material is mixed with auxiliary material easily lead
Cause material layering.
The patent CN201210266439 of Yongguang Pharmaceutical Co., Ltd.'s application discloses a kind of scheme for lacosamide for treating epilepsy
Piece and preparation method thereof, the invention prepare piece with conventional method again after being wrapped up using common inclusion material scheme for lacosamide
Agent.Clathrate process in this method is needed using special installations such as grinders, undergoes dissolving, grinding and dry step, not only
Technique is cumbersome, and time-consuming longer, at home under pharmaceutical industry current condition, it is difficult to which commercialization promotes and applies.Inventor passes through spy
Different disintegrant species and unique disintegrant feed postition make the present invention that need not first handle scheme for lacosamide raw material inclusion, but
It can achieve the effect that the dissolution rate for significantly improving preparation.
The content of the invention
Present invention aim to address raw material in existing scheme for lacosamide quick-release tablet technology is loose light, easily layering is mixed；
Fine powder of pelletizing is more, poor fluidity；Preparation dissolution rate is relatively low, and inclusion technique needs special installation, and technique is cumbersome, is unfavorable for business
The problem of metaplasia is produced.Inventor by test prove present invention accomplishes《Pharmacopeia》In to the requirements in solid pharmaceutical preparation and fit
For the industrialized production of domestic existing pharmaceutical technology.
The solid pharmaceutical preparation of the present invention contains the scheme for lacosamide for accounting for said preparation total weight 10%~60%, and chemical name is：
(R) -- 2-- acetamidos -- N-- benzyls -- 3-- methoxypropionamides, molecular formula be：C13H18N2O3, structural formula is：
The solid pharmaceutical preparation contains disintegrant, diluent, adhesive, glidant and profit necessary to reaching the object of the invention
Lubrication prescription, wherein, disintegrant and diluent are divided into interior additional two parts of adduction.
The physical attributes such as heap density and angle of repose of the present invention by measuring raw material and granulation particle are selected matched
Special type auxiliary material, and combine preparation process improvement, achieve the purpose that ensure formulation content together improve dissolution rate.
Interior plus diluent is to solve the problem of the loose light mixing easily layering of raw material, after raw material is made to pelletize, significantly improve particle
Heap density；Additional diluent can solve the problem of the more poor fluidities of fine powder after granulation；After additional disintegrant can make tablet meet water
Fater disintegration is particle, promotes the infiltration of moisture；It is tiny that interior plus disintegrant, which can then make to meet the rapid disintegration of water inside particle,
Particle.
In the solid pharmaceutical preparation of the present invention contains plus disintegrant, dosage in the formulation for total formulation weight 2.5%~
15%, interior plus disintegrant can be it is a kind of in croscarmellose sodium, sodium carboxymethyl starch and calcium carboxymethylcellulose or
Several mixtures.In currently preferred plus disintegrant is croscarmellose sodium, and preferable amount in the formulation is
The 5%~10% of total formulation weight.
The solid pharmaceutical preparation of the present invention adds diluent in containing, and dosage in the formulation is the 5%~15% of total formulation weight,
Interior plus diluent can be mixtures one or more of in microcrystalline cellulose, mannitol and dextrin.Add in currently preferred
Diluent is relatively close to for heap density and raw material, the microcrystalline cellulose PH102 of good fluidity (angle of repose close to 40), in order to
Loose raw material is uniformly mixed, and preferable amount in the formulation is the 8%~15% of total formulation weight.
The pharmaceutical preparation of the present invention contains at least one adhesive, and dosage in the formulation is the 0.5% of total formulation weight
~3%, adhesive can be one in hydroxypropylcellulose, hydroxypropyl methylcellulose, povidone, polyethylene glycol and sodium carboxymethylcellulose
Kind or several mixtures.Currently preferred adhesive is hydroxypropyl methylcellulose, and preferable amount in the formulation is total for preparation
The 0.5%~1% of weight.
The solid pharmaceutical preparation of the present invention contains additional disintegrant, dosage in the formulation for total formulation weight 2.5%~
15%, additional disintegrant is 1 with interior plus disintegrant weight ratio:1.Additional disintegrant can be crospovidone and low substitution hydroxyl
One or two kinds of mixture in third cellulose.Currently preferred additional disintegrant is crospovidone CL (bulk densitys
0.35g/cm3Left and right, tap density 0.50g/cm3Left and right, 110~130 μm of average grain diameter), in order to be mixed with particle, simultaneously
Mobility is not influenced, preferable amount in the formulation is the 5%~10% of total formulation weight.
The solid pharmaceutical preparation of the present invention contains additional diluent, dosage in the formulation for total formulation weight 10%~
35%, additional diluent can be that (German JRS companies production, is colloidal silicon dioxide and microcrystalline cellulose to optimization microcrystalline cellulose
Plain weight ratio 2：98 mixtures prepared), pregelatinized starch, (production of French Roquette Freres is mannitol/composites of starch
Mannitol is with starch weight than 80:20 mixtures prepared) and microcrystalline cellulose/glycerin monostearate compound (Ireland
Kai Airui groups produce, and are microcrystalline cellulose and glycerin monostearate weight ratio 98:2 mixture) in it is one or more of
Mixture.Currently preferred additional diluent is heap density and particle close to (bulk density 0.35g/cm3Left and right, tap density
0.46g/cm3Left and right), the optimization microcrystalline cellulose of good fluidity (angle of repose be less than 35,110 μm of average grain diameter), in order to
Particle is uniformly mixed, while improves mobility, and preferable amount in the formulation is the 20%~30% of total formulation weight.
The solid pharmaceutical preparation of the present invention contains at least one glidant, and dosage in the formulation is the 0.1% of total formulation weight
~3%, glidant can be mixtures one or more of in colloidal silicon dioxide and talcum powder.Currently preferred glidant
For colloidal silicon dioxide, preferable amount in the formulation is the 0.5%~1% of total formulation weight.
The pharmaceutical preparation of the present invention contains at least one lubricant, and dosage in the formulation is the 0.5% of total formulation weight
~3%, lubricant can be magnesium stearate, stearic acid, hydrogenated vegetable oil, sodium stearyl fumarate, Compritol 888 ATO and poly- second
One or more of mixture in glycols.Currently preferred lubricant is magnesium stearate, and preferable amount in the formulation is
The 0.5%~1% of total formulation weight.
In addition, the present invention also provides a kind of preparation methods of scheme for lacosamide solid pharmaceutical preparation, which is characterized in that including following
Step：(1) scheme for lacosamide, interior plus disintegrant, interior plus diluent are added in into adhesive granulation, dry mixture after mixing
One；(2) additional diluent, additional disintegrant, glidant and lubricant are added in into mixture one, total mixed, tabletting.
The solid pharmaceutical preparation of the present invention is to be suitble to oral immediate release drug formulations, can be general thin garment piece, Orally disintegrating
Piece, capsule etc., preferred tablet, particularly preferred general thin garment piece.It is optional that tablet is coated, it is led using pharmacy
The gastric solubility coating material of domain routine, such as based on the hydroxypropyl methylcellulose or polyvinyl alcohol of various molecular weight.In addition the bag
Clothing can contain conventional pigment, such as titanium dioxide etc..
Description of the drawings
Additional (Examples 1 to 3) is with adding (comparative example 2) stripping curve comparison diagram in Fig. 1 disintegrants in disintegrant
Additional (Examples 1 to 3) and additional (comparative example 1) the stripping curve comparison diagram of disintegrant in Fig. 2 disintegrants
The specific sample position schematic diagrames of Fig. 3,1--9 is respectively to sample specific location in figure
Specific embodiment
The present invention is described in further detail by the following examples, but the invention is not limited in these embodiments.
Embodiment 1 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH102 24g
Croscarmellose sodium 24g
Hydroxypropyl methylcellulose 2.4g
Crospovidone CL 24g
Optimize microcrystalline cellulose 60g
Colloidal silicon dioxide 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process：
(1) recipe quantity scheme for lacosamide, microcrystalline cellulose PH102, croscarmellose sodium are put in wet-mixing machine,
In 15min at separately sampled three parts of the position in mixer upper, middle and lower three, measure content calculates uniformity of dosage units.Granulation, drying
Obtain mixture one.
(2) optimization microcrystalline cellulose, crospovidone CL, colloidal silicon dioxide and stearic acid are added in into mixture one
Magnesium, it is total mixed.
(3) tabletting is coated, packaging.
Embodiment 2 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH102 36g
Croscarmellose sodium 12g
Hydroxypropyl methylcellulose 2.4g
Crospovidone CL 12g
Optimize microcrystalline cellulose 72g
Colloidal silicon dioxide 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process：
(1) recipe quantity scheme for lacosamide, microcrystalline cellulose PH102, croscarmellose sodium are put in wet-mixing machine,
In 15min at separately sampled three parts of the position in mixer upper, middle and lower three, measure content calculates uniformity of dosage units.Granulation, drying
Obtain mixture one.
(2) optimization microcrystalline cellulose, crospovidone CL, colloidal silicon dioxide and stearic acid are added in into mixture one
Magnesium, it is total mixed.
(3) tabletting is coated, packaging.
Embodiment 3 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH102 30g
Croscarmellose sodium 18g
Hydroxypropyl methylcellulose 2.4g
Crospovidone CL 18g
Optimize microcrystalline cellulose 66g
Colloidal silicon dioxide 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process：
(1) recipe quantity scheme for lacosamide, microcrystalline cellulose PH102, croscarmellose sodium are put in wet-mixing machine,
In 15min at separately sampled three parts of the position in mixer upper, middle and lower three, measure content calculates uniformity of dosage units.Granulation, drying
Obtain mixture one.
(2) optimization microcrystalline cellulose, crospovidone CL, colloidal silicon dioxide and stearic acid are added in into mixture one
Magnesium, it is total mixed.
(3) tabletting is coated, packaging.
It is compared for convenience of with embodiment, spy enumerates following comparative example, carries out comparative study.
Comparative example 1 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH102 24g
Hydroxypropyl methylcellulose 2.4g
Crospovidone CL 48g
Optimize microcrystalline cellulose 60g
Colloidal silicon dioxide 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process：
(1) by recipe quantity scheme for lacosamide, microcrystalline cellulose PH102 pelletizes, dries to obtain mixture one after mixing.
(2) optimization microcrystalline cellulose, crospovidone CL, colloidal silicon dioxide and stearic acid are added in into mixture one
Magnesium, it is total mixed.
(3) tabletting is coated, packaging.
Comparative example 2 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH102 24g
Croscarmellose sodium 48g
Hydroxypropyl methylcellulose 2.4g
Optimize microcrystalline cellulose 60g
Colloidal silicon dioxide 2.4g
Magnesium stearate 2.4g
Gastric solubility film coating pre-mix dose 7.2g
Preparation process：
(1) by recipe quantity scheme for lacosamide, microcrystalline cellulose PH102, croscarmellose sodium pelletize after mixing,
Dry mixture one.
(2) optimization microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate are added in into mixture one, it is total mixed.
(3) tabletting is coated, packaging.
Comparative example 3 (1000 amounts)
Scheme for lacosamide 100g
Microcrystalline cellulose PH101 24g
Croscarmellose sodium 24g
Preparation process：
Recipe quantity scheme for lacosamide, microcrystalline cellulose PH101, croscarmellose sodium are put in wet-mixing machine, in
15min calculates uniformity of dosage units in separately sampled three parts of the position in mixer upper, middle and lower three, measure content.
Evaluation：
Experiment one：Stripping curve is measured (with reference to foundation：2010 editions two annex X C of Chinese Pharmacopoeia) difference Example 1
~3 and the tablet of comparative example 1 and the gained of comparative example 2 carry out stripping curve test, medium is that the hydrochloric acid solution 900mL of pH1.0 (takes
9ml hydrochloric acid adds water 1000mL mixings), rotating speed：50 revs/min, test solution temperature：37 ± 0.5 DEG C, UV Detection wavelengths：
210nm respectively at 5 minutes, 10 minutes, sampling 10mL tests in 15 minutes, while adds synthermal isometric dissolution medium.It will
Result of the test and the dissolution data of patent CN201210266439 are compared, the result is shown in Figure 1 and Fig. 2 and table 1.
1 Examples 1 to 3 of table and the dissolution data comparison result of patent CN201210266439
As can be seen from Table 1,5 minutes dissolution rates of 1--3 of the embodiment of the present invention are implemented than patent CN201210266439
Example 1--2 is substantially good；10 minutes dissolution data of patent CN201210266439 Examples 1 to 2 are also not so good as the embodiment of the present invention 1
~3 10 minutes dissolution data, and 15 minutes dissolution data are basically identical, it follows that conclusion：The present invention is without using raw material
It can achieve the purpose that Fast Stripping in the case of inclusion technique, effect is better than the prior art.
From Fig. 1 and Fig. 2, the dissolution rate at Examples 1 to 3 (additional in disintegrant) each time point will be apparently higher than comparison
Example 1 (disintegrant is additional) and comparative example 2 (adding in disintegrant).
Experiment two：Angle of repose is measured (with reference to foundation：《Pharmacy》5th edition -- People's Health Publisher)
Measuring instrument：BT--1000 type Powder Determinations instrument (Dandong Bai Te Instrument Ltd.)
Measurement process：Vibration-free tables device is put into the location hole in instrument center, then puts receiver and angle of repose sample table.
Instrument front door is shut, gets out sample, timer is transferred to 3 minutes or so, opens vibration screen cover, opens the power switch of instrument
It switchs with vibrating screen, is slowly fed in charge door with small spoon, material is trickled down by sieve, discharge port on sample table, forms cone
Body.When sample full of sample table and in symmetrical cone after, stop charging, close vibrating screen power supply, goniometer is placed in examination
It is concordant with the inclined-plane of cone material heap simultaneously close to material heap on the left of sample pallet, measure angle of repose.It should be from three not when measuring angle of repose
It with position finding angle of repose, is then averaged, which is the angle of repose (θ r) of this sample.Result of the test is shown in Table 2 Hes
Table 3.
(Examples 1 to 3) angle of repose comparing result before and after the granulation of 2 raw material of table
As shown in Table 2, after raw material granulation, angle of repose is already close to 40 ° (it is generally acknowledged that 40 ° of angle of repose ＜ is adapted to work
Industry metaplasia is produced), mobility is obviously improved, but also needs to further improve for industrialized production.
Additional front and rear (Examples 1 to 3) angle of repose comparing result of 3 diluent of table
As shown in Table 3, angle of repose is obviously reduced after diluent is additional, can meet the requirement of industrialized production completely.
Experiment three：Heap density is measured (with reference to foundation：《Pharmacy》5th edition -- People's Health Publisher)
One, 50ml graduated cylinders are taken, are put in precision electronic balance, are reset.It takes sample appropriate, is slowly added into above-mentioned graduated cylinder, until
Stop during 20ml graduation marks, accurately weighed example weight M1 (g).Graduated cylinder is put on testing stand, up-down vibration several times, until sample
Volume no longer changes, and records the volume V1 (ml) of sample at this time.Result of the test is shown in Table 4.
(Examples 1 to 3) heap density comparing result before and after the granulation of 4 raw material of table
As seen from the above table, after raw material granulation, the heap density of particle dramatically increases.
Experiment four：Uniformity of dosage units sample point, detection and computational methods are (with reference to foundation：U.S. FDA《Mixture homogeneity refers to
South》- 2003 editions)
Take each embodiment and 3 sample of comparative example appropriate (being approximately equivalent to containing scheme for lacosamide 11mg), it is accurately weighed, put 100ml
In volumetric flask, add constant volume after purifying water dissolution, be test solution.Above-mentioned test solution is taken to measure extinction at 210nm
Degree calculates each sample content and uniformity of dosage units (limit：Uniformity of dosage units RSD≤3%).Fig. 3 is seen in specific sample position.Experiment
It the results are shown in Table 5.
Add mixed material uniformity of dosage units comparing result in the different diluents of table 5.
As shown in Table 5, the interior uniformity of dosage units that diluent is added to use microcrystalline cellulose PH102 (Examples 1 to 3) is about
1.5% or so, and the use of the uniformity of dosage units of microcrystalline cellulose PH101 (comparative example 3) is about 4%, it cannot be guaranteed mixing
The homogeneity of material.
Experiment five：Stability test
This experiment is carried out with reference to Chinese Pharmacopoeia (the two annex XIXC of version in 2010) stability test guideline.Accelerating
In experiment, sample obtained in embodiment 2 is placed in the environment of 40 DEG C ± 2 DEG C of temperature, relative humidity 75% ± 5%, point
It was not detected at 1 month, 2 months, 3 months and 6 months；In long term test, sample obtained in embodiment 2 is placed
25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10% environment in, be detected at 3 months and 6 months, and by data
It is compared with patent CN201210266439.It the results are shown in Table 6.
The stability data comparing result of 6 embodiment 2 of table and comparison patent (patent CN201210266439)
As can be seen from Table 6：The embodiment of the present invention 2 is accelerating to place 3 months under the conditions of long term test, character, dissolution
The indexs such as degree, content and related substance have no significant change, and therefore, the present invention need not carry out raw material inclusion processing and equally may be used
To obtain good stabilizing effect.
Claims (4)
1. a kind of scheme for lacosamide solid pharmaceutical preparation, comprising scheme for lacosamide, interior plus disintegrant, additional disintegrant, interior plus diluent, additional
Diluent, adhesive, glidant and lubricant；
Wherein scheme for lacosamide content is the 10%~60% of the total formulation weight；
The interior plus disintegrant is croscarmellose sodium, and dosage is the 2.5%~15% of total formulation weight；
The additional disintegrant is crospovidone CL, and dosage is the 2.5%~15% of total formulation weight；
The additional disintegrant is 1 with interior plus disintegrant weight ratio:1；
The interior plus diluent is microcrystalline cellulose PH102, and dosage is the 5%~15% of total formulation weight；
The additional diluent is optimization microcrystalline cellulose, and dosage is the 10%~35% of total formulation weight.
2. scheme for lacosamide solid pharmaceutical preparation as described in claim 1, it is characterised in that the binder dosage is total formulation weight
The 0.5%~3% of amount；Glidant dosage is the 0.1%~3% of total formulation weight；Lubricant quantity is total formulation weight
0.5%~3%；
Described adhesive is a kind of in hydroxypropylcellulose, hydroxypropyl methylcellulose, povidone, polyethylene glycol and sodium carboxymethylcellulose
Or several mixture；
The glidant is mixtures one or more of in colloidal silicon dioxide and talcum powder；
The lubricant is magnesium stearate, stearic acid, hydrogenated vegetable oil, sodium stearyl fumarate, Compritol 888 ATO and poly- second two
One or more of mixture in alcohols.
3. preparing the method for the scheme for lacosamide solid pharmaceutical preparation according to claim 1-2 any claims, feature exists
In comprising the following steps：(1) by scheme for lacosamide, interior plus disintegrant, interior plus diluent add in after mixing adhesive granulation,
Dry mixture one；(2) additional diluent, additional disintegrant, glidant and lubricant are added in into mixture one, it is total mixed,
Tabletting.
4. scheme for lacosamide solid pharmaceutical preparation as described in claim 1, which is characterized in that it is that general thin garment piece or oral cavity collapse
Solve piece.
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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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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN111000812B (en) * | 2020-01-03 | 2021-06-18 | 石药集团中奇制药技术（石家庄）有限公司 | Preparation method of lacosamide tablets |
| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102816083A (en) * | 2012-07-30 | 2012-12-12 | 永光制药有限公司 | Preparation method of lacosamide |
| 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 |
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| KR101732731B1 (en) * | 2013-04-02 | 2017-05-08 | 주식회사 바이오파마티스 | Pharmaceutical compositions for easy control of releasing pattern of lacosamide or pharmaceutically acceptable salts thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN102816083A (en) * | 2012-07-30 | 2012-12-12 | 永光制药有限公司 | Preparation method of lacosamide |
| 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 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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