CN103948553A - Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet - Google Patents
Lamotrigine sustained release tablet and preparation method of lamotrigine sustained release tablet Download PDFInfo
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- CN103948553A CN103948553A CN201410162902.5A CN201410162902A CN103948553A CN 103948553 A CN103948553 A CN 103948553A CN 201410162902 A CN201410162902 A CN 201410162902A CN 103948553 A CN103948553 A CN 103948553A
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Abstract
The invention aims to provide a lamotrigine sustained release tablet, which is stable in drug release and higher in medication safety and is characterized by comprising lamotrigine with the effective therapeutic dose and physiologically acceptable pharmaceutical accessories. The lamotrigine sustained release tablet disclosed by the invention has the characteristics of being convenient for drug delivery, lasting in effect, stable in curative effect, low in toxic and side effect and the like.
Description
Invention field
The present invention relates to a kind of pharmaceutical preparation for the treatment of epilepsy and preparation method thereof, belong to the medication of neurosurgery class disease, be specifically related to a kind of lamotrigine slow releasing tablet and preparation method thereof.
Background of invention
Lamotrigine, 3,5-diaminourea-6-(2,3-Dichlorobenzene base)-1,2,4-triazine is disclosed in US4602017 and EP0021121.The LAMICTAL by name of the commodity containing lamotrigine product being sold on market by GlaxoSmithKline group of companies
tM.These products comprise that at treatment CNS disease, particularly epilepsy, pain, edema, multiple sclerosis and psychosis indication bipolarity mental disorder (bipolar disorder) is effective especially.
The various tablet formulations of lamotrigine have been ratified for selling, for example, and containing conventional tabletting instantaneous relase (IR) tablet of 25mg, 50mg, 100mg, 150mg or 200mg active component.These tablet formulations are administered once every day, twice or three times.For joining containing for the lamotrigine in the antuepileptic therapeutic scheme of valproic acid, during the 1st week and the 2nd week, every other day titration 25mg, during the 3rd week and the 4th week, is increased to 25mg every day.After this starting stage, by increasing dosage 25-50mg/ days, can reach the maintenance dose of 100-400mg/ days.If lamotrigine is joined in the enzyme induction antuepileptic (EIAEDS) without valproic acid, the dosage during the 1st week and the 2nd week is 50mg/ days so, and thereafter, dosage is 100mg/ days, and be administered twice every day.In order to reach the maintenance dose of 300-500mg/ days being administered twice every day, every 1-2 weekly dose can increase 100mg/ days.These dosage regimens provide the lamotrigine of therapeutic dose.
In addition, WO92/13527 has described the tablet formulation that comprises water dispersible tablets (containing lamotrigine and a kind of dispersant), wherein this water dispersible tablets comprises lamotrigine and dispersant, wherein said dispersant is that for example Montmorillonitum of a kind of expansive clay and its are present in the granule of described tablet conventionally, to obtain a kind of a kind of tablet that passes through 710 μ m filter screen dispersion liquids that can be dispersed in water to obtain in 3 minutes.Described in the time that jitter time is less than 5 minutes, tablet can optionally carry out film coatings.Cash sale is sold and can wholely be swallowed, chew or be dispersed in the bite-dispersion tablets agent in a small amount of water, and it is containing 2mg, 5mg, 25mg or 100mg active component, and these give pediatric patients conventionally.
The commercially available other medicines that are used for the treatment of epilepsy are, but be not limited to, carbamazepine (TegretolTM), valproate (Depakote TM), tiagabine (Gabitril TM), levetiracetam (levetiracetam, Keppra TM), gabapentin (Neurontin TM) and phenytoin (Dilantin TM).Carbamazepine has instantaneous relase tablet, time delay to discharge chewable tablet (CarbatroI, time delay discharges pearl) or Tegretol-XR osmotic tablet and oral administration liquid.Third defends hydrochlorate instantaneous relase tablet and suspension.In the U.S., valproate has divalproex sodium (Depakote), a kind of (coatings) tablet that makes the hangover, and it contains sodium valproate+valproate of 1:1 in preparation, and makes the divalproex sodium ER of hangover.Gabapentin, tiagabine and levetiracetam have instantaneous relase tablet.Di Lanting has the form of " kapseal " can change release.
The tablet formulation of the lamotrigine of selling on market now, once arrive in stomach release of active ingredients immediately.Any time point that I.4-4.8 peak plasma concentration appears at after administration hour.Its shortcoming is that the plasma concentration (pharmacokinetics curve (PK)) that conventional tablet obtains is periodically, obtains a peak plasma concentration after administration, then before upper once administration, occurs a plasma concentration low ebb.
Particularly for the treatment of epilepsy, low ebb may cause explosive epilepsy, in some patient, peak plasma concentration may cause the generation of some adverse effect (AE), or at the initial stage before reaching peak plasma concentration, the growth rate of plasma concentration also may affect the distribution of AE.
Also do not know at present whether lamotrigine is absorbed in gastrointestinal tract.Carrying out in the process of local absorption research, recent findings is in the time that medicine is transported to any point between the harmonization of the stomach ascending colon in gastrointestinal tract, and the trap of lamotrigine is identical.No matter the medicine giving is solid or liquid, their trap is also identical.
An advantage of slow releasing preparation is the compliance that has increased patient.
Socio-economic factor can not affect compliance: rich, good education and healthy patient probably has identical compliance with the patient outside these kinds.In most cases, epilepsy is a kind of lifelong disease, and it needs consistent and enough antuepileptic (AED) blood level with earth control epilepsy.In addition, it is conventionally believed that, each epilepsy may increase the risk that epilepsy occurs again, and worsens total prediction.Therefore be, AED level and the prevention epilepsy subsequently that remains enough to epilepsy patient's primary treatment object.The dosage regimen of complying with appointment is absolutely necessary to maintaining treatment blood level.
Epilepsy patient treats through conventional multi-medicament.The patient who suffers from serious epilepsy or intractable epilepsy epilepsy often needs the composite reagent of two or more AEDs, to control fully epilepsy.In addition, the patient who simultaneously suffers from other chronic complicating diseases for example depression, heart disease or diabetes also needs to adhere to dosage regimen every day, and this point is very general.
The treatment of bipolarity mental disorder is recommended to be administered once for one day at present, reduces but preparation of the present invention rises the plasma concentration of medicine, therefore can predict, and preparation of the present invention has brought useful effect to patient.
For the treatment of pain, every day, a slice was highly profitable because pain is a lasting morbid state, therefore by by day or the most weak proper timing of patient's pain in evening Cmax is provided, slow releasing preparation will slow down patient's pain.
The invention provides a kind of lamotrigine slow releasing tablet, can significantly treat epilepsy, processing technology is simple, and dissolution is reliable and stable.
Summary of the invention
The invention provides a kind of lamotrigine slow releasing tablet, can significantly treat epilepsy, processing technology is simple, and dissolution is reliable and stable.
On the one hand, the invention provides one 1, a kind of lamotrigine slow releasing tablet, wherein said slow releasing tablet is made up of lamotrigine, controlled-release material, filler, binding agent, lubricant, and described lamotrigine consumption accounts for 10～50% of recipe quantity.
Some embodiments therein, slow releasing tablet of the present invention, wherein said controlled-release material is selected from one or more in hydroxypropyl methylcellulose K100, ethyl cellulose, methylcellulose, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, sodium alginate, cellulose diacetate, Triafol T, glyceryl monostearate, hydroxy methocel, and described controlled-release material consumption accounts for 0～50% of recipe quantity.
Some embodiments therein, slow releasing tablet of the present invention, wherein said filler is selected from microcrystalline Cellulose, mannitol, low-substituted hydroxypropyl cellulose, polyvinyl alcohol, poly-phthalic acid vinyl acetate, Polyethylene Glycol, chitosan, sucrose, lactose, starch, dextrin, Icing Sugar, crosslinked polyethylene than coughing up one or more in protective embankment ketone, cross-linking sodium carboxymethyl cellulose, pregelatinized Starch, titanium dioxide, and described filler loading accounts for 0～50% of recipe quantity.
Some embodiments therein, slow releasing tablet of the present invention, wherein said binding agent is selected from one or more in water, ethanol, dehydrated alcohol, starch slurry, PVP K30, crospolyvinylpyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families, and described binder dosage accounts for 0～20% of recipe quantity.
Some embodiments therein, slow releasing tablet of the present invention, wherein said lubricant is selected from one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month extension alcohol magnesium sulfate, and described lubricant quantity accounts for 0.1～10% of recipe quantity.
Some embodiments therein, slow releasing tablet of the present invention, wherein said slow releasing tablet is made up of following component:
Some embodiments therein, slow releasing tablet of the present invention, wherein said slow releasing tablet is made up of following component:
On the other hand, the present invention relates to a kind of preparation method of slow releasing tablet of the present invention, it comprises following steps: (1) prepares binding agent and get the binding agent of recipe quantity and make the binding agent of 10% (W/W), for subsequent use; (2) granulate after 80 orders sieve respectively by lamotrigine, filler, together put into mixer-granulator with controlled-release material, filler, mix, evenly, add suitable amount of adhesive to carry out wet granulation, take out the granule 20 mesh sieves granulate that wets, after oven dry, cross 20 mesh sieve granulate, for subsequent use; (3) tabletting is by the lubricant of the granule making and recipe quantity, and after mix homogeneously, detection level is determined sheet weight, tabletting.
Lamotrigine is made to slow releasing tablet and there is following advantage:
1, with conventional formulation comparison, slow releasing preparation rate of releasing drug is steady, approaches Zero order rate process, can overcome " peak valley " phenomenon producing after ordinary preparation multiple dose administration.After conventional formulation is taken medicine, drug level rises to rapidly maximum, and then due to metabolism, excretion and Degradation, reduce rapidly again, drug level is controlled between minimum effective drug concentration and maximum safe concentration more difficult;
2, can make in body the effective blood drug concentration length of holding time, and steadily, utilization ratio of drug can reach 80～90%, and the utilization rate of conventional medicine is only 40～60%;
3, can reduce medicine to gastrointestinal side effect.Conventional formulation is due to disintegrate stripping rapidly in intestinal after oral, large to GI irritation, makes controlled release preparation and can reduce side effect;
4, obviously extended the medicine constant release time, therefore reduced medicining times, improve patient's compliance, alleviate and irritate and untoward reaction, be specially adapted to the medicine that short need of half-life are frequently taken.
5, slow releasing tablet steady quality of the present invention, release profiles is consistent with contrast medicine.Clinical trial simultaneously proves, with the current own lamotrigine slow releasing tablet bioequivalence through listing.
Excipient of the present invention comprises, but be not limited to, ion-exchanger, aluminum, aluminium stearate, lecithin, serum albumin, as human albumin, buffer substance is as phosphate, glycine, sorbic acid, potassium sorbate, the partial glycerol ester admixture of saturated vegetable fatty acid, water, salt or electrolyte, as protamine sulfate, sodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salt, colloid silicon, magnesium trisilicate, polyvinylpyrrolidone, polyacrylate, wax, polyethylene-polyoxypropylene-blocking-up polymer, lanoline, sugar, as lactose, dextrose plus saccharose, starch is as corn starch and potato starch, the derivant of cellulose and it is as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate, natural gum powder, Fructus Hordei Germinatus, gelatin, Pulvis Talci, adjuvant is as cocoa butter and suppository wax, oily as Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, safflower oil, Oleum Sesami, olive oil, Semen Maydis oil and Oleum Glycines, glycols compound, as propylene glycol and Polyethylene Glycol, esters is as ethyl oleate and ethyl laurate, agar, buffer agent is as magnesium hydroxide and aluminium hydroxide, alginic acid, pyrogen-free water, Deng oozing salt, Lin Ge (family name) solution, ethanol, phosphate buffer solution, and other nontoxic proper lubrication agent are as sodium laurylsulfate and magnesium stearate, coloring agent, releasing agent, coating dress material, sweeting agent, flavoring agent and spice, antiseptic and antioxidant.
Pharmaceutical composition of the present invention can also optionally contain one or more diluent.The example of diluent comprises mannitol, sorbitol, biphosphate calcium dihydrate, microcrystalline Cellulose and efflorescence cellulose.Preferred diluent is microcrystalline Cellulose.Microcrystalline Cellulose can be obtained from several suppliers, comprises Avicel PH101, Avicel PH102, Avicel PH103, Avicel PH105 and Avicel PH200 that FMC Corporation manufactures.
Pharmaceutical composition of the present invention can also optionally contain disintegrating agent.Disintegrating agent can be the one in several modified starches, modified cellulose polymer or polycarboxylic acids, such as crosslinked Carboxymethyl cellulose sodium, Explotab, polacrilin potassium and calcium carboxymethylcellulose (CMCCalcium).In one embodiment, disintegrating agent is croscarmellose sodium.Croscarmellose sodium NF type A obtains with trade name " Ac-di-sol " on market.
Pharmaceutical composition of the present invention can also optionally contain one or more surfactants or wetting agent.Surfactant can be anion, cation or neutral surface active agent.Anion surfactant comprises sodium lauryl sulfate, dodecyl sodium sulfate, oleyl sodium sulfate and the sodium laurate mixing with stearate and Talcum.Cationic surfactant comprises benzalkonium chloride and alkyl trimethyl ammonium bromide.Neutral surface active agent comprises glycerol list olein, polyoxyethylene sorbitan fatty acid ester, polyvinyl alcohol and anhydro sorbitol fat.The embodiment of wetting agent comprises poloxamer, polyoxyethylene alkyl ether, castor oil derivatives and polyoxyethylene 8 stearate fat.
The present invention can also optionally join antioxidant in preparation, thereby gives its chemical stability.Antioxidant is selected from the extract of a-tocopherol, Y-tocopherol, S-tocopherol, tocopherol enrichment natural origin, sodium or calcium salt, the Vitamin C acyl cetylate of L-AA and it, amass wealth by heavy taxation propyl propionate, amass wealth by heavy taxation misery ester, amass wealth by heavy taxation sour dodecyl ester, Yoshinox BHT (BHT) and butylated hydroxyanisol (BHA).In one embodiment, antioxidant is BHT or BHA.
The preferred dosage form of drug composition of the present invention is the tablet of preparing by compression method.Described tablet can carry out film with the mixture such as hydroxypropyl cellulose and hydroxypropyl emthylcellulose, contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian in this mixture; The mixture of polyvinyl alcohol (PVA) and Polyethylene Glycol (PEG), contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian; Or any other suitable instant-free coating agent.Coating provides taste masked and other stability to final tablet.What commercially available film provided for Colorcon is preparation mixture of powders
The present invention can also add sweeting agent and/or fumet.
Detailed description of the invention
Further explain the present invention below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1
Prescription:
Preparation process
1, the PVP K30 that preparation polyvidone alcoholic solution is got recipe quantity is made the alcoholic solution of 10% (w/w), for subsequent use;
2, granulate after 80 orders sieve respectively by lamotrigine, mannitol, together put into mixer-granulator with hypromellose, microcrystalline Cellulose, mix, add polyvidone alcoholic solution to carry out wet granulation after evenly, take out the granule 20 mesh sieves granulate that wets.After oven dry, cross 20 mesh sieve granulate, for subsequent use.
3, tabletting is by the magnesium stearate of the granule making and recipe quantity, and after mix homogeneously, detection level is determined sheet weight, with φ 16x7 stamping.
Embodiment 2
Prescription:
Preparation process
1, preparation crospolyvinylpyrrolidone alcoholic solution, the crospolyvinylpyrrolidone of getting recipe quantity is made the alcoholic solution of 10% (w/w), for subsequent use;
2, granulate after 80 orders sieve respectively by lamotrigine, lactose, together put into mixer-granulator with hypromellose, microcrystalline Cellulose, mix, add polyvidone alcoholic solution to carry out wet granulation after evenly, take out the granule 20 mesh sieves granulate that wets.After oven dry, cross 20 mesh sieve granulate, for subsequent use.
3, tabletting is by the magnesium stearate of the granule making and recipe quantity, and after mix homogeneously, detection level is determined sheet weight, with φ 16x7 stamping.
Embodiment 3
Prescription:
Preparation process
1, preparation polyvidone alcoholic solution, the polyvidone of getting recipe quantity is made the alcoholic solution of 10% (W/W), for subsequent use;
2, granulate after 80 orders sieve respectively by lamotrigine, mannitol, together put into mixer-granulator with hypromellose, microcrystalline Cellulose, mix, add polyvidone alcoholic solution to carry out wet granulation after evenly, take out the granule 20 mesh sieves granulate that wets.After oven dry, cross 20 mesh sieve granulate, for subsequent use.
3, tabletting is by the magnesium stearate of the granule making and recipe quantity, and after mix homogeneously, detection level is determined sheet weight, with φ 16x7 stamping.
Biological activity test
In order to investigate release in vitro effect of the present invention, according to drug release determination method (two annex X D first methods of Chinese Pharmacopoeia version in 2005), apparatus presses dissolution method the second subtraction unit, measured the vitro release of lamotrigine slow releasing tablet prepared by the present invention.
Taking 0.2% sodium dodecyl sulfate solution 900ml as solvent, rotating speed is per minute 75 to turn, and operation, got respectively solution 5ml at 2 hours, 4 hours, 8 hours and 12 hours in accordance with the law, filter, and the instant solution that supplements same volume in process container.Measure respectively subsequent filtrate appropriate, measure according to the method under assay item.Separately get lamotrigine reference substance (the commercially available slow releasing tablet of GSK, specification: 50mg) appropriate, accurately weighed, also quantitatively dilute and become the solution of every 1ml containing 10 μ g by same dissolution with solvents, be measured in the same method.
Calculate respectively the every burst size at different time.Slow releasing tablet of the present invention is in the burst size of 2 hours, 4 hours, 8 hours and 12 hours.Lamotrigine slow releasing tablet prepared by the embodiment of the present invention, release characteristic is as shown in table 1.
Result of the test shows, the former patent drugs lamotrigine slow releasing tablet release in vitro behavior of grinding of the lamotrigine slow releasing tablet of preparing according to embodiment 1 and GlaxoSmithKline PLC company has concordance.
For the lamotrigine slow releasing tablet curative effect that further checking is prepared according to embodiment 1, carry out Bioequivalence Test.
50 men's health experimenters divide two groups to carry out single dose test, the bioavailability of the lamotrigine slow releasing tablet that the lamotrigine slow releasing tablet that mensuration is prepared according to embodiment 1 is produced with respect to GlaxoSmithKline PLC company.After single oral dose lamotrigine slow release test film and reference sheet (being lamotrigine 50mg/ sheet x2 sheet), the blood drug level of measuring lamotrigine through time process calculate the main pharmacokinetic parameter of tested and reference preparation Chinese medicine.50 experimenter's single oral dose reference preparation lamotrigine slow releasing tablet 100mg (50mg/ sheet x2 sheet) and be subject to test preparation lamotrigine slow releasing tablet 100mg (50mg/ sheet x2 sheet), result shows, the former patent drugs lamotrigine slow releasing tablet of grinding of the lamotrigine slow releasing tablet of preparing according to embodiment 1 and GlaxoSmithKline PLC company, press AUC ∞ and say calculating, when single dose test, in test preparation, the relative bioavailability of lamotrigine is 109.3 ± 12.7%.AUC and C
maxthrough number conversion rear difference analysis is checked, T
maxthrough Wilcoxon signed rank test, the difference that shows that there are no significant.AUC and C
maxto showing through two one-side t-inspections after number conversion, test preparation and reference preparation bioequivalence.
Claims (8)
1. a lamotrigine slow releasing tablet, wherein said slow releasing tablet is made up of lamotrigine, controlled-release material, filler, binding agent, lubricant, and described lamotrigine consumption accounts for 10～50% of recipe quantity.
2. slow releasing tablet according to claim 1, wherein said controlled-release material is selected from one or more in hydroxypropyl methylcellulose K100, ethyl cellulose, methylcellulose, Hydroxypropyl Methylcellulose Phathalate, cellulose acetate-phthalate, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl-cellulose, cellulose acetate, sodium alginate, cellulose diacetate, Triafol T, glyceryl monostearate, hydroxy methocel, and described controlled-release material consumption accounts for 0～50% of recipe quantity.
3. slow releasing tablet according to claim 1, wherein said filler is selected from microcrystalline Cellulose, mannitol, low-substituted hydroxypropyl cellulose, polyvinyl alcohol, poly-phthalic acid vinyl acetate, Polyethylene Glycol, chitosan, sucrose, lactose, starch, dextrin, Icing Sugar, crosslinked polyethylene than coughing up one or more in protective embankment ketone, cross-linking sodium carboxymethyl cellulose, pregelatinized Starch, titanium dioxide, and described filler loading accounts for 0～50% of recipe quantity.
4. slow releasing tablet according to claim 1, wherein said binding agent is selected from one or more in water, ethanol, dehydrated alcohol, starch slurry, PVP K30, crospolyvinylpyrrolidone, hydroxypropyl methylcellulose and/or other cellulose families, and described binder dosage accounts for 0～20% of recipe quantity.
5. slow releasing tablet according to claim 1, wherein said lubricant is selected from one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycols, month extension alcohol magnesium sulfate, and described lubricant quantity accounts for 0.1～10% of recipe quantity.
6. according to the slow releasing tablet described in claim 1-5 any one, wherein said slow releasing tablet is made up of following component:
7. according to the slow releasing tablet described in claim 1-5 any one, wherein said slow releasing tablet is made up of following component:
8. a preparation method for slow releasing tablet described in any one in claim 1-7, it comprises following steps: (1) prepares binding agent and get the binding agent of recipe quantity and make the binding agent of 10% (W/W), for subsequent use; (2) granulate after 80 orders sieve respectively by lamotrigine, filler, together put into mixer-granulator with controlled-release material, filler, mix, evenly, add suitable amount of adhesive to carry out wet granulation, take out the granule 20 mesh sieves granulate that wets, after oven dry, cross 20 mesh sieve granulate, for subsequent use; (3) tabletting is by the lubricant of the granule making and recipe quantity, and after mix homogeneously, detection level is determined sheet weight, tabletting.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104473895A (en) * | 2014-11-20 | 2015-04-01 | 美吉斯制药（厦门）有限公司 | Lamotrigine orally disintegrating sustained release tablets |
| CN110072521A (en) * | 2016-12-16 | 2019-07-30 | 爱杜西亚药品有限公司 | Pharmaceutical composition comprising T-type calcium channel blocker |
| CN114767872A (en) * | 2022-03-21 | 2022-07-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| CN114796146A (en) * | 2022-04-28 | 2022-07-29 | 上海奥科达生物医药科技有限公司 | Slow-release preparation of lamotrigine and preparation method thereof |
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| CN101229169A (en) * | 2002-07-29 | 2008-07-30 | 葛兰素集团有限公司 | Sustained release formulations comprising lamotrigine |
| WO2009011705A1 (en) * | 2007-07-18 | 2009-01-22 | Supernus Pharmaceuticals, Inc. | Enhanced formulations of lamotrigine |
| CN101647784A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine sustained-release tablet and preparation method thereof |
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2014
- 2014-04-22 CN CN201410162902.5A patent/CN103948553A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101229169A (en) * | 2002-07-29 | 2008-07-30 | 葛兰素集团有限公司 | Sustained release formulations comprising lamotrigine |
| WO2009011705A1 (en) * | 2007-07-18 | 2009-01-22 | Supernus Pharmaceuticals, Inc. | Enhanced formulations of lamotrigine |
| CN101647784A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine sustained-release tablet and preparation method thereof |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104473895A (en) * | 2014-11-20 | 2015-04-01 | 美吉斯制药（厦门）有限公司 | Lamotrigine orally disintegrating sustained release tablets |
| CN110072521A (en) * | 2016-12-16 | 2019-07-30 | 爱杜西亚药品有限公司 | Pharmaceutical composition comprising T-type calcium channel blocker |
| CN110072521B (en) * | 2016-12-16 | 2022-11-29 | 爱杜西亚药品有限公司 | Pharmaceutical combination comprising a T-type calcium channel blocker |
| CN114767872A (en) * | 2022-03-21 | 2022-07-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| CN114767872B (en) * | 2022-03-21 | 2023-08-22 | 则正(上海)生物科技有限公司 | Application of polacrilin potassium in preparation of osmotic pump boosting layer, nifedipine osmotic pump tablet and preparation method |
| CN114796146A (en) * | 2022-04-28 | 2022-07-29 | 上海奥科达生物医药科技有限公司 | Slow-release preparation of lamotrigine and preparation method thereof |
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Application publication date: 20140730 |
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