CN104840443A - Medicine composition containing active ingredients of pregabalin - Google Patents
Medicine composition containing active ingredients of pregabalin Download PDFInfo
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- CN104840443A CN104840443A CN201510275818.9A CN201510275818A CN104840443A CN 104840443 A CN104840443 A CN 104840443A CN 201510275818 A CN201510275818 A CN 201510275818A CN 104840443 A CN104840443 A CN 104840443A
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Abstract
The invention belongs to the field of medicinal preparations, and particularly relates to a pregabalin slow release medicine composition. The pregabalin slow release medicine composition comprises active ingredients and excipients, wherein the active ingredients are pregabalin or pharmaceutically acceptable salts of the pregabalin; the excipients comprise a matrix forming agent and a swelling agent; the matrix forming agent is a mixture of polyvinyl acetate and polyvinylpyrrolidone; the swelling agent is selected from one or any combination from croscarmellose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and polyoxyethylene. The medicine composition is suitable for oral administration once in each day; the number of medication times is reduced; the blood concentration peak-to-valley ratio is reduced; meanwhile, the proper swelling agent is selected, so that the gastric retention can be reached, and the problem of stability caused by peroxides can also be avoided; the product stability is improved; the therapy effect can be achieved through once medication in each day; the effect of the medicine composition is equivalent to that of quick release preparations. The medicine composition is manly used for treating epilepsy, neuropathic pain and the like.
Description
Technical field
The invention belongs to technical field of medicine.Be specifically related to a kind of stable combination of oral medication that can improve gastric transit time, be applicable to daily once.
Background technology
α in lyrica and central nervous system
2there is high affinity in-δ site (ancillary subunit of valtage-gated calcium channel), and relating to the endogenous inhibitory nerve relevant with the adjustment of brain neuronal activity, to transmit matter gaba (GABA) relevant.Lyrica has antiseizure activity, and is applicable to treat following disease: epilepsy, herpes neuralgia etc.Lyrica capsule is quick releasing formulation, and during treatment for above indication, usage is every day 2 or bestows patient 3 times.For the patient needing Long-term taking medicine, QD takes medicine and can improve the compliance of patient.Take medicine every day and once also can reduce medicine Cmax in blood and alleviate or avoid potential, undesirable side effect relevant with dosage, also increase efficacy of drugs by the least concentration Cmin be increased in blood plasma.
Clinical research shows, lyrica is Absorbable rod in the small intestinal and ascending colon of the mankind, but in the outer less absorption of hepatic flexure of colon, show that the average absorption window of lyrica is on average about 6 hours or shorter, every day multiple dosing, the blood drug level of medicine can be caused to produce obviously fluctuation, must frequent drug administration to keep the blood drug level of quite stable.The effective dose of lyrica is 150-600mg/ days, gives with divided dose.Every day taken 3 times by lyrica capsule, and medicine blood drug level can be caused to raise rapidly, and then due to drug distribution, metabolism and excretion, drug level reduces rapidly.So the utilization ratio of drug of quick releasing formulation is lower.General slow releasing preparation technique effect is undesirable, improves the tablet holdup time under one's belt, thus the absorption improving medicine is a good thinking.
Patent CN101330907 is similarly the daily sustained-release administration compositions once containing lyrica, and this patent sweller is only only limitted to employ polyvinylpolypyrrolidone and reaches tablet expansion effect.Compared for the tablet swelliong power of polyvinylpolypyrrolidone and cross-linking sodium carboxymethyl cellulose, result shows that cross-linking sodium carboxymethyl cellulose is close in tablet longitudinal dilatation ability with polyvinylpolypyrrolidone, lateral expansion ability cross-linking sodium carboxymethyl cellulose is better than polyvinylpolypyrrolidone, in conjunction with the sheet shape of this product, preferred cross-linking sodium carboxymethyl cellulose, meanwhile, polyvinylpolypyrrolidone itself contains peroxide, the compositions existence and stability risk of formation.
Summary of the invention
The invention provides a kind of pharmaceutical composition containing lyrica, be applicable to every day once oral, reduce times for spraying, reducing blood drug level peak valley ratio, simultaneously by selecting suitable sweller, can not only Entogastric lingering be reached, also can avoid the stability problem that peroxide brings, improve the stability of product, achieving takes medicine every day simultaneously once can reach therapeutic effect, with quick releasing formulation bioequivalence.Release Mechanisms is: this compositions contact aqueous medium can expand by fast volume, extends the tablet holdup time under one's belt, and by sustained-release matrix material, slow releasing medicine, improves drug absorption, reduces medicining times.
This pharmaceutical composition oral administration enters in stomach, and after contact gastric juice, quick imbibition, extends the gastric emptying time, and sustained release activity composition, finally, pharmaceutical composition leaves stomach and enters small intestinal, sustained release lyrica in small intestinal.Extend active component and can effectively widen the absorption window relevant to rapid release administration in the release time of gastric, thus allow QD administration.
A kind of pharmaceutical composition of the present invention, comprise active component and excipient, described active component is lyrica or its pharmaceutically acceptable salt, excipient comprises matrix formers and sweller, described matrix formers is the mixture of polyvinyl acetate and polyvinylpyrrolidone, and described sweller is selected from one of cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, polyoxyethylene or its combination in any.
Matrix formers polyvinyl acetate povidone mixture in the present invention, be the homopolymer of 1-ethenyl-pyrrolidine-2-ketone, molecular weight Mw is generally about 1 × 10
3to about 1 × 10
7, about 2.5 × 10
3to about 3 × 10
6or about 1 × 10
4to about 1 × 10
5.This polymer is purchased from BASF, and its commodity are called KOLLIDON SR.This polymer is the spraying dry physical mixture that polyvinyl acetate mixes with 8:2 ratio with polyvidone.Containing 80% polyvinyl acetate (molecular weight Mw is about 450000) and 19% PVP K30. another about containing 0.8% sodium lauryl sulphate and about 0.6% silicon dioxide as stabilizing agent.Described matrix formers can discharge by regulating drug to a certain extent, can be used for adjustment sheet weight.
Wherein said sweller is water solublity or insoluble polymer, and described sweller runs into aqueous medium, can absorb water fast and make volume be able to undergoes rapid expansion, thus whole tablet volume is increased, and reaches the effect of Entogastric lingering.And sweller can also by such as producing passage or affecting drug release rate by forming hydrophilic colloid.Sweller kind is different, its swelling effect has difference, the degrees of expansion being embodied in the whole volume of tablet, transverse direction, longitudinal direction etc. has comparatively significant difference, in conjunction with the tablet profile of this product and the Swelling Capacity of sweller, prioritizing selection cross-linking sodium carboxymethyl cellulose, can purchased from German JRS, commodity are called VIVASOL; Also can purchased from American FMC, commodity are called Ad-Di-Sol.
Sweller as same effect has low-substituted hydroxypropyl cellulose, its water insoluble and alcohol, but swellable.Can purchased from the L-HPC LH-11 of ShinEtsu.Carboxymethyl starch sodium is starch carboxy methylation ether sodium salt, has Three Estate, A, B, C, and difference is the content of sodium, can purchased from the Explotab of Primojel or JRS of Avebe.
Another sweller polyoxyethylene in said composition, have various grade according to molecular weight, commodity are called POLYOX.Polyoxyethylene is the homopolymer of oxirane, and its molecular weight is generally 1 × 10
5to about 1 × 10
7or about 1 × 10
6to about 1 × 10
7.This sweller of 5%-30% is preferably comprised in compositions.
Pharmaceutical composition of the present invention, the mass percent of wherein said active component in pharmaceutical composition is 2% to 60%, preferred 7-30%; The mass percent of matrix formers in pharmaceutical composition is 10% to 70%, preferred 20-50%, most preferably 20-35%; The mass percent of sweller in pharmaceutical composition is 15% to 50%.
Generally speaking, the amount being added to the active component of said composition is 25-600mg, preferred 80-300mg.
In pharmaceutical composition of the present invention, containing two or more phase, preferably, wherein at least one contain mutually at least following substances as excipient: the mixture of (1) polyvinyl acetate and polyvidone, its ratio is the 20-50%/sheet of compositions; (2) cross-linking sodium carboxymethyl cellulose, its ratio is the 15-50%/sheet of compositions; (3) carbomer, its ratio is the 1-10%/sheet of compositions; (4) polyoxyethylene, its ratio is the 5-30%/sheet of compositions.
Pharmaceutical composition of the present invention, described polyoxyethylene be selected from N750,205, N12K, N60K, 301, COAGULANT, one of 303 or the combination of any two kinds.Preferably, described polyoxyethylene is the combination of the N60K or 301 of 5%-20%/sheet and N12K or N750 of 5%-20%/sheet; Or described polyoxyethylene is the COAGULANT of 5%-15%/sheet.
Except matrix formers and sweller, pharmaceutical composition of the present invention, also comprises lubricant and gellant, can change the release characteristics of medicine.Wherein lubricant is selected from one of magnesium stearate, Pulvis Talci, castor oil hydrogenated or combination in any, preferred magnesium stearate.Gel, also claims hydrophilic colloid, and when contacted, this gel can form cementitious mixtures, delays the diffusion of medicine by dosage form, thus extends the time being discharged medicine by dosage form.This gel general accounts for 1% to 20% of composition total weight, and preferably about 1% to 10%.Gellant is selected from carbomer, polysaccharide or both combinations, and preferred carbomer, wherein said polysaccharide is selected from xanthan gum, inulin, guar gum, one of carob and carrageenin or combination in any.
Carbomer is the high molecular polymer of acrylic acid bonding allyl sucrose or tetramethylolmethane allyl ether.Calculate by dry product, should be 56.0% ~ 68.0% containing carboxylic acid group (-COOH).Such as can select Carbopol 971 or Carbopol 71G.
Said composition can also contain any suitable excipient produced required for tablet, such as: solvable or insoluble diluent (lactose, microcrystalline Cellulose, mannitol etc.); Lubricant (magnesium stearate, Pulvis Talci, hydrogenated castor wet goods) and fluidizer (silicon dioxide etc.).
Adopt common production technology, by direct pressed powder or by dry press granule-making then tabletting all can produce tablet of the present invention.Tablet hardness, at 200-300N, can obtain the tablet of the qualified friability of some strength.Tablet mould has certain specification, and tablet is met gastric juice and expanded at least 9 millimeters.Under this hardness, tablet slow releasing medicine.
Accompanying drawing explanation
Fig. 1 be the release profiles of embodiments of the invention 1-3 in 0.06N hydrochloric acid solution and former grind draw in patent with reference to curve release conditions comparison diagram;
Fig. 2 be the release profiles of embodiments of the invention 4-6 in 0.06N hydrochloric acid solution and former grind draw in patent with reference to curve release conditions comparison diagram;
Fig. 3 be the release profiles of embodiments of the invention 7-9 in 0.06N hydrochloric acid solution and former grind draw in patent with reference to curve release conditions comparison diagram.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in further details, but is not limited thereto.
Carry out in laboratory equlpment the preparation of tablet that batch is this product of 1kg, material choice and preparation method as follows.
Lyrica raw material meets correlated quality requirement, and inert matter is respectively matrix formers: cross-linking sodium carboxymethyl cellulose, steps on Mel father and son company limited purchased from Germany is auspicious; Sweller: cross-linking sodium carboxymethyl cellulose, purchased from German BASF; Sweller: polyoxyethylene N60K and N12K, purchased from Shanghai Ka Lekang; Gel: carbomer, purchased from the extraordinary Chemical Co., Ltd. of Lu Borun; Lubricant: magnesium stearate, purchased from Distributions in Liaocheng of Shandong Province A Hua.
Mixed by supplementary material except magnesium stearate in the three-dimensional hopper mixer of 5L, time 5min, rotating speed 15 revs/min can meet the mixing homogeneity of mixed powder.Magnesium stearate is crossed 40 orders to join in the above supplementary material mixed, continue to mix with above parameter, 5 minutes.The mixed powder mixed is carried out tabletting, and hardness is between 200 to 300N.Finally carry out coating with the happy health coating powder of 85F serial card, increase weight about 3%.
Embodiment 1 to 9
Prescription one to nine (corresponding respectively to embodiment 1 to 9) in table 1,2,3 represents the laboratory scale compositions containing lyrica and various excipient, and table 4 represents external swelling degree and the release behavior of above-mentioned composition.Table 5 shows the stability (percentage composition of major impurity lactams) of described embodiment.For above embodiment, all components except magnesium stearate is mixed in hopper mixer, and reach certain mixing uniformity; Then magnesium stearate is crossed 40 mesh sieves to enter, then mix, under 200-300N hardness, tabletted is heavily the tablet of 1125mg.
The pharmaceutical composition of table 1 containing lyrica
| Composition | Prescription one (mg/ sheet) | Prescription two (mg/ sheet) | Prescription three (mg/ sheet) |
| Lyrica | 75 | 75 | 75 |
| Polyvinyl acetate povidone mixture | 200 | 345 | 500 |
| Cross-linking sodium carboxymethyl cellulose | 550 | 400 | 200 |
| Polyoxyethylene N60K | 120 | 120 | 290 |
| Polyoxyethylene N12K | 60 | 150 | 0 |
| Carbomer | 110 | 25 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Sheet weight | 1125 | 1125 | 1125 |
The pharmaceutical composition of table 2 containing lyrica
| Composition | Prescription four (mg/ sheet) | Prescription five (mg/ sheet) | Prescription six (mg/ sheet) |
| Lyrica | 150 | 150 | 150 |
| Polyvinyl acetate povidone mixture | 200 | 355 | 500 |
| Cross-linking sodium carboxymethyl cellulose | 500 | 325 | 200 |
| Polyoxyethylene N60K | 120 | 100 | 180 |
| Polyoxyethylene N12K | 65 | 125 | 35 |
| Carbomer | 80 | 60 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Sheet weight | 1125 | 1125 | 1125 |
The pharmaceutical composition of table 3 containing lyrica
| Composition | Prescription seven (mg/ sheet) | Prescription eight (mg/ sheet) | Prescription nine (mg/ sheet) |
| Lyrica | 300 | 300 | 300 |
| Polyvinyl acetate povidone mixture | 250 | 300 | 200 |
| Cross-linking sodium carboxymethyl cellulose | 270 | 300 | 250 |
| Polyoxyethylene N60K | 100 | 120 | 250 |
| Polyoxyethylene N12K | 0 | 25 | 65 |
| Carbomer | 195 | 70 | 50 |
| Magnesium stearate | 10 | 10 | 10 |
| Sheet weight | 1125 | 1125 | 1125 |
Tablet swelling degree
The speed of tablet volumetric expansion is measured at 37 DEG C, USP II device in 0.06N hydrochloric acid solution.Physical property measures its length, width and thickness, and measurement point is respectively 0.5h, 1h, 2h and 6h, and result is as table 4.
The pharmaceutical composition external dilatancy of table 4 containing lyrica
In 0.06N hydrochloric acid solution, slurry processes 50 turns measures.
Known by the measurement result of table 4, the medicine in embodiments of the invention 1-9 all has stronger swellability, makes medicine enter in stomach, rapid expanding, and improving the holdup time under one's belt becomes possibility.
Tablet stability
The tablet of preparation is placed in HDPE bottle and adds silica-gel desiccant one bag (specification: 2.0g/ bag), under being put in 30 ± 2 DEG C and 65 ± 5% relative humiditys, carry out stability test.Sample point is respectively 1 month, 2 months and 3 months, uses HPLC to analyze pregabalin content and lactam content, the results are shown in Table 5.
Table 5 embodiment stability data---the percentage composition of impurity lactams
| 0 day | 1 month | 2 months | 3 months | |
| Prescription one | 0.05 | 0.12 | 0.17 | 0.24 |
| Prescription two | 0.04 | 0.11 | 0.16 | 0.24 |
| Prescription three | 0.05 | 0.12 | 0.17 | 0.24 |
| Prescription four | 0.03 | 0.11 | 0.13 | 0.16 |
| Prescription five | 0.05 | 0.10 | 0.10 | 0.16 |
| Prescription six | 0.04 | 0.12 | 0.12 | 0.15 |
| Prescription seven | 0.03 | 0.09 | 0.12 | 0.15 |
| Prescription eight | 0.04 | 0.08 | 0.12 | 0.15 |
| Prescription nine | 0.04 | 0.07 | 0.12 | 0.11 |
Known by the stability data of table 5, excipient selected by the present invention and active component have the good compatibility, can ensure the stability of product.
The former patent CN101330907 that grinds authorizes [0198] section in text to carry out related text description to [0205] section to the release in vitro of slow released pregabalin sheet, the present inventor carries out curve simulation to it, obtain the former In-vitro release curves (with reference to curve) grinding patent, and the release profiles of the product of embodiments of the invention one to nine in 0.06N hydrochloric acid solution is contrasted with it, result is as Fig. 1-3.
The release profiles of Fig. 1-3 shows that compositions of the present invention can effective Drug controlled release, reaches slow release effect.Compare with the former In-vitro release curves described in patent CN101330907 that grinds, result shows that both release profiles are similar, reduces bioequivalence risk, improves product stability simultaneously.
Non-clinical Pharmacokinetics is tested
The exploitation of slow released pregabalin sheet is intended to the administration number of times reducing lyrica capsule, reduce the peak-to-valley ratio of blood drug level, alleviate poisonous side effect of medicine, the most important thing is the bioequivalence reaching both simultaneously, therefore present inventor has performed lyrica capsule and self-control slow releasing tablet pharmacokinetic in cynomolgus monkey.
Experiment initial designs is the dual crossing administration of two cycles, and establishes the LC-MS/MS quantitative analysis method of lyrica in machin blood plasma, and has carried out system approach checking, and analytical method meets the related specifications of Determination of Biological Samples.Use WinNonlin software (6.3 editions) to calculate pharmacokinetic parameter according to non-compartment model, adopt t method of inspection to carry out statistical analysis to plasma exposure amount (AUC).
Detailed pharmacokinetic parameter, statistical result and Drug-time curve refer to table 6.
The oral lyrica of table 6 machin is by the pharmacokinetic parameter of lyrica after test preparation and reference preparation
The statistical result of (AUC through dose modification)
A:AUCadjust=AUC
mean/ Dose, b:P>0.05 represent there was no significant difference, c:F%=AUC
0-tadjust (T)/AUC
0-tadjust (R);
Experimental result display machin under high fat breakfast condition oral give product slow released pregabalin sheet (by test preparation) of the present invention after AUC and machin is oral in fasted condition gives the lyrica capsule (reference preparation that goes on the market, trade name " Le Ruika ", Pfizer company) AUC compare, without remarkable significant difference.Lyrica is 118.99% by test preparation relative to reference preparation bioavailability.
Machin in fasted condition oral give product slow released pregabalin sheet of the present invention after AUC and the machin oral lyrica capsule that gives to go on the market in fasted condition AUC compared with, without remarkable significant difference.Lyrica is 108.16% by test preparation relative to reference preparation bioavailability.
Slow released pregabalin sheet no matter on an empty stomach or under high fat breakfast condition, Cmax is all low than reference preparation by about 30%, prompting slow releasing tablet while not affecting effectiveness, the likely security concern brought of reduction peak valley effect to a certain extent.In addition, take a blood sample to last after administration 12h, all comparatively reference preparation is high for the blood drug level of slow releasing tablet under two kinds for the treatment of conditions, and prompting slow releasing tablet maintains persistent period of effective blood drug concentration will comparatively reference preparation be long, and this puts and also supports slow releasing tablet more long period administration of clinical period to a certain extent.
Claims (10)
1. a pharmaceutical composition, comprise active component and excipient, described active component is lyrica or its pharmaceutically acceptable salt, excipient comprises matrix formers and sweller, described matrix formers is the mixture of polyvinyl acetate and polyvinylpyrrolidone, and described sweller is selected from one of cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, polyoxyethylene or its combination in any.
2. pharmaceutical composition according to claim 1, the mass percent of wherein said active component in pharmaceutical composition is 2% to 60%, preferred 7-30%; The mass percent of matrix formers in pharmaceutical composition is 10% to 70%, preferred 20-50%, most preferably 20-35%; The mass percent of sweller in pharmaceutical composition is 15% to 50%.
3. pharmaceutical composition according to claim 1, is characterized in that, said composition contains two or more phase, wherein at least one contain mutually at least following substances as excipient:
(1) mixture of polyvinyl acetate and polyvidone, its ratio is the 20-50%/sheet of compositions;
(2) cross-linking sodium carboxymethyl cellulose, its ratio is the 15-50%/sheet of compositions;
(3) carbomer, its ratio is the 1-10%/sheet of compositions;
(4) polyoxyethylene, its ratio is the 5-30%/sheet of compositions.
4. pharmaceutical composition according to claim 3, is characterized in that, described polyoxyethylene be selected from N750,205, N12K, N60K, 301, COAGULANT, one of 303 or the combination of any two kinds.
5. pharmaceutical composition according to claim 3, is characterized in that, described polyoxyethylene is the combination of the N60K or 301 of 5%-20%/sheet and N12K or N750 of 5%-20%/sheet, or is the COAGULANT of 5%-15%/sheet.
6. pharmaceutical composition according to claim 1, is characterized in that, this pharmaceutical composition also comprises lubricant and gellant, and lubricant is selected from one of magnesium stearate, Pulvis Talci, castor oil hydrogenated or combination in any, preferred magnesium stearate; Gellant is selected from carbomer, polysaccharide or both combinations, and preferred carbomer, wherein said polysaccharide is selected from xanthan gum, inulin, guar gum, one of carob and carrageenin or combination in any.
7. pharmaceutical composition according to claim 1, during wherein said pharmaceutical composition thereof aqueous medium, tablet volumetric expansion is to about 9 millimeters or more large scale.
8. pharmaceutical composition according to claim 1, can be detained about 3 little of about 14 hours in Stomach in Patients after said composition is oral.
9. pharmaceutical composition according to claim 1, said composition is used for the treatment of the neuropathic pain such as epilepsy, herpes neuralgia.
10. pharmaceutical composition according to claim 1, said composition is oral, once a day.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106606495A (en) * | 2015-10-27 | 2017-05-03 | 四川海思科制药有限公司 | Pregabalin sustained-release tablet medicinal composition and preparation method thereof |
| CN107998074A (en) * | 2017-12-13 | 2018-05-08 | 广州大光制药有限公司 | Pregabalin oral administration solution and preparation method thereof |
| WO2019238068A1 (en) * | 2018-06-13 | 2019-12-19 | 北京泰德制药股份有限公司 | Sustained-release pregabalin composition and preparation method therefor |
| CN110585153A (en) * | 2018-06-13 | 2019-12-20 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN110974798A (en) * | 2019-12-19 | 2020-04-10 | 江苏优仿医药科技有限公司 | Pharmaceutical composition, sustained-release tablet and preparation method thereof |
| CN111053749A (en) * | 2018-10-16 | 2020-04-24 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN113143874A (en) * | 2020-01-07 | 2021-07-23 | 华宇药品股份有限公司 | Sustained-release formulations of pregabalin |
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| CN101330907A (en) * | 2005-11-02 | 2008-12-24 | 辉瑞产品公司 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent |
| CN103702664A (en) * | 2011-07-26 | 2014-04-02 | 柳韩洋行 | Sustained release tablet comprising pregabalin through two-phase release-controlling system |
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| CN101330907A (en) * | 2005-11-02 | 2008-12-24 | 辉瑞产品公司 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent |
| CN101011393A (en) * | 2007-02-16 | 2007-08-08 | 广州贝氏药业有限公司 | Irbesartan gastric retention sustained-release pharmaceutical composition |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106606495A (en) * | 2015-10-27 | 2017-05-03 | 四川海思科制药有限公司 | Pregabalin sustained-release tablet medicinal composition and preparation method thereof |
| CN107998074A (en) * | 2017-12-13 | 2018-05-08 | 广州大光制药有限公司 | Pregabalin oral administration solution and preparation method thereof |
| WO2019238068A1 (en) * | 2018-06-13 | 2019-12-19 | 北京泰德制药股份有限公司 | Sustained-release pregabalin composition and preparation method therefor |
| CN110585153A (en) * | 2018-06-13 | 2019-12-20 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN111741748A (en) * | 2018-06-13 | 2020-10-02 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| US11938222B2 (en) | 2018-06-13 | 2024-03-26 | Beijing Tide Pharmaceutical Co., Ltd. | Pregabalin sustained release composition and method for preparing the same |
| CN111053749A (en) * | 2018-10-16 | 2020-04-24 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN111053749B (en) * | 2018-10-16 | 2022-07-15 | 北京泰德制药股份有限公司 | Pregabalin sustained-release composition and preparation method thereof |
| CN110974798A (en) * | 2019-12-19 | 2020-04-10 | 江苏优仿医药科技有限公司 | Pharmaceutical composition, sustained-release tablet and preparation method thereof |
| CN113143874A (en) * | 2020-01-07 | 2021-07-23 | 华宇药品股份有限公司 | Sustained-release formulations of pregabalin |
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| Publication number | Publication date |
|---|---|
| CN104840443B (en) | 2018-04-27 |
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