CN104800176A - Brivaracetam orally-disintegrating tablets and preparation method thereof - Google Patents
Brivaracetam orally-disintegrating tablets and preparation method thereof Download PDFInfo
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- CN104800176A CN104800176A CN201510202995.4A CN201510202995A CN104800176A CN 104800176 A CN104800176 A CN 104800176A CN 201510202995 A CN201510202995 A CN 201510202995A CN 104800176 A CN104800176 A CN 104800176A
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Abstract
The invention relates to brivaracetam orally-disintegrating tablets. The brivaracetam orally-disintegrating tablets can be prepared from the following components in parts by weight: 18-32 parts of brivaracetam, 2-10 parts of a disintegrating agent with rapid disintegration property, 30-75 parts of a hydrophilic filling agent, 1.45-4 parts of a flavoring agent and at least one of 0.2-1.5 parts of a lubricating agent and 0.5-2.5 parts of a flow aid. The invention also provides a preparation method of the brivaracetam orally-disintegrating tablets. The brivaracetam orally-disintegrating tablets provided by the invention have good disintegration property and mouth feeling, and the preparation method is simple and easy to operate.
Description
Technical field
The present invention relates to a kind of Bu Waxitan preparation, be specifically related to a kind of Bu Waxitan oral cavity disintegration tablet and preparation method thereof.
Background technology
Epilepsy is a kind of long-term chronic brain diseases, be the unexpected abnormal excessive of brain cell caused by cerebral lesion discharge cause brain function imbalance syndrome.At present, antiepileptic can be divided into three generations according to development history, and first on behalf of traditional classical AEDs, comprises phenytoin Sodium, carbamazepine and western natrium valericum etc.; Second on behalf of modern AEDs, comprises phenytoin Sodium, carbamazepine, levetiracetam and adds spray fourth etc.; The third generation is new A EDs, comprises Bu Waxitan, carabersat, retigabine etc.Bu Waxitan wherein, by the inhibitory action of SV2A height affinity interaction and sodium-ion channel, significantly improve antiepileptic activity, the good toleration aspect with good safety and pharmacokinetics, particularly central nervous system is obviously better than other antiepileptic.
Existing Bu Waxitan medicine, mainly comprising slow releasing tablet, is that the application for a patent for invention file of CN201410407641.9 discloses a kind of prolongation delivery formulations containing 2-OXo-1-pyrrolidine derivatives as the application number application for a patent for invention file that is CN200980120221.X discloses a kind of pharmaceutical composition, application number comprising Brivaracetam; Application number is that the application for a patent for invention file of CN200980145588.7 discloses a kind of prolongation delivery formulations comprising 2-OXo-1-pyrrolidine derivatives; Application number is that the application for a patent for invention file of CN200980145828.3 discloses a kind of prolongation delivery formulations containing 2-OXo-1-pyrrolidine derivatives; Application number is that the application for a patent for invention file of CN201410370727.9 discloses a kind of prolongation delivery formulations comprising 2-OXo-1-pyrrolidine derivatives.
But, the patient of epilepsy shows as unexpected unconsciousness and whole body convulsive seizure mostly, or show as unexpected disturbance of consciousness and muscular tension disappearance, or to show as head and muscle of upper extremity be that main bilateral rhythmicity myoclonus is twitched, or in status epilepticus (show as persistence outbreak or recurrent exerbation companion intermission consciousness function do not recover), therefore Bu Waxitan is prepared as the ordinary tablet or slow releasing tablet that need to swallow, the compliance that patient takes is very poor, even may block trachea, there is potential danger.
Summary of the invention
The object of the present invention is to provide and a kind ofly take safety, disintegrating property is good, mouthfeel is good a kind of Bu Waxitan oral cavity disintegration tablet, the present invention also provides the preparation method of this Bu Waxitan oral cavity disintegration tablet.
For solving the problem, the technical solution adopted in the present invention is as follows:
A kind of Bu Waxitan oral cavity disintegration tablet, it is prepared material and comprises following component according to parts by weight: Bu Waxitan 18-32 part, has disintegrating agent 2-10 part of fast disintegration property, hydrophilic filler 30-75 part, correctives 1.45-4 part, at least one in lubricant and fluidizer; Described lubricant is 0.2-1.5 part, and described fluidizer is 0.5-2.5 part.
In the present invention, preferred scheme is that the material of preparing of described Bu Waxitan oral cavity disintegration tablet also comprises non-hydrophilic filler 10-30 part.
In the present invention, preferred scheme is that described non-hydrophilic filler is selected from microcrystalline Cellulose, starch and cyclodextrin.
In the present invention, preferred scheme for described in there is fast disintegration property disintegrating agent be selected from crosslinked polyethylene pyrrole and iron alkane ketone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose; Described correctives is one or more the combination in anhydrous citric acid, cyclamate, tartaric acid, menthol, sucralose, aspartame and essence.
In the present invention, preferred scheme is described fluidizer is micropowder silica gel and/or Pulvis Talci, and described lubricant is magnesium stearate and/or sodium stearyl fumarate, and described hydrophilic filler is at least one in mannitol, lactose, PEG-6000 and xylitol.
In the present invention, preferred scheme is that described Bu Waxitan oral cavity disintegration tablet is made up of the following component according to parts by weight: Bu Waxitan 18-32 part, microcrystalline Cellulose 10-30 part, mannitol 20-40 part, lactose 10-25 part, anhydrous citric acid 0.5-1 part, crospolyvinylpyrrolidone 2-10 part, sucralose 0.75-2 part, menthol 0.2-1, micropowder silica gel 0.5-2.5 part and sodium stearyl fumarate 0.2-1 part.Mannitol absorbs heat when disintegrate, makes user feel nice and cool, also has certain sweet feel simultaneously, and can not grittiness sense.
In the present invention, preferred scheme is that described Bu Waxitan oral cavity disintegration tablet is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 21.6 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.
The present invention also provides the preparation method of this Bu Waxitan oral cavity disintegration tablet, and it comprises the steps: to have taken each component, mix homogeneously according to formula ratio; Then direct powder compression method is utilized to obtain product.
The present invention also provides the preparation method of this Bu Waxitan oral cavity disintegration tablet, it comprises the steps: to have taken each component by formula, then by wet granulation after Bu Waxitan, the disintegrating agent with fast disintegration property, hydrophilic filler and correctives premix, dryly granule must be done, then add fluidizer, lubricant carries out tabletting, obtained product.
The present invention also provides the preparation method of this Bu Waxitan oral cavity disintegration tablet, and it comprises the steps: to have taken each component, mix homogeneously by formula, then adopts freeze-drying to obtain product.Freeze-drying, refer to medicine material to be added to the water and make medicinal liquid, then medicinal liquid is freezing at low temperatures, moisture contained in medicinal liquid is build-up ice, then dry under vacuum conditions, allow moisture be that gaseous state carries out dry method by solid state sublimation, the medicines structure obtained loosens, include a large amount of small spaces, the chance water capacity is soluble, is usually used in the preparation of disintegrating tablet.Freeze-drying, generally comprises pre-freeze (medicinal liquid made adding water freezes), distillation (sublimation drying), parsing-desiccation (redrying) three phases.In the present invention, adopt freeze-drying to prepare Bu Waxitan oral cavity disintegration tablet, its step is specific as follows: 1) medicinal liquid preparation: the medicine getting formula ratio is added to the water, and makes medicinal liquid; 2) pre-freeze: by medicinal liquid pre-freeze 2-20h at the temperature of-42 ~-38 DEG C; 3) distil: vacuum be 0.95-1.1mbar, baffle temperature be the condition of 4-6 DEG C under distillation process 14-18h; 4) parsing-desiccation: vacuum be 0.65-0.8mbar, baffle temperature be the condition of 23-27 DEG C under distillation process 2-4h, obtain product.
Compared with prior art, tool of the present invention has the following advantages: the Bu Waxitan of oral cavity disintegration tablet dosage form of the present invention, make patient directly medicine can be put into mouth when taking, medicine can run into saliva and disintegrate occurs, rear onset is absorbed along with the autonomous of patient or involuntary swallowing act enter digestive system, make to take medicine more light, safety, avoids the problems such as the administration when patient twitches of traditional medicine is difficult; In addition, formula of the present invention by the selection of component and proportioning thereof, such that the disintegrating property of Bu Waxitan oral cavity disintegration tablet is better, mouthfeel is better; In addition, its preparation method is simple, easy to operate.
Below in conjunction with detailed description of the invention, the present invention is described in detail.
Detailed description of the invention
Embodiment 1
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 21.6 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.This Bu Waxitan oral cavity disintegration tablet is made up of following steps: taken each component by formula, mix homogeneously, then adopts freeze-drying to obtain product; Described freeze-drying step specific as follows: 1) medicinal liquid preparation: the medicine getting formula ratio is added to the water, and makes medicinal liquid; 2) pre-freeze: by medicinal liquid pre-freeze 12h at the temperature of-40 DEG C; 3) distil: vacuum be 1.05mbar, baffle temperature be the condition of 5 DEG C under distillation process 12h; 4) parsing-desiccation: vacuum be 0.75mbar, baffle temperature be the condition of 25 DEG C under distillation process 3h, obtain product.
Embodiment 2
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 18 parts, microcrystalline Cellulose 26 parts, 20 parts, mannitol, lactose 25 parts, anhydrous citric acid 0.5 part, crospolyvinylpyrrolidone 10 parts, sucralose 0.75 part, menthol 1, micropowder silica gel 0.5 part and sodium stearyl fumarate 1.5 parts.Its preparation method is with embodiment 1.
Embodiment 3
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 32 parts, microcrystalline Cellulose 26 parts, 40 parts, mannitol, lactose 10 parts, anhydrous citric acid 1 part, crospolyvinylpyrrolidone 2 parts, sucralose 2 parts, menthol 0.2, micropowder silica gel 2.5 parts and sodium stearyl fumarate 0.2 part.Its preparation method is with embodiment 1.
Embodiment 4
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of following steps: taken each component by formula, mix homogeneously, and then adopt freeze-drying to obtain product, its component, proportioning are all identical with embodiment 1.
Embodiment 5
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of following steps: taken each component by formula, mix homogeneously, then by wet granulation after Bu Waxitan, the disintegrating agent with fast disintegration property, hydrophilic filler and correctives premix, dryly granule must be done, then tabletting after additional lubricant, fluidizer, obtains product, and its component, proportioning are all identical with embodiment 1.
Comparative example 1
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 13.5 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, cross-linking sodium carboxymethyl cellulose 8 parts, cyclamate 1.5 parts, apple essence 0.5, micropowder silica gel 1.3 parts and magnesium stearate 0.4 part.Its preparation method is with embodiment 1.
Comparative example 2
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, hydroxy methocel 13.5 parts, xylitol 32 parts, lactose 19 parts, 0.8 part, tartaric acid, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.Its preparation method is with embodiment 1.
Comparative example 3
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 10 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.Its preparation method is with embodiment 1.
Comparative example 4
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 28 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.Its preparation method is with embodiment 1.
Comparative example 5
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 14 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 10 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.Its preparation method is with embodiment 1.
Comparative example 6
A kind of Bu Waxitan oral cavity disintegration tablet, it is made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 14 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 1.5 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.Its preparation method is with embodiment 1.
Experimental example
Choose hardness and be the obtained Bu Waxitan oral cavity disintegration tablet of embodiments of the invention 1-5, the comparative example 1-6 of 32 ± 5N, then its mouthfeel, disintegrating property are tested, wherein disintegrating property is mainly evaluated using disintegration as index, wherein for mouthfeel evaluation mainly with whether grittiness sense, whether have uncomfortable taste, whether there is refrigerant sense for index and evaluate.
Wherein:
Sand type appraisement system: 4 points, completely without sand type; 3 points, slightly sand type; 2 points, obviously feel grittiness sense; 1 point, serious sand type.
Taste evaluation system: 4 points, without uncomfortable taste; 3 points, slightly uncomfortable taste; 2 points, obviously to feel to have be not taste; 1 point, uncomfortable sense of taste is serious.
Refrigerant sense appraisement system: 4 points, very refrigerant; 3 points, refrigerant; 2 points, slightly refrigerant sense; 1 point, without refrigerant sense.
Choose 220 volunteers to test, 220 volunteers are divided into groups, often organize 20, often group corresponding by embodiment 1-5, the Bu Waxitan oral cavity disintegration tablet that comparative example 1-6 obtains puts into the mouth of volunteer, then record the time of the complete disintegrate of oral cavity disintegration tablet, after disintegrate completely, utilize clear water to gargle, then record volunteer Bu Waxitan oral cavity disintegration tablet mouthfeel is experienced, and mark, the score value calculating mean value then will often organized, concrete data refer to following table 1:
Table 1: embodiment 1-5, the Bu Waxitan oral cavity disintegration tablet disintegrating property of comparative example 1-6, mouthfeel evaluation table
| Disintegration/s | Sand type/point | Taste/point | Refrigerant sense/point | |
| Embodiment 1 | 12.8 | 4 | 4 | 3.9 |
| Embodiment 2 | 16.7 | 3.6 | 3.7 | 3.7 |
| Embodiment 3 | 17.2 | 3.7 | 3.5 | 3.6 |
| Embodiment 4 | 14.3 | 3.7 | 3.6 | 3.8 |
| Embodiment 5 | 13.9 | 3.8 | 3.7 | 3.8 |
| Comparative example 1 | 19.2 | 3.2 | 3.0 | 3.3 |
| Comparative example 2 | 20.1 | 3.1 | 2.9 | 3.1 |
| Comparative example 3 | 16.9 | 3.1 | 3.2 | 3.0 |
| Comparative example 4 | 18.2 | 3.4 | 3.2 | 3.2 |
| Comparative example 5 | 18.5 | 3.1 | 3.2 | 3.0 |
| Comparative example 6 | 23.1 | 3.0 | 3.1 | 3.3 |
From data in table 1, Bu Waxitan oral cavity disintegration tablet of the present invention has good disintegrating property and mouthfeel, and wherein embodiment 1 effect is optimum.
Above-mentioned embodiment is only the preferred embodiment of the present invention; can not limit the scope of protection of the invention with this, change and the replacement of any unsubstantiality that those skilled in the art does on basis of the present invention all belong to the present invention's scope required for protection.
Claims (10)
1. Yi Zhong Bu Waxitan oral cavity disintegration tablet, it is characterized in that it is prepared material and comprises following component according to parts by weight: Bu Waxitan 18-32 part, has disintegrating agent 2-10 part of fast disintegration property, hydrophilic filler 30-75 part, correctives 1.45-4 part, at least one in lubricant and fluidizer; Described lubricant is 0.2-1.5 part, and described fluidizer is 0.5-2.5 part.
2. Bu Waxitan oral cavity disintegration tablet according to claim 1, is characterized in that: the material of preparing of described Bu Waxitan oral cavity disintegration tablet also comprises non-hydrophilic filler 10-30 part.
3. Bu Waxitan oral cavity disintegration tablet according to claim 2, is characterized in that: described non-hydrophilic filler is selected from microcrystalline Cellulose, starch and cyclodextrin.
4. Bu Waxitan oral cavity disintegration tablet according to claim 1, is characterized in that: described in there is fast disintegration property disintegrating agent be selected from crosslinked polyethylene pyrrole and iron alkane ketone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose; Described correctives is one or more the combination in anhydrous citric acid, cyclamate, tartaric acid, menthol, sucralose, aspartame and essence.
5. Bu Waxitan oral cavity disintegration tablet according to claim 1, it is characterized in that: described fluidizer is micropowder silica gel and/or Pulvis Talci, described lubricant is magnesium stearate and/or sodium stearyl fumarate, and described hydrophilic filler is at least one in mannitol, lactose, PEG-6000 and xylitol.
6. Bu Waxitan oral cavity disintegration tablet according to claim 1, is characterized in that being made up of the following component according to parts by weight: Bu Waxitan 18-32 part, microcrystalline Cellulose 10-30 part, mannitol 20-40 part, lactose 10-25 part, anhydrous citric acid 0.5-1 part, crospolyvinylpyrrolidone 2-10 part, sucralose 0.75-2 part, menthol 0.2-1, micropowder silica gel 0.5-2.5 part and sodium stearyl fumarate 0.2-1 part.
7. Bu Waxitan oral cavity disintegration tablet according to claim 6, is characterized in that being made up of the following component according to parts by weight: Bu Waxitan 23 parts, microcrystalline Cellulose 21.6 parts, 32 parts, mannitol, lactose 19 parts, anhydrous citric acid 0.8 part, crospolyvinylpyrrolidone 8 parts, sucralose 1.5 parts, menthol 0.5, micropowder silica gel 1.3 parts and sodium stearyl fumarate 0.4 part.
8. the preparation method of the Bu Waxitan oral cavity disintegration tablet according to any one of claim 1-7, is characterized in that comprising the steps: to have taken each component, mix homogeneously according to formula ratio; Then direct powder compression method is utilized to obtain product.
9. the preparation method of the Bu Waxitan oral cavity disintegration tablet according to any one of claim 1-7, it is characterized in that comprising the steps: to have taken each component by formula, then by wet granulation after Bu Waxitan, the disintegrating agent with fast disintegration property, hydrophilic filler and correctives premix, dryly granule must be done, then add fluidizer, lubricant carries out tabletting, obtained product.
10. the preparation method of the Bu Waxitan oral cavity disintegration tablet according to any one of claim 1-7, is characterized in that comprising the steps: to have taken each component, mix homogeneously by formula, then adopts freeze-drying to obtain product.
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| US20190125725A1 (en) * | 2016-05-12 | 2019-05-02 | Jubilant Generics Limited | Pharmaceutical compositions comprising brivaracetam |
| CN109833300A (en) * | 2017-11-28 | 2019-06-04 | 浙江京新药业股份有限公司 | A kind of antiepileptic Orally administered composition and preparation method thereof |
| CN110638743A (en) * | 2019-10-25 | 2020-01-03 | 乐普制药科技有限公司 | Composition containing brivaracetam |
| CN111374956A (en) * | 2018-12-28 | 2020-07-07 | 上海迪赛诺生物医药有限公司 | Improved quick-release preparation of brivaracetam |
| CN113288872A (en) * | 2020-02-21 | 2021-08-24 | 广东东阳光药业有限公司 | Composition of 2-pyrrolidone derivative and preparation method thereof |
| CN114272216A (en) * | 2021-10-11 | 2022-04-05 | 浙江歌文达生物医药科技有限公司 | Freeze-dried preparation of 2-oxo-1-pyrrolidine derivative and preparation thereof |
| EP3964201A4 (en) * | 2020-07-09 | 2022-12-28 | Shanghai Bocimed Pharmaceutical Co., Ltd. | Brivaracetam pharmaceutical composition, preparation method therefor and application thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
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| US20190125725A1 (en) * | 2016-05-12 | 2019-05-02 | Jubilant Generics Limited | Pharmaceutical compositions comprising brivaracetam |
| CN109833300A (en) * | 2017-11-28 | 2019-06-04 | 浙江京新药业股份有限公司 | A kind of antiepileptic Orally administered composition and preparation method thereof |
| CN111374956A (en) * | 2018-12-28 | 2020-07-07 | 上海迪赛诺生物医药有限公司 | Improved quick-release preparation of brivaracetam |
| CN110638743A (en) * | 2019-10-25 | 2020-01-03 | 乐普制药科技有限公司 | Composition containing brivaracetam |
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| CN113288872A (en) * | 2020-02-21 | 2021-08-24 | 广东东阳光药业有限公司 | Composition of 2-pyrrolidone derivative and preparation method thereof |
| EP3964201A4 (en) * | 2020-07-09 | 2022-12-28 | Shanghai Bocimed Pharmaceutical Co., Ltd. | Brivaracetam pharmaceutical composition, preparation method therefor and application thereof |
| CN114272216A (en) * | 2021-10-11 | 2022-04-05 | 浙江歌文达生物医药科技有限公司 | Freeze-dried preparation of 2-oxo-1-pyrrolidine derivative and preparation thereof |
| CN114272216B (en) * | 2021-10-11 | 2023-07-04 | 浙江歌文达生物医药科技有限公司 | Freeze-dried preparation of 2-oxo-1-pyrrolidine derivative and preparation thereof |
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Application publication date: 20150729 |