CN105106142B - It is a kind of containing according to lyophilized oral formulations of piperazine azoles and preparation method thereof - Google Patents
It is a kind of containing according to lyophilized oral formulations of piperazine azoles and preparation method thereof Download PDFInfo
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- CN105106142B CN105106142B CN201510605714.XA CN201510605714A CN105106142B CN 105106142 B CN105106142 B CN 105106142B CN 201510605714 A CN201510605714 A CN 201510605714A CN 105106142 B CN105106142 B CN 105106142B
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- piperazine azoles
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Abstract
The present invention provides a kind of containing according to lyophilized oral formulations of piperazine azoles and preparation method thereof, belong to field of pharmaceutical preparations.The lyophilized oral formulations include survival dose according to piperazine azoles and a pharmaceutic adjuvant.Raw material and auxiliary material are prepared into lyophilized oral formulations by the preparation method by using desivac.The present invention according to a piperazine azoles bulk pharmaceutical chemicals by that will be prepared into lyophilized oral formulations, so as to fill up the blank according to piperazine azoles in lyophilized formulations technical field, it is not only various Sexual behavior mode that clinical patients provide pharmaceutical dosage form, and containing can be with fater disintegration according to a lyophilized oral formulations for piperazine azoles, so that quickly being absorbed by patient according to piperazine azoles Fast Stripping, bioavilability is improved；Meanwhile the lyophilized oral formulations need not can allow some drugs to transport to absorb by mucous membrane with water in patient's intraoral disintegration, it is achieved thereby that being absorbed before stomach, avoid drug and the stimulation of stomach is damaged, improve the compliance of clinical patients.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, in particular to it is a kind of containing according to the lyophilized oral formulations of piperazine azoles and
Its preparation method.
Background technology
According to a piperazine azoles（Brexpiprazole）As schizophrenia and major depressive disorder（MDD）Auxiliary treatment medication,
Its chemical name is 7- [4-4（4- benzos [b] thiophene -4- bases-piperazine -1- bases）Stare at oxygroup] -1H- quinoline-2-ones, chemical constitution
Formula is as follows：
The compound is ratified to list by U.S. Food and Drug Administration, and dosage form is common oral administration solid piece
Agent is produced using direct pressure closing, and specification has 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, and the auxiliary material used makes for conventional tablet
Nonactive prescription auxiliary material, such as lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, low substitution hydroxyl
Third cellulose, magnesium stearate and stomach dissolution type film coating powder etc..This kind of tablet be common quick release tablet, the general In Vitro Dissolution time
In 30min, dissolution limit is more than 85%, but disintegration time needs just be disintegrated completely completely for 5 ~ 10 minutes at the soonest.
It was found from according to piperazine azoles physicochemical property, the compound is insoluble in water, physicochemical property and commercialized product A Li piperazines
Azole is seemingly.It needs to control the grain size of bulk pharmaceutical chemicals using special production technology, makes its Fast Stripping in conventional tablet.
It was found from application publication number is the Chinese patent of CN104023750A, the patent is using its cyclodextrin of sulfobutyl ether times
Or aqueous solution is made after its cyclodextrin is included again in hydroxypropyl, and inclusion compound is made parenteral solution or lyophilized parenteral solution.
And the technology of oral freeze-dried preparation will be prepared into according to piperazine azoles at present also in blank using desivac.
The content of the invention
To solve the above-mentioned problems, it is an object of the invention to provide it is a kind of containing according to the lyophilized oral formulations of piperazine azoles and
Its preparation method, by desivac oral freeze-dried preparation will be prepared into according to a piperazine azoles, to provide pharmaceutical dosage form for clinical patients
Various Sexual behavior mode；To shorten the disintegration time of drug, make drug Fast Stripping and be rapidly absorbed；Meanwhile make drug need not
Want water that can be absorbed before intraoral disintegration realizes stomach.
The present invention realizes in the following ways：
It is a kind of containing according to a lyophilized oral formulations for piperazine azoles, including following components：According to a piperazine 0.25 ~ 4.0mg of azoles, adhesive
1 ~ 5mg freezes skeleton 5 ~ 30mg of proppant, flavoring agent 0.001mg ~ 0.8mg1.
Lyophilized oral formulations refer to by main ingredient and auxiliary material quantitative separating in certain mold, lyophilized to remove moisture and be made
High porosity solid pharmaceutical preparation.
Advantage using the solid orally ingestible of desivac production is that tablet weight is light；Moisture is small, is conducive to medicine
The stability of object；And its disintegration rate is fast, it is only necessary to can just be disintegrated out completely within several seconds, so that drug can be rapidly molten
Go out and be rapidly absorbed；Meanwhile using desivac production lyophilized formulations woth no need to water can in intraoral disintegration so that
Some drugs can turn remote by oral mucosa, be absorbed before realizing stomach.
Therefore, it is above-mentioned to contain the diversity for according to the lyophilized oral formulations of piperazine azoles not being only clinical patients offer pharmaceutical dosage form
Selection, and can biological utilisation so that quickly being absorbed by patient according to piperazine azoles Fast Stripping, be improved with fater disintegration
Degree；Meanwhile the lyophilized oral formulations need not can be such that some drugs turn by mucous membrane with water in patient's intraoral disintegration
It transports and absorbs, it is achieved thereby that being absorbed before stomach, avoid drug and the stimulation of stomach is damaged, improve the compliance of clinical patients
Property.
The bitter taste or other irritation tastes of drug can be removed by above-mentioned flavoring agent, so as to add drug administration
Mouthfeel.
It is above-mentioned according to the dosage of piperazine azoles be 0.25 ~ 4.0mg, be preferably 2.5mg；The dosage of above-mentioned adhesive is 1 ~ 5mg, excellent
Elect 3mg as；The dosage of above-mentioned lyophilized skeleton proppant is 5 ~ 30mg, is preferably 18mg；The dosage of above-mentioned flavoring agent is 0.001mg
~ 0.81mg is preferably 0.4mg.
Further, it is described according to the particle diameter distribution of piperazine azoles be D9075 μm of ＜.
In order to which lyophilized oral formulations is made to be more prone to dissolve out and are disintegrated, it is preferable that above-mentioned to be according to a particle diameter distribution for piperazine azoles
D90<75 μm, during such drug administration, be conducive to the dissolution of lyophilized oral formulations due to smaller according to the grain size of piperazine azoles and collapse
Solution, make the oral freeze-dried preparation be more prone to intraoral disintegration and be more conducive to improve its bioavilability；And grain
Footpath is smaller according to a piperazine azoles delicate mouthfeel, no sand feeling, so as to be conducive to taking for drug.
Further, described adhesive is at least one of for pharmagel, gelatin hydrolysate, xanthans and polyphenol, the jelly
Dry skeletal support agent is PEARLITOL 25C, xylitol, sorbierite, glucose sugar and at least one of Lactis Anhydrous, the flavoring agent
For at least one of aspartame, anhydrous citric acid, tartaric acid, fumaric acid and Sucralose.
Preferably, while using aspartame and anhydrous citric acid as flavoring agent.Aspartame as Sweet flavor modifier,
Anhydrous citric acid is as acidity regulator.
D90Refer to that the cumulative particle sizes distribution number of a sample reaches grain size corresponding when 90%.Its physical significance is grain
Footpath accounts for 90% less than its particle.
Further, the disintegration time of the lyophilized oral formulations is less than 10 seconds, water content<2%.
, it is necessary to which different water contents is to ensure its optimum stabilization for different drugs, it is preferable that the jelly
The water content of dry oral formulations<2%, so that this is freeze-dried with optimal stability.
Simultaneously as PEARLITOL 25C is crystalline solid before and after lyophilized and has non-hygroscopic, thus it is sweet by using D-
Dew alcohol is conducive to control the water content of lyophilized oral formulations, and manufactured lyophilized oral as the caffolding agent of lyophilized oral formulations
Preparation is not easy the moisture absorption.
It is a kind of containing according to a preparation method for the lyophilized oral formulations of piperazine azoles, be used to prepare above-mentioned containing according to a jelly for piperazine azoles
Dry oral formulations, comprise the following steps：
A. after lyophilized skeleton proppant, flavoring agent and the adhesive of recipe quantity being dissolved in purified water, under agitation
It adds in through crushing according to a piperazine azoles, obtains suspension solution；It keeps the skin wet again by with liquid weight to recipe quantity, through abundant shear agitation
After obtain stablizing suspension solution；
B. the stabilization suspension solution obtained in step A is packed respectively and be poured into each cold aluminium foil model, and using liquid
It is transferred in freeze drier and is freeze-dried after the quick-frozen shaping of nitrogen spray technique, make moisture<2%, obtain lyophilized oral
Preparation；
C. the lyophilized oral formulations in step B are subjected to quick heat sealed package using aluminium foil.
It is packed by using aluminium foil heat-sealing, the lyophilized oral formulations moisture absorption can be effectively prevented, avoided due to the moisture absorption
Influence the disintegration of lyophilized oral formulations.
Further, described in step A crushed and crushed using airflow pulverization according to piperazine azoles according to a piperazine azoles,
The crushing is D according to the particle size distribution range of piperazine azoles102 μm of ＜, D5025 μm of ＜, D9075 μm of ＜.
To be crushed by using airflow pulverization according to piperazine azoles so that after crushing according to a particle size distribution range for piperazine azoles
For D102 μm of ＜, D5025 μm of ＜, D9075 μm of ＜, so that the lyophilized oral formulations finally prepared by this method take mouth
Sense is more preferable, avoids generating sand feeling due to grain size is larger.
Airflow pulverization is existing crushing material technology, is employed corresponding to be crushed according to piperazine azoles raw material
Airflow pulverization.
Further, the freeze-drying in step B includes lyophilization, continues drying out and freeze-day with constant temperature.
In freeze-drying, in order to which preferably moisture content in lyophilized oral formulations is removed by lyophilization, above-mentioned freezing
It is dry to include lyophilization, continue drying out and freeze-day with constant temperature, in this way, the moisture content in lyophilized oral formulations is fully distilled
It dries and makes the water content of lyophilized oral formulations<2%.
Further, the lyophilization includes lyophilization first stage and lyophilization second stage, and the distillation is dry
The sublimation temperature of dry first stage is -45 ~ -25 DEG C, drying time 1.5h；The sublimation temperature of the lyophilization second stage
For -15 ~ -5 DEG C, drying time 1h；
It is described to continue drying out including continuing drying out the first stage and continuing drying out second stage, it is described to continue drying out the first rank
The drying temperature of section is -2 ~ 15 DEG C, drying time 1h；The drying temperature for continuing drying out second stage is 20 ~ 40 DEG C, is done
The dry time is 1h；
The drying temperature of the freeze-day with constant temperature is 50 DEG C, drying time 0.5h.
Pass through temperature-gradient method so that the moisture content in lyophilized oral formulations is more prone to distil and remove, therefore is conducive to drop
The water content of low lyophilized oral formulations, so that lyophilized oral formulations are more stablized.
Beneficial effects of the present invention：
The present invention according to a piperazine azoles bulk pharmaceutical chemicals by that will be prepared into lyophilized oral formulations, so as to fill up according to piperazine azoles lyophilized
The blank in preparation technique field, only clinical patients do not provide various Sexual behavior mode of pharmaceutical dosage form, and contain according to piperazine azoles
Lyophilized oral formulations, so that quickly being absorbed by patient according to piperazine azoles Fast Stripping, can improve biological profit with fater disintegration
Expenditure；Meanwhile the lyophilized oral formulations need not can allow some drugs to pass through mucous membrane with water in patient's intraoral disintegration
It transports and absorbs, it is achieved thereby that being absorbed before stomach, avoid drug and the stimulation of stomach is damaged, improve the compliance of clinical patients
Property.
Description of the drawings
Fig. 1 be described in embodiment 4 using airflow pulverization to according to the piperazine azoles bulk pharmaceutical chemicals grain size that carries out that treated
Distribution map.
Specific embodiment
Embodiment 1
It present embodiments provides three kinds to contain according to a lyophilized oral formulations for piperazine azoles, prescription and content are respectively such as the following table 1
It is shown.
Table 1
Readily comprehensible, above-mentioned lyophilized formulations auxiliary material can also use other similar auxiliary materials to replace, the dosage root of each auxiliary material
Factually border service condition makes corresponding adjustment, to meet the survival dose requirement of auxiliary material.
Aspartame or anhydrous citric acid can also be used alone in above-mentioned prescription as flavoring agent, dosage for 0.001 ~
0.81mg.Preferably, while aspartame and anhydrous citric acid are used as flavoring agent, to adjust sweet taste and tart flavour.
Embodiment 2
Present embodiments provide it is a kind of be used to prepare described in embodiment 1 contain according to the lyophilized oral formulations of piperazine azoles
Preparation method comprises the following steps：
A. purified water 1400ml is measured in container, adds in the PEARLITOL 25C, aspartame and anhydrous citric acid of recipe quantity,
Pharmagel is added after stirring and dissolving；After pharmagel stirring and dissolving, add in through smashing according to a piperazine azoles bulk pharmaceutical chemicals, and stir
It mixes to form suspension solution, by with liquid weight, fully shear agitation is carried out after keeping the skin wet to recipe quantity, is stirred 30 minutes or more
It obtains stablizing suspension solution.
B. the stabilization suspension solution in step A is poured into the unit dose package of 0.3ml in cold aluminium foil model, using liquid
Nitrogen（-80℃）The quick-frozen shaping of spray technique, and be transferred in freeze drier and carry out lyophilization, continue drying out and constant temperature is done
It is dry, moisture is made to be less than 2%, obtains lyophilized oral formulations.
The drying temperature of lyophilization first stage is -45 DEG C ~ -25 DEG C, drying time 1.5h；Lyophilization second-order
The drying temperature of section is -15 DEG C ~ -5 DEG C, drying time 1h.
The drying temperature for continuing drying out the first stage is -2 DEG C ~ 15 DEG C, drying time 1h；Continue drying out second stage
Drying temperature is 20 DEG C ~ 40 DEG C, drying time 1h.
The temperature of freeze-day with constant temperature is 50 DEG C, drying time 0.5h.
Be readily appreciated that ground, in order to control reduce lyophilized oral formulations in water content, above-mentioned each drying temperature and
Each drying time can make appropriate adjustment according to actual fabrication process.
C. dried lyophilized oral formulations are subjected to quick heat sealed package using aluminium foil, prevent lyophilized oral formulations from inhaling
Tide.
Embodiment 3
The present embodiment contains three kinds in embodiment 1 has carried out quality evaluation according to a lyophilized oral formulations for piperazine azoles,
Including：
（1）Disintegration is evaluated：Product is put on glass planar, 1 is added dropwise at tablet 0.5cm in product surface drips
（About 0.02ml）And accurate timing；It is required that measuring 10, the disintegration time standard limits of every must not be 10 seconds.
（2）Mouthfeel is evaluated：10 volunteers carry out mouthfeel evaluation, and product is put the tip of the tongue, when observing disintegration situation and recording
Between, whether there are the sand feeling, sour-sweet taste whether good etc. after disintegration completely.
（3）Character Evaluation：It is required that product surface is smooth；It is complete to pack demoulding.
（4）Moisture is evaluated：Moisture is measured using Fei Xiushifa, it is desirable that product moisture content must not cross 2%.
Its quality evaluation result is as shown in table 2 below.
Table 2
As shown in Table 2, using 75 μm of particle diameter distribution D90 ＜ according to a lyophilized oral formulations made of piperazine azoles bulk pharmaceutical chemicals,
Surface is smooth, and packaging demoulding is complete；Determination of moisture is respectively less than 2%；Disintegration time is quick, is respectively less than 10 seconds；And it is good in taste,
Without sand feeling, sour-sweet taste is suitable.
Embodiment 4
Using airflow pulverization to being handled according to a piperazine azoles bulk pharmaceutical chemicals, and granularity is carried out using laser granulometry
Measure of spread, measurement result is as shown in Figure 1, particle size distribution range is D102 μm of ＜, D5025 μm of ＜, D9075 μm of ＜, it is seen that make
It can make fully to be crushed according to a piperazine azoles raw material with airflow pulverization.
Embodiment 5
It is tested according to influence of the grain size of piperazine azoles to prepared lyophilized oral formulations：Used in prescription 1 ~ 3 in embodiment 1
Be that particle diameter distribution is D according to a piperazine azoles90Less than 75 μm, and by the quality evaluation result in embodiment 2（Table 2）It understands, in this model
Grain size in enclosing does not influence disintegration time limited and mouthfeel.So selection is used without air-flow crushing according to a piperazine azoles bulk pharmaceutical chemicals（D90
For 350 μm）With using common mechanical crush after according to a piperazine azoles bulk pharmaceutical chemicals（D90For 150 μm）The prescription of according to the form below 3 carries out respectively
It investigates, whether see influences disintegration time limited and mouthfeel.
Table 3
The preparation method of prescription 4 and the preparation method of punishment 5 described in embodiment 2.
The quality evaluating method of prescription 4 and prescription 5 is the same as the quality evaluating method of embodiment 2, evaluation result such as the following table 4 institute
Show.
Table 4
Compared from table 4 and table 2, using without air-flow crushing according to a piperazine azoles bulk pharmaceutical chemicals（D90For 350 μm）With adopt
After being crushed with common mechanical according to a piperazine azoles bulk pharmaceutical chemicals（D90For 150 μm）The lyophilized oral formulations prepared respectively, shape, moisture
Content and disintegration time are with using particle diameter distribution D9075 μm of ＜'s does not have according to a lyophilized oral formulations made of piperazine azoles bulk pharmaceutical chemicals
Notable difference, it is therefore, basic to the character, moisture and disintegration time of lyophilized oral formulations according to the grain size of piperazine azoles bulk pharmaceutical chemicals
It has not significant impact.
But found by comparing, mouthfeel can be had an impact according to a piperazine azoles grain size, using particle diameter distribution D9075 μm of ＜'s
According to the good in taste of lyophilized oral formulations made of piperazine azoles bulk pharmaceutical chemicals, without sand feeling, and use without air-flow crushing
According to a piperazine azoles bulk pharmaceutical chemicals（D90For 350 μm）With using common mechanical crush after according to a piperazine azoles bulk pharmaceutical chemicals（D90For 150 μm）Respectively
The mouthfeel of the lyophilized oral formulations of preparation is poor, there is sand feeling, therefore in order to improve mouthfeel, is taken convenient for freeze-dried, excellent
Selection of land, using particle diameter distribution D9075 μm of ＜'s prepares lyophilized oral formulations according to a piperazine azoles bulk pharmaceutical chemicals.
The foregoing is only a preferred embodiment of the present invention, is not intended to limit the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.Within the spirit and principles of the invention, that is made any repaiies
Change, equivalent substitution, improvement etc., should all be included in the protection scope of the present invention.
Claims (5)
- It is 1. a kind of containing according to a lyophilized oral formulations for piperazine azoles, which is characterized in that including following components：According to a piperazine azoles 0.25~ 4.0mg, 1~5mg of pharmagel, 5~30mg of PEARLITOL 25C, 0.001~0.01mg of aspartame, anhydrous citric acid 0.2~ 0.8mg, described according to the particle diameter distribution of piperazine azoles is 75 μm of D90 ＜, and the disintegration times of the lyophilized oral formulations is less than 10 seconds, water Part content<2%.
- 2. it is a kind of containing according to a preparation method for the lyophilized oral formulations of piperazine azoles, it is used to prepare lyophilized mouth described in claim 1 Formulation, which is characterized in that comprise the following steps：A. after the PEARLITOL 25C of recipe quantity, aspartame, anhydrous citric acid and pharmagel being dissolved in purified water, in stirring bar It is added under part through crushing according to a piperazine azoles, obtains suspension solution；It keeps the skin wet again by with liquid weight to recipe quantity, through fully shearing It obtains stablizing suspension solution after stirring；B. the stabilization suspension solution obtained in step A is packed respectively and be poured into each cold aluminium foil model, and sprayed using liquid nitrogen It is transferred in freeze drier and is freeze-dried after the quick-frozen shaping of mist technology, make moisture<2%, obtain lyophilized oral system Agent；C. the lyophilized oral formulations in step B are subjected to quick heat sealed package using aluminium foil.
- 3. preparation method according to claim 2, which is characterized in that use air-flow powder according to piperazine azoles described in step A Broken technology crush and crushed according to a piperazine azoles, the crushing is D according to the particle size distribution range of piperazine azoles102 μm of ＜, D50 25 μm of ＜, D9075 μm of ＜.
- 4. preparation method according to claim 3, which is characterized in that it is dry that the freeze-drying in step B includes distillation It is dry, continue drying out and freeze-day with constant temperature.
- 5. preparation method according to claim 4, which is characterized in that the lyophilization includes the lyophilization first stage With lyophilization second stage, the sublimation temperature of the lyophilization first stage is -45~-25 DEG C, drying time 1.5h； The sublimation temperature of the lyophilization second stage is -15~-5 DEG C, drying time 1h；It is described continue drying out including continuing drying out the first stage and continuing drying out second stage, it is described to continue drying out the first stage Drying temperature is -2~15 DEG C, drying time 1h；The drying temperature for continuing drying out second stage is 20~40 DEG C, dry Time is 1h；The drying temperature of the freeze-day with constant temperature is 50 DEG C, drying time 0.5h.
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| CN105412036A (en) * | 2015-12-24 | 2016-03-23 | 北京康立生医药技术开发有限公司 | Brexpiprazole orally disintegrating tablets |
| EP3500247B1 (en) * | 2016-08-16 | 2020-05-27 | H e x a l Aktiengesellschaft | Immediate release tablet of a benzothiophene compound |
| US11072605B2 (en) | 2017-02-02 | 2021-07-27 | Hexal Ag | Crystalline brexpiprazole |
| WO2023240971A1 (en) * | 2022-06-16 | 2023-12-21 | 江苏慧聚药业股份有限公司 | Pharmaceutical composition and brexpiprazole orally dissolving film |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103889425A (en) * | 2011-10-14 | 2014-06-25 | 大塚制药株式会社 | TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF |
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| JP2012121850A (en) * | 2010-12-09 | 2012-06-28 | Otsuka Pharmaceut Co Ltd | Oral fast-dissolving composition of aripiprazole |
| JP2013253038A (en) * | 2012-06-07 | 2013-12-19 | Otsuka Pharmaceut Co Ltd | Intraoral dissolving type film preparation |
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| CN103889425A (en) * | 2011-10-14 | 2014-06-25 | 大塚制药株式会社 | TABLET INCLUDING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR SALT THEREOF |
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| Title |
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| 冷冻干燥法制备口腔速崩片的研究进展;李平;《科技创新导报》;20081231(第7期);第53-55页 * |
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