CN104116741B - Vilazodone Hydrochloride composition and preparation method thereof - Google Patents
Vilazodone Hydrochloride composition and preparation method thereof Download PDFInfo
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- CN104116741B CN104116741B CN201310146602.3A CN201310146602A CN104116741B CN 104116741 B CN104116741 B CN 104116741B CN 201310146602 A CN201310146602 A CN 201310146602A CN 104116741 B CN104116741 B CN 104116741B
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Abstract
For denomination of invention Vilazodone Hydrochloride composition and preparation method thereof the present invention relates to a kind of Vilazodone Hydrochloride composition and preparation method thereof, the composition includes Vilazodone Hydrochloride, altogether microcarrier and the pharmaceutically acceptable auxiliary material of oral solid formulation.Preparation method is to crush Vilazodone Hydrochloride after microcarrier mixes together, then be uniformly mixed with the pharmaceutically acceptable auxiliary material of oral solid formulation.Resulting composition agent in vitro dissolution greatly improve, and vivo biodistribution availability with
Description
Technical field
The present invention relates to the pharmaceutical compositions and preparation method thereof containing Vilazodone Hydrochloride, belong to pharmaceutical technology field.
Background technique
With social development, the pressure of spirit, psychology brought by fast pace etc., the disease incidence of depression obviously increases
Add.Depression includes monopolar depression (i.e. major depressive disorder and depression), adjustment disorder, slight depression, season
The multiple types such as affective disorders, anxiety disorder are saved, wherein major depressive disorder is also known as major depressive disorder, and symptom includes:
It is depressed, the interest of daily routines is reduced, weight or appetite are decreased obviously, are had a sleepless night or hypersomnia, be on tenterhooks/paced
(psychomotor agitation), feeling of fatigue or hypersomnia, sense of guilt self are belittled, suicidal thought.It will affect patient after the onset
Work, sleep, study, diet and recreation.
Vilazodone Hydrochloride (vilazodone hydrochloride) has the structure such as formula I, chemical name are as follows: 5- 4-
4- (5- cyano-1 H-indol -3- base) butyl ] -1- piperazinyl ] -2- benzofuran oxalyl amine hydrochlorate is first indoles alkane
Base amine antidepressants, belong to selective serotonin reuptake inhibitor and 5-HT1AAcceptor portion agonist.
Existing literature for Vilazodone Hydrochloride crystal form study it is wide, wherein notification number be CN100384841C,
A variety of crystal habit forms that Vilazodone Hydrochloride is in the patent document of CN101139345B have given disclosure, including salt
Sour vilazodone solvate crystal form, Vilazodone Hydrochloride hydrate crystal forms and Vilazodone Hydrochloride anhydride crystals Form, Wella assistant
Ketone dihydrochloride crystal form, amorphous Vilazodone Hydrochloride.Following " crystal forms " of the invention classification is according to CN100384841C document
In each crystal form class definition.
Food and Drug Adminstration of the US is in approval on January 21st, 2011 Vilazodone Hydrochloride tablet (trade name) for treating severe adult's depression, the prior art indicate that Vilazodone Hydrochloride crystal form IV has relatively preferably
The properties such as dissolution,What is used that is to say Vilazodone Hydrochloride crystal form IV.Vilazodone Hydrochloride different crystal forms
Dissolution properties difference is larger, and the dissolution of the Vilazodone Hydrochloride crystal form other than above-mentioned crystal form IV is poor, is difficult to be used as preparation
Drug, conventional preparation technique means are difficult to the agent in vitro dissolution of each crystal form reaching consistent, these means include: reduction grain
Diameter, pH adjusting agent, solubilizer, solid dispersions etc..
In view of Vilazodone Hydrochloride other than above-mentioned crystal form IV the dissolution problem of crystal form and Vilazodone Hydrochloride in medicine
With substantial worth, be very necessary for Vilazodone Hydrochloride crystal form composition and preparation method research.The present invention is just
By the application of several formulations means, solves the above problem, so that the solid pharmaceutical preparation of Vilazodone Hydrochloride different crystal forms, reaches
WithDissolution it is consistent, and in animal body withThe effect of bioequivalence.
Summary of the invention
The definition of Vilazodone Hydrochloride different crystal forms of the present invention and Vilazodone Hydrochloride in patent CN100384841C
The definition of different crystal forms is consistent.
An object of the present invention is to provide a kind of Vilazodone Hydrochloride composition, to solve demineralizing acid vilazodone crystal form
The low problem of other each crystal form poor solubilities other than IV, vivo biodistribution availability improves dissolution in vitro and vivo biodistribution benefit
Expenditure.
Vilazodone Hydrochloride composition of the present invention is achieved through the following technical solutions:
The composition includes Vilazodone Hydrochloride, altogether microcarrier and the pharmaceutically acceptable auxiliary material of oral solid formulation.Wherein
The microcarrier altogether refers to mixes co-micronised carrier in advance with Vilazodone Hydrochloride in the compositions of the present invention, plays
The effect for promoting Vilazodone Hydrochloride dissolution in composition, improving bioavilability.
Further, Vilazodone Hydrochloride is Vilazodone Hydrochloride crystal form, including the Vilazodone Hydrochloride in addition to crystal form IV
Crystal form.
Further, the weight ratio of microcarrier and Vilazodone Hydrochloride is 0.1~7:1 altogether, preferred weight ratio is 0.5~
5:1.
Further, microcarrier is cyclodextrin, cyclodextrine derivatives, lactose, mannitol, microcrystalline cellulose, is crosslinked and gathers altogether
It is one such or a variety of to tie up ketone.The cyclodextrine derivatives are selected from betadex, HYDROXYPROPYL BETA-CYCLODEXTRIN.
Further, the pharmaceutically acceptable auxiliary material of oral solid formulation includes filler, disintegrating agent, lubricant, glidant.
Wherein filler is in lactose, mannitol, microcrystalline cellulose, starch, cellulose-lactose, mannitol-starch, starch-lactose
It is one or more；Disintegrating agent is selected from dried starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crospovidone, crosslinking
One of sodium carboxymethylcellulose is a variety of；Glidant is selected from the one or two of silica, colloidal silicon dioxide；Lubrication
Agent is selected from one of magnesium stearate, talcum powder, Macrogol 6000 or a variety of.
Further, dosage of each component accounts for the ratio of composition total weight in composition are as follows: Vilazodone Hydrochloride: 5%~
12%, total microcarrier: 1%~80%, filler: 10%~80%, disintegrating agent: 0.1%~5%；Lubricant: 0.1%~3%, glidant:
0.1%~3%.It is preferred that dosage of each component accounts for the ratio of composition total weight are as follows: Vilazodone Hydrochloride 8%~10%, total microcarrier: 5%
~70%, filler: 10%~60%, disintegrating agent: 0.5%~4%, lubricant: 0.5%~2.5%, glidant: 0.5%~2.5%.
Further, surfactant can also be added in the composition, and the surfactant includes ionic surface
Activating agent and nonionic surface active agent.
Further, surfactant is selected from lauryl sodium sulfate, phosphatide, poloxamer class, polyethoxylated castor-oil plant
One of oils, ethoxylation polysorbate esters, poly- hydroxystearate class are a variety of, preferably dodecyl sulphate
Sodium, phosphatide, Pluronic/Lutrol F 44, PLURONICS F87, poloxamer 237, Pluronic/Lutrol F 108, poloxamer188, polysorbate
80, polysorbate 60, polysorbate 40, polysorbate 20, Cremophor EL, Cremophor RH40, Cremophor
One of RH60 or a variety of.
Further, the dosage of surfactant accounts for the ratio of composition total weight are as follows: and 0.05%~10%, preferred dosage
It is 0.5%~8%.
Another object of the present invention is to provide the preparation method of above-mentioned Vilazodone Hydrochloride composition, feature is as follows: will
Vilazodone Hydrochloride crushes after microcarrier mixes together, is uniformly mixed with the pharmaceutically acceptable auxiliary material of oral solid formulation, makes
At tablet or capsule.
Further, microcarrier mixes Vilazodone Hydrochloride together, and being crushed to partial size is 1~20 μm.
Further, the alcohol of surfactant can also be added after Vilazodone Hydrochloride together microcarrier co-grinding
Solution or aqueous solution, be dispersed, it is dry after be uniformly mixed again with the pharmaceutically acceptable medium of oral solid formulation, be made tablet or
Capsule.
In addition, the grinding mode of the Vilazodone Hydrochloride mixture of microcarrier together include grind, air-flow crushing etc.,
The progress of the equipment such as ball mill, airslide disintegrating mill, colloid mill can be used.The technique that tablet or capsule is made includes wet granulation, does
Method granulation, direct tablet compressing, powder directly fill capsule, particles filled capsule etc..
It is an advantage of the present invention that overcoming prior art defect, solve other salt in addition to crystal form IV in the prior art
The In Vitro Dissolution problem of sour vilazodone crystal form preparation, and also improve composition vivo biodistribution availability.In addition, of the invention
Surfactant can also be added in composition, dissolution problem can be better solved.
Detailed description of the invention
Fig. 1 embodiment 1-8 prepare sample withDissolution curve comparison (0.1mol/L hydrochloric acid solution is medium).
Fig. 2 embodiment 1-8 prepare sample withDissolution curve compares (acetum that volume fraction is 0.1% is medium).
Fig. 3 embodiment 1-8 prepare sample withDissolution curve compares (water is medium).
Specific embodiment
The present invention is further elaborated combined with specific embodiments below, but does not limit the present invention.
Vilazodone Hydrochloride used in the present invention refers to Vilazodone Hydrochloride crystal form.
Patent document (the specification that following Vilazodone Hydrochloride different crystal forms used are CN100384841C according to notification number
Page 24~29) preparation gained, other agents useful for same are commercially available.
Embodiment 1
The preparation of 1 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride powder particle diameter is uniformly mixed, direct tablet compressing to 5 μm with other auxiliary materials in prescription
Tablet is made or powder is directly filling at capsule.
Embodiment 2
The preparation of 2 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride powder particle diameter to 5 μm, in prescription in addition to silica, magnesium stearate
Other auxiliary materials are uniformly mixed, and the aqueous solution granulation of polyoxyethylene sorbitan monoleate is added, silica, magnesium stearate is added after dry, whole grain
Tablet is made in mixing, tabletting.
Embodiment 3
The preparation of 3 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: powder particle diameter is to 20 μm after Vilazodone Hydrochloride is mixed with lactose, betadex, with its in prescription
He is uniformly mixed auxiliary material, and tablet is made in direct tablet compressing or powder is directly filling at capsule.
Embodiment 4
The preparation of 4 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride is crushed to 15 μm of partial size after mixing with mannitol, the ethanol solution of phosphatide is added,
Be dispersed, it is dry after be uniformly mixed with other auxiliary materials in prescription, wet granule compression tablet be made after tablet or wet granulation it is filling at
Capsule.
Embodiment 5
The preparation of 5 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride is crushed to 10 μm of partial size after mixing with crospovidone, and poloxamer188 is added
Aqueous solution, be dispersed, it is dry after be uniformly mixed with other auxiliary materials in prescription, tablet is made in direct tablet compressing or powder is directly filling
At capsule.
Embodiment 6
The preparation of 6 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride is crushed to 8 μm of partial size after mixing with mannitol, mixes with other auxiliary materials in prescription
Uniformly, tablet or Sprinkle Caps are made in wet granulation.
Embodiment 7
The preparation of 7 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride is crushed to partial size after mixing with HYDROXYPROPYL BETA-CYCLODEXTRIN be 5 μm, and poly- mountain is added
The aqueous solution of pear ester 80 is dispersed, is uniformly mixed after drying with other auxiliary materials in prescription, and tablet is made in direct tablet compressing or powder is straight
It connects filling at capsule.
Embodiment 8
The preparation of 8 Vilazodone Hydrochloride tablets/capsules of table
Preparation process: Vilazodone Hydrochloride is crushed to 2 μm of partial size after mixing with microcrystalline cellulose, and Cremophor is added
The ethanol solution of RH40 is dispersed, is uniformly mixed after drying with other auxiliary materials in prescription, and tablet or capsule is made in wet granulation.
9 dissolution rate of embodiment is investigated
60 revs/min of revolving speed, 37 ± 0.5 DEG C of temperature, distinguished by 2010 editions annex of Chinese Pharmacopoeia (Ⅹ C of annex) using paddle method
Using 0.1mol/L hydrochloric acid solution, 0.1%(volume fraction) acetum and water is media, determined by ultraviolet spectrophotometry dissolution rate,
As the result is shown: sample 1 and 2 is in 0.1%(volume fraction) in acetic aid medium dissolution it is still, but molten in 0.1mol/L hydrochloric acid and water
It is lower out, sample 3~8 withIn Vitro Dissolution reach consistent (attached drawing 1,2,3) in different media.
The test of 10 pharmacokinetics of embodiment
Make by oneself tablet withAgent carries out pharmacokinetics comparison, is tested using dog PK under a fed conditions.Take 8
Beagle dog, half male and half female.Experiment is intersected using two stages binary cycle, by own control contrived experiment scheme.
Vilazodone tablet (40mg/ piece) pharmacokinetic parameter afterwards is administered orally in table 9Beagle dog
The result shows that sample 1 and 2 withBiological inequivalence, TmaxThere is significant difference through nonparametric method inspection
(P>0.05)；Sample 3~8 withBioequivalence, TmaxThrough nonparametric method examine no significant difference (P >
0.05)。
Claims (15)
1. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, wherein the microcarrier altogether is selected from lactose, mannitol, microcrystalline cellulose
One of element, crospovidone, cyclodextrin, betadex, HYDROXYPROPYL BETA-CYCLODEXTRIN are a variety of；The oral administration solid system
The pharmaceutically acceptable auxiliary material of agent includes filler, disintegrating agent, lubricant, glidant；The filler be selected from lactose, mannitol,
One of microcrystalline cellulose, starch, cellulose-lactose, mannitol-starch, starch-lactose are a variety of, the disintegrating agent choosing
One from dried starch, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, crospovidone, croscarmellose sodium
Kind is a variety of, and the glidant is selected from one or both of silica, colloidal silicon dioxide, and the lubricant is selected from tristearin
One of sour magnesium, talcum powder, Macrogol 6000 are a variety of；Dosage of each component accounts for the ratio of composition total weight are as follows: hydrochloric acid
Vilazodone 5% ~ 12%, microcarrier 1% ~ 80%, filler 10% ~ 80%, disintegrating agent 0.1% ~ 5%, lubricant 0.1% ~ 3% help stream altogether
Agent 0.1% ~ 3%.
2. composition according to claim 1, it is characterised in that: the weight ratio of microcarrier and Vilazodone Hydrochloride altogether are as follows:
0.1 ~ 7:1.
3. composition according to claim 2, it is characterised in that: the weight ratio of microcarrier and Vilazodone Hydrochloride altogether are as follows:
0.5-5:1.
4. composition according to claim 1, it is characterised in that: dosage of each component accounts for the ratio of composition total weight are as follows:
Vilazodone Hydrochloride 8% ~ 10%, total microcarrier: 5% ~ 70%, filler: 10% ~ 60%, disintegrating agent: 0.5% ~ 4%, lubricant: 0.5% ~
2.5%, glidant: 0.5% ~ 2.
5. composition according to any one of claim 1 to 4, it is characterised in that: surfactant can also be added, it is described
The dosage of surfactant accounts for the ratio of composition total weight are as follows: 0.05% ~ 10%.
6. composition according to claim 5, it is characterised in that: the dosage of the surfactant accounts for composition total weight
Ratio are as follows: 0.5% ~ 8%.
7. composition according to claim 5, it is characterised in that: surfactant includes ionic surfactant and non-
Ionic surfactant.
8. composition according to claim 7, it is characterised in that: surfactant be selected from phosphatide, lauryl sodium sulfate,
One in poloxamer class, GREMAPHOR GS32 class, ethoxylation polysorbate esters and poly- hydroxystearate class
Kind is a variety of.
9. composition according to claim 1, it is characterised in that: can also be in Vilazodone Hydrochloride microcarrier mixing together
After crushing, the alcoholic solution or aqueous solution of surfactant is added, is dispersed, can pharmaceutically be connect with oral solid formulation again after drying
It is uniformly mixed by medium.
10. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is lactose and betadex altogether.
11. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is mannitol altogether.
12. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is crospovidone altogether.
13. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is mannitol altogether.
14. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is HYDROXYPROPYL BETA-CYCLODEXTRIN altogether.
15. a kind of Vilazodone Hydrochloride composition, the composition includes Vilazodone Hydrochloride, altogether microcarrier and oral solid formulation
Pharmaceutically acceptable auxiliary material, which is characterized in that Vilazodone Hydrochloride is crushed to 1 ~ 20 μm after microcarrier mixes together, then with mouth
The pharmaceutically acceptable auxiliary material of oral solid preparation is uniformly mixed, and the composition is grouped as by the group of following weight ratio:
Wherein, microcarrier is microcrystalline cellulose altogether.
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105125512B (en) * | 2015-09-09 | 2018-04-17 | 山东大学 | A kind of crystalline substance V-type Puerarin tablet and preparation method thereof |
| US10688090B2 (en) | 2016-11-02 | 2020-06-23 | Sunshine Lake Pharma Co., Ltd. | Vilazodone inclusion complexes, compositions and preparation thereof |
| CN106667939A (en) * | 2017-02-14 | 2017-05-17 | 万全万特制药（厦门）有限公司 | Orally disintegrating tablet containing vilazodone hydrochloride and preparation method thereof |
| WO2020119701A1 (en) * | 2018-12-13 | 2020-06-18 | 广东东阳光药业有限公司 | Vilazodone solid dispersion and preparation method therefor |
| CN111346097B (en) * | 2018-12-22 | 2023-03-24 | 江苏先声药业有限公司 | Composition and preparation method thereof |
| JP2024501527A (en) * | 2020-12-23 | 2024-01-12 | 上海雲晟研新生物科技有限公司 | Vilazodone pharmaceutical composition, its manufacturing method and application |
| WO2023098745A1 (en) * | 2021-11-30 | 2023-06-08 | 广东东阳光药业有限公司 | Vilazodone composition, pharmaceutical preparation thereof, preparation therefor, and use thereof |
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| CN102267985A (en) * | 2011-06-15 | 2011-12-07 | 上海医药工业研究院 | Preparation method for vilazodone and hydrochloride thereof |
| CN102949364A (en) * | 2011-08-30 | 2013-03-06 | 天津药物研究院 | Sustained release tablet containing effective component hydrochloric acid vilazodone |
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| CN102267985A (en) * | 2011-06-15 | 2011-12-07 | 上海医药工业研究院 | Preparation method for vilazodone and hydrochloride thereof |
| CN102249979A (en) * | 2011-07-12 | 2011-11-23 | 上海开义医药化工有限公司 | Method for preparing 3-(4-chlorobutyryl)-1H-indole-5-methylcyanogen |
| CN102949364A (en) * | 2011-08-30 | 2013-03-06 | 天津药物研究院 | Sustained release tablet containing effective component hydrochloric acid vilazodone |
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Effective date of registration: 20160707 Address after: 210042 Xuanwu District, Xuanwu District, Jiangsu, Nanjing No. 699 -18 Applicant after: Jiangsu Simcere Pharmaceutical Co., Ltd. Address before: 210042 Xuanwu District, Xuanwu District, Jiangsu, Nanjing No. 699 -18 Applicant before: Jiangsu Simcere Pharmaceutical Research Company Limited Applicant before: Jiangsu Simcere Pharmaceutical Co., Ltd. |
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