CN104523645A - Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate - Google Patents
Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate Download PDFInfo
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- CN104523645A CN104523645A CN201410664350.8A CN201410664350A CN104523645A CN 104523645 A CN104523645 A CN 104523645A CN 201410664350 A CN201410664350 A CN 201410664350A CN 104523645 A CN104523645 A CN 104523645A
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Abstract
The invention provides a paroxetine mesylate tablet core, and a preparation method of a coated tablet of paroxetine mesylate. Each paroxetine mesylate tablet core comprises 10 to 40mg of active pharmaceutical ingredient paroxetine mesylate, 20 to 90% of a water insoluble filler, 10 to 60% of a water soluble filler, 3 to 30% of a disintegrating agent, 0 to 10% of an adhesive, and 0.1 to 10% of a flow aid and a lubricant. The paroxetine mesylate tablet core is prepared via wet-method granulation or spray granulation of the ingredients above, and tabletting. The invention also provides the preparation method of the paroxetine mesylate coated tablet. A coating material is opacifying agent-containing opadry or a coating powder composed of 0.5 to 4% of a film forming agent, 0.1 to 2% of a plasticizer, 0.1 to 1% of a colouring agent, 0.1 to 2% of an opacifier, and 0.1 to 1% of a lubricant. The paroxetine mesylate tablet core is subjected to coating using a coating liquid prepared from the coating material. The ingredients of the coating material are commonly used; the preparation method is stable; film coating is capable of covering bitter taste and hemp taste of the main drug, increasing light stability, and improving compliance of patients and stability of preparations. The coated tablet prepared via the preparation method is qualified and stable.
Description
Technical field
The invention belongs to medical art; be specifically related to a kind of oral be the pharmaceutical preparation of the coated tablet of methanesulfonic acid paroxetine containing principal agent; this tablet adopts conventional adjuvant; adopt conventional wet granulation technology; simple to its preparation method, easy to operate; improve quality and the stability of pharmaceutical preparation, have wide range of applications, be applicable to large-scale production.
Background technology
Paroxetine is phenylpiperidine derivative, be a kind of selectivity 5-HT reuptake inhibitor, belong to the antidepressant drug of citalopram, fluoxetine, Sertraline, clomipramine one class, be clinically widely used in Cure of depression, during common dose, other mediators are had no significant effect.Improve the concentration of 5-HT in nerve synapse gap by stoping absorbing again of 5-HT, thus produce antidepressant effect.Can absorb completely after oral, food and medicine all do not affect it and absorb.Have first pass effect, after administration only 1% be present in body circulation, plasma protein binding rate is 93%, can be distributed in each histoorgan of whole body, also by mammary gland secretion.Main through liver metabolism, generate uridylic acid compound, excrete finally by kidney, fraction is discharged from feces through bile secretion.
First paroxetine is that trade name is registered in Sweden (1991), Finland (1992), Denmark (1993), Iceland and Norway with Seroxato by Novo Nordisk Co., Ltd, gives GlaxoSmithKline PLC afterwards by the worldwide power of sale.GlaxoSmithKline PLC company pushed it against market in 1993, and within 2002, the U.S. ratifies its controlled release preparation, and within 2003, FDA ratifies again effect of paroxetine in treating social anxiety disorder, and continued treatment premenstrual dysphoric disorder.Within 2004, FDA have approved the 5th indication of this product: the intermittent treatment of premenstrual dysphoric disorder.Skyepharma company elementary introduction to drug delivery technique (GEOMATRIX) and the perfect adaptation of GlaxoSmithKline PLC company paroxetine, further promote the sale of this product.Clinical research confirmation, this product significantly reduces nauseating incidence rate, and this is most SSRI(selectivity serotonin reuptake transporter blocker) the common untoward reaction of class medicine.The treatment interruption rate of this product is also remarkable in SSRI class antidepressants.
Methanesulfonic acid paroxetine (paroxetine mesylate), chemistry (-)-trans-4R-(4-fluorophenyl by name)-3S-{ [3 ', 4 '-(methylene-dioxy) phenoxy group] methyl }-piperidine methanesulfonic acid salt.Molecular formula: C19H20FNO3. CH3SO3H. molecular weight: 425.5 its structural formulas are as follows:
。
At present, the dosage form of paroxetine hydrochloride listing mostly comparatively is conventional tablet, slow releasing tablet, controlled release tablet etc., the patent of preparation relevant both at home and abroad mostly at present is the various dosage forms of its hydrochlorate, Synthon B. V. of Holland just obtained the patent right of compound as far back as 1997, within 2003, U.S. FDA have approved the tablet of the salts of paroxetine of trade name PEXEVA, in the description of its approval, composition has the suitable paroxetine of active component to be 10mg, other adjuvant comprises calcium hydrogen phosphate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, magnesium stearate, carboxymethyl starch sodium, titanium dioxide, red ferric oxide etc., but the current domestic formulation patent about mesylate is there are no relevant report.
Paroxetine belongs to highly dissoluble high-permeability class medicine according to Biopharmaceutics Classification.Report is had to claim light stability poor.From the stability of current existing paroxetine hydrochloride, having good stability of its high humidity, high temperature, points out the tablet of its mesylate also can adopt conventional method preparation, just can ensure quality and the stability of preparation.
Summary of the invention
The invention provides the preparation method of a kind of methanesulfonic acid paroxetine label and coated tablet thereof, because of bitterness and the numb taste of medicine itself, so the coated tablet prescription of gained of the present invention is for commonly using adjuvant and stable preparation process, film coating had both masked the bitterness of principal agent and numb taste, turn improve light stability, improve the compliance of user and the stability of preparation, the coated tablet obtained through this method is up-to-standard and stable.Goal of the invention: in order to find the tablet producing technology of conventional salts of paroxetine, make its applied range, technique more easily realizes, and makes the steady quality of product and the compliance that patient is taken raising, be conducive to production control cost, realize extensive industrialization.
For achieving the above object, the present invention's technical solution problem by the following technical programs.
The invention provides a kind of containing the label of active component methanesulfonic acid paroxetine and the preparation method of coated tablet, that its label comprises active constituents of medicine methanesulfonic acid paroxetine is 10-40mg, water-insoluble filler 20%-90%, water-soluble filler 10%-60%, disintegrating agent 3%-30%, binding agent 0-10%, fluidizer and lubricant 0.1%-10%; The preparation method of this label is according to above-mentioned Core formulation, carries out wet method or spray granulation, then tabletting; The coating material that label is prepared with following prescription or the Opadry containing opacifier carry out coating, and coating material consists of: the coloring agent of the film former of 0.5%-4%, the plasticizer of 0.1%-2%, 0.1%-1%, opacifier are the lubricant of 0.1%-2% and 0.1%-1%.
Active constituents of medicine is methanesulfonic acid paroxetine, and contained by every sheet, the amount of principal agent composition is 10-40 mg.
Preferably, the water-soluble filler in label is lactose, mannitol, glucose, sorbitol, sucrose one or more compositionss wherein, and accounting for label percentage by weight is 10%-60%.
Preferably, the water-insoluble filler in label is calcium hydrogen phosphate, calcium carbonate, calcium sulfate, microcrystalline Cellulose, starch, pregelatinized Starch one or more compositionss wherein, and accounting for label percentage by weight is 20%-90%.
Disintegrating agent in label is one or more compositionss wherein such as carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone, and accounting for label percentage by weight is 3%-30%.
Binding agent in label is one or more compositionss wherein such as alcohol-water solution, PVP K30, low-viscosity hydroxypropylmethylc,llulose of water, 10%-70%, and accounting for label percentage by weight is 0%-10%.
The fluidizer of label and lubricant are one or more compositionss wherein such as silicon dioxide, magnesium stearate, Pulvis Talci, and accounting for label percentage by weight is 0%-10%.
The preparation method of label is wet granulation or spray granulation, and its feature comprises and comprising the steps:
A) supplementary material pulverized 100 mesh sieves respectively;
B) by the adjuvant mix homogeneously of raw material and above-mentioned mistake 100 mesh sieve, binding agent wet granulation or spray granulation is added, and dry and granulate;
C) above-mentioned dry granule is added fluidizer and lubricant, mix homogeneously, and tabletting.
The coating material of tablet is Opadry containing opacifier or the material formulation by following label weight: the coloring agent of the film former of 0.5%-4%, the plasticizer of 0.1%-2%, 0.1%-1%, opacifier are the compositions of the lubricant of 0.1%-2% and 0.1%-1%, and accounting for label percentage by weight is 0%-10%.
Beneficial effect: compared with the preparation method of prior art tablet, the present invention makes tablet cover the disagreeable taste of medicine itself by the preparation and coating method utilizing conventional tablet, improve stability, and preparation technology can make the stripping of four of sheet media similar with former control formulation of grinding, the quality of sheet and stability are improved, enhance the compliance of patient to medicine.
Specific embodiment
Referring to specific embodiment, the present invention is described.It will be appreciated by those skilled in the art that these embodiments are only for illustration of the present invention, its scope do not limited the present invention in any way.
Embodiment 1
| Component | Usage percentage % |
| Methanesulfonic acid paroxetine | 13 |
| Mannitol | 30 |
| Calcium hydrogen phosphate | 14 |
| MCC | 35 |
| Low-substituted hydroxypropyl cellulose | 6 |
| PVPK30 | 0.5 |
| Magnesium stearate | 0.5 |
| Silicon dioxide | 1 |
Its preparation method comprises the steps:
(1) respectively supplementary material was pulverized 100 sieve, PVPK30 is dissolved in the water be mixed with 3% aqueous solution, for subsequent use.Respectively by after the raw material after pulverizing, mannitol, calcium hydrogen phosphate, MCC, low-substituted hydroxypropyl cellulose mix homogeneously, granulate with above-mentioned binding agent PVPK30 solution 20 mesh sieve prepared, drying under 50-60 DEG C of condition, 20 mesh sieve granulate, add magnesium stearate, silicon dioxide mix homogeneously, tabletting obtains label;
(2) by soluble in water for Opadry be mixed with 12% Coating Solution;
(3) label that step obtains is added preheating in seed-coating machine, with the coating solution coating obtained in (2), coating weight gain is preferably total tablet and weighs 3%, obtains coated tablet;
(4) result of the test:
Compressibility: good, tablet weight variation ± 3%, hardness is 50-70N
The friability of label: conform with the regulations
Content: 98.7%
Related substance: 0.14%
Dissolution: be greater than 85% in 15 minutes.
Embodiment 2
| Component | Usage percentage % |
| Methanesulfonic acid paroxetine | 13 |
| Lactose | 20 |
| MCC | 59 |
| Cross-linking sodium carboxymethyl cellulose | 6 |
| PVPK30 | 0.5 |
| Magnesium stearate | 0.5 |
| Silicon dioxide | 1 |
Its preparation method comprises the steps:
(1) respectively supplementary material was pulverized 100 sieve, PVPK30 is dissolved in the water be mixed with 3% aqueous solution, for subsequent use.Respectively by after the raw material after pulverizing, lactose, MCC, cross-linking sodium carboxymethyl cellulose mix homogeneously, granulate with above-mentioned binding agent PVPK30 solution 20 mesh sieve prepared, drying under 50-60 DEG C of condition, 20 mesh sieve granulate, add magnesium stearate, silicon dioxide mix homogeneously, tabletting obtains label;
(2) by soluble in water for Opadry be mixed with 12% Coating Solution;
(3) label that step obtains is added preheating in seed-coating machine, with the coating solution coating obtained in (2), coating weight gain is preferably total tablet and weighs 3%, obtains coated tablet;
(4) result of the test:
Compressibility: good, tablet weight variation ± 3%, hardness is 50-70N
The friability of label: conform with the regulations
Content: 99.1%
Related substance: 0.12%
Dissolution: be greater than 85% in 15 minutes.
Embodiment 3
| Component | Usage percentage % |
| Methanesulfonic acid paroxetine | 13 |
| Mannitol | 10 |
| Calcium hydrogen phosphate | 50 |
| MCC | 15 |
| Low-substituted hydroxypropyl cellulose | 10 |
| HPMCE5 | 0.5 |
| Magnesium stearate | 0.5 |
| Silicon dioxide | 1 |
Its preparation method comprises the steps:
(1) respectively supplementary material was pulverized 100 sieve, HPMCE5 is dissolved in the water be mixed with 3% aqueous solution, for subsequent use.Respectively by after the raw material after pulverizing, mannitol, calcium hydrogen phosphate, MCC, low-substituted hydroxypropyl cellulose mix homogeneously, granulate with above-mentioned binding agent HPMCE5 solution 20 mesh sieve prepared, drying under 50-60 DEG C of condition, 20 mesh sieve granulate, add magnesium stearate, silicon dioxide mix homogeneously, tabletting obtains label;
(2) by soluble in water for Opadry be mixed with 12% Coating Solution;
(3) label that step obtains is added preheating in seed-coating machine, with the coating solution coating obtained in (2), coating weight gain is preferably total tablet and weighs 3%, obtains coated tablet;
(4) result of the test:
Compressibility: good, tablet weight variation ± 3%, hardness is 50-70N
The friability of label: conform with the regulations
Content: 99.5%
Related substance: 0.13%
Dissolution: be greater than 85% in 15 minutes.
Embodiment 4
| Component | Usage percentage % |
| Methanesulfonic acid paroxetine | 26 |
| Calcium hydrogen phosphate | 24 |
| Pregelatinized Starch | 42 |
| Carboxymethyl starch sodium | 6 |
| PVPK30 | 0.5 |
| Magnesium stearate | 0.5 |
| Silicon dioxide | 1 |
Its preparation method comprises the steps:
(1) respectively supplementary material was pulverized 100 sieve, PVPK30 is dissolved in the water be mixed with 3% aqueous solution, for subsequent use.Respectively by after the raw material after pulverizing, calcium hydrogen phosphate, pregelatinized Starch, carboxymethyl starch sodium mix homogeneously, granulate with above-mentioned binding agent PVPK30 solution 20 mesh sieve prepared, drying under 50-60 DEG C of condition, 20 mesh sieve granulate, add magnesium stearate, silicon dioxide mix homogeneously, tabletting obtains label;
(2) by soluble in water for Opadry be mixed with 12% Coating Solution;
(3) label that step obtains is added preheating in seed-coating machine, with the coating solution coating obtained in (2), coating weight gain is preferably total tablet and weighs 3%, obtains coated tablet;
(4) result of the test:
Compressibility: good, tablet weight variation ± 3%, hardness is 50-70N
The friability of label: conform with the regulations
Content: 98.9%
Related substance: 0.15%
Dissolution: be greater than 85% in 15 minutes.
Embodiment 5
| Component | Usage percentage % |
| Methanesulfonic acid paroxetine | 19 |
| Mannitol | 23 |
| Calcium hydrogen phosphate | 14 |
| MCC | 35 |
| Low-substituted hydroxypropyl cellulose | 6 |
| PVPK30 | 0.5 |
| Magnesium stearate | 0.5 |
| Silicon dioxide | 1 |
Its preparation method comprises the steps:
(1) respectively supplementary material was pulverized 100 sieve, PVPK30 is dissolved in the water be mixed with 3% aqueous solution, for subsequent use.Respectively by after the raw material after pulverizing, mannitol, calcium hydrogen phosphate, MCC, low-substituted hydroxypropyl cellulose mix homogeneously, granulate with above-mentioned binding agent PVPK30 solution 20 mesh sieve prepared, drying under 50-60 DEG C of condition, 20 mesh sieve granulate, add magnesium stearate, silicon dioxide mix homogeneously, tabletting obtains label;
(2) Coating Solution preparation: label weight ratio 95%, coating powder: filmogen hydroxypropyl emthylcellulose 3.3%, plasticizer polyethylene glycol 6000 account for 0.35%, Pulvis Talci 0.35%, titanium dioxide 0.65%, iron oxide yellow and iron oxide red 9.5:0.5 percentage ratio 0.5%.Ethanol coating material being dissolved in 75% is mixed with the solution of 8% percentage by weight;
(3) label that step obtains is added preheating in seed-coating machine, with the coating solution coating obtained in (2), coating weight gain is preferably total tablet and weighs 3%, obtains coated tablet;
(4) result of the test:
Compressibility: good, tablet weight variation ± 3%, hardness is 50-70N
The friability of label: conform with the regulations
Content: 99.8%
Related substance: 0.13%
Dissolution: be greater than 85% in 15 minutes.
Claims (9)
1. the label containing active component methanesulfonic acid paroxetine and a coated tablet, is characterized in that: every sheet that a) label comprises active constituents of medicine methanesulfonic acid paroxetine is 10-40mg, water-insoluble filler 20%-90%, water-soluble filler 10%-60%, disintegrating agent 3%-30%, binding agent 0-10%, fluidizer and lubricant 0.1%-10%; B) preparation method of this label is according to above-mentioned Core formulation, carries out wet method or spray granulation, then tabletting; C) coating material is Opadry containing opacifier or consists of: the coloring agent of the film former of 0.5%-4%, the plasticizer of 0.1%-2%, 0.1%-1%, opacifier are forming of the lubricant proportioning of 0.1%-2% and 0.1%-1%.
2. active constituents of medicine according to claim 1 is methanesulfonic acid paroxetine, and contained by every sheet, the amount of principal agent composition is 10-40 mg.
3. water-soluble filler according to claim 1 is lactose, mannitol, glucose, sorbitol, sucrose one or more compositionss wherein.
4. water-insoluble filler according to claim 1 is calcium hydrogen phosphate, calcium carbonate, calcium sulfate, microcrystalline Cellulose, starch, pregelatinized Starch one or more compositionss wherein.
5. disintegrating agent according to claim 1 is one or more compositionss wherein such as carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone.
6. binding agent according to claim 1 is one or more compositionss wherein such as alcohol-water solution, PVP K30, low-viscosity hydroxypropylmethylc,llulose of water, 10%-70%.
7. fluidizer according to claim 1 and lubricant are one or more compositionss wherein such as silicon dioxide, magnesium stearate, Pulvis Talci.
8. the preparation method of label described in claim 1 is wet granulation or spray granulation, and its feature comprises and comprising the steps:
A) supplementary material pulverized 100 mesh sieves respectively;
B) by the adjuvant mix homogeneously of raw material and above-mentioned mistake 100 mesh sieve, binding agent wet granulation or spray granulation is added, and dry and granulate;
C) above-mentioned dry granule is added fluidizer and lubricant, mix homogeneously, and tabletting.
9. coating material according to claim 1 is Opadry containing opacifier or the material formulation by following label weight: the coloring agent of the film former of 0.5%-4%, the plasticizer of 0.1%-2%, 0.1%-1%, opacifier are the lubricant of 0.1%-2% and 0.1%-1%, or one or more compositionss wherein, accounting for label percentage by weight is 0%-10%.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410664350.8A CN104523645A (en) | 2014-11-20 | 2014-11-20 | Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410664350.8A CN104523645A (en) | 2014-11-20 | 2014-11-20 | Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate |
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| CN201410664350.8A Pending CN104523645A (en) | 2014-11-20 | 2014-11-20 | Paroxetine mesylate tablet core, and preparation method of coated tablet of paroxetine mesylate |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108309948A (en) * | 2018-05-11 | 2018-07-24 | 新华制药（高密）有限公司 | Cetirizine hydrochloride Tablets and preparation method thereof |
| CN109771381A (en) * | 2017-11-13 | 2019-05-21 | 北京万生药业有限责任公司 | A kind of Paxil pharmaceutical preparation |
| CN110037995A (en) * | 2019-04-17 | 2019-07-23 | 石家庄龙泽制药股份有限公司 | A kind of stable proxetine hydrochloride tablets agent and preparation method thereof |
| CN111803460A (en) * | 2020-07-20 | 2020-10-23 | 华益药业科技(安徽)有限公司 | Production process of paroxetine tablets |
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| CN1315949A (en) * | 1998-07-02 | 2001-10-03 | 史密丝克莱恩比彻姆有限公司 | Salts of paroxetine |
| CN1787811A (en) * | 2003-04-16 | 2006-06-14 | 斯索恩有限公司 | Orally disintegrating tablets |
| CN101548958A (en) * | 2008-04-03 | 2009-10-07 | 北京德众万全药物技术开发有限公司 | Dispersing tablet containing terbinafine hydrochloride |
| CN103083273A (en) * | 2011-11-01 | 2013-05-08 | 上海睿智化学研究有限公司 | Imatinib mesylate tablet cores, coated tablets, and preparation method thereof |
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2014
- 2014-11-20 CN CN201410664350.8A patent/CN104523645A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1315949A (en) * | 1998-07-02 | 2001-10-03 | 史密丝克莱恩比彻姆有限公司 | Salts of paroxetine |
| CN1787811A (en) * | 2003-04-16 | 2006-06-14 | 斯索恩有限公司 | Orally disintegrating tablets |
| CN101548958A (en) * | 2008-04-03 | 2009-10-07 | 北京德众万全药物技术开发有限公司 | Dispersing tablet containing terbinafine hydrochloride |
| CN103083273A (en) * | 2011-11-01 | 2013-05-08 | 上海睿智化学研究有限公司 | Imatinib mesylate tablet cores, coated tablets, and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109771381A (en) * | 2017-11-13 | 2019-05-21 | 北京万生药业有限责任公司 | A kind of Paxil pharmaceutical preparation |
| CN109771381B (en) * | 2017-11-13 | 2021-02-19 | 北京福元医药股份有限公司 | Paroxetine medicinal preparation |
| CN108309948A (en) * | 2018-05-11 | 2018-07-24 | 新华制药（高密）有限公司 | Cetirizine hydrochloride Tablets and preparation method thereof |
| CN110037995A (en) * | 2019-04-17 | 2019-07-23 | 石家庄龙泽制药股份有限公司 | A kind of stable proxetine hydrochloride tablets agent and preparation method thereof |
| CN111803460A (en) * | 2020-07-20 | 2020-10-23 | 华益药业科技(安徽)有限公司 | Production process of paroxetine tablets |
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