CN106822907A - A kind of two-phase delivery formulations containing racecadotril and preparation method thereof - Google Patents
A kind of two-phase delivery formulations containing racecadotril and preparation method thereof Download PDFInfo
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- CN106822907A CN106822907A CN201611240544.0A CN201611240544A CN106822907A CN 106822907 A CN106822907 A CN 106822907A CN 201611240544 A CN201611240544 A CN 201611240544A CN 106822907 A CN106822907 A CN 106822907A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/265—Esters, e.g. nitroglycerine, selenocyanates of carbonic, thiocarbonic, or thiocarboxylic acids, e.g. thioacetic acid, xanthogenic acid, trithiocarbonic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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Abstract
The present invention relates to medicine field, and in particular to a kind of racecadotril two-phase delivery formulations and preparation method thereof.Said preparation is made up of the medicine-containing particle etc. of different release performances, and the consumption of its component is in terms of weight/mass percentage composition：Sustained release medicine-containing particle 10~90%, quick-release medicine-containing particle 10~90%, lubricant 0.1~0.5%, flavor enhancement 0.1~1.0%.Two-phase delivery formulations of the invention not only effectively cover the bitter taste of racecadotril, and effective blood concentration, and preparation process is simple, favorable reproducibility, suitable industrialized production are can guarantee that again.
Description
Technical field
The present invention relates to a kind of racecadotril preparation, more particularly to a kind of two-phase delivery formulations containing racecadotril
And preparation method thereof.
Technical background
Diarrhoea is always the enterogastric diseases for receiving much concern, and has the incidence of disease higher, particularly infant and elderly population.
With other anti diar rhea medicine phases ratios, racecadotril (Racecadotril) is a kind of anti-diarrheal for having novel mechanism, its
It is alternative, reversibly suppress enkephalinase, extend the physiologically active of alimentary canal endogenous enkephalins, so as to suppress water and electricity
Solution matter excessive secretion plays its anti-CaM antibody, with compared with the anti-secretion of high specific, it is adaptable to which various diarrhoea are suited the medicine to the illness
Treatment, and be easy to absorb, works rapidly, adverse reaction it is small, safe, be particularly suitable for infant patient.Therefore, racemization card
Many songs are presently the most preferable anti-diarrheal, and market potential is huge.
Racecadotril is the compound that racemic form is present, i.e. (±) N- (2- acetyl mercaptos methyl isophthalic acids-oxo -3-
Phenyl propyl) glycine benzyl ester (chemical structural formula is as follows).The medicine is developed by French Bioproject companies, in
Listed with trade name Tiorfan in France first within 1993, for treating adult acute's diarrhoea.
This product oral absorption is rapid, into being changed into active metabolite (±)-N- (1- oxygen -2- mercapto first rapidly after in vivo
Base -3- phenylpropyls) glycine, the intensity to enkephalin enzyme inhibitory action is relevant with dosage, and being reached in 30 minutes has clinic
The enkephalinase activity inhibitory action of meaning；Meanwhile, the biological half-life t of the medicine1/2About 3 hours, it is metabolized supersession rate phase
To very fast.Therefore, internal metabolic characteristics according to the medicine and preferably play its clinical efficacy, it is desirable to which the pharmaceutical preparation needs tool
Early stage quickly releases the drug feature, in a short time can quick release go out certain dose, be rapidly achieved action effect；Then slowly release
Medicine is put, drug concentration is maintained in effective therapeutic domain, that is, requires that tool early stage quick-release, the two-phase of later stage sustained release release the drug special
Levy.
Meanwhile, racecadotril is the lipophilic compound for being practically insoluble in water, and taste is extremely bitter, it therefore meets the medicine
While preparation has suitable release characteristic, also need effectively to cover its bad mouthfeel, and use the technical methods such as conventional coating to enter
During row taste masking, often face medicine and be difficult to the problems such as effectively discharging.
There is partial monopoly to report for the pharmaceutical preparation, but be concentrated mainly on the formulations such as tablet, capsule aspect.U.S.Pat.
No.6919093 B2 are disclosed using coating material Eudragit firstAqueous dispersion is pelletized, and utilizes agent high
Amount apricot taste essence etc. covers the bitter taste of racecadotril, but the method is high to equipment requirement, it is difficult to while it is simultaneously effective to reach taste masking
The effect of release, while becauseThe complicated composition of emulsifying agent and apricot taste essence, easily causes in aqueous dispersion
The problems such as finished product contaminant overstandard；The A of CN 102166197 disclose many to racemization card using materials such as spray method sodium alginates
Bent microencapsulation treatment, so as to reach taste masking effect, but the method complex process and relatively costly.Therefore, can meet taste masking and
Effective drug release feature, and industrialized technology preparation can be adapted to, exploitation racecadotril preparation is had important practical significance.
The content of the invention
In view of dosage form selection of the racecadotril in terms of pediatric patients medication, while taking into account the bitter taste of the medicine and releasing
Medicine feature request, the present invention provides a kind of two-phase drug release preparation with racecadotril as main ingredient, it is therefore an objective to both effective taste maskings, and
Effective blood concentration is can guarantee that, the technical solution adopted by the present invention is：
A kind of delivery formulations of two-phase containing racecadotril for treating pediatric patients diarrhoea, it includes racecadotril by quick-release
Medicine-containing particle, racecadotril sustained release medicine-containing particle, said preparation is oral solid formulation.
The delivery formulations of two-phase containing racecadotril of above-mentioned treatment pediatric patients diarrhoea, also comprising flavor enhancement and lubricant.
A kind of delivery formulations of two-phase containing racecadotril for treating pediatric patients diarrhoea, are by quick-release medicine-containing particle, sustained release
Medicine-containing particle, flavor enhancement, the oral solid formulation of lubricant composition.
Quick-release medicine-containing particle of the present invention is racecadotril quick-release medicine-containing particle；Sustained release medicine-containing particle of the present invention
For racecadotril is sustained medicine-containing particle.
Using conventional wet granulation technique, selection two kinds of conventional auxiliary materials of ethyl cellulose and Hydroxypropyl methylcellulose are used as viscous
Mixture, prepares sustained release medicine-containing particle, using the certain hydrophily of Hydroxypropyl methylcellulose using the slow controlled release characteristics of ethyl cellulose
Prepare quick-release medicine-containing particle, then by two kinds of medicine-containing particles of different rate of releasing drug by a certain percentage with suitable lubricant, adjust
Taste agent etc. mix, be prepared into tool two-phase drug release pharmaceutical preparation, should preparation is simple, taste masking effect is good, tool early stage speed
Release, the later stage sustained release two-phase drug release characteristic.
Wherein,
Sustained release medicine-containing particle, is uniformly mixed by racecadotril, filler and slow-release material, after wet method softwood, passed through
Prepared by extruding granulation mode, gained dry particl size controlling is in 0.42~0.71mm.Wherein, racecadotril accounts for slow-releasing granules matter
Amount percentage is 1.0%-5.0%, preferably 3.0%；It is 0.5~10.0 that slow-release material accounts for slow-releasing granules mass percent, preferably
2.5%；Filler can select one or more of sucrose, lactose, mannitol, sorbierite, microcrystalline cellulose, dextrin, starch, excellent
Select sucrose；Slow-release material can select ethyl cellulose, acrylic resin, gelatin, sodium alginate, methylcellulose, polyethylene glycol,
One or more of polyvinyl alcohol, preferred, ethyl.
Quick-release medicine-containing particle, is uniformly mixed by racecadotril, filler and immediate release material, after wet method softwood, passed through
Extrusion preparation mode is prepared into immediate-release granules, and gained dry particl size controlling is in 0.42~0.71mm.Wherein, racecadotril is accounted for
Immediate-release granules mass percent is 1.0%-5.0%, preferably 3.0%；Immediate release material account for immediate-release granules mass percent for 0.5~
10.0, preferably 1.5%；Filler can select one kind of sucrose, lactose, mannitol, sorbierite, microcrystalline cellulose, dextrin, starch
Or several, preferably sucrose；Immediate release material can select one or more of Hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP, excellent
Select Hydroxypropyl methylcellulose.
The effective dose of racecadotril is in 5-50mg in racecadotril two-phase of the invention drug release preparation, preferably
30mg；The drug quality ratio of sustained release medicine-containing particle contained therein and quick-release medicine-containing particle is 9:1 to 1:Between 9, preferably 1-3:
1, most preferably mass ratio is 6:4.
Then, medicine-containing particle is mixed with suitable lubricant, flavor enhancement, is packed.Wherein, lubricant accounts for recipe quantity 0.1
~2.0%, preferably 0.2%；Flavor enhancement accounts for recipe quantity 0.1~1.0%, preferably 0.3%.Lubricant can select silica, hard
One or more of fatty acid magnesium, sodium stearyl fumarate, preferably silica.Flavor enhancement selection standard fruits essence, such as peach taste
Essence, orange taste essence etc..
Compared with prior art, the advantage of the invention is that：
(1) using the certain hydrophilic Hydroxypropyl methylcellulose of tool, promote medicine and the contact of dissolution medium and improve medicine
Dissolution rate, reaches quick-release drug release effect, and the taste masking that also can to a certain extent be had by pelletizing is acted on；It is fine using water-insoluble ethyl
The skeleton slow releasing function of element is tieed up, medicine is slowly discharged, meanwhile, processed using this parcel, effectively mask racecadotril
Bitter taste；The combination of two ways, so as to realize two-phase drug release and effectively cover the bad mouthfeel of racecadotril.
(2) preparation process is simple of the present invention, favorable reproducibility, low for equipment requirements, be using conventional wet granulation technique
Can complete, suitable process metaplasia is produced.
Brief description of the drawings
Fig. 1 is the In Vitro Dissolution figure of sustained release, quick-release and finished product two-phase delivery formulations in embodiment 2.
Specific embodiment
With reference to embodiment, the present invention will be further described, but not limited to this.
Embodiment 1：
Prescription
(1) medicine-containing particle prescription composition
Medicine-containing particle preparation process and technique are：Medicine and sucrose are crushed in certain particle size range, by medicine, sugarcane
Sugar, ethyl cellulose or Hydroxypropyl methylcellulose put mixing 5min in wet granulator；Purified water is added, softwood is prepared；Then will
Softwood puts the granulation of the eye mesh screen of oscillating granulator 40；The particle for being formed 50 ± 5 DEG C of drying to moisture in vacuum drying chamber contain
Amount is less than 1%, then with 40 mesh sieve whole grains, obtains final product.
(2) racecadotril two-phase drug release preparation composition
Sustained release medicine-containing particle and quick-release medicine-containing particle are placed in mix according to the above ratio with peach taste essence, aerosil
Mixing dispenses to obtain every bag of finished product containing final preparation 3.0g, 30mg containing main ingredient up to uniform in device, double as containing racecadotril
Phase delivery formulations.
Embodiment 2：
Prescription
(1) medicine-containing particle prescription composition
Medicine-containing particle preparation process and technique are：Medicine and sucrose are crushed in certain particle size range, by medicine, sugarcane
Sugar, ethyl cellulose or Hydroxypropyl methylcellulose put mixing 5min in wet granulator；Purified water is added, softwood is prepared；Then will
Softwood puts the granulation of the eye mesh screen of oscillating granulator 40；The particle for being formed 50 ± 5 DEG C of drying to moisture in vacuum drying chamber contain
Amount is less than 1%, then with 40 mesh sieve whole grains, obtains final product.
(2) racecadotril two-phase drug release preparation composition
Sustained release medicine-containing particle and quick-release medicine-containing particle are placed in mix according to the above ratio with peach taste essence, aerosil
Mixing dispenses to obtain every bag of finished product containing final preparation 3.0g, 30mg containing main ingredient up to uniform in device, double as containing racecadotril
Phase delivery formulations.
Embodiment 3：
Prescription
(1) medicine-containing particle prescription composition
Medicine-containing particle preparation process and technique are：Medicine and sucrose are crushed in certain particle size range, by medicine, sugarcane
Sugar, ethyl cellulose or Hydroxypropyl methylcellulose put mixing 5min in wet granulator；Purified water is added, softwood is prepared；Then will
Softwood puts the granulation of the eye mesh screen of oscillating granulator 40；The particle for being formed 50 ± 5 DEG C of drying to moisture in vacuum drying chamber contain
Amount is less than 1%, then with 40 mesh sieve whole grains, obtains final product.
(2) racecadotril two-phase drug release preparation composition
Sustained release medicine-containing particle and quick-release medicine-containing particle are placed in mix according to the above ratio with peach taste essence, aerosil
Mixing dispenses to obtain every bag of finished product containing final preparation 3.0g, 30mg containing main ingredient up to uniform in device, double as containing racecadotril
Phase delivery formulations.
Embodiment 4：
Mouthfeel investigation result to the different drug release particles of the gained of embodiment 1~3 and finished product preparation see the table below.
Note：Excellent 85-100, good 70-85, middle 55-70 are poor<55.
As seen from the above table, use water-insoluble ethyl cellulose as slow-release material to racecadotril in embodiment 1~3
After carrying out pelletization treatment, its bitter taste can be effectively covered, and with the increase of ethyl cellulose usage ratio in granulation prescription, taste masking
It is better；Racecadotril is pelletized as adhesive using hydrophilic Hydroxypropyl methylcellulose in embodiment 1~3
Afterwards, also show certain taste masking effect, but the material can not preferably Drug controlled release and bitter feature after having, and with hydroxypropyl
The increase performance of methylcellulose usage ratio becomes apparent.By the medicine-containing particle of different rate of releasing drug by certain in embodiment 1~3
After ratio mixing,
And under the effect such as flavor enhancement, without hardship sense and bitter taste residual, in good taste, children are easy to receive finished product preparation.()
Embodiment 5：
Medicine-containing particle, quick-release medicine-containing particle, and finished product two-phase delivery formulations will be sustained in embodiment 2, be carried out respectively external
Dissolution is determined.In Vitro Dissolution experiment condition：The lauryl sodium sulfate of medium 0.5% (SDS)；Rotating speed 50rpm；37.0 DEG C of temperature.
Dissolution result is as shown in Figure 1.As seen from the figure, racecadotril sustained release medicine-containing particle 5min dissolution rates are only about in embodiment 2
11%, and slowly discharged with the time, the dissolution terminal of 120min is about 76%, has slow-release feature；And racecadotril is fast
Release medicine-containing particle 5min dissolution rates and be about 86%, drug release is rapid, and reaches drug release terminal in 15min or so, complete close to release.
After the medicine-containing particle of two kinds of different drug release characteristics is mixed by a certain percentage, the initial dissolution rate of finished product preparation is about 40%, so
Gradually slowly discharged with the time afterwards, show obvious two-phase drug release characteristic, obtain excellent result of extraction.
According to the disclosure of the present invention, those skilled in the art can to greatest extent using the present invention.Therefore, it is above-mentioned
Preferred embodiment is merely illustrative of, rather than limits the scope of the present invention by any way.
Claims (13)
1. a kind of racecadotril two-phase delivery formulations, it is characterised in that it includes racecadotril quick-release medicine-containing particle, racemization
Cadotril is sustained medicine-containing particle, and said preparation is oral solid formulation.
2. racecadotril two-phase delivery formulations according to claim 1, it is characterised in that said preparation is by quick-release pastille
Particle, sustained release medicine-containing particle, flavor enhancement, the oral solid formulation of lubricant composition.
3. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that：The quick-release pastille
Grain is made up of racecadotril, filler and immediate release material, and the filler of the quick-release medicine-containing particle is sucrose, lactose, sweet
One or more of dew alcohol, sorbierite, microcrystalline cellulose, dextrin, starch, preferably sucrose；The quick-release of the quick-release medicine-containing particle
Material is one or more of Hydroxypropyl methylcellulose, hydroxypropyl cellulose, PVP, preferably Hydroxypropyl methylcellulose.
4. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that：The sustained release pastille
Grain is made up of racecadotril, filler and slow-release material, and the filler of the sustained release medicine-containing particle is sucrose, lactose, sweet
One or more of dew alcohol, sorbierite, microcrystalline cellulose, dextrin, starch, preferably sucrose；The sustained release of the sustained release medicine-containing particle
Material is ethyl cellulose, acrylic resin, gelatin, sodium alginate, methylcellulose, polyethylene glycol, one kind of polyvinyl alcohol
Or several, preferred, ethyl.
5. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that flavor enhancement is fragrant peach taste
The standard fruits essence such as essence, orange taste essence.
6. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that lubricant is titanium dioxide
One or more of silicon, magnesium stearate, sodium stearyl fumarate, preferably silica.
7. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that every part of racecadotril is double
The effective dose of the racecadotril in phase delivery formulations is in 5-50mg, preferably 30mg.
8. racecadotril two-phase delivery formulations according to claim 1 and 2, it is characterised in that sustained release medicine-containing particle and speed
The mass ratio of medicine-containing particle is released 9:1 to 1:Between 9, preferably 1-3:1, most preferably 6:4.
9. racecadotril two-phase delivery formulations according to claim 3, it is characterised in that each group in quick-release medicine-containing particle
Point mass percent be：Racecadotril 1.0-5.0%, immediate release material 0.5-10.0%.
10. racecadotril two-phase delivery formulations according to claim 4, it is characterised in that each group in sustained release medicine-containing particle
Point mass percent be：Racecadotril 1.0-5.0%, slow-release material 0.5-10.0%.
11. racecadotril two-phase delivery formulations according to claim 5, it is characterised in that flavor enhancement accounts for whole biphase system
The mass percent of agent is 0.1-1.0%.
12. racecadotril two-phase delivery formulations according to claim 6, it is characterised in that lubricant accounts for whole biphase system
The mass percent of agent is 0.1-2.0%.
13. preparation method that two-phase delivery formulations are dissipated containing racecadotril according to claim any one of 1-12, it is special
Levy is to comprise the following steps：Racecadotril, filler, immediate release material or slow-release material are uniformly mixed, wet method softwood
Afterwards, quick-release medicine-containing particle or sustained release medicine-containing particle are prepared by extruding granulation mode, medicine-containing particle size controlling is in 0.42-
0.71mm。
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| CN201611240544.0A CN106822907B (en) | 2016-12-29 | 2016-12-29 | Two-phase release preparation containing racecadotril and preparation method thereof |
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| CN201611240544.0A CN106822907B (en) | 2016-12-29 | 2016-12-29 | Two-phase release preparation containing racecadotril and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108740677A (en) * | 2018-06-22 | 2018-11-06 | 化州化橘红药材发展有限公司 | A kind of Exocarpium Citri Grandis slow-release solid beverage and preparation method thereof |
| CN112220757A (en) * | 2020-10-16 | 2021-01-15 | 重庆市义力医药科技有限公司 | Nicotine particle composition, preparation method and preparation device thereof |
| GB2586201A (en) * | 2019-05-14 | 2021-02-17 | Orbit Pharmaceuticals | A stable powder formulation of racecadotril |
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|---|---|---|---|---|
| CN101442990A (en) * | 2006-05-15 | 2009-05-27 | 生物计划公司 | New form of administration of racecadotril |
| CN102091051A (en) * | 2009-12-14 | 2011-06-15 | 北京科信必成医药科技发展有限公司 | Allopurinol dual-release preparation and preparation method thereof |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
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2016
- 2016-12-29 CN CN201611240544.0A patent/CN106822907B/en active Active
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101442990A (en) * | 2006-05-15 | 2009-05-27 | 生物计划公司 | New form of administration of racecadotril |
| CN102091051A (en) * | 2009-12-14 | 2011-06-15 | 北京科信必成医药科技发展有限公司 | Allopurinol dual-release preparation and preparation method thereof |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
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| CARLA M. LOPES ET AL.: ""Compressed mini-tablets as a biphasic delivery system"", 《INTERNATIONAL JOURNAL OF PHARMACEUTICS》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108740677A (en) * | 2018-06-22 | 2018-11-06 | 化州化橘红药材发展有限公司 | A kind of Exocarpium Citri Grandis slow-release solid beverage and preparation method thereof |
| GB2586201A (en) * | 2019-05-14 | 2021-02-17 | Orbit Pharmaceuticals | A stable powder formulation of racecadotril |
| CN112220757A (en) * | 2020-10-16 | 2021-01-15 | 重庆市义力医药科技有限公司 | Nicotine particle composition, preparation method and preparation device thereof |
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| CN106822907B (en) | 2021-02-09 |
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