CN105853385A - Ticagrelor oral-disintegrating sustained release tablet and preparation method thereof - Google Patents
Ticagrelor oral-disintegrating sustained release tablet and preparation method thereof Download PDFInfo
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- CN105853385A CN105853385A CN201610193561.7A CN201610193561A CN105853385A CN 105853385 A CN105853385 A CN 105853385A CN 201610193561 A CN201610193561 A CN 201610193561A CN 105853385 A CN105853385 A CN 105853385A
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- China
- Prior art keywords
- ticagrelor
- sustained release
- sustained
- mouth
- microballoon
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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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
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
Abstract
The invention discloses a ticagrelor oral-disintegrating sustained release tablet, belongs to the field of medicinal preparations, and concretely relates to a sustained release preparation rapidly disintegrating in the oral cavity after being taken. The ticagrelor oral-disintegrating sustained release tablet is prepared through the following steps: preparing microcapsules with a sustained release effect from a main medicine and a suitable capsule material, proportioning the microcapsules and auxiliary materials, and carrying out wet granulation, wherein the auxiliary materials comprise a filler, an adhesive, a disintegrating agent, a lubricant and a flavoring. The ticagrelor oral-disintegrating sustained release tablet can rapidly disintegrate in the oral cavity after being orally taken, can continuously and stably release in vivo after being orally taken, can reduce the acute thrombus formation risk of patients, increases the compliance of the patients, and has important clinic application values.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation treating angiocardiopathy, be specifically related to a kind of ticagrelor mouth and collapse sustained release tablets
And preparation method thereof, belong to field of pharmaceutical preparations.
Background technology
Ticagrelor (Ticagrelor) is that the oral antidiabetic developed by Astrazeneca AB (AstraZeneca) coagulates
Collection medicine.Ticagrelor obtains European Union in December, 2010 to be ratified for reducing acute coronary syndrome (ACS) patient's blood
The generation of bolt event, trade name Brilique on European market.This medicine obtains U.S. FDA approval, business on July 20th, 2011
The name of an article is Brilinta.
Ticagrelor is a kind of novel, has selective anticoagulant, is also first reversible mating type P2Y12 gland
Glycosides diphosphonic acid acceptor (ADP) antagonist, can reversibly purine 2 receptor subtype on vasoactive smooth muscle cell (VSMC)
P2Y12, the platelet aggregation causing ADP has obvious inhibitory action, can be effectively improved the symptom of acute coronary patient.With
Clopidogrel in early days is compared, and blood platelet will not be caused irreversible impact, after stopping the treatment, anticoagulation by ticagrelor
Effect can quickly weaken or reverse, and in a couple of days, hematoblastic coagulation function will recover.The medicine quickly reversed is more suitable for hat
The patient of shape artery bypass surgery, or have multivessel disease and the patient of by-pass operation may be accepted.
Although ticagrelor demonstrates the superiority than clopidogrel in clinical research, but the ticagrelor half-life only has
12 hours, for maintaining drug effect, need to take medicine every day 2 times, cause patient's compliance poor, and this product patient mostly is person in middle and old age colony,
This results in patient easily occurs missing medicine and being late for the generation of the situation of taking medicine.Because the anticoagulant effect of ticagrelor is in drug withdrawal
After can quickly reverse, direct drug withdrawal be likely to increase the thrombotic risk of patients acuity, cause the heart stalk or apoplexy.For solving this
Problem, patent CN102657629 discloses a kind of ticagrelor sustained release preparation, and patient only need to take and a piece of can play treatment every day
Effect, but this method produces another problem immediately: this medicine patient mostly is the elderly, and its swallow is more weak, ticagrelor every day
180mg need to be taken, make sustained release tablets and necessarily cause its tablet weight relatively big, be unfavorable for that patient swallows on the contrary.Patent
Ticagrelor quick-release/sustained-release double-layer tablet disclosed in CN201310522017, this problem the most unresolved.
Based on problem above, the open a kind of ticagrelor mouth of the present invention collapses sustained release tablets, in oral cavity after said preparation is not only oral
In rapidly disintegration, and active ingredient continued smooth in vivo release after taking medicine, medicining times can be reduced, be effectively improved patient and take medicine
Compliance.
Summary of the invention
It is desirable to provide one is rapid at Orally disintegrating after taking, mouthfeel is excellent, and the most sustainable steadily releases
The ticagrelor mouth put collapses sustained release tablets and preparation method thereof.
Ticagrelor mouth of the present invention collapses sustained release tablets, it is characterised in that the ticagrelor containing tool slow release effect is micro-
Ball, in addition with filler, adhesive, disintegrant, lubricant, flavouring；
Described sustained-release micro-spheres drugloading rate is 40 ~ 80%, preferably 50 ~ 70%；
Described sustained-release micro-spheres also comprises capsule material and emulsifying agent；
Described capsule material one or many in ethyl cellulose, PLA, Poly(D,L-lactide-co-glycolide (PLGA)
Kind, preferred, ethyl, its weight accounting for microballoon is 20 ~ 60%, preferably 30 ~ 50%；Described emulsifying agent is selected from dodecyl
One or more in sodium sulphate, PLURONICS F87, Tween 80, preferably PLURONICS F87, its weight accounting for microballoon is 0.5 ~
3%, preferably 1 ~ 2%；
Described sustained-release micro-spheres uses following methods to prepare: be codissolved in main ingredient and capsule material in organic solvent forming oil phase, by breast
Agent is dissolved in organic solvent saturated aqueous solution formation aqueous phase, and oil phase is slowly dropped in aqueous phase formation microballoon, adds appropriate
Water, makes microballoon separate out, washing, i.e. obtains microballoon after removing moisture；Wherein organic solvent is ethyl acetate；
It is 20 ~ 80% that described sustained-release micro-spheres accounts for the weight of oral disnitegration tablet, preferably 50 ~ 70%；
Described filler is selected from glucose, sucrose, lactose, xylitol, converted starch, microcrystalline cellulose, maltodextrin, sweet dew
One or more in alcohol, sorbierite, preferably mannitol and microcrystalline cellulose；Its weight ratio is 5 ~ 90%, preferably 20 ~
80%；
Described adhesive is selected from ethylmethylcellulose, methylcellulose, sodium carboxymethylcellulose, maltodextrin, starch, pre-
One or more in gelling starch, HEMC, HPMC, hydroxypropyl cellulose, PVP, excellent
Elect HPMC as；Its weight ratio is 0.5 ~ 30%, preferably 2 ~ 10%；
Disintegrant selected from low-substituted hydroxypropyl cellulose, PVPP, Ac-Di-Sol, sodium carboxymethyl starch,
One or more in pregelatinized starch, cornstarch, farina, preferably PVPP；Its weight ratio is 0.5 ~
30%, preferably 2 ~ 15%；
One or more in magnesium stearate, stearic acid, talcum powder, superfine silica gel powder of described lubricant, are preferably tristearin
Acid magnesium；Its weight ratio is 0.1 ~ 5%, preferably 0.5 ~ 2%；
Described flavouring is one or more in Aspartame, saccharin sodium, acesulfame potassium, Sucralose, stevioside, is preferably
Acesulfame potassium；Its weight ratio is 0.1 ~ 5%, preferably 0.5 ~ 2%；
Described oral disnitegration tablet uses wet granulation to prepare.
Specific embodiments
The following is the specific embodiment of the present invention, technical scheme is described further, but the present invention
Protection domain is not limited to these embodiments.Every change without departing substantially from present inventive concept or equivalent replacement are included in the present invention
Protection domain within.
Embodiment 1: ticagrelor mouth collapses the preparation of sustained release tablets
Prescription forms:
Preparation technology:
(1) it is codissolved in ticagrelor and ethyl cellulose in ethyl acetate forming oil phase, lauryl sodium sulfate is dissolved in second
Acetoacetic ester saturated aqueous solution is formed aqueous phase, oil phase is slowly dropped in aqueous phase formation microballoon, adds suitable quantity of water, make microballoon analyse
Go out, pure water three times, dry at 60 DEG C to constant weight and i.e. obtain microballoon；
(2) weigh ticagrelor sustained-release micro-spheres and microcrystalline cellulose PH101 and low-substituted hydroxypropyl cellulose mixes, use
Purified water pelletize, 24 mesh pelletize, 50 DEG C dry pellet moisture to 1 ~ 3%, the 24 whole grains of mesh, additional magnesium stearate and Aspartame pressure
Make sheet.It is micro-sweet that the ticagrelor mouth that this prescription prepares collapses sustained release tablets entrance, and the Orally disintegrating time is less than 30 seconds.
Embodiment 2: ticagrelor mouth collapses the preparation of sustained release tablets
Prescription forms:
Preparation technology:
(1) it is codissolved in ticagrelor and PLA in ethyl acetate forming oil phase, PLURONICS F87 is dissolved in ethyl acetate and satisfies
With formation aqueous phase in the aqueous solution, oil phase is slowly dropped in aqueous phase formation microballoon, adds suitable quantity of water, make microballoon separate out, pure water
Washing three times, fluidized bed drying to constant weight i.e. obtains microballoon；
(2) weigh ticagrelor sustained-release micro-spheres and maltodextrin, HPMC and PVPP mix, use
Purified water pelletize, 24 mesh pelletize, 50 DEG C dry pellet moisture to 1 ~ 3%, the 24 whole grains of mesh, additional talcum powder, magnesium stearate and trichlorine
Sucrose tabletted.It is sweet that the ticagrelor mouth that this prescription prepares collapses sustained release tablets entrance, and the Orally disintegrating time is less than 30 seconds.
Embodiment 3: ticagrelor mouth collapses the preparation of sustained release tablets
Prescription forms:
Preparation technology:
(1) it is codissolved in ticagrelor and PLGA in ethyl acetate forming oil phase, Tween 80 is dissolved in ethyl acetate saturated water-soluble
Liquid is formed aqueous phase, oil phase is slowly dropped in aqueous phase formation microballoon, adds suitable quantity of water, make microballoon separate out, pure water three
Secondary, fluidized bed drying to constant weight i.e. obtains microballoon；
(2) weigh ticagrelor sustained-release micro-spheres and mannitol, microcrystalline cellulose PH101 and pregelatinized starch, use purified water system
Grain, 24 mesh pelletize, 50 DEG C dry pellet moisture to 1 ~ 3%, the 24 whole grains of mesh, additional magnesium stearate and stevioside tabletted.At this
It is sweet that the ticagrelor mouth that side prepares collapses sustained release tablets entrance, and the Orally disintegrating time is less than 30 seconds.
Embodiment 4: ticagrelor mouth collapses the preparation of sustained release tablets
Prescription forms:
Preparation technology:
(1) it is codissolved in ticagrelor and ethyl cellulose in ethyl acetate forming oil phase, PLURONICS F87 is dissolved in acetic acid second
Ester saturated aqueous solution is formed aqueous phase, oil phase is slowly dropped in aqueous phase formation microballoon, adds suitable quantity of water, make microballoon separate out,
Pure water three times, dries at 60 DEG C to constant weight and i.e. obtains microballoon；
(2) weigh ticagrelor sustained-release micro-spheres and xylitol, microcrystalline cellulose PH101 and pregelatinized starch, use purified water system
Grain, 24 mesh pelletize, 50 DEG C dry pellet moisture to 1 ~ 3%, the 24 whole grains of mesh, additional magnesium stearate and acesulfame potassium tabletted.At this
It is sweet that the ticagrelor mouth that side prepares collapses sustained release tablets entrance, and the Orally disintegrating time is less than 30 seconds.
The mensuration of stripping curve:
Dissolution rate during dissolution determination uses " Chinese Pharmacopoeia (version in 2015) four " general rule in the present invention and drug release determination
Method (0931) second method (paddle method) device, with pH6.8 phosphate buffer (900ml) as dissolution medium, rotating speed is 50rpm.Right
Embodiment 1 is measured to embodiment 4, and result see table:
It can be seen from the results that ticagrelor mouth prepared by embodiment 1-4 collapses, sustained release tablets medicine in 24h is sustainable steadily to be released
Putting, patient only needs to take and a piece of i.e. can reach required curative effect every day, greatly reduces the thrombotic risk of patients acuity, and
Mouthfeel is excellent, is significantly improved the Compliance of patient.
Claims (11)
1. a ticagrelor mouth collapses sustained release tablets, it is characterised in that contain the ticagrelor microballoon of tool slow release effect in preparation, this
Outer also have filler, adhesive, disintegrant, lubricant, flavouring.
Sustained-release micro-spheres the most according to claim 1, it is characterised in that the drugloading rate of microballoon is 40 ~ 80%, preferably 50 ~ 70%；
It is further characterized in that, possibly together with capsule material and emulsifying agent in addition to main ingredient in microballoon.
Sustained-release micro-spheres the most according to claim 2, it is characterised in that described capsule material selected from ethyl cellulose, PLA,
One or more in Poly(D,L-lactide-co-glycolide (PLGA), preferred, ethyl, its weight accounting for micro-capsule is 20 ~
60%, preferably 30 ~ 50%；Described emulsifying agent one or many in lauryl sodium sulfate, PLURONICS F87, Tween 80
Kind, preferably PLURONICS F87, its weight accounting for micro-capsule is 0.5 ~ 3%, preferably 1 ~ 2%.
Sustained-release micro-spheres the most according to claim 2, it is characterised in that sustained-release micro-spheres uses following methods to prepare: by main ingredient
It is codissolved in organic solvent forming oil phase with capsule material, emulsifying agent is dissolved in organic solvent saturated aqueous solution formation aqueous phase, by oil
It is slowly dropped in aqueous phase formation microballoon mutually, adds suitable quantity of water, make microballoon separate out, washing, i.e. obtain microballoon after removing moisture；Wherein
Organic solvent is ethyl acetate.
Sustained-release micro-spheres the most according to claim 1, it is characterised in that sustained-release micro-spheres account for the weight of oral disnitegration tablet be 20 ~
80%, preferably 50 ~ 70%.
Ticagrelor mouth the most according to claim 1 collapses sustained release tablets, it is characterised in that described filler is selected from grape
One or more in sugar, sucrose, lactose, xylitol, converted starch, microcrystalline cellulose, maltodextrin, mannitol, sorbierite,
Being preferably mannitol and microcrystalline cellulose, its weight ratio is 5 ~ 90%, preferably 20 ~ 80%.
Ticagrelor mouth the most according to claim 1 collapses sustained release tablets, it is characterised in that described adhesive is selected from ethyl first
Base cellulose, methylcellulose, sodium carboxymethylcellulose, maltodextrin, starch, pregelatinized starch, HEMC,
One or more in HPMC, hydroxypropyl cellulose, PVP, preferably HPMC；Its weight
Ratio is 0.5 ~ 30%, preferably 2 ~ 10%.
Ticagrelor mouth the most according to claim 1 collapses sustained release tablets, it is characterised in that described disintegrant is selected from low replacement
Hydroxypropyl cellulose, PVPP, Ac-Di-Sol, sodium carboxymethyl starch, pregelatinized starch, cornstarch,
One or more in farina, preferably PVPP；Its weight ratio is 0.5 ~ 30%, preferably 2 ~ 15%.
Ticagrelor mouth the most according to claim 1 collapses sustained release tablets, it is characterised in that described lubricant is selected from stearic acid
One or more in magnesium, stearic acid, talcum powder, superfine silica gel powder, preferably magnesium stearate；Its weight ratio is 0.1 ~ 5%, preferably
It is 0.5 ~ 2%.
Ticagrelor mouth the most according to claim 1 collapses sustained release tablets, it is characterised in that described flavouring is A Siba
One or more in sweet, saccharin sodium, acesulfame potassium, Sucralose, stevioside, preferably acesulfame potassium；Its weight ratio is 0.1 ~ 5%,
It is preferably 0.5 ~ 2%.
11. collapse sustained release tablets according to the ticagrelor mouth described in claim 1, it is characterised in that described oral disnitegration tablet uses wet
Prepared by legal system grain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610193561.7A CN105853385A (en) | 2016-03-31 | 2016-03-31 | Ticagrelor oral-disintegrating sustained release tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610193561.7A CN105853385A (en) | 2016-03-31 | 2016-03-31 | Ticagrelor oral-disintegrating sustained release tablet and preparation method thereof |
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| Publication Number | Publication Date |
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| CN105853385A true CN105853385A (en) | 2016-08-17 |
Family
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610193561.7A Pending CN105853385A (en) | 2016-03-31 | 2016-03-31 | Ticagrelor oral-disintegrating sustained release tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109700784A (en) * | 2019-03-11 | 2019-05-03 | 梁江丽 | Ticagrelor sustained-release micro-spheres and its preparation and application |
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|---|---|---|---|---|
| CN101862297A (en) * | 2009-04-14 | 2010-10-20 | 上海医药工业研究院 | Water-insoluble medicine sustained-release pellet, sustained-release orally disintegrating tablet thereof and preparation method thereof |
| CN102232934A (en) * | 2010-04-21 | 2011-11-09 | 上海医药工业研究院 | Pulsatile pellet, pulsatile orally disintegrating tablet containing same, and preparation methods and applications thereof |
| CN102406938A (en) * | 2011-11-29 | 2012-04-11 | 北京阜康仁生物制药科技有限公司 | Medicine composition for resisting thrombosis |
| CN102579362A (en) * | 2012-02-23 | 2012-07-18 | 浙江工业大学 | Felodipine slow-release microspheres and preparation method thereof |
| CN102657629A (en) * | 2012-05-14 | 2012-09-12 | 深圳市华力康生物医药有限公司 | Ticagrelor sustained-release tablet system and preparation method thereof |
| CN103054826A (en) * | 2012-12-27 | 2013-04-24 | 北京阜康仁生物制药科技有限公司 | Orally disintegrating tablet of memantine hydrochloride sustained-release pellets and preparation method thereof |
| CN103520164A (en) * | 2013-10-30 | 2014-01-22 | 程刚 | Ticagrelor sustained-release preparation |
| CN103800336A (en) * | 2014-03-06 | 2014-05-21 | 北京恩成康泰生物科技有限公司 | Composition with anti-thrombus active medicine |
-
2016
- 2016-03-31 CN CN201610193561.7A patent/CN105853385A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862297A (en) * | 2009-04-14 | 2010-10-20 | 上海医药工业研究院 | Water-insoluble medicine sustained-release pellet, sustained-release orally disintegrating tablet thereof and preparation method thereof |
| CN102232934A (en) * | 2010-04-21 | 2011-11-09 | 上海医药工业研究院 | Pulsatile pellet, pulsatile orally disintegrating tablet containing same, and preparation methods and applications thereof |
| CN102406938A (en) * | 2011-11-29 | 2012-04-11 | 北京阜康仁生物制药科技有限公司 | Medicine composition for resisting thrombosis |
| CN102579362A (en) * | 2012-02-23 | 2012-07-18 | 浙江工业大学 | Felodipine slow-release microspheres and preparation method thereof |
| CN102657629A (en) * | 2012-05-14 | 2012-09-12 | 深圳市华力康生物医药有限公司 | Ticagrelor sustained-release tablet system and preparation method thereof |
| CN103054826A (en) * | 2012-12-27 | 2013-04-24 | 北京阜康仁生物制药科技有限公司 | Orally disintegrating tablet of memantine hydrochloride sustained-release pellets and preparation method thereof |
| CN103520164A (en) * | 2013-10-30 | 2014-01-22 | 程刚 | Ticagrelor sustained-release preparation |
| CN103800336A (en) * | 2014-03-06 | 2014-05-21 | 北京恩成康泰生物科技有限公司 | Composition with anti-thrombus active medicine |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109700784A (en) * | 2019-03-11 | 2019-05-03 | 梁江丽 | Ticagrelor sustained-release micro-spheres and its preparation and application |
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Application publication date: 20160817 |
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