CN106924205A - A kind of sustained release preparation containing Baricitinib - Google Patents
A kind of sustained release preparation containing Baricitinib Download PDFInfo
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- CN106924205A CN106924205A CN201511005734.XA CN201511005734A CN106924205A CN 106924205 A CN106924205 A CN 106924205A CN 201511005734 A CN201511005734 A CN 201511005734A CN 106924205 A CN106924205 A CN 106924205A
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- baricitinib
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4188—1,3-Diazoles condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
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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
- A61K9/20—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
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Abstract
A kind of a kind of sustained release preparation containing Baricitinib, and in particular to preparation method of Baricitinib sustained release preparations.Technical problem solved by the invention provides blood concentration stabilization after a kind of administration, can realize the sustained release preparation of steady release Baricitinib in 24 hours.It is mainly by main ingredient, sustained-release matrix matrix and acceptable auxiliary material is made sustained release preparation of the present invention in galenic pharmacy.It is mainly used in treating rheumatoid arthritis.Long-acting slow-release can be realized using Baricitinib sustained release preparations of the present invention, peak concentration, valley are reduced, and blood concentration is more stable, can meet and steadily be discharged in 24 hours, only needs within 1st to take once.
Description
Technical field
The invention belongs to field of medicaments, and in particular to a kind of drugs for rheumatoid arthritis Baricitinib
Sustained release preparation.
Background technology
Baricitinib, its chemical entitled 1- (ethylsulfonyl) -3- [4- (7H- pyrrolo-es [2,3-d] pyrimidine
- 4- bases) -1H- pyrazol-1-yls] -3- azetidine acetonitriles, concrete structure formula is as follows：
Baricitinib is to carry out the medicine for treating rheumatoid arthritis with affiliate's Incyte joint developments by gift.
Rheumatoid arthritis is a kind of autoimmune disease, it is characterized by arthritis and the destruction of joint progressive.Entirely
Ball has more than 23,000,000 RA patients, suffer from this sick women about male three times.Current rheumatoid joint
Inflammation treatment includes using non-steroidal anti-inflammatory drug, and oral class improves state of an illness medicine such as methopterin, and selection
Property for participate in rheumatoid arthritis pathogenic process biological mediator injection class biological agent.
Baricitinib is a kind of oral JAK inhibitor, it is intended to block inflammatory signals and treatment amynologic disease (bag
Include rheumatoid arthritis) the basic cause of disease.Baricitinib is currently in three phases of rheumatoid arthritis
During the second stage of clinical development of clinical development and psoriasis and nephrosis.
The content of the invention
Technical problem solved by the invention provides blood concentration stabilization after a kind of administration, can realize that 24 is small
When interior steady release Baricitinib sustained release preparation.
My company since 2013 i.e. to Baricitinib bulk drugs and the development work of various form of administration.
It is believed that can maintain the blood concentration of stabilization using new sustained release preparation technique, avoid the ripple of blood concentration
It is dynamic outer, it is also possible to facilitate patient to be particularly the use of senile memory loss patient, with Practical significance.
The present invention is intended to develop a kind of sustained release preparation of Baricitinib, blood concentration stabilization after administration, to reduce
The incidence of adverse reaction, improves the security of medication, to reach the purpose of long-acting slow-release.
The key factor of influence sustained release preparation of the present invention is exactly the selection to sustained-release matrix matrix.Inventor find with
HPMC K4M and HPMC K100M is specifically matching somebody with somebody as sustained-release matrix matrix
Under than relation, drug release stabilization can be shown, the small characteristic of blood concentration fluctuation reaches drug release in 24 hours, one
Day takes effect once.
Sustained release preparation of the present invention can be made into the one kind in conventional sustained-release tablet, Duracaps, slow releasing pellet,
Preparing the conventional auxiliary material of these formulations has filler, lubricant, wetting agent, adhesive, disintegrant etc., ability
Field technique personnel can carry out preparation according to clinical application situation and the suitable auxiliary material of target formulation selection.
Sustained-release tablet is made up of the component that following weight is matched：Main ingredient：200 parts of Baricitinib；Sustained release
Skeletal matrix：110-120 parts, by HPMC K4M：HPMC K100M=5:1 group
Into；Filler：30-45 parts；Lubricant：In right amount (it is smoothly to feed and slice that consumption is beneficial to compressing tablet,
Sticking is reduced, particle and the friction between particle, tablet and nib wall is reduced so that tablet smooth and beautiful appearance is advisable)；
Wetting agent and/adhesive：In right amount (consumption soaks with by component, bond be made particle be advisable in order to compressing tablet).
Specifically, filler can use dextrin, lactose, microcrystalline cellulose, starch, sucrose, polyvinyl pyrrole
At least one of pyrrolidone K30.Lubricant can be using at least one of magnesium stearate, talcum powder, superfine silica gel powder.
It is the ethanol or water of more than 90%v/v, preferably more than 90%v/v that wetting agent and/or adhesive can use concentration
Ethanol.
Inventor determines that being made Baricitinib sustained-release tablets with the component of following weight proportions can realize 24
The purpose of hour steady drug release, its prescription ratio is：Main ingredient：10 parts of Baricitinib；Sustained-release matrix
Matrix：120 parts, i.e. 100 parts of HPMC K4M, 20 parts of HPMC K100M；
Filler：41.5 parts；Lubricant：In right amount；Wetting agent and/or adhesive：In right amount.Wherein,
Filler preferably sucrose, lactose and PVP three mixing；10 parts of proportions' preferably sucrose,
24 parts of lactose, 7.5 parts of PVP.Wherein, more than 90%v/v ethanol can be used as viscous
Mixture is applied to preparation Baricitinib sustained-release tablets of the present invention.
When the preparation method of sustained release preparation of the present invention, its step is as follows：A, mixing Baricitinib, sustained release
Skeletal matrix；B, add the pharmaceutically acceptable auxiliary material of preparation and be made sustained release preparation of the present invention.Wherein, delay
The main component matched by following weight of release formulation is constituted：Main ingredient：10 parts of Baricitinib；Sustained release bone
Frame matrix：110-120 parts, by HPMC K4M: HPMC K100M=5:
1 composition.Such as suitable figuration can be added according to the demand of spansule, sustained-release tablet, sustained release pellet formulation
Agent is made corresponding sustained release preparation.Wherein, the preparation method of sustained-release tablet of the present invention is made up of following steps：
A, mixing Baricitinib, sustained-release matrix matrix, filler；B, addition wetting agent and/or adhesive,
Softwood processed, dries, granulation；C, addition lubricant, mixing, compressing tablet are obtained final product.Wherein, sustained-release tablet by
The component composition of following weight proportioning：Main ingredient：10 parts of Baricitinib；Sustained-release matrix matrix：
110-120 parts, it is made up of HPMC K4M: HPMC K100M=5: 1；
Filler：30-45 parts；Lubricant：In right amount；Wetting agent and/or adhesive：In right amount.According to upper
The sustained-release tablet stated obtained by method can also be using the conventional tablet processing mode such as Cotton seeds.The present invention
Baricitinib sustained release preparations are mainly used in rheumatic or rheumatoid arthritis, osteoarthritis, tatanic ridge
Vertebra inflammation, gout, dysmenorrhoea etc.；Can be used for joint sprain, soft tissue injury, fracture pain and postoperative pain etc..
Long-acting slow-release can be realized using Baricitinib sustained release preparations of the present invention, peak concentration, valley are reduced, blood
Concentration is more stable, can especially meet and steadily be discharged in 24 hours, only needs within 1st to take once.
Specific embodiment
Illustrated below by way of specific description of embodiments of the present invention but do not limit the present invention.Inventor develops
During Baricitinib sustained release preparations of the present invention, the place of Baricitinib sustained release preparations is screened using following methods
Side, tablet is made by each prescription：A, mixing Baricitinib, sustained-release matrix matrix, filler；B、
Wetting agent and/or adhesive, softwood processed is added to dry, granulation；C, addition lubricant, mixing, pressure
Piece, obtains final product.In the above-mentioned methods, granulation is that less than 70 DEG C dry using 40 mesh galvanized wire sieve series grain,
Then lubricant is added after 40-60 mesh galvanized iron bolting silk whole grain.First, the above method is first according to by following realities
Apply a 1-8 and be made sustained-release tablet, and its release is determined with reference to following method, assay method is as follows：According to releasing
Degree of putting determination method (two the first methods of annex X D of Chinese Pharmacopoeia version in 2000), using dissolution method
(two the first methods of annex X C of Chinese Pharmacopoeia version in 2000) device, with phosphate buffer
(pH7.2) 900ml is solvent, and rotating speed is 100 turns per minute, is operated in accordance with the law, 1,4,8,12 and 16
Hour takes solution 5ml respectively, filters, and supplements mutually synthermal, same volume phosphorus in process container simultaneously
Phthalate buffer (pH7.2)：Precision measures subsequent filtrate in right amount respectively, and the phthalate buffer (pH7.2) that respectively phosphorates is fixed
Amount dilution is made in every 1ml the solution containing about 5~10 μ g, according to AAS (Chinese Pharmacopoeia
Two A of annex IV of version in 2000), trap is determined respectively at 260nm wavelength；Another precision is weighed at 60 DEG C
Baricitinib reference substances through phosphorus pentoxide drying under reduced pressure to constant weight are appropriate, and phosphorate phthalate buffer
(pH7.2) dissolve and be quantitatively diluted in every 1ml the solution containing about 8 μ g, be measured in the same method trap, point
The every burst size in different time is not calculated.
Embodiment 1
Prescription
| Supplementary material | Recipe quantity (g) |
| Baricitinib | 10 |
| Hydroxypropyl methyl cellulose | 60 |
| Lactose | 45 |
| Dextrin | 35 |
| Magnesium stearate | 0.75 |
Technique：
(1) Baricitinib, Hydroxypropyl methylcellulose, lactose are sieved for subsequent use.
(2) HPMC solution is prepared appropriate as adhesive, it is standby.
(3) recipe quantity Baricitinib, Hydroxypropyl methylcellulose, lactose mixing are weighed, adhesive granulation is added,
Recipe quantity magnesium stearate is added to be well mixed after drying.
(4) compressing tablet.
(5) it is coated：The coloured film coating agent for taking recipe quantity is configured to coating solution (oxygen barrier, lucifuge).Plain piece is put
In coating pan, wrap film clothing of spraying is drying to obtain.
Embodiment 2
Prescription
| Supplementary material | Recipe quantity (g) |
| Baricitinib | 10 |
| HPMC K4M | 56 |
| Sucrose | 10 |
| Lactose | 80 |
| Magnesium stearate | In right amount |
| Superfine silica gel powder | In right amount |
| Talcum powder | In right amount |
Technique：
(1) Baricitinib, HPMC K4M, lactose, sucrose are sieved for subsequent use.
(2) HPMC solution is prepared appropriate as adhesive, it is standby.
(3) recipe quantity Baricitinib, Hydroxypropyl methylcellulose, lactose mixing are weighed, adhesive granulation is added,
Recipe quantity magnesium stearate is added to be well mixed after drying.
(4) compressing tablet.
(5) it is coated：The coloured film coating agent for taking recipe quantity is configured to coating solution (oxygen barrier, lucifuge).Plain piece is put
In coating pan, wrap film clothing of spraying is drying to obtain.
Embodiment 3
Prescription：
| Supplementary material | Recipe quantity (g) |
| Baricitinib | 10 |
| HPMC K4M | 100 |
| HPMC K100M | 20 |
| Sucrose | 10 |
| Lactose | 24 |
| PVP K30 | 7.5 |
| 95%v/v ethanol solutions | In right amount |
| Magnesium stearate | In right amount |
| Superfine silica gel powder | In right amount |
| Talcum powder | In right amount |
Technique：
(1) by Baricitinib, HPMC K4M, HPMC K100M, sucrose, breast
Sugar sieves for subsequent use.
(2) 95%v/v ethanol solutions are prepared appropriate as solvent, it is standby.
(3) weigh recipe quantity Baricitinib, HPMC K4M, HPMC K100M,
Lactose mixes, and adds adhesive granulation, and recipe quantity magnesium stearate, superfine silica gel powder, talcum powder are added after drying
It is well mixed.
(4) compressing tablet.
(5) it is coated：The coloured film coating agent for taking recipe quantity is configured to coating solution (oxygen barrier, lucifuge).Plain piece is put
In coating pan, wrap film clothing of spraying is drying to obtain.
Embodiment 4, Baricitinib spansule and preparation method thereof
Prescription：
| Supplementary material | Mg/ |
| Sucrose capsule core (0.5~0.7mm) | 100 parts |
| Baricitinib | 10 parts |
| Plasticizer | 0.5~3.7 part |
| Slow-release material | 110 parts |
| Antiplastering aid | 0~13 part |
Above-mentioned sustained release agent refers to HPMC K4M, HPMC K100M, ethyl cellulose
(EC) one of cellulose acetate, Eudragit (acrylic resin), Aquacoat or it
Optionally secondly or both more than mixture.Plasticizer refers to triethyl citrate, PEG-4000
Antiplastering aid refers to talcum powder, magnesium stearate, superfine silica gel powder.
The preparation of spansule is mainly segmented into three steps, and the first step is that raw material is adhered to by appropriate adhesive
In blank capsule core, pellet core is made.Second step is sustained clothing film to pellet core bag to control the release of medicine.
The filling of the 3rd step capsule.
Embodiment 5
| Supplementary material | Mg/ |
| Sucrose capsule core (0.5~0.7mm) | 180 |
| Baricitinib | 18 |
| Adhesive | 10 |
| Utech | 110 |
| Talcum powder | 5 |
Technique：
Baricitinib is weighed by above-mentioned, the adhesive described in adhesive is hydroxypropyl cellulose, water-soluble with purifying
Solution；Blank capsule core is taken, is placed in fluidized-bed coating machine, the raw material after dissolving is put into liquid bath, constantly stirred
Mix, open machine, adjusting parameter starts to be coated, and after being finished with the raw material after dissolving, starts to warm up holding thing
Material temperature degree is dried 30 minutes more than 40 degree, cooling, discharging, closing machine；Weighed especially by recipe quantity
Very, talcum powder, lauryl sodium sulfate, purified water, talcum powder configuration sustained-release coating layer.By pastille micropill,
It is put into fluidized-bed coating machine, sustained release coating liquid is placed into feed tank, adjusted parameter, starts to be coated,
Keep temperature of charge more than 40 degree, dry 30 minutes, cooling, discharging, closing machine；By above-mentioned coating
Pastille micropill afterwards uses capsule filling machine, and pastille micropill is put into 0# capsules；Above-mentioned capsule is used into aluminium
Modeling blister packaging machine, is packaged into aluminium-plastic panel, packed products.
Pharmacokinetics experiment in animal body
Experimental technique is as follows：Experiment is divided into two groups, every group of 6 dogs；Control group gives oral ordinary preparation, often
Day is twice；Experimental group gives oral sustained release preparation of the invention, once a day；The drug specifications of experimental group is right
According to the twice of group.Respectively after administration 1,2,4,8,12,24 hours, take serum and determine Baricitinib
Blood concentration, as a result show：Area under the drug-time curve (AUC) of the control combination experimental group in Each point in time
Without marked difference.
The In Vitro Dissolution of sustained release preparation：
| Time (hour) | 1 | 2 | 4 | 8 | 12 | 24 |
| Release (%) | 14 | 20 | 31 | 44 | 51 | 61 |
The In Vitro Dissolution of ordinary preparation：
| Time (hour) | 1 | 2 | 4 | 8 | 12 | 24 |
| Release (%) | 8 | 100 | 31 | 44 | 51 | 61 |
Claims (10)
1.Baricitinib sustained release preparations, it is characterised in that：It is mainly the component matched by following weight and constitutes：
10 parts of main ingredient Baricitinib, sustained-release matrix matrix：50-120 parts, by HPMC K4M, hydroxyl
The mixture composition of the third methylcellulose K100M or both macromolecular materials；On both high molecular bases
On, including but not limited to other macromolecular materials, such as hydroxyethyl cellulose, hydroxypropyl cellulose and carboxymethyl
Cellulose, etc.；Acceptable auxiliary material is made sustained release preparation in can also adding galenic pharmacy in preparation, such as stearic
Sour magnesium, talcum powder, etc..
2. Baricitinib sustained release preparations according to claim 1, it is characterised in that：Described is acceptable
Auxiliary material have filler, lubricant, wetting agent, adhesive, disintegrant.
3. Baricitinib sustained release preparations according to claim 1, it is characterised in that：The sustained release preparation
It is the one kind in sustained-release tablet, Duracaps, sustained release pellet.
4. Baricitinib sustained release preparations according to claim 3, it is characterised in that：The sustained-release tablet
It is made up of component of the following weight with skin：Main ingredient：10 parts of Baricitinib；Sustained-release matrix matrix：110-120
Part, by HPMC K4M：HPMC K100M=5:1 composition；Filler：30-45
Part；Lubricant：In right amount；Wetting agent and/adhesive：In right amount.
5. Baricitinib sustained release preparations according to claim 4, it is characterised in that：The sustained-release tablet
It is made up of component of the following weight with skin：Main ingredient：10 parts of Baricitinib；Sustained-release matrix matrix：120
Part, i.e. 100 parts of HPMC K4M：20 parts of HPMC；Filler：41.5 parts；
Lubricant：In right amount；Wetting agent and/or adhesive：In right amount.
6. according to claim 4 or 5 described in Baricitinib sustained release preparations, it is characterised in that：Institute
The filler stated is dextrin, lactose, microcrystalline cellulose, starch, sucrose, PVP K30
At least one of.
7. according to claim 4 or 5 described in Baricitinib sustained release preparations, it is characterised in that：Institute
The filler stated is the mixture of sucrose, lactose and PVP K30；It is preferred that the weight of three is matched somebody with somebody
Than being 8:16:5, preferably 10 parts of sucrose, 24 parts of lactose, 7.5 parts of PVP.
8. Baricitinib sustained release preparations according to claim 4 or 5, it is characterised in that：The lubrication
Agent is at least one of magnesium stearate, talcum powder, superfine silica gel powder.
9. Baricitinib sustained release preparations according to claim 4 or 5, it is characterised in that：The wetting
It is the ethanol or water of more than 90%v/v, the preferably second of more than 90%v/v that agent and/or adhesive can use concentration
Alcohol.
10. Baricitinib sustained release preparations according to claim 4 or 5, it is characterised in that：The sustained release
Preparation includes sustained-release tablet ..., and the preparation method of wherein sustained-release tablet is made up of following steps：
A, mixing Baricitinib, sustained-release matrix matrix, filler；
B, addition wetting agent and/or adhesive, softwood processed are dried, granulation；
C, addition lubricant, mixing, compressing tablet are obtained final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511005734.XA CN106924205A (en) | 2015-12-29 | 2015-12-29 | A kind of sustained release preparation containing Baricitinib |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511005734.XA CN106924205A (en) | 2015-12-29 | 2015-12-29 | A kind of sustained release preparation containing Baricitinib |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106924205A true CN106924205A (en) | 2017-07-07 |
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ID=59458464
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201511005734.XA Pending CN106924205A (en) | 2015-12-29 | 2015-12-29 | A kind of sustained release preparation containing Baricitinib |
Country Status (1)
| Country | Link |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109381437A (en) * | 2018-11-06 | 2019-02-26 | 威海贯标信息科技有限公司 | A kind of Ba Ruike replaces tablet composition |
| EP3725305A1 (en) * | 2019-04-17 | 2020-10-21 | Zentiva K.S. | Pharmaceutical composition containing baricitinib hydrobromide |
| CN112263568A (en) * | 2020-10-29 | 2021-01-26 | 瑞阳制药股份有限公司 | AMG337 sustained-release preparation and preparation method thereof |
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Application publication date: 20170707 |