CN106361719A - Eltrombopag liquid capsule and preparation method thereof - Google Patents
Eltrombopag liquid capsule and preparation method thereof Download PDFInfo
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- CN106361719A CN106361719A CN201610728650.7A CN201610728650A CN106361719A CN 106361719 A CN106361719 A CN 106361719A CN 201610728650 A CN201610728650 A CN 201610728650A CN 106361719 A CN106361719 A CN 106361719A
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- liquid capsule
- handkerchief
- capsule
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- mixing
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K31/415—1,2-Diazoles
- A61K31/4152—1,2-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. antipyrine, phenylbutazone, sulfinpyrazone
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to an eltrombopag liquid capsule and a preparation method thereof. The eltrombopag liquid capsule is prepared by dissolving eltrombopag in an auxiliary material to obtain content, and then filling a hard capsule shell with the content. The auxiliary material includes a solvent, a surfactant, a co-surfactant, an anti-oxidant, a pH regulator, a proper amount of water, etc. The liquid capsule overcomes the defects that the eltrombopag is low in dissolubility and is difficult to dissolve, and has many specifications and complex production process, thereby bringing better selection on medicine dosage forms for patients.
Description
Technical field
The present invention relates to the formulation art of thrombocytopenia medicine, more particularly, to Ai Qu pool handkerchief liquid capsule and its preparation side
Method.
Background technology
Ai Qu pool handkerchief piece is common by ligand drugmaker of the U.S. and Britain Ge Lan element Smith Ke Lai pharmaceutical Co. Ltd
Exploitation, and in 2008 obtain the U.S. fda approval listing, existing specification have 12.5mg, 25mg, 50mg, 75mg, 100mg (all with
C25h22n4o4 counts) 5 specifications.
The patent technics comparing of Yuan Yan company is complicated, need to be through following steps: Ai Qu pool handkerchief micronization;Ai Qu pool handkerchief with little
Partial supplementary material mixes, wet granulation, is dried, granulate;Dry particl is mixed with most of adjuvant;Lubricant is added always to mix;Tabletting;Bag
Clothing.
Complex process described in above-mentioned patent, also needs to after wet granulation to add a large amount of adjuvants to improve mobility and could press
Piece;Simultaneously because granule and additional adjuvant powder physical property difference are big, exist during mixing difficult uniformly, tabletting when compressed shape be deteriorated
Different big problem.Simultaneously because Ai Qu pool handkerchief piece specification is many, such as by the way of equal proportion is amplified, due to tablet weight variation, tabletting, bag
During clothing, different size needs different process;As by the way of same piece weight, then the supplementary product consumption of each specification and species be not
With the pigment also needing to different colours during coating is distinguished by.Increased the complexity of product in a word.This patent does not exist at present
Domestic authorized.
It is necessary to provide a kind of new technology that this medicine is improved, thus increasing its different normalized form, in addition,
Some defects of the existing conventional art of customer service.
Content of the invention
It is an object of the invention to provide a kind of process is simple, the Ai Qu that rapid-action, bioavailability is high pool handkerchief liquid glue
Capsule.
Filling liquid capsule, as a kind of new agent technology receiving much concern in recent years, has multiple outstanding advantages, comprising:
(1) improve the bioavailability of medicine: one of problem of oral insoluble drug is that its bioavailability is low, this kind of medicine
It is prepared into non-aqueous solution, suspension, emulsion or hot-melt object fill hard capsule again, absorption can be improved, improve bioavailability.
(2) improve medicine stability: some medicines go bad because of moisture absorption or oxidation in atmosphere, by they are dispersed or dissolved in parent
In lipid implant, can be allowed to and outside air and moisture isolation, improve the stability of medicine.(3) dust and pollution are reduced: mouth
It is also easy to produce dust, the side effect of the suction of medicine fine particle or medicine itself is to operator in oral solid formulation manufacturing processes
Bring potential health hazard.And filling liquid capsule will not produce dust, it is to avoid this kind of pollution, less work infringement, carry
High security, improve working environment.(4) simplify production technology, improve stability and repeatability: medicine mix with adjuvant after between
Fill hard capsule, can complete technological process after sealing, enormously simplify production technology reduces cost.Filling liquid capsule with
Powder or granule are compared, and because medicaments uniformity is dispersed or dissolved in implant, its content uniformity is higher, and by can be accurate
The divided dose pump of adjustment loading, the dosage of capsule 's content is more accurate.This technology is especially meaningful to small dose drug.
Ai Qu pool handkerchief due to slightly molten in water, almost insoluble in acid condition, tell using 0.5% by therefore former triturate
Warm -80 aqueous solutions are as dissolution medium;Even if so its dissolution in acid medium is still less than 50% (45min) dissolution
Speed is slow and release not exclusively limits its body absorption significantly.
Ai Qu pool handkerchief is made liquid capsule, quick release completely, can improve and absorb in vivo, improve biological utilisation
Degree.
Ai Qu pool handkerchief, to damp and hot stable, therefore nor affects on its stability using this dosage form of liquid capsule.
Its content of solution liquid capsule can be divided into three kinds at present: hydrophilic solution: the type mainly adopts peg conduct
Solvent, and add the materials such as a small amount of tween 80, glycerol.Some materials are incompatible with hollow gelatin hard softgel shell, particularly
Water, water quality solvent and glycerol (glycerol) can make capsule shells fast softening, and ethanol and low molecule peg can make capsule shells quickly take off
Water simultaneously leads to it to become fragile in a short time, and one of method of solution is with peg400 and water accurate balance.In addition structure containing polyoxyethylene
Material store up long after easily decompose and produce low molecule aldehydes, and aldehyde radical can occur chemical reaction with gelatin softgel shell, cause softgel shell solid
Change it is impossible to quick dissolve, the release of impact content.It is thus desirable to increasing the stabilizers such as a certain amount of antioxidant.Oil solution
Type: the type mainly adopts vegetable oil or other oils dissolving medicine, therefore it is required that medicine must have higher fat-soluble.Root
According to similar compatibility principle, such medicine is difficult in the gastro-intestinal Fluid being discharged into human body in oil solution, simultaneously because oils and fatss are in vivo
Absorption is also required to the time;Therefore this mode is difficult to play rapid delivery of pharmaceuticals and improves the effect absorbing.Self-emulsifying type: such
Type is mainly made up of oil phase, emulsifying agent, cosurfactant.Because the free energy needed for emulsifying is very low, 37 DEG C of water in vitro
Bath, spontaneous one-tenth breast under gentle agitation or under internal stomach, the wriggling of intestinal, form small emulsion droplet.It utilizes its huge ratio table
Area, can be greatly improved the bioavailability of such medicine, and emulsion also can be overcome to take, and volume is big, wayward it is stable
The shortcomings of property, the hydrolysis and medicine of the water unstable medicine pessimal stimulation to stomach, intestinal can be avoided simultaneously.
Due to there is surfactant or highly dissoluble solvent in above-mentioned prescription, therefore capsule shells are necessary for water white transparency
, otherwise the pigment in softgel shell can gradually be transferred in medicinal liquid, causes the phenomenons such as medicinal liquid variable color, component migration.
Another object of the present invention is to providing a kind of Ai Qu to moor the preparation method of handkerchief liquid capsule.
In order to solve problem present in background technology, realize foregoing invention purpose, the present invention adopts the following technical scheme that
A kind of Ai Qu moors handkerchief liquid capsule, and including content and capsule shells, described content includes 2.5%~15% Ai Qu pool handkerchief,
20%~60% solvent, 0.5%~15% surfactant, 1%~20% cosurfactant, 0.05~2% antioxidant,
0.05~3%ph regulator and the moisture less than 12%;Above-mentioned degree is weight percentage.
Described solvent includes Polyethylene Glycol (peg), TC;Propylene glycol, glycerol, butanediol;Lecithin
In fat, medium chain length fatty acid triglyceride, polyoxypropylene Hard Fat alcohol ether (ppg) series, Allyl carbonate, triacetyl glycerine a kind of or
Multiple mixing.
Described surfactant includes polyoxyethylene 40- castor oil hydrogenated (rh40), polyoxyethylene 35- Oleum Ricini
(el35), polyoxyethylene sorbitan fatty acid ester (TWEEN Series), in Span (Span series) a kind of or
Multiple mixing.
Described cosurfactant is including a kind of or many in Polyethylene Glycol (peg), propylene glycol, glycerol, butanediol
Plant mixing.
Described antioxidant includes 2,6- di-tert-butyl-4-methy phenol (bht), Butylated hydroxyanisole (bha), life
Educate one or more mixing in phenol and its esters.
Described ph regulator includes monoethanolamine, diethanolamine, triethanolamine, trometamol, a kind of or many in Oleic acid
Plant mixing.After addition ph regulator, the ph of content should be more than 8.0.
Described moisture can be brought into in other adjuvants;Can be for absorbing the moisture of environment in content process for preparation;
Can also be specifically added into after content for preparing to be formed.
Described capsule shells be mainly water white gelatin material, Hypromellose material, in polyvinyl alcohol material
One or more mixing.As needed, can add in softgel shell production process a certain amount of antioxidant such as sodium sulfite etc. with
Improve the stability of softgel shell.This product adopts the commercially available capsule shells dedicated for liquid filling body, and this softgel shell has special construction, can
To close well and to prevent liquid from flowing out from capsule cap capsule body seam;Using this softgel shell, also need after capsule filling can be avoided
To prevent the sealing compound of leakage in seam coating, thus simplifying technique and equipment.
The invention also discloses a kind of Ai Qu moors the preparation method of handkerchief liquid capsule it is characterised in that mixing above-mentioned adjuvant
Close, then add Ai Qu pool handkerchief stirring and dissolving to form content, finally by Contents Fill in special hard capsule case at room temperature
In.
Brief description
Fig. 1 is different stripping curve in the ph6.8 phosphate solution of 0.3% tween 80 (w/v) for the prescription.
Fig. 2 is different stripping curve in the water of 0.3% tween 80 (w/v) for the prescription.
Fig. 3 is different stripping curve in the ph4.5 acetic acid-Acetate Solution of 0.3% tween 80 (w/v) for the prescription.
Fig. 4 is different stripping curve in the ph1.2 hydrochloric acid solution of 0.3% tween 80 (w/v) for the prescription.
Beneficial effect
Ai Qu of the present invention pool handkerchief liquid capsule solves that Ai Qu pool handkerchief dissolubility is low, tablet dissolution is slow, specification is many,
The shortcomings of complex process, this liquid capsule is convenient for production, rapid-action.
Specific embodiment
With reference to embodiment, the present invention is explained and illustrated in more detail.It should be appreciated that given embodiment
Being merely illustrative property, it constitutes any restriction to the scope of the present invention never in any form.
Embodiment 1
Content is taking hydrophilic solution as a example
Prescription
Title | Ratio/% | Effect |
Ai Qu moors handkerchief | 10 | Principal agent |
peg400 | 50 | Solvent |
TC | 23.4 | Solvent |
Glycerol | 5 | Cosurfactant |
Tween 80 | 2.5 | Surfactant |
bht | 0.15 | Antioxidant |
Monoethanolamine | 0.5 | Ph regulator |
Purified water | In right amount | Solvent |
Technique:
(1) weigh peg400 by recipe quantity, TC, glycerol, Tween 80, monoethanolamine are placed in Agitation Tank
In, it is uniformly mixed;
(2) weigh bht and Ai Qu pool handkerchief by recipe quantity, add to and stir in above-mentioned mixed liquor to dissolving, form solution;
(3) measure above-mentioned solution moisture content testing, according to the whole moisture of result addition appropriate purified water regulation to 8% about;
(4) using above-mentioned solution as Contents Fill in special hard capsule case, obtain final product.
Investigate content and contained the impact to capsule shells for the different moisture, result is as follows:
Investigation condition: 40 ± 2 DEG C, 75 ± 5%rh;
Terms of packing: aluminum-plastic packaged.
Leaching condition: the ph6.8 phosphate buffer 900ml of 0.5% tween 80 (w/v), 50 turns of paddle method, take within 45 minutes
Sample;
Limit is the 80% of labelled amount.
According to the above results, this product should be specifically noted that the moisture controlling during producing and storing.
Embodiment 2
Content is taking self-emulsifying type as a example
Prescription
Technique:
(1) weigh ppg-11 by recipe quantity, rh40, triacetyl glycerine, peg400, monoethanolamine are placed in Agitation Tank,
It is uniformly mixed;
(2) weigh tocopherol and Ai Qu pool handkerchief by recipe quantity, add to and stir in above-mentioned mixed liquor to dissolving, form solution;
(3) using above-mentioned solution as Contents Fill in special hard capsule case, obtain final product.
By embodiment 1,2 be obtained sample with former grind product (rld: Ai Qu pool handkerchief piece by ligand drugmaker of the U.S. and English
State Ge Lan element Smith Ke Lai pharmaceutical Co. Ltd joint development) carry out dissolution comparison, result such as Fig. 1-4.Due to tween 80
Solubilization substantially, for obtaining the stripping curve with preferable separating capacity, tween 80 consumption is down to 0.3%.
According to the above results, exist substantially with the former stripping curve grinding tablet product by the liquid capsule that embodiment 1,2 is obtained
Difference (leaching condition: the buffer 900ml of 0.3% tween 80 (w/v), 50 turns of paddle method).No matter liquid capsule is in which kind of dissolution
In medium, dissolution during 5min is attained by more than 85%.And affected by dissolubility, in addition to ph6.8 medium, former to grind tablet molten
Go out speed and be considerably slower than liquid capsule, final stripping quantity is also well below liquid capsule.Therefore in the form of liquid capsule, can
Successfully avoid Ai Qu pool handkerchief dissolubility by ph affected greatly, in acid the little shortcoming of dissolubility.According to dissolution in vitro and internal medicine
Thing release, the relatedness absorbing, compare with tablet, and Ai Qu moors handkerchief liquid capsule and is likely to be of faster absorption and higher biology
Availability.
Claims (9)
1. a kind of Ai Qu moors handkerchief liquid capsule, including content and capsule shells it is characterised in that described content includes 2.5%
~20% Ai Qu pool handkerchief two monoethanolamine salt, 20%~60% solvent, 0.5%~20% surfactant, 1%~25% helps table
Face activating agent, 0.05~2% antioxidant, 0.05~3%ph regulator and the moisture less than 12%;Above-mentioned degree
It is weight percentage, each constituent mass percentage ratio sum is 100%.
2. a kind of Ai Qu pool handkerchief liquid capsule according to claim 1 is it is characterised in that described solvent includes poly- second two
Alcohol (peg), TC;Propylene glycol, glycerol, butanediol;Lecithin, medium chain length fatty acid triglyceride, polyoxypropylene
One or more mixing in Hard Fat alcohol ether (ppg) series, Allyl carbonate, triacetyl glycerine.
3. a kind of Ai Qu pool handkerchief liquid capsule according to claim 1 is it is characterised in that described surfactant includes
Polyoxyethylene 40- castor oil hydrogenated (rh40), polyoxyethylene 35- Oleum Ricini (el35), polyoxyethylene sorbitan fatty acid
One or more mixing in ester (TWEEN Series), Span (Span series).
4. a kind of Ai Qu according to claim 1 moors handkerchief liquid capsule it is characterised in that described cosurfactant bag
Include including one or more mixing in Polyethylene Glycol (peg), propylene glycol, glycerol, butanediol.
5. a kind of Ai Qu according to claim 1 moors handkerchief liquid capsule it is characterised in that described antioxidant includes 2,
6- di-tert-butyl-4-methy phenol (bht), Butylated hydroxyanisole (bha), mixes for one or more in tocopherol and its esters
Close.
6. a kind of Ai Qu pool handkerchief liquid capsule according to claim 1 is it is characterised in that described ph regulator includes list
One or more mixing in ethanolamine, diethanolamine, triethanolamine, trometamol, Oleic acid.Content after addition ph regulator
Ph should be more than 8.0.
7. a kind of Ai Qu according to claim 1 moors handkerchief liquid capsule it is characterised in that described moisture can be other
Bring in adjuvant;Can be for absorbing the moisture of environment in content process for preparation;Can also be formed after content specially for preparing
Add.
8. a kind of Ai Qu according to claim 1 moors handkerchief liquid capsule it is characterised in that described capsule shells are mainly no
One or more mixing in the transparent gelatin material of color, Hypromellose material, polyvinyl alcohol material.As needed, can be
A certain amount of antioxidant such as sodium sulfite etc. is added to improve the stability of softgel shell in softgel shell production process.
9. a kind of Ai Qu moors the preparation method of handkerchief liquid capsule it is characterised in that mixing adjuvant, then adds Chinese mugwort at room temperature
Bent pool handkerchief two monoethanolamine salt stirring and dissolving forms content, finally by Contents Fill in special hard capsule case, wherein, institute
The adjuvant stated is 20%~60% solvent, 0.5%~20% surfactant, 1%~25% cosurfactant, 0.05~
2% antioxidant, 0.05~3%ph regulator and the moisture less than 12%;Above-mentioned degree is weight percentage, respectively
Constituent mass percentage ratio it.
Priority Applications (1)
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CN201610728650.7A CN106361719A (en) | 2016-08-25 | 2016-08-25 | Eltrombopag liquid capsule and preparation method thereof |
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CN201610728650.7A CN106361719A (en) | 2016-08-25 | 2016-08-25 | Eltrombopag liquid capsule and preparation method thereof |
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Family
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CN201610728650.7A Pending CN106361719A (en) | 2016-08-25 | 2016-08-25 | Eltrombopag liquid capsule and preparation method thereof |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109893503A (en) * | 2017-12-11 | 2019-06-18 | 武汉武药科技有限公司 | A kind of Ai Qubo pa oral administration mixed suspension and preparation method thereof |
WO2021055820A1 (en) * | 2019-09-20 | 2021-03-25 | Novartis Ag | 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid and its salts formulation |
EP3829576A4 (en) * | 2018-08-02 | 2022-05-11 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A pharmaceutical composition comprising eltrombopag olamine |
EP4054566A4 (en) * | 2019-11-07 | 2023-12-06 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A capsule comprising eltrombopag olamine |
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CN1652842A (en) * | 2002-05-22 | 2005-08-10 | 史密丝克莱恩比彻姆公司 | 3'- (2z)- 1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy- 1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) |
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CN1652842A (en) * | 2002-05-22 | 2005-08-10 | 史密丝克莱恩比彻姆公司 | 3'- (2z)- 1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy- 1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) |
CN1568942A (en) * | 2003-07-22 | 2005-01-26 | 范敏华 | Liquid capsule and production method thereof |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN109893503A (en) * | 2017-12-11 | 2019-06-18 | 武汉武药科技有限公司 | A kind of Ai Qubo pa oral administration mixed suspension and preparation method thereof |
EP3829576A4 (en) * | 2018-08-02 | 2022-05-11 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A pharmaceutical composition comprising eltrombopag olamine |
WO2021055820A1 (en) * | 2019-09-20 | 2021-03-25 | Novartis Ag | 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid and its salts formulation |
EP4054566A4 (en) * | 2019-11-07 | 2023-12-06 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | A capsule comprising eltrombopag olamine |
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Application publication date: 20170201 |