CN110269844A - A kind of preparation method based on ink-jet 3D printing olanzapine orally-disintegrating tablet - Google Patents
A kind of preparation method based on ink-jet 3D printing olanzapine orally-disintegrating tablet Download PDFInfo
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- CN110269844A CN110269844A CN201810213166.XA CN201810213166A CN110269844A CN 110269844 A CN110269844 A CN 110269844A CN 201810213166 A CN201810213166 A CN 201810213166A CN 110269844 A CN110269844 A CN 110269844A
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- disintegrating tablet
- olanzapine
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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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
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Abstract
The present invention provides one kind based on ink-jet 3D printing olanzapine orally-disintegrating tablet and preparation method thereof, and the oral disintegrating tablet coheres liquid by the spraying of 3D printer spray head and drug powder is cohered molding.According to pre-set parameter, modeling, and import in the control system of 3D printing rapidform machine;The powder count by weight percentage, by Olanzapine 4-9%, filler 82-93%, dry adhesives 5-15%, superfine silica gel powder 0.1-1.0%, corrigent 0-2%.It mixes in proportion, is fitted into powder box;Liquid will be cohered to be fitted into print cartridge;Control system output order prints olanzapine orally-disintegrating tablet, coheres taking-up to oral disintegrating tablet, removes the extra powder of surrounding, after drying to obtain the final product.The features such as olanzapine orally-disintegrating tablet that the present invention is prepared has disintegration rate fast, and the compliance of patient on medication can be improved, especially facilitates old man, child, dysphagia person.
Description
Technical field
The invention belongs to drug design techniques field, specially a kind of preparation based on ink-jet 3D printing olanzapine orally-disintegrating tablet
Method.
Background technique
Three-dimensional printing technology (three dimension printing, 3DP) is a kind of based on digital model
Rapid shaping technique.The U.S. that the core concept of 3D printing originates from the end of the 19th century earliest, until the last century 80's end is by fiber crops
The exploitation of the Institute of Technology, province just has blank.3D printing technique is on computer software according to the number such as the CAD model of object or CT
According to design structure three-dimensional stereo model, according to the concept of " successively printing, be layering ", by the accumulation of material, with powder
The adhesive materials such as shape metal or plastics, viscous liquid, rapidly and precisely manufacture has special external form or complex internal structure
Object.
3D printing technique is widely applied in fields such as biologic medical, automobile manufacture, aerospace, cultural creatives.Currently,
The 3D printing technique developed specifically includes that fused glass pellet, Stereolithography, 3 D-printing molding, layer separated growth
Deng.3D printing technique also can be used in the preparation of pharmaceutical preparation.On August 5th, 2015, U.S. Food and Drug Administration's approval
First of Aprecia drugmaker uses Spritam(Levetiracetam of 3D printing technique preparation, levetiracetam)
Rapidly dissolving tablet listing indicates that 3D printing becomes a kind of new formulation technology.
Olanzapine (olanzapine) also known as Zyprexa are that Lilly company, the U.S. develops, and in October, 1996 lists in the U.S.
It is a kind of treat schizoid atypia anti-semen antibody, clinical test shows it than antipsychotics such as haloperidol
There are better curative effect and the outer side effect of less cone.Commercially available Olanzapine Tablets disintegration time is long, is not able to satisfy patient's urgent need still
The demand of medication.Therefore olanzapine orally-disintegrating tablet is prepared using 3D printing technique to be of great significance.
Summary of the invention
It is an object of the invention to overcome the shortcomings of the existing dosage form of current Olanzapine Tablets, provides a kind of simple process, collapses
The solution time is short, action speed is fast, is suitble to the 3D printing olanzapine orally-disintegrating tablet of dysphagia.
To achieve the goals above, the present invention adopts the following technical scheme:
1. the object of the present invention is achieved like this: one kind preparing olanzapine orally-disintegrating tablet, feature based on ink-jet 3D printing technique
It is, is calculated by mass percentage, formula includes following components: Olanzapine 3-10%, filler 80-95%, dry adhesives 2-
15%, superfine silica gel powder 0.1-1.0%, corrigent 0-2%, are prepared using 3D printing technique.
It is calculated by mass percentage, formula includes following components: Olanzapine 4-9%, filler 82-93%, dry adhesives
5-15%, superfine silica gel powder 0.1-1.0%, corrigent 0-2%.
The filler include but is not limited to sucrose, pregelatinized starch, dextrin, lactose, microcrystalline cellulose, mannitol,
Sorbierite or xylitol.
The dry adhesives include but is not limited to PVP K30, sodium carboxymethylcellulose, hydroxypropyl cellulose.
The corrigent includes but is not limited to Sucralose, Aspartame, stevioside, essence or Mai Litian.
Described coheres the water or ethanol solution that liquid is 25-75% ethanol solution, PVP K30.
1. a kind of preparation method based on ink-jet 3D printing olanzapine orally-disintegrating tablet, it is characterised in that: the following steps are included:
(1) it according to the parameter set in advance, using software modelings such as CAD, and is converted into stl formatted file and imports 3D printer
LTY software control system in;
(2) it is calculated by mass percentage, Olanzapine, filler, dry adhesives, superfine silica gel powder, corrigent is uniformly mixed, make
It is fitted into for medicinal powder in the powder box of 3D printing rapidform machine;
(3) liquid will be cohered to be fitted into print cartridge;
(4) control system output order, control 3D printing rapidform machine print olanzapine orally-disintegrating tablet: power spreading device is first in powder
Bed one layer of upper berth medicinal powder, then printing head is mobile in the selection area of X-Y axis direction and sprays and coheres liquid, is the of oral disintegrating tablet
One layer;Then in the Z-axis direction, by axis body movement by the height of spray coating described in powder bed entire lowering, power spreading device is on powder bed
Second layer powder is spread, is repeated above operation, so successively printing completes the printing of oral disintegrating tablet until reaching the spraying number of plies;
It is taken out after oral disintegrating tablet coheres, extra powder around removal, after drying to obtain the final product.
2. 3D printing according to claim 1 prepares olanzapine orally-disintegrating tablet, which is characterized in that described presets
3D printing parameter it is as follows:
The spray rate is that spraying drop amount * sprays frequency.
Beneficial effects of the present invention:
Using 3D printing technique printing olanzapine orally-disintegrating tablet have drug releasing rate it is fast, can be improved patient on medication according to
The features such as from property, especially facilitate old man, child, dysphagia person;Moreover, relatively existing technology, 3D printing technique can roots
According to the customized dosage for being suitable for patient of the individual difference of patient, individual administration and precisely treatment are realized, to reduce trouble
Person takes the piece number or reduces the step of pharmacist cuts tablet, so that pharmaceutical preparation is played greatest treatment efficacy, and drop poisonous side effect of medicine
To minimum.
Innovative point of the invention:
The present invention prepares tablet medicine using 3D printing technique, and the personalized printing of drug may be implemented, can also effectively solve
The problems such as certainly traditional pressing prepares the disintegrating tablet occurred when tablet medicine, loose pieces.
The present invention prints drug using the process for spraying binding liquid on drug powder, tablet compactibility obtained in this way
It is good, while mechanical property is more preferable.
Specific embodiment
Below with reference to embodiment, the present invention is further illustrated, but not as limiting the scope of protection of the present invention.
Embodiment 1
Prescription is as follows:
3D printing parameter is as follows:
The preparation method is as follows:
(1) it according to the parameter set in advance, using software modelings such as CAD, and is converted into stl formatted file and imports 3D printer
LTY software control system in;
(2) it is calculated by mass percentage, Olanzapine, mannitol, PVP K30, superfine silica gel powder is mixed in proportion, make
It is fitted into for medicinal powder in the powder box of 3D printing rapidform machine;
(3) -50% ethanol solution of 1% PVP K30 is fitted into print cartridge;
(4) control system output order, control 3D printing rapidform machine print olanzapine orally-disintegrating tablet: power spreading device is first in powder
The medicinal powder that bed upper berth a layer thickness is 0.1mm, then printing head is mobile in the selection area of X-Y axis direction and sprays bonding
Liquid is the first layer of oral disintegrating tablet;Then in the Z-axis direction, it is moved by axis body by powder bed entire lowering 0.1mm, power spreading device
It in powder bed upper berth second layer powder, repeats above operation, so successively printing completes oral disintegrating tablet until reaching the spraying number of plies
Printing;
(5) it coheres taking-up to oral disintegrating tablet, removes the extra powder of surrounding, after drying to obtain the final product.
Embodiment 2
Prescription is as follows:
3D printing parameter is as follows:
The preparation method is as follows:
(1) it according to the parameter set in advance, using software modelings such as CAD, and is converted into stl formatted file and imports 3D printer
LTY software control system in;
(2) it is calculated by mass percentage, in proportion by Olanzapine, sucrose, sodium carboxymethylcellulose, superfine silica gel powder, Aspartame
It is uniformly mixed, is fitted into as medicinal powder in the powder box of 3D printing rapidform machine;
(3) -50% ethanol solution of 1% PVP K30 is fitted into print cartridge;
(4) control system output order, control 3D printing rapidform machine print olanzapine orally-disintegrating tablet: power spreading device is first in powder
The medicinal powder that bed upper berth a layer thickness is 0.2mm, then printing head is mobile in the selection area of X-Y axis direction and spraying is cohered
Liquid is the first layer of oral disintegrating tablet;Then in the Z-axis direction, it is moved by axis body by powder bed entire lowering 0.2mm, power spreading device
It in powder bed upper berth second layer powder, repeats above operation, so successively printing completes oral disintegrating tablet until reaching the spraying number of plies
Printing;
(5) it coheres taking-up to oral disintegrating tablet, removes the extra powder of surrounding, after drying to obtain the final product.
Embodiment 3
Prescription is as follows:
3D printing parameter is as follows:
The preparation method is as follows:
(1) it according to the parameter set in advance, using software modelings such as CAD, and is converted into stl formatted file and imports 3D printer
LTY software control system in;
(2) it is calculated by mass percentage, by Olanzapine, sucrose, hydroxypropyl cellulose, PVP K30, superfine silica gel powder, trichlorine sugarcane
Sugar mixes in proportion, and is fitted into the powder box of 3D printing rapidform machine as medicinal powder;
(3) 50% ethanol solution is fitted into print cartridge;
(4) control system output order, control 3D printing rapidform machine print olanzapine orally-disintegrating tablet: power spreading device is first in powder
The medicinal powder that bed upper berth a layer thickness is 0.2mm, then printing head is mobile in the selection area of X-Y axis direction and spraying is cohered
Liquid is the first layer of oral disintegrating tablet;Then in the Z-axis direction, it is moved by axis body by powder bed entire lowering 0.2mm, power spreading device
It in powder bed upper berth second layer powder, repeats above operation, so successively printing completes oral disintegrating tablet until reaching the spraying number of plies
Printing;
(5) it coheres taking-up to oral disintegrating tablet, removes the extra powder of surrounding, after drying to obtain the final product.
Claims (6)
1. one kind prepares olanzapine orally-disintegrating tablet based on ink-jet 3D printing technique, which is characterized in that be calculated by mass percentage, match
Side includes following components: Olanzapine 3-10%, filler 80-95%, dry adhesives 2-15%, superfine silica gel powder 0.1-1.0%, flavoring
Agent 0-2%, is prepared using 3D printing technique.
2. 3D printing olanzapine orally-disintegrating tablet according to claim 1, characterized in that each component mass percent are as follows:
Olanzapine 4-9%, filler 82-93%, dry adhesives 5-15%, superfine silica gel powder 0.1-1.0%, corrigent 0-2%.
3. 3D printing Amlodipine Besylate Tablet oral disintegrating tablet according to claim 1, it is characterised in that: the filler packet
Include but be not limited to sucrose, pregelatinized starch, dextrin, lactose, microcrystalline cellulose, mannitol, sorbierite or xylitol.
4. 3D printing Amlodipine Besylate Tablet oral disintegrating tablet according to claim 1, it is characterised in that: the dry adhesives
Including but not limited to PVP K30, sodium carboxymethylcellulose, hydroxypropyl cellulose.
5. 3D printing Amlodipine Besylate Tablet oral disintegrating tablet according to claim 1, it is characterised in that: the corrigent packet
Include but be not limited to Sucralose, Aspartame, stevioside, essence or Mai Litian.
6. the preparation method of 3D printing Amlodipine Besylate Tablet oral disintegrating tablet according to claim 6, it is characterised in that: described
Cohere liquid be 25-75% ethanol solution, PVP K30 water or ethanol solution.
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Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2010070091A1 (en) * | 2008-12-19 | 2010-06-24 | Ratiopharm Gmbh | Oral dispersible tablet |
CN101904824A (en) * | 2009-06-04 | 2010-12-08 | 齐鲁制药有限公司 | Olanzapine orally-disintegrating tablet preparation and preparation method thereof |
CN102631331A (en) * | 2012-04-26 | 2012-08-15 | 北京哈三联科技股份有限公司 | Olanzapine oral disintegration tablet and preparation method thereof |
CN106511285A (en) * | 2016-09-20 | 2017-03-22 | 南方医科大学 | 3D printing breviscapine orally disintegrating tablet and preparation method thereof |
CN107669648A (en) * | 2017-11-07 | 2018-02-09 | 互竑实业(上海)有限公司 | A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof |
-
2018
- 2018-03-15 CN CN201810213166.XA patent/CN110269844A/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2010070091A1 (en) * | 2008-12-19 | 2010-06-24 | Ratiopharm Gmbh | Oral dispersible tablet |
CN101904824A (en) * | 2009-06-04 | 2010-12-08 | 齐鲁制药有限公司 | Olanzapine orally-disintegrating tablet preparation and preparation method thereof |
CN102631331A (en) * | 2012-04-26 | 2012-08-15 | 北京哈三联科技股份有限公司 | Olanzapine oral disintegration tablet and preparation method thereof |
CN106511285A (en) * | 2016-09-20 | 2017-03-22 | 南方医科大学 | 3D printing breviscapine orally disintegrating tablet and preparation method thereof |
CN107669648A (en) * | 2017-11-07 | 2018-02-09 | 互竑实业(上海)有限公司 | A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof |
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