CN108926543A - A kind of Olanzapine oral disnitegration tablet and preparation method thereof - Google Patents
A kind of Olanzapine oral disnitegration tablet and preparation method thereof Download PDFInfo
- Publication number
- CN108926543A CN108926543A CN201710382896.8A CN201710382896A CN108926543A CN 108926543 A CN108926543 A CN 108926543A CN 201710382896 A CN201710382896 A CN 201710382896A CN 108926543 A CN108926543 A CN 108926543A
- Authority
- CN
- China
- Prior art keywords
- olanzapine
- oral disnitegration
- tablet according
- disnitegration tablet
- preparation
- Prior art date
- 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
-
- 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
- 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
-
- 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
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
Abstract
This application involves a kind of novel Olanzapine oral disnitegration tablets and preparation method thereof, belong to technical field of medicine.The olanzapine orally-disintegrating tablet includes Olanzapine, composition grain and additive, and direct tablet compressing is made.
Description
Technical field
This application involves field of pharmaceutical preparations, and in particular to a kind of novel Olanzapine oral disnitegration tablet and its preparation side
Method.
Background technique
Olanzapine（Olanzapine）The entitled 2 methyl-1 0- of chemistry（4- methyl-1-piperazine）- 4H- thieno [2,3-b]
[1,5] benzodiazepine, for schizophrenia and the urgency of other mental diseases for having serious positive symptom and/or negative symptoms
Property the phase and maintain the phase treatment, also can be relieved the secondary affective symptom of schizophrenia and related disease.
Olanzapine has many advantages, such as that long-term efficacy is good, Small side effects, has been faced as a kind of antipsychotic agent
The highly recognition of bed doctor.External listing dosage form has conventional tablet, oral disnitegration tablet, intramuscular injection agent etc. at present, domestic main
For conventional tablet.The disadvantages of right ordinary tablet is typically due to patient and mismatches treatment, poor there are Compliance, and for old man,
Dysphagia group needs more to nurse investment；And intramuscular injection price is higher, patient's compliance is equally poor.
Olanzapine orally-disintegrating tablet chance saliva, which can be disintegrated rapidly, is dispersed into fine particle, enters Digestive with the swallowing act of patient
System, drug-eluting are accelerated, bioavilability can be improved, the effective of clinical treatment is also improved while improving patient's compliance
Property and emergency.
It is commercially used for preparing Olanzapine oral disnitegration tablet mainly at present including that grind Eli Lilly company dry using freezing for original
Dry technology and TEVA company prepare Olanzapine oral disnitegration tablet using wet granular molding technique.But both preparation method techniques are multiple
It is miscellaneous, production cost is higher, get up so far without extensive development at home.
Summary of the invention
This application provides a kind of Olanzapine oral disnitegration tablet and preparation method thereof, the Olanzapine prepared with the preparation method
Orally disintegrating tablet stability is good, convenient to take, good patient compliance, and production cost is low.
Olanzapine oral disnitegration tablet described herein, it includes Olanzapine, composition grain and additive；Wherein combine
Composition granule includes that lactose and low-substituted hydroxypropyl cellulose, microcrystalline cellulose PH101, weight percent are as follows：
。
Its preparation process is to use HPMC E5 LV aqueous solution for adhesive, and 30 meshes granulation whole grain obtains
It arrives.
Olanzapine oral disnitegration tablet described herein, by weight percentage, specific composition is as follows：
。
The additive is lactose, low-substituted hydroxypropyl cellulose, corrigent, two or more in lubricant；It rectifys
Taste agent is aspartame or acesulfame potassium；Lubricant is one of magnesium stearate, talcum powder, silica or a variety of；Prepare work
Skill is：By Olanzapine, composition grain and additive direct tablet compressing after mixing, will be remixed after Olanzapine and lactose premix
Tabletting better effect.
Specific embodiment
The application is illustrated by following instance and further appreciates that olanzapine orally-disintegrating tablet preparation and preparation method thereof,
But following instance is not limited to scope of the present application.
Embodiment one
。
Preparation：Hydroxypropyl methyl cellulose is configured to 2%（W/W）Aqueous solution, by the lactose of 16g, microcrystalline cellulose PH101,
Low-substituted hydroxypropyl cellulose is pelletized with this solution, 30 mesh sieves, and drying controls other in 1%-3%, with prescription of moisture
Material is uniformly mixed；Flow of Goods and Materials is good in tableting processes, easy filler, and slice weight is stablized, and without sticking occur, puckery rush phenomenon, sliver
The tablet surface of phenomenon, compression moulding is smooth, and disintegration time limited is in 1min.
Embodiment two
。
Preparation：Hydroxypropyl methyl cellulose is configured to 5%（W/W）Aqueous solution by the lactose of 16g, microcrystalline cellulose PH101, low takes
For hydroxypropyl cellulose, this solution is pelletized, 30 mesh sieves, and drying controls unclassified stores of the moisture in 1%-3%, with prescription
It is uniformly mixed；Flow of Goods and Materials is good in tableting processes, easy filler, slice weight stablize, and without occur sticking, it is puckery rush phenomenon, sliver phenomenon,
The tablet surface of compression moulding is smooth, and disintegration time limited is in 1min.
Embodiment three
。
Preparation：Hydroxypropyl methyl cellulose is configured to 3%（W/W）Aqueous solution, by the lactose of 16g, microcrystalline cellulose PH101,
Low-substituted hydroxypropyl cellulose is pelletized with this solution, 30 mesh sieves, and drying controls other in 1%-3%, with prescription of moisture
Material is uniformly mixed；Flow of Goods and Materials is good in tableting processes, easy filler, and slice weight is stablized, and without sticking occur, puckery rush phenomenon, sliver
The tablet surface of phenomenon, compression moulding is smooth, and disintegration time limited is in 1min.
Comparative example
。
Preparation：Bulk pharmaceutical chemicals are crossed 80 meshes with interior plus material to mix 3 times, using 3% hydroxypropyl methyl cellulose（W/W）Aqueous solution
As adhesive, the granulation of 30 meshes, drying, control moisture is in 1%-3%, after converting yield, additional material is added and is uniformly mixed；Pressure
Flow of Goods and Materials is good during piece, easy filler, slice weight stablize, and without occur sticking, it is puckery rush phenomenon, sliver phenomenon, compression moulding
Tablet surface is smooth, and disintegration time limited is in 1min.
Stability study
Carry out 10 days and influence factor test in 20 days respectively according to stability guideline, related detection method is according to USP39（It is high
Imitate liquid phase detection）, each embodiment and normal wet granulation sample effects factorial experiments result it is as follows：
。
Compared with common wet granulation technology sample, the sample impurity increasing degree that is obtained using preparation process in the application
Smaller, the stability of product is more preferably.
Claims (8)
1. a kind of Olanzapine oral disnitegration tablet includes Olanzapine, composition grain and additive.
2. Olanzapine oral disnitegration tablet according to claim 1, told composition grain includes lactose and low-substituted hydroxypropyl
Base cellulose, microcrystalline cellulose PH101, weight percent are as follows：
。
3. Olanzapine oral disnitegration tablet according to claim 2, the preparation process of the composition grain is using hydroxypropyl
Ylmethyl cellulose E5LV aqueous solution makees adhesive, and 30 meshes are pelletized obtained by whole grain.
4. Olanzapine oral disnitegration tablet according to claim 1, by weight percentage, composition is as follows：
。
5. Olanzapine oral disnitegration tablet according to claim 1, the additive is lactose, low substituted hydroxy-propyl fiber
Element, corrigent, two or more in lubricant.
6. Olanzapine oral disnitegration tablet according to claim 6, the corrigent is aspartame or acesulfame potassium.
7. olanzapine orally-disintegrating tablet according to claim 6, the lubricant is magnesium stearate, in talcum powder, silica
It is one or more.
8. olanzapine orally-disintegrating tablet according to claim 1, preparation method is by Olanzapine, composition grain, additive
Direct tablet compressing after mixing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710382896.8A CN108926543A (en) | 2017-05-26 | 2017-05-26 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710382896.8A CN108926543A (en) | 2017-05-26 | 2017-05-26 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN108926543A true CN108926543A (en) | 2018-12-04 |
Family
ID=64451534
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710382896.8A Pending CN108926543A (en) | 2017-05-26 | 2017-05-26 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN108926543A (en) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006074951A2 (en) * | 2005-01-14 | 2006-07-20 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Orally disintegrating composition of olanzapine or donepezil |
| 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 |
| CN104510717A (en) * | 2013-09-27 | 2015-04-15 | 江苏豪森药业股份有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
| CN104887634A (en) * | 2015-05-07 | 2015-09-09 | 河北龙海药业有限公司 | Olanzapine orally disintegrating tablets and preparation method thereof |
-
2017
- 2017-05-26 CN CN201710382896.8A patent/CN108926543A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006074951A2 (en) * | 2005-01-14 | 2006-07-20 | Krka, Tovarna Zdravil, D.D., Novo Mesto | Orally disintegrating composition of olanzapine or donepezil |
| 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 |
| CN104510717A (en) * | 2013-09-27 | 2015-04-15 | 江苏豪森药业股份有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
| CN104887634A (en) * | 2015-05-07 | 2015-09-09 | 河北龙海药业有限公司 | Olanzapine orally disintegrating tablets and preparation method thereof |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20181204 |
|
| RJ01 | Rejection of invention patent application after publication |