CN104887634B - Olanzapine oral disnitegration tablet and preparation method thereof - Google Patents
Olanzapine oral disnitegration tablet and preparation method thereof Download PDFInfo
- Publication number
- CN104887634B CN104887634B CN201510228805.6A CN201510228805A CN104887634B CN 104887634 B CN104887634 B CN 104887634B CN 201510228805 A CN201510228805 A CN 201510228805A CN 104887634 B CN104887634 B CN 104887634B
- Authority
- CN
- China
- Prior art keywords
- olanzapine
- tablet
- oral disnitegration
- 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.)
- Active
Links
Abstract
The present invention relates to a kind of Olanzapine oral disnitegration tablet and preparation method thereof, belong to technical field of medicine.Olanzapine oral disnitegration tablet prepared by the present invention can be disintegrated in 1min;Good mouthfeel, without obvious sand type, 1min is stopped in mouth also without bitter taste, oral disnitegration tablet bitter taste prepared by relatively direct pressed disc method is obviously improved;Dissolution rate can reach 90% or so, 30min dissolution be complete in 10min;And friability is respectively less than 0.5%, meet transport shelf appeal, and prescription simple possible, technical maturity is stable, is easy to industrialized production.
Description
Technical field
The present invention relates to a kind of oral disnitegration tablet and preparation method thereof, and in particular to a kind of Olanzapine oral disnitegration tablet and its
Preparation method, belong to technical field of medicine.
Background technology
Olanzapine chemical name is:2- methyl -4- (4- methyl isophthalic acids-piperazinyl) -10H- thienos [2,3-B] [1,5] benzene
And diazepine, it is a kind of atypical antipsychotic agents.Olanzapine is applied to schizophrenia and other has serious positive symptom
(such as:Vain hope, illusion, the disturbance of thought, hostility and suspect) and/or negative symptoms (such as:Apathy, emotion and society move back
Contracting, poverty of speech) mental disease acute stage and maintaining treatment, can also alleviate schizophrenia and the common Secondary cases of relevant disease
Affective symptom.
Olanzapine is developed by Lilly Co., Eli., is listed in the U.S. within 1996, in Discussion on Chinese Listed, 2003 within 1999
State is classified as fiest-tire medication by schizophrenia guideline of prevention and treatment.Olanzapine has long-term efficacy good as antipsychotic agent
And the advantages of Small side effects, the highly recognition of clinician is obtained, listing formulation at present has conventional tablet, oral disnitegration tablet, mouth
Chamber dispersible tablet, capsule and intramuscular injection agent.
The peroral dosage form listed earliest is conventional tablet.But because easily there is mismatching treatment now in mental patient
As and part old man, child patient swallow poor, the shortcomings that ordinary tablet is not easy to swallow can cause patient compliance
Difference, or even there is the possibility of the threat to life such as choke food.In addition, oral capsule and intramuscular injection formulation equally exist patient compliance
The shortcomings that poor.
The Olanzapine oral disnitegration tablet of Lilly development was approved listing by U.S. FDA in 2000.The dosage form tablet
It is not usually required to water or only need a small amount of water when taking, tablet is placed in lingual surface, without chewing, meets saliva and is disintegrated rapidly.Should
Formulation to children, old man, be unable to leave the bed and severely-disabled patient's optimum.The formulation can be disintegrated rapidly after being put into mouth to be dispersed in
In saliva, medicine can be by the mucosal absorption in oral cavity or esophagus, and bioavilability is higher than ordinary preparation, can also mitigate by first mistake
Side effect caused by metabolism.
Common Orally disintegrating piece preparation method has direct compression method, desivac, wet granulation pressed disc method, dry granulation again
Pressed disc method, pressed film method, enteric-coated micro-pill pressed disc method etc. afterwards.At present, foreign countries prepare Olanzapine oral disnitegration tablet frequently with desivac.Freeze
The oral disnitegration tablet that dry process goes out disintegrating property in mouth is splendid, but tablet friability is high, during transport deposit etc. easily by
Damage, it is higher to packing instructions, and lyophilized technique is costly, is seldom promoted the use of in the country of China.The conventional preparation work in the country
Skill is direct compression method, and the more other technical costs of oral disnitegration tablet prepared by the technique are low, conventional production device, technical process letter
Single, tablet physical is functional.But direct compression method prepares oral disnitegration tablet and need to add flavouring to cover the hardship of Olanzapine
Taste, glutinous punching is easily caused when dosage is big, dosage hour does not reach taste masking effect.
There are two published Olanzapine oral disnitegration tablet patents the country at present, and CN101904824 discloses a kind of use
The mixture of mannitol and lactose prepares Olanzapine oral disnitegration tablet as filler by direct tablet compressing technique.
Phosphorus is added using mannitol and lactose or microcrystalline cellulose or their mixture first as filler in CN102631331
Sour hydrogen calcium improves disintegrating property, disintegration time within 30s, preparation technology still using direct compression method, in prescription plus
Enter flavouring to cover Olanzapine bitter taste.
" Olanzapine oral disintegration tablet " disclosed in WO2006115770 prepares oral disnitegration tablet with compression moulding, during disintegration
Between be less than 20s, friability is smaller, but compression moulding technique is more complicated, and equipment is expensive, and domestic pharmacy corporation is using less.
WO2006087629 discloses " a kind of rapidly disintegrating formulation of antipsychotic drug ", using Olanzapine as model drug, with 70
~85% filler, 1~10% disintegrant, 0.4~7% lubricant is prescription, is prepared using direct compression method.This is special
Specific disintegration time, hardness range and friability data are not referred in profit.Olanzapine mouth disclosed in above-mentioned two patents collapses
All preferably individually with mannitol, or individually using lactose as filler.And practice have shown that, individually using mannitol as filler, tablet
Hardness formability is preferable, but disintegrating property is poor;Individually then easily occurs sliver phenomenon in production by filler of lactose.
Therefore, it is domestic there is still a need for the new preparation method of exploitation to carry out production cost relatively low, disintegrating property and mouthfeel and good
Olanzapine oral disnitegration tablet.
The content of the invention
The present invention in view of the shortcomings of the prior art and patient demand, there is provided a kind of Olanzapine oral disnitegration tablet, the nitrogen difficult to understand
Flat mouth cavity disintegrating tablet is convenient to take, good patient compliance, and disintegration is without bitter taste, taste good in mouth.In addition, the present invention provides the Austria
The preparation method of nitrogen flat mouth cavity disintegrating tablet.
Technical problem of the present invention is realized by following technical scheme.
A kind of Olanzapine oral disnitegration tablet, it is prepared by the component of following parts by weight:It is Olanzapine taste masked particle 15, sweet
Reveal alcohol 200SD 18.5~37.5, microcrystalline cellulose 36~55, dry adhesives 2, disintegrant 5~8, lubricant 1.0, colouring agent
0.5;
Wherein, Olanzapine taste masked particle is prepared by the component of following parts by weight:Olanzapine 5, Parteck deltaM
4.5th, microcrystalline cellulose 4.5, polyvinylpyrrolidone 0.45, hydroxypropyl methyl cellulose 0.50, polyethylene glycol 0.05.
Above-mentioned Olanzapine oral disnitegration tablet, the microcrystalline cellulose are selected from microcrystalline cellulose PH101, microcrystalline cellulose
PH103, microcrystalline cellulose PH301;Preferably microcrystalline cellulose PH301.
Above-mentioned Olanzapine oral disnitegration tablet, the dry adhesives are selected from hydroxypropyl methyl cellulose, hydroxypropyl cellulose;It is excellent
Select hydroxypropyl methyl cellulose.
Above-mentioned Olanzapine oral disnitegration tablet, the disintegrant are selected from Ac-Di-Sol, crosslinked polyethylene pyrroles
Alkanone, preferably PVPP.
Above-mentioned Olanzapine oral disnitegration tablet, the lubricant are selected from magnesium stearate, calcium stearate, zinc stearate, micro mist silicon
Glue, talcum powder;It is preferred that magnesium stearate.
Above-mentioned Olanzapine oral disnitegration tablet, the colouring agent are selected from yellow ferric oxide, red ferric oxide or both arbitrary proportion
Combination;It is preferred that yellow ferric oxide.
As a preferred embodiment of the present invention, Olanzapine oral disnitegration tablet of the present invention by following parts by weight group
It is grouped into:
Olanzapine taste masked particle 15, Parteck deltaM 18.5~37.5, microcrystalline cellulose PH301 36~55, hydroxypropyl
Methylcellulose 2, PVPP 5~8, magnesium stearate 1.0, yellow ferric oxide 0.5;
Wherein, Olanzapine taste masked particle is prepared by the component of following parts by weight:Olanzapine 5, Parteck deltaM
4.5th, microcrystalline cellulose 4.5, polyvinylpyrrolidone 0.45, hydroxypropyl methyl cellulose 0.50, polyethylene glycol 0.05.
As currently preferred concrete scheme, Olanzapine oral disnitegration tablet of the present invention, its 1000 by following
The component of proportioning is made:
Olanzapine taste masked particle formula:
Olanzapine Orally disintegrating slice prescription:
A kind of method for preparing above-mentioned Olanzapine oral disnitegration tablet, comprises the following steps:
(1) Olanzapine taste masked particle is prepared
1. recipe quantity Olanzapine, microcrystalline cellulose, mannitol are crossed into 80 mesh sieves, material is standby;
2. taking the polyvinyl pyrrolidone of recipe quantity to be slowly added into the water being stirred continuously, concentration, which is made, is
10% binder solution;
3. Olanzapine, microcrystalline cellulose, mannitol are directly mixed to uniform;
4. well mixed material is poured into binder solution, softwood is made;
Pelletize, dry 5. softwood is put into oscillating granulator, dried particle is carried out whole using 50~65 mesh sieves
Grain simultaneously controls pellet moisture to be higher than 2.0%, and gained particle is standby;
6. HPMC is uniform with distilled water stirring and dissolving, add the polyethylene glycol of recipe quantity, stirring and dissolving
Uniformly, 80 mesh sieves are crossed;
7. by step, 5. 6. gained coating solution is put into fluid bed and carries out granule coating gained particle and step, and use bottom is sprayed
Art for coating, control blower fan 15~25Hz of frequency, 40~60 DEG C of heating-up temperature, 1.5~2.5kg/cm of atomizing pressure3, constant flow pump
3~6rpm of speed, obtain Olanzapine taste masked particle;
(2) preparation of Olanzapine oral disnitegration tablet
It is 1. Olanzapine taste masked particle and mannitol, microcrystalline cellulose, dry adhesives, disintegrant, lubricant, colouring agent is straight
Connect well mixed;
2. tabletting, using hardness, piece weight, tablet weight variation as index, hardness is controlled in 3~5kg/mm2。
The present inventor has found during Olanzapine oral disnitegration tablet is studied, and mannitol has sweet taste and refrigerant in itself
Sense, mobility compressibility is good, can improve the bitter taste of tablet as filler, improves mouthfeel, but mannitol dosage crosses conference
Cause oral disnitegration tablet friability high, used to solve problem above patent CN102631331 with being mentioned in CN101904824
The lactose filler that acts as a supplement improves compressibility, reduces friability, but the use of lactose causes Olanzapine oral disnitegration tablet
Sliver is very serious.This point also illustrate that the experimental very strong of technical field of medicine, supplementary product kind or its proportioning it is a little
Perhaps change, the influence for preparation technique effect is not it is contemplated that having to pass through continuing to optimize for design space, it is also necessary to is passed through
Suitable prescription can just be found out by crossing those skilled in the art and paying substantial amounts of creative work.And the present invention has surprisingly found that,
Using microcrystalline cellulose PH301 and Parteck deltaM mixed filler, added by interior in Olanzapine taste masked particle with additional,
So that Olanzapine oral disnitegration tablet of the present invention achieves friability less than 0.5%, disintegration time is within 30s, in mouth
Disintegration is without bitter taste, without sand type without bitter taste, taste good, the good technique effect of good patient compliance.Specifically, in Olanzapine
In in taste masked particle plus use is using weight ratio as 1:The mixing filling of 1 microcrystalline cellulose PH301 and Parteck deltaM composition
Agent, (namely additional) is used outside Olanzapine taste masked particle using weight ratio as 1.86:1 microcrystalline cellulose PH301 and sweet
Reveal the mixed filler of alcohol 200SD compositions, be aided with other auxiliary materials and its proportioning, overall co-ordination, synergy so that the present invention
Prepared Olanzapine oral disnitegration tablet can be disintegrated in 1min;Good mouthfeel, without obvious sand type, stop in mouth
Stay 1min also without bitter taste, oral disnitegration tablet bitter taste prepared by relatively direct pressed disc method is obviously improved;Dissolution rate can reach in 10min
Dissolution is complete by 90% or so, 30min;And friability is respectively less than 0.5%, meet transport shelf appeal, and prescription simply may be used
OK, technical maturity is stable, is easy to industrialized production.In addition, Olanzapine oral disnitegration tablet of the present invention employs a kind of novelty
Preparation method, i.e. granule coating taste masking technology, without adding flavouring, by controlling blower fan 15~25Hz of frequency, heating temperature
40~60 DEG C of degree, 1.5~2.5kg/cm of atomizing pressure3, the specific parameter such as 3~6rpm of constant current pump speed, final direct tablet compressing
3~5kg/mm of obtained oral disnitegration tablet hardness2, the preparation method is also to acquired by Olanzapine oral disnitegration tablet of the present invention
Technique effect generate certain effect, preparation method production efficiency of the present invention is high, with reference to common press device and letter
Either simplex skill, industrialization degree is high, is suitable for extensive promotion and application.
Specific implementation method
The present invention will be elaborated further with reference to following examples, it is to be understood that, following embodiments are used only for explaining
The present invention is stated and explained, and is not limit the scope of the invention.
It should be appreciated that for referred in the present invention but without describe in detail method, step, device, instrument, material etc.,
Those of ordinary skill can use correlation method well known in the art, step, device, instrument, material etc., or according to this area
General knowledge and technology obtain.
Prepared in experimental example and tester as do not proposed in addition, using equipment same as below:The multi-functional streams of the A of WBF- II
Change bed seed-coating machine, WK-60 oscillating granulators, TDP-1.5 single-punch tablet presses, YD-I type hardness tester testers etc..
Embodiment 1:The preparation of Olanzapine oral disnitegration tablet
Formula:
Prescription containing olanzapine particles:
Granule coating liquid prescription:
Hydroxypropyl methyl cellulose 0.50g
Polyethylene glycol 0.05g
Orally disintegrating tablet recipe:
Preparation process:
(1) Olanzapine taste masked particle is prepared
1. recipe quantity Olanzapine, microcrystalline cellulose, mannitol are crossed into 80 mesh sieves, material is standby;
2. taking the polyvinyl pyrrolidone of recipe quantity to be slowly added into the water being stirred continuously, concentration is made
For 10% binder solution;
3. Olanzapine, microcrystalline cellulose, mannitol are directly mixed to uniform;
4. well mixed material is poured into binder solution, softwood is made;
Pelletize, dry 5. softwood is put into oscillating granulator, dried particle is carried out whole using 50~65 mesh sieves
Grain simultaneously controls pellet moisture to be higher than 2.0%, and gained particle is standby;
6. HPMC is uniform with distilled water stirring and dissolving, add the polyethylene glycol of recipe quantity, stirring and dissolving
Uniformly, 80 mesh sieves are crossed;
7. by step, 5. 6. gained coating solution is put into fluid bed and carries out granule coating gained particle and step, and use bottom is sprayed
Art for coating, control blower fan 15~25Hz of frequency, 40~60 DEG C of heating-up temperature, 1.5~2.5kg/cm of atomizing pressure3, constant flow pump
3~6rpm of speed, obtain Olanzapine taste masked particle;
(2) preparation of Olanzapine oral disnitegration tablet
It is 1. Olanzapine taste masked particle and mannitol, microcrystalline cellulose, dry adhesives, disintegrant, lubricant, colouring agent is straight
Connect well mixed;
2. tabletting, using hardness, piece weight, tablet weight variation as index, hardness is controlled in 3~5kg/mm2。
Embodiment 2:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 3:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 4:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 5:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 6:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 7:The preparation of Olanzapine oral disnitegration tablet
Formula:
Taste masked particle prescription and technique are the same as embodiment 1;Tablet manufacture is the same as embodiment 1.
Embodiment 8:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose model therein is changed into
PH101。
Embodiment 9:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose model therein is changed into
PH103。
Reference examples 1:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 2, it is a difference in that a microcrystalline cellulose all changes mannitol into.
Reference examples 2:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 2, it is a difference in that and mannitol therein is all changed into microcrystalline cellulose
Element.
Reference examples 3:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose therein is changed into lactose.
Reference examples 4:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and mannitol therein is changed into lactose.
Reference examples 5:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose model therein is changed into
PH105。
Reference examples 6:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose model therein is changed into
PH200。
Reference examples 7:The preparation of Olanzapine oral disnitegration tablet
With reference to the formula and preparation method of embodiment 6, it is a difference in that and microcrystalline cellulose model therein is changed into
PH302。
Testing example 1
(1) disintegration of tablet overtime check
According to state food and drug administration's medicine evaluate that center on May 8th, 2007 delivers " FDA is issued
Oral disnitegration tablet guideline draft and discussion ", Chinese oral disnitegration tablet key Quality Control, the present invention use " static method "
Detect oral disnitegration tablet disintegration time.Specific method:Using diameter 1.5cm teat glass, add and be preheated to 37 DEG C pure
Water 2mL, then by tablet input wherein, stand, the time required to calculating tablet from the contact water surface to completion disintegration;Oral disnitegration tablet
Disintegration time should be in 1 minute;The granularity of residue is controlled after disintegration, it is desirable to which residue should pass through No. 2 sieves completely after disintegration
(can be rinsed with a small amount of water).
(2) tablet friability inspection
According to《Pharmacopoeia of People's Republic of China》In the two annex XG of version in 2010 under " tablet friability inspection technique " item
Method is carried out, and calculates less loss weight %.If the anomalies such as fracture, cracking or crushing occur is considered as unqualified tablet, no longer enter
Row less loss weight calculates.
(3) Dissolution of Tablet inspection
According to《Pharmacopoeia of People's Republic of China》Two methods of annex XC " dissolution method " second of version in 2010 are carried out.With
0.1mol/LHCL 900mL are dissolution medium, rotating speed 50r/min, 37 DEG C of temperature, record 5min, 10min, 15min, 20min,
30min dissolution rate.Press《Pharmacopoeia of People's Republic of China》The A UV-VIS spectrophotometries of two annex of version in 2010 IV are examined
Survey, Detection wavelength 260nm.
(4) the slaking test inspection of oral disnitegration tablet in the oral cavity
6 healthy volunteers are chosen, oral cavity is cleaned with water, takes a tablet to be placed in lingual surface at random, without water, also do not chew,
Tongue is allowed suitably to move up and down, record tablet with stopwatch is disintegrated required time, as intraoral disintegration time completely in the oral cavity.
Then medicinal powder is spued and gargled, immediate record mouthfeel, if without obvious sand type, no bitter taste, no hard-core, be considered as good mouthfeel.
Olanzapine oral disnitegration tablet coherence check the results are shown in Table 1 in each embodiment and reference examples.
The Olanzapine oral disnitegration tablet correlated quality inspection result of table 1
Conclusion:Olanzapine oral disnitegration tablet prepared by embodiment 1~9 can be disintegrated in 1min;Good mouthfeel, nothing
Obvious sand type, 1min is stopped in mouth also without bitter taste, oral disnitegration tablet bitter taste prepared by relatively direct pressed disc method is obvious
Improve;Dissolution rate can reach 90% or so, 30min dissolution be complete in 10min;And friability is respectively less than 0.5%, meet transport
Shelf appeal.Olanzapine Orally disintegrating piece performance prepared by reference examples 1~7 in disintegration time, mouthfeel and compressibility etc. one or
Many aspects decrease compared with embodiment 1~9.
The preparation of the Olanzapine oral disnitegration tablet of 3 batches 10000/batches is carried out according to embodiment 6, and the oral cavity of preparation is collapsed
Solve piece and carry out quality testing.Disintegration time, friability, dissolution rate, Orally disintegrating time and mouthfeel, which check, uses institute of the present invention
State method.Testing result is shown in Table 2.
2 embodiment of table, 6 three batches of 10000 Olanzapine oral disnitegration tablet quality measurements
Conclusion:Olanzapine Orally disintegrating tablet recipe simple possible prepared by the present invention, technical maturity is stable, is easy to industrialize
Production.The Olanzapine oral disnitegration tablet that especially prepared by embodiment 6 has good performance, external rapid disintegration, it is only necessary to 30s with
It is interior;It is disintegrated in oral cavity comparatively fast, without obvious sand type, no bitter taste, it is contemplated that patient's compliance is good;Friability is small, and breakage is few, meets
Shipping storage requirement;In Vitro Dissolution is very fast, dissolution rate more than 90% in 10min, can fast onset curative effect for patient.
It the above is only the preferred embodiment of the present invention, be not intended to limit the invention, come for those skilled in the art
Say, under the premise without departing from the principles of the invention, some improvement that can also make, retouching, equivalent substitution, should be included in this
Within the protection domain of invention.
Claims (2)
1. a kind of Olanzapine oral disnitegration tablet, it is characterised in that its 1000 components by following proportioning are made:
Olanzapine taste masked particle formula:
Olanzapine Orally disintegrating slice prescription:
A kind of 2. method for preparing Olanzapine oral disnitegration tablet as claimed in claim 1, it is characterised in that including following step
Suddenly:
(1) Olanzapine taste masked particle is prepared
1. recipe quantity Olanzapine, microcrystalline cellulose, mannitol are crossed into 80 mesh sieves, material is standby;
2. take appropriate polyvinyl pyrrolidone to be slowly added into the water being stirred continuously, be made concentration be 10% it is viscous
Mixture solution;
3. Olanzapine, microcrystalline cellulose, mannitol are directly mixed to uniform;
4. well mixed material is poured into binder solution, softwood is made;
Pelletize, dry 5. softwood is put into oscillating granulator, dried particle carries out whole grain simultaneously using 50~65 mesh sieves
Pellet moisture is controlled to be higher than 2.0%, gained particle is standby;
6. HPMC is uniform with distilled water stirring and dissolving, the polyethylene glycol of recipe quantity is added, stirring and dissolving is uniform,
Cross 80 mesh sieves;
7. by step, 5. 6. gained coating solution is put into fluid bed and carries out granule coating gained particle and step, the spray coating of use bottom
Technique, control blower fan 15~25Hz of frequency, 40~60 DEG C of heating-up temperature, 1.5~2.5kg/cm of atomizing pressure3, constant current pump speed 3
~6rpm, obtain Olanzapine taste masked particle;
(2) preparation of Olanzapine oral disnitegration tablet
It is 1. Olanzapine taste masked particle and mannitol, microcrystalline cellulose, dry adhesives, disintegrant, lubricant, colouring agent is directly mixed
Close uniform;
2. tabletting, using hardness, piece weight, tablet weight variation as index, hardness is controlled in 3~5kg/mm2。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510228805.6A CN104887634B (en) | 2015-05-07 | 2015-05-07 | Olanzapine oral disnitegration tablet and preparation method thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201510228805.6A CN104887634B (en) | 2015-05-07 | 2015-05-07 | Olanzapine oral disnitegration tablet and preparation method thereof |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104887634A CN104887634A (en) | 2015-09-09 |
CN104887634B true CN104887634B (en) | 2017-12-26 |
Family
ID=54020881
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201510228805.6A Active CN104887634B (en) | 2015-05-07 | 2015-05-07 | Olanzapine oral disnitegration tablet and preparation method thereof |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104887634B (en) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106265559B (en) * | 2016-07-22 | 2019-03-19 | 江苏豪森药业集团有限公司 | Olanzapine oral disnitegration tablet and preparation method thereof |
CN108926543A (en) * | 2017-05-26 | 2018-12-04 | 万全万特制药江苏有限公司 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
CN109498578A (en) * | 2017-09-14 | 2019-03-22 | 万全万特制药江苏有限公司 | Stable Olanzapine composition and preparation method thereof |
CN113974172A (en) * | 2021-11-22 | 2022-01-28 | 国圣制药(上海)有限公司 | Production process of calcium-magnesium tablets |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1613442A (en) * | 2003-11-06 | 2005-05-11 | 常州市第四制药厂有限公司 | Disintegrants for deodoring effectively and their preparation |
CN102716097A (en) * | 2012-05-29 | 2012-10-10 | 浙江华海药业股份有限公司 | Method for controlling medicament release rate of orally disintegrating tablet |
CN103156860A (en) * | 2011-12-13 | 2013-06-19 | 无锡万全医药技术有限公司 | Olanzapine composition and preparation method thereof |
CN104523631A (en) * | 2015-02-02 | 2015-04-22 | 刘平 | Preparation method of olanzapine orally disintegrating tablet for treating depression |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1883456B (en) * | 2005-06-20 | 2010-12-15 | 常州市第四制药厂有限公司 | Flavor-hidden pharmaceutical granule, preparation method and use thereof |
-
2015
- 2015-05-07 CN CN201510228805.6A patent/CN104887634B/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1613442A (en) * | 2003-11-06 | 2005-05-11 | 常州市第四制药厂有限公司 | Disintegrants for deodoring effectively and their preparation |
CN103156860A (en) * | 2011-12-13 | 2013-06-19 | 无锡万全医药技术有限公司 | Olanzapine composition and preparation method thereof |
CN102716097A (en) * | 2012-05-29 | 2012-10-10 | 浙江华海药业股份有限公司 | Method for controlling medicament release rate of orally disintegrating tablet |
CN104523631A (en) * | 2015-02-02 | 2015-04-22 | 刘平 | Preparation method of olanzapine orally disintegrating tablet for treating depression |
Also Published As
Publication number | Publication date |
---|---|
CN104887634A (en) | 2015-09-09 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN101184489B (en) | Pharmaceutical composition | |
JP3069458B2 (en) | Orally disintegrating tablet and production method thereof | |
KR101465803B1 (en) | Orally disintegratable tablet | |
CN104887634B (en) | Olanzapine oral disnitegration tablet and preparation method thereof | |
WO2000078292A1 (en) | Quickly disintegrating solid preparations | |
JPWO2002032403A1 (en) | Oral fast disintegrating pharmaceutical composition and method for producing the same | |
JP2017519783A (en) | Abuse deterrent immediate release formulation containing non-cellulose polysaccharide | |
JP2001163770A (en) | Intraorally rapid disintegration tablet and method for producing the same | |
CN102631331A (en) | Olanzapine oral disintegration tablet and preparation method thereof | |
TW201023850A (en) | Compression-molded preparation and method for producing the same | |
CN101461788B (en) | Phloroglucine orally disintegrating tablet and preparation method thereof | |
EP3020416A1 (en) | Ultrafast-disintegrating tablet and method for manufacturing same | |
CN101874790A (en) | Orally disintegrating tablet of Rasagiline or medicine salts thereof and preparation method thereof | |
US10864165B2 (en) | Super-rapid disintegrating tablet, and method for producing same | |
JP2002308760A (en) | Composition for compression molding and use thereof | |
EP3238712B1 (en) | Very rapidly disintegrating tablet, and method for producing same | |
CN100544709C (en) | Antithrombotic chemical compound can be in mouth dispersive pharmaceutical composition | |
JP2002138055A (en) | Intraoral quick disintegration type compression molding and its production method | |
CN109700773A (en) | A kind of ticagrelor preparation compositions and preparation method thereof | |
CN100536829C (en) | Erigeron breviscapus oral caving fast disintegration tablet and its preparation method | |
JP2018158947A (en) | Live bacteria-containing preparation | |
CN101766605B (en) | Pramipexole-contained pharmaceutical composition capable of being dispersed in mouth | |
JP4828707B2 (en) | Solid compression formulation | |
Lende et al. | Formulation development and evaluation of mouth dissolving tablet of anti-allergic drug (Astemizole) | |
JP2008133294A (en) | Tablet disintegrated in buccal cavity |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
GR01 | Patent grant |