CN104706603A - Olanzapine freeze-drying orally disintegrating tablet and preparation method thereof - Google Patents
Olanzapine freeze-drying orally disintegrating tablet and preparation method thereof Download PDFInfo
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- CN104706603A CN104706603A CN201310684258.3A CN201310684258A CN104706603A CN 104706603 A CN104706603 A CN 104706603A CN 201310684258 A CN201310684258 A CN 201310684258A CN 104706603 A CN104706603 A CN 104706603A
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- freeze
- olanzapine
- orally disintegrating
- disintegrating tablet
- dry orally
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Abstract
The invention provides an olanzapine freeze-drying orally disintegrating tablet and its preparation method. The orally disintegrating tablet comprises a skeleton propping agent and an adhesive. The skeleton propping agent is mannitol, and the adhesive is one or more selected from gelatin, hydrolyzed gelatin and pullulan. In order to improve properties of the tablet, a preservative, a corrective agent and the like also can be added. By adding hydrolyzed gelatin into the orally disintegrating tablet, the medicament can be better absorbed in oral mucosa and esophagus mucosa. The invention also provides a preparation method of the orally disintegrating tablet.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of olanzapine freeze-dry orally disintegrating tablet and preparation method thereof.
Background technology
Olanzapine (Olanzapine) is a kind of atypia antipsychotic drug, be mainly used in treating the schizoid positive symptom, and also have part curative effect to negative symptoms, simultaneously it has mitigation to the depression caused by schizophrenia, the affective disorder such as manic and mood disorders.Olanzapine develops on the basis of last generation medicine clozapine, and olanzapine ordinary tablet obtained FDA approval listing in 1996, olanzapine oral cavity disintegration tablet is then in granted listing in 2000.
Oral cavity disintegration tablet is a kind of tablet that can rely on saliva rapid solution or disintegrate in the oral cavity, and its advantages is embodied in: take medicine rapidly, avoid first pass effect.Oral cavity disintegration tablet is called for short oral cavity disintegration tablet, and it is generally reach fater disintegration by the instant capacity of the loose porous of tablet itself and adjuvant.
The preparation method of oral cavity disintegration tablet can be divided into two classes: the first kind is by removing the solvent introduced in production process, obtaining loose porous tablet.When adopting water to do in this type of preparation method to dissolve, be by freezing drying under reduced pressure except anhydrating, tablet Central Plains is come the space that hydrone takies and is become cavity, thus obtains loose porous tablet; When adopt organic solvent time, then can remove dissolving molecule in atmospheric conditions, make the intermediate particle of film-making or tablet loose porous, obtain oral cavity disintegration tablet.Equations of The Second Kind is by selecting suitable adjuvant, obtains loose porous tablet in production process.These class methods are in tablet granulation process, and the method in tableting processes controls to obtain loose porous tablet, and it is higher to the requirement of adjuvant.
There is vacuum freeze-drying method in first kind method at present, become mould volatility process etc.Vacuum freeze-drying method becomes solid by freezing for the medicinal liquid in mould, then vacuum drying under cryogenic, and moisture is by distillation removing, and the space that originally in tablet, hydrone takies becomes cavity, obtains loose porous tablet.The tablet obtained by the method in the oral cavity disintegration time is the shortest, and production process is without hot conditions, and tablet water content is low, is conducive to improving medicine stability.
Solver R.P.Scherer company as dosage regimen develops early stage freeze-dry orally disintegrating tablet preparation method, and forms the brand of oneself
.But different crude drug has different physicochemical properties, suitable adjuvant to be selected in preparation process, adopt suitable process.
The disintegration time of existing olanzapine oral cavity disintegration tablet is extremely short, although disintegrate, disintegrate thing is the husky shot-like particle of agglomerate, and mouthfeel is poor, and rate of releasing drug comparatively slowly, is unsuitable for clothes for patients use, and be unfavorable for the mucosa absorption of medicine at oral mucosa and esophageal mucosa membrane injury, onset is slow.
Summary of the invention
In order to improve the oral compliance of olanzapine oral cavity disintegration tablet further, improving the mucosa absorption rate of olanzapine at oral mucosa and esophageal mucosa membrane injury, improving relative bioavailability, the invention provides a kind of olanzapine freeze-dry orally disintegrating tablet and preparation method thereof.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, this freeze-dry orally disintegrating tablet is made up of the substrate of 3 ~ 4 weight portions and the olanzapine of 5 weight portions,
Substrate comprises skeletal support agent, binding agent,
Skeletal support agent is mannitol,
Binding agent is selected from one or both or three kinds in gelatin, gelatin hydrolysate, Pullulan.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, the binding agent of this freeze-dry orally disintegrating tablet is the mixed system that gelatin and gelatin hydrolysate form by weight 3 ~ 4:1.
Gelatin is insoluble to organic solvent, be insoluble to cold water, in cold water, imbibition is to self 5-10 times, is soluble in warm water, cooling forms gel, molten point is between 24-28 DEG C, and its dissolubility differs very little with solidification temperature, the molecular weight 15000 ~ 250000 of gelatin, the present invention adopt jelly power be 220,240 gelatin, there is stronger pulling force or solidness, be conducive to the friability improving tablet, the stability in tablet transportation.
To be gelatin obtained by hydrolysis at acid condition or alkali condition or hot pressing condition or enzyme effect gelatin hydrolysate.Peptide bond fission after hydrolysis, become polypeptide, molecular weight is down to 2000 ~ 10000, and the molecular weight ratio gelatin of gelatin hydrolysate is low, can be dissolved in the water under room temperature.And no longer congeal after its cooling, therefore the suspending effect of gelatin hydrolysate is comparatively strong, keeps medicinal liquid to have the higher uniformity.Because gelatin hydrolysate viscosity is little, adds in oral cavity disintegration tablet and be conducive to disintegrate.Gelatin hydrolysate has strong coverage effect, thus has cushioning effect to dripping of irritant drugs and abnormal flavour medicine, and gelatin hydrolysate has Stabilization to other additive simultaneously.Gelatin hydrolysate is the same with gelatin, is the material in protein with strong protective colloid action, can promotes the emulsifying of water-insoluble olanzapine, improves dispersion stabilization.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, the skeletal support agent of this freeze-dry orally disintegrating tablet and the weight ratio of binding agent are 4 ~ 5:1.Skeletal support agent mannitol is for the formation of the basic configuration of tablet, and binding agent is then for keeping the shape of tablet.The proper proportion of skeletal support agent and binding agent can keep the friability that tablet is good.Mannitol is soluble in water, is easy in the oral cavity dissolve.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, the antiseptic of this freeze-dry orally disintegrating tablet also containing 0.0005 ~ 0.001 weight portion, antiseptic is selected from soluble metyl hydroxybenzoate and/or soluble propylhydroxybenzoate.
Gelatin, gelatin hydrolysate be subject to moisture content, temperature, humidity impact and go bad, so antiseptic can be added improve the stability of tablet.Antimicrobial spectrum scope as antiseptic Nepal tortoise beetle ester sodium and Nepal gold propyl ester sodium is different, and two kinds of antiseptic conbined usage have wider antibacterial range.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, this freeze-dry orally disintegrating tablet also containing the correctives of 0.00033 ~ 0.00066 weight portion, correctives be selected from aspartame, three ficolls one or both.
Add appropriate correctives and can improve the easy acceptabilily of people to tablet of taking medicine.
The invention provides a kind of olanzapine freeze-dry orally disintegrating tablet, the specification of this freeze-dry orally disintegrating tablet is for containing olanzapine 5mg or 10mg or 15mg.
The invention provides a kind of preparation method of olanzapine freeze-dry orally disintegrating tablet, the method comprises the steps:
Dissolve: mixed by the water of substrate with 10 times of matrix weight, add olanzapine, fixed molten, 20 DEG C ~ 80 DEG C constant temperature high-speed stirred, fixed molten is the volume determining finally to configure medicinal liquid, obtains the tablet of required specification.
The time that during higher temperature, constant temperature stirs is unsuitable long, and long-time higher temperature stirs and part of gelatin may be caused to be hydrolyzed, and affects preparation nature.High-speed stirred refers to that rotating speed is at 3500 turns ~ 4000 turns per minute.
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by set amount;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min,
With the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
The invention provides a kind of preparation method of olanzapine freeze-dry orally disintegrating tablet, the method can add de-airing step between dissolving step and injection step,
Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 5 ~ 25min.
The invention provides a kind of preparation method of olanzapine freeze-dry orally disintegrating tablet, the method can add ice crystal incubation step between injection step and step of freeze drying,
Ice crystal is hatched: after quick-freezing, medicinal liquid preserves 12h ~ 24h in-40 DEG C ~-90 DEG C environment.
The invention provides a kind of preparation method of olanzapine freeze-dry orally disintegrating tablet, the method can add fast freezing step between injection step and ice crystal incubation step,
Quick-freezing: mould is placed in 5min ~ 10min under the condition of-70 DEG C ~-110 DEG C.
Specific embodiment
Be below the specific embodiment of the present invention, described embodiment is used for further explanation of the present invention, the protection domain be not intended to limit the present invention.
Embodiment one
Olanzapine Orally disintegrating tablet recipe:
Olanzapine 5.00g
Mannitol 2.40g
Gelatin 0.60g
Water is appropriate
Preparation process is as follows:
Dissolve: mannitol, gelatin are mixed with 35ml water, add olanzapine, be dissolved to 100ml, 40 DEG C of constant temperature stir; Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 5min;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by 0.2ml/ sheet;
Quick-freezing: mould is placed in 10min under the condition of-70 DEG C;
Ice crystal is hatched: after quick-freezing, medicinal liquid preserves 12h in-40 DEG C ~-90 DEG C environment;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min,
With the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
Embodiment two
Olanzapine Orally disintegrating tablet recipe:
Olanzapine 4.50g
Mannitol 3.00g
Gelatin 0.60g
Water is appropriate
Preparation process is as follows:
Dissolve: mannitol, gelatin are mixed with 36ml water, add olanzapine, be dissolved to 60ml, 60 DEG C of constant temperature stir; Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 10min;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by 0.2ml/ sheet;
Quick-freezing: mould is placed in 10min under the condition of-80 DEG C;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min,
With the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
Embodiment three
Olanzapine Orally disintegrating tablet recipe:
Preparation process is as follows:
Dissolve: mannitol, gelatin, gelatin hydrolysate are mixed with 30ml water, add olanzapine, be dissolved to 100ml, 40 DEG C of constant temperature stir;
Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 5min;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by 0.2ml/ sheet;
Quick-freezing: mould is placed in 10min under the condition of-90 DEG C;
Ice crystal is hatched: after quick-freezing, medicinal liquid preserves 24h in-40 DEG C ~-90 DEG C environment;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min,
With the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
Embodiment four
Olanzapine Orally disintegrating tablet recipe:
Preparation process is as follows:
Dissolve: mannitol, gelatin, gelatin hydrolysate are mixed with the water of 40ml, add olanzapine, be dissolved to 200ml, 20 DEG C of constant temperature stir;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by 0.2ml/ sheet;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min, with the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
Embodiment five
Olanzapine Orally disintegrating tablet recipe:
Preparation process is as follows:
Dissolve: mannitol, gelatin, gelatin hydrolysate are mixed with the water of 37ml, add olanzapine, be dissolved to 100ml, 80 DEG C of constant temperature stir;
Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 25min;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by 0.2ml/ sheet;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min, with the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
Concrete test
Take from system five batches of olanzapine oral cavity disintegration tablets respectively to test, wherein slaking test adopts artificial saliva to be disintegrate medium, and test temperature is 37 DEG C.Artificial saliva adopts ISO/TR10271 standard, and its composition is specially: NaCl0.400g, KCl0.400g, CaCl22H2O0.795g, NaH2-PO42H2O0.780g, Na2S2H2O0.005g, carbamide 1.000g, distilled water 1000mL.
Result of the test sees the following form:
Claims (10)
1. an olanzapine freeze-dry orally disintegrating tablet, this freeze-dry orally disintegrating tablet is made up of the substrate of 3 ~ 4 weight portions and the olanzapine of 5 weight portions,
It is characterized in that substrate comprises: skeletal support agent, binding agent,
Skeletal support agent is mannitol,
Binding agent is selected from one or both or three kinds in gelatin, gelatin hydrolysate, Pullulan.
2. olanzapine freeze-dry orally disintegrating tablet according to claim 1, is characterized in that binding agent is the mixed system that gelatin and gelatin hydrolysate form by weight 3 ~ 4:1.
3. olanzapine freeze-dry orally disintegrating tablet according to claim 1, is characterized in that the weight ratio of skeletal support agent and binding agent is 4 ~ 5:1.
4. olanzapine freeze-dry orally disintegrating tablet according to claim 1, it is characterized in that the antiseptic of this freeze-dry orally disintegrating tablet also containing 0.0005 ~ 0.001 weight portion, antiseptic is selected from soluble metyl hydroxybenzoate and/or soluble propylhydroxybenzoate.
5. olanzapine freeze-dry orally disintegrating tablet according to claim 1, is characterized in that this freeze-dry orally disintegrating tablet also containing the correctives of 0.00033 ~ 0.00066 weight portion, correctives be selected from aspartame, three ficolls one or both.
6. the olanzapine freeze-dry orally disintegrating tablet according to Claims 1 to 5 any one, is characterized in that this freeze-dry orally disintegrating tablet specification is for containing olanzapine 5mg or 10mg or 15mg.
7. prepare a method for the olanzapine freeze-dry orally disintegrating tablet described in claim 1 ~ 6 any one, the method comprises the steps:
Dissolve: the water of substrate with 10 ~ 17 times of matrix weight is mixed, adds olanzapine, fixed molten, 20 DEG C ~ 80 DEG C constant temperature high-speed stirred;
Injection molding: draw the medicinal liquid that previous step is stirred, injects mould by set amount;
Lyophilizing: the mould of populated medicinal liquid is placed in freeze dryer, at-10 DEG C, vacuum 0.5mbar, keeps 30min,
With the ramp to 0 DEG C of 1 DEG C/4min,
0 DEG C of insulation 60min,
25 DEG C are warming up to 1 DEG C/1min,
25 DEG C of insulation 30min;
Packaging: cover teleblem packaging, print lot number and date.
8. method according to claim 7, is characterized in that, between dissolving step and injection step, add de-airing step,
Degassed: to use high speed centrifugation degassing method or vacuum outgas method or ultrasonic degas method, degassing time 5 ~ 25min.
9. method according to claim 7, is characterized in that, adds ice crystal incubation step between injection step and step of freeze drying,
Ice crystal is hatched: after quick-freezing, medicinal liquid preserves 12h ~ 24h in-40 DEG C ~-90 DEG C environment.
10. method according to claim 9, is characterized in that, between injection step and ice crystal incubation step, add fast freezing step,
Quick-freezing: mould is placed in 5min ~ 10min under the condition of-70 DEG C ~-110 DEG C.
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| CN201310684258.3A CN104706603A (en) | 2013-12-13 | 2013-12-13 | Olanzapine freeze-drying orally disintegrating tablet and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105106141A (en) * | 2015-09-22 | 2015-12-02 | 成都欣捷高新技术开发有限公司 | Freeze-drying oral preparation containing olanzapine and preparation method of freeze-drying oral preparation |
| CN106389362A (en) * | 2016-08-31 | 2017-02-15 | 安徽省润生医药股份有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
| CN109078004A (en) * | 2017-06-13 | 2018-12-25 | 量子高科（北京）研究院有限公司 | A kind of freeze-drying oral disnitegration tablet and preparation method thereof |
| CN110151718A (en) * | 2019-06-13 | 2019-08-23 | 厦门医学院 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
| CN113768890A (en) * | 2021-10-11 | 2021-12-10 | 北京阳光诺和药物研究股份有限公司 | Lurasidone freeze-dried orally disintegrating tablet and preparation method and application thereof |
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| CN1689649A (en) * | 2004-04-30 | 2005-11-02 | 量子高科（北京）研究院有限公司 | Oral cavity quick dissolving preparation and production method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105106141A (en) * | 2015-09-22 | 2015-12-02 | 成都欣捷高新技术开发有限公司 | Freeze-drying oral preparation containing olanzapine and preparation method of freeze-drying oral preparation |
| CN106389362A (en) * | 2016-08-31 | 2017-02-15 | 安徽省润生医药股份有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
| CN109078004A (en) * | 2017-06-13 | 2018-12-25 | 量子高科（北京）研究院有限公司 | A kind of freeze-drying oral disnitegration tablet and preparation method thereof |
| CN109078004B (en) * | 2017-06-13 | 2021-05-04 | 北京量子高科制药科技有限公司 | Freeze-dried orally disintegrating tablet and preparation method thereof |
| CN110151718A (en) * | 2019-06-13 | 2019-08-23 | 厦门医学院 | A kind of Olanzapine oral disnitegration tablet and preparation method thereof |
| CN113768890A (en) * | 2021-10-11 | 2021-12-10 | 北京阳光诺和药物研究股份有限公司 | Lurasidone freeze-dried orally disintegrating tablet and preparation method and application thereof |
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