CN104510717A - Olanzapine orally disintegrating tablet and preparation method thereof - Google Patents
Olanzapine orally disintegrating tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to an olanzapine orally disintegrating tablet and a preparation method thereof. The orally disintegrating tablet has a disintegration time limit of less than or equal to 10 seconds, and comprises: a) 2%-15% of olanzapine by weight; b) 20%-78% of mannitol by weight; c) 10%-40% of microcrystalline cellulose by weight; d) 1%-20% of crosslinked povidone by weight; e) 0.2%-5% of aspartame by weight; and f) 0.3%-4% of magnesium stearate by weight. From the perspective of whole effect, the olanzapine orally disintegrating tablet provided by the invention has the characteristics of fast disintegration speed, simple technological steps, low cost, and convenient oral administration, thus being suitable for wide promotion and application.
Description
Technical field
The present invention relates to field of medicine preparations, particularly relate to olanzapine orally-disintegrating tablet and preparation method thereof.
Background technology
Along with the prolongation of average human life and the decline of age growth swallow, oral tablet administration mode becomes the problem that people pay close attention to.According to estimates, about there is the people of 50% to have any problem to Tablet and Capsula of swallowing, have impact on the compliance of Drug therapy.At department of pediatrics and old medicine, there is very large demand to the solid preparation dissolving in water or suspend, can chew or can dissolve rapidly in mouth, then can meet this demand without the need to the oral flash-dispersion formulations that just can disperse or dissolve rapidly with water and swallowing act.Can be dispersed or dissolved in saliva rapidly after this dosage form puts into mouth, medicine is by oral cavity or intraesophageal mucosal absorption, and bioavailability is higher than ordinary preparation, and the side effect caused by first pass metabolism also can alleviate.
Oral cavity disintegration tablet refers to be placed on lingual surface and automatically disintegrate can become countless microgranule and a kind of new medicinal preparation of sweet mouthfeel in 30 seconds.Because its disintegration rate is fast, it is rapid to absorb, and need not drink water after taking medicine, therefore very applicable especial patients (psychosis, senile dementia, epileptic patient etc.) and old man, child take.Usually lyophilization, mechanography, direct compression process is adopted when preparing oral cavity disintegration tablet both at home and abroad at present.
Olanzapine is applicable to schizophrenia and other has the psychotic acute stage of the serious positive symptom and/or negative symptoms and the treatment of maintenance phase, also can alleviate the Secondary cases affective symptom of schizophrenia and relevant disease.This product, as antipsychotic agent, has the advantage that long-term efficacy is good and side effect is little, obtains the height accreditation of clinician.
Compared with other technologies (as lyophilization, compression moulding), adopt direct compression technique to prepare the technique of olanzapine orally-disintegrating tablet more simply, cost is low, does not need special production equipment.This technology can improve insoluble drug dissolution rate, usually with the good filler of mobility, binding agent and disintegrating agent, and is aided with appropriate lubricant and correctives, can obtains the good oral cavity disintegration tablet of mouthfeel.Existing direct compression technique is prepared in olanzapine orally-disintegrating tablet patent, and its disintegration is all greater than 10 seconds.
CN101904824 discloses " olanzapine orally-disintegrating tablet preparation and preparation method thereof ", select mannitol and lactose use in conjunction as filler, with 35%-74% mannitol and 10%-40% lactose for filler, the microcrystalline Cellulose of 0%-10% is as dry adhesives, the disintegrating agent of 2%-10%, the correctives of 0.1%-6%, the lubricant of 0.4%-3%, its disintegration was at 15 seconds to 45 seconds.
Aforementioned patents disclose olanzapine orally-disintegrating tablet preparation prescription and preparation method thereof, and be with technique of direct powder compression preparation, but it is not optimized screening to dry adhesives and disintegrating agent ratio, disintegration is long, and patient medication compliance is poor.
Summary of the invention
In order to solve the problems of the technologies described above, the invention provides a kind of olanzapine orally-disintegrating tablet and preparation method thereof.
Technical solution of the present invention is as follows: adopt mannitol as filler in prescription, microcrystalline Cellulose as dry adhesives, polyvinylpolypyrrolidone as disintegrating agent, aspartame as correctives, magnesium stearate as lubricant, mixed pressuring plate direct with olanzapine.
The invention provides a kind of olanzapine orally-disintegrating tablet, its disintegration is less than or equal to 10 seconds.With mass ratio range, it comprises following composition:
A) olanzapine of 2% to 15% weight ratio;
B) mannitol of 20% to 78% weight ratio;
C) microcrystalline Cellulose of 10% to 40% weight ratio;
D) polyvinylpolypyrrolidone of 1% to 20% weight ratio;
E) aspartame of 0.2% to 5% weight ratio; With
F) magnesium stearate of 0.3% to 4% weight ratio.
Wherein weight ratio is each component and the ratio of composition total weight.
Preferably, described oral cavity disintegration tablet comprises:
A) olanzapine of 3% to 12% weight ratio;
B) mannitol of 25% to 78% weight ratio;
C) microcrystalline Cellulose of 12% to 35% weight ratio;
D) polyvinylpolypyrrolidone of 3% to 12% weight ratio;
E) aspartame of 0.2% to 2% weight ratio; With
F) magnesium stearate of 0.5% to 3% weight ratio.
Preferred, in described tablet, mannitol accounts for the ratio of tablet total weight amount is 25% to 78%, preferably 30% to 78%.The particle size distribution of described mannitol is preferably 50% particle diameter lower than 100 μm, and 90% particle diameter is lower than 250 μm.
Preferably, in described tablet, microcrystalline Cellulose accounts for the ratio of tablet total weight amount is 12% to 35%, preferably 12% to 32%; Described microcrystalline Cellulose particle size distribution is preferably 50% particle diameter lower than 150 μm, and 90% particle diameter is lower than 250 μm.After adopting such particle diameter can better with other adjuvant particularly mannitol mix homogeneously, thus play better molding effect.And inventor is surprised to find it and affects significantly existence during formulation disintegrates.
Further, in described tablet, polyvinylpolypyrrolidone accounts for the ratio of tablet total weight amount is 3% to 12%, preferably 3% to 9%.Described polyvinylpolypyrrolidone particle size distribution is preferably 50% particle diameter lower than 90 μm, and 90% particle diameter is lower than 150 μm.
Inventor is through the surprised discovery of great many of experiments, when adopting technique of direct powder compression to prepare olanzapine orally-disintegrating tablet, Parteck deltaM is as filler, microcrystalline Cellulose PH102 or Type102 is as dry adhesives, polyvinylpolypyrrolidone XL is as disintegrating agent, both ensured that powder had good mobility and compressibility, ensured again that tablet had very fast disintegration.
The present invention also aims to provide a kind of method preparing described olanzapine orally-disintegrating tablet, it adopts technique of direct powder compression, and concrete steps are as follows:
1) by principal agent olanzapine and aspartame porphyrize respectively, cross 100 mesh sieves, take recipe quantity, by the two mix homogeneously;
2) microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol are crossed 60 mesh sieves respectively, take respectively according to quantity, and join in the hybrid medicine in step 1) in order successively, mixing;
3) to step 2) in gained hybrid medicine in add the magnesium stearate of recipe quantity, sieve, mixing, carries out intermediates content detection, after determining that sheet is heavy, adopts direct compression technology tabletting, to obtain final product.
The present invention adopts mannitol as filler, microcrystalline Cellulose is as dry adhesives, polyvinylpolypyrrolidone is as disintegrating agent, and aspartame is as correctives, and magnesium stearate is as lubricant, by above-mentioned specific preparation prescription, in conjunction with the screening to each component best prescription content, inventor is surprised to find, and it is very fast that Olanzapine Tablets of the present invention effect on the whole shows as disintegration rate, good mouthfeel, the quality of the pharmaceutical preparations is stablized.
Commercially available olanzapine orally-disintegrating tablet is yellow lyophilizing sheet, and its preparation technology adopts lyophilization, the equipment needed for this technology and running cost high, batch limited, the operating time is long, and tablet thickness is about 1mm, bad mechanical strength, can not stand common aluminum plastic pack.The present invention adopts technique of direct powder compression to prepare olanzapine orally-disintegrating tablet, its technical process is simple, and adopt conventional tablet production equipment to produce, cost is low, with short production cycle, mechanical strength is good, and end product quality is stablized, and surprisingly, the conventional tablet that the present invention obtains, thickness is the thickness 3mm of conventional formulation, and but can significantly improve the dissolution rate of property medicine hard to tolerate, disintegration rate is even better than lyophilizing sheet.Preparation method processing step of the present invention is simple, and cost is low, consumes energy low, with short production cycle, is suitable for promotion and application widely.
Detailed description of the invention
In order to the present invention and acquired effect thereof are described better, further illustrate below in conjunction with specific embodiment.But scope of the present invention is not limited to the concrete scheme of embodiment.
Embodiment 1:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Embodiment 2:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Embodiment 3:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Embodiment 4:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Embodiment 5:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Embodiment 6:
Preparation: this dosage form can use conventional tablet pharmaceutical equipment to produce, and with the preparation of direct compression technique, concrete preparation method is as follows: by principal agent olanzapine and aspartame respectively porphyrize cross 100 mesh sieves, take recipe quantity, will both mix homogeneously.Microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol cross 60 mesh sieves respectively, take respectively according to quantity and add successively in above-mentioned hybrid medicine in order and mix, then the magnesium stearate of recipe quantity is added, to sieve mixing, carry out intermediates content detection, determine that sheet adopts direct compression technology tabletting after heavy, to obtain final product.
Experimental example 1, disintegration time mensuration
The test bit of disintegration of each embodiment, friability, tablet hardness, dissolution is as follows:
From the above-mentioned every data recorded: adopt the oral cavity disintegration tablet that the method is obtained, its disintegration is less than 10 seconds, hardness 3-5kg/cm
2, friability is less than 0.5%, 5min dissolution in 0.1N HCL solution and is greater than 90%.
Experimental example 2, to compare with the commercially available thin slice disintegration of tablet time limit
By the present invention and commercially availablely to contrast closest to formulation disintegrates effect, wherein comparative example prescription consists of:
The comparing result of disintegration is as follows:
| Embodiment | Preparation thickness | Disintegration |
| Embodiment 1 | 3mm | 8.6s |
| Embodiment 2 | 3mm | 7.5s |
| Embodiment 3 | 3mm | 5.3s |
| Embodiment 4 | 3mm | 7.2s |
| Embodiment 5 | 3mm | 6.5s |
| Embodiment 6 | 3mm | 7.8s |
| Comparative example | 1mm | 9.2s |
As can be seen from above-mentioned testing result, conventional tablet of the present invention can reach the close even better disintegration rate with sheet preparation.
Experimental example 3, factors influencing:
Olanzapine tablet finished product in embodiment 1 to embodiment 6 is placed in surface plate, investigates under high temperature (60 DEG C) high humidity (relative humidity 92.5%) condition, be specially, respectively sample is placed in 60 DEG C of calorstats,
In the lighting box of relative humidity 92.5% environment and 4500LX, each embodiment influence factor result is as follows:
Experimental example 4, to compare with the CN101904824 formulation disintegrates time limit
Comparative example:
According to the method described by CN101904824, inventors performed contrast test, prescription is as follows:
Preparation: mixing of olanzapine, filler, binding agent, disintegrating agent, correctives being sieved, add lubricant subsequently and always mix, final direct compression obtains olanzapine orally-disintegrating tablet.
Disintegration time mensuration: get this product 6, checks according to the method (Chinese Pharmacopoeia version in 2010 two annex Ⅹ A) under disintegration detection method tablet item, does not leave over the disintegration time of time as this product of block on mesh.
Experimental result: test the tablet of formula preparation gained when hardness is 3-5kg/cm2 according to CN101904824, its disintegration is 28 seconds, and hardness is at 1-3kg/cm
2time, its disintegration is 21 seconds, and friability is greater than 1%.
From above-mentioned experiment, according to olanzapine orally-disintegrating tablet and gained tablet significant difference disintegration of the present invention of CN101904824 gained, and olanzapine orally-disintegrating tablet is applicable to mental patient, and its disintegration rate is faster, absorb faster, therefore products obtained therefrom of the present invention has better curative effect to patient.
Note: in invention formulation prescription, the percent of each component is all weight percentage.
Claims (7)
1. an olanzapine orally-disintegrating tablet, is characterized in that, its disintegration is less than or equal to 10 seconds.
2. an olanzapine orally-disintegrating tablet, is characterized in that, it comprises:
A) olanzapine of 2% to 15% weight ratio;
B) mannitol of 20% to 78% weight ratio;
C) microcrystalline Cellulose of 10% to 40% weight ratio;
D) polyvinylpolypyrrolidone of 1% to 20% weight ratio;
E) aspartame of 0.2% to 5% weight ratio; With
F) magnesium stearate of 0.3% to 4% weight ratio.
3. olanzapine orally-disintegrating tablet according to claim 2, is characterized in that, it comprises:
A) olanzapine of 3% to 12% weight ratio;
B) mannitol of 25% to 78% weight ratio;
C) microcrystalline Cellulose of 12% to 35% weight ratio;
D) polyvinylpolypyrrolidone of 3% to 12% weight ratio;
E) aspartame of 0.2% to 2% weight ratio; With
F) magnesium stearate of 0.5% to 3% weight ratio.
4. olanzapine orally-disintegrating tablet according to claim 2, is characterized in that, the weight ratio of described mannitol is 25% to 78%, and wherein 50% particle diameter is lower than 100 μm, and 90% particle diameter is lower than 250 μm.
5. olanzapine orally-disintegrating tablet according to claim 2, is characterized in that, the weight ratio of described microcrystalline Cellulose is 12% to 35%, and wherein 50% particle diameter is lower than 150 μm, and 90% particle diameter is lower than 250 μm.
6. olanzapine orally-disintegrating tablet according to claim 2, is characterized in that, the weight ratio of described polyvinylpolypyrrolidone is 3% to 12%, and wherein 50% particle diameter is lower than 90 μm, and 90% particle diameter is lower than 150 μm.
7. prepare a method for the olanzapine orally-disintegrating tablet according to any one of claim 1-6, it is characterized in that, it adopts technique of direct powder compression, and concrete steps are:
1) by principal agent olanzapine and aspartame porphyrize respectively, cross 100 mesh sieves, take recipe quantity, by the two mix homogeneously;
2) microcrystalline Cellulose, polyvinylpolypyrrolidone and mannitol are crossed 60 mesh sieves respectively, take respectively according to quantity, and join in the hybrid medicine in step 1) in order successively, mixing;
3) to step 2) in gained hybrid medicine in add the magnesium stearate of recipe quantity, sieve, mixing, carries out intermediates content detection, after determining that sheet is heavy, adopts direct compression technology tabletting, to obtain final product.
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Cited By (5)
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| 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 |
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| CN113730365A (en) * | 2021-08-10 | 2021-12-03 | 杭州新诺华医药有限公司 | Olanzapine orally disintegrating tablet and preparation method thereof |
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| CN104510717B (en) | 2019-02-05 |
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