Olanzapine orally disintegrating tablet and preparation process thereof

A technology for olanzapine and orally disintegrating tablets, applied in the field of olanzapine orally disintegrating tablets and their preparation, can solve the problems of content uniformity, poor absorption and stability, poor taste, slow dissolution, etc., and achieve the advantages of absorption and stability , good absorption and stability, moderate sweetness

Pending Publication Date: 2020-07-17
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The tablet prescription disclosed in patent CN104510717 is 2% to 15% by weight of olanzapine, 20% to 78% by weight of mannitol, 10% to 40% by weight of microcrystalline cellulose, 1% to 20% by weight Crospovidone, 0.2% to 5% by weight of aspartame, 0.3% to 4% by weight of magnesium stearate, the process is direct compression technology, and the filler in the prescription is mannitol, During scale-up production, too much mannitol in the prescription may easily lead to sticking and punching during tablet compression, resulting in poor tablet formability
[0006] The tablet provided by the patent CN106265559 is olanzapine granule which is obtained by granulating the water dispersion system of olanzapine, mannitol, crospovidone and polyvinyl acetate. The preparation method disclosed in this patent adopts the spray drying method. More cumbersome, high production cost, low production efficiency
[0007] The orally disintegrating tablet prepared by the above patent has a gritty feeling, poor taste, slow dissolution, and poor content uniformity, absorption and stability

Method used

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  • Olanzapine orally disintegrating tablet and preparation process thereof
  • Olanzapine orally disintegrating tablet and preparation process thereof
  • Olanzapine orally disintegrating tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] A kind of olanzapine orally disintegrating tablet, it comprises following composition:

[0054]

[0055] Specifically select the above composition, wherein a preparation method of orally disintegrating tablet is as follows:

[0056] (1) Pass 30.5 parts by weight of sorbitol and 0.5 parts by weight of sucralose through a 60-mesh sieve in advance, mix with 0.5 parts by weight of micropowdered silica gel, and granulate;

[0057] (2) add the olanzapine of 5.0 weight parts, the anhydrous lactose of 15.3 weight parts, the cross-linked polyvidone of 10.1 weight parts and cross 80 mesh sieves, mix with the cross-linked sodium carboxymethyl cellulose of 1.5 weight parts, Whole grain;

[0058] (3) Add 3 parts by weight of magnesium stearate to the mixture obtained in step (1) and step (2) for total mixing, and detect the particle content;

[0059] (4) The mixed material is directly compressed into tablets.

Embodiment 2

[0061] A kind of olanzapine orally disintegrating tablet, it comprises following composition:

[0062]

[0063] Specifically select the above composition, wherein a preparation method of orally disintegrating tablet is as follows:

[0064] (1) 20.7 parts by weight of mannitol and 1.2 parts by weight of aspartame are passed through a 60-mesh sieve, mixed with 1.2 parts by weight of silicon dioxide, and granulated;

[0065] (2) add the olanzapine of 15.5 weight parts, the cornstarch of 20.2 weight parts, the crospovidone of 15.4 weight parts and cross 80 mesh sieves, mix with the croscarmellose sodium of 3.1 weight parts, and complete grain;

[0066] (3) Add 2 parts by weight of magnesium stearate to the mixture obtained in step (2) for total mixing, and detect the particle content;

[0067] (4) The mixed material is directly compressed into tablets.

Embodiment 3

[0069] A kind of olanzapine orally disintegrating tablet, it comprises following composition:

[0070]

[0071] Specifically select the above composition, wherein a preparation method of orally disintegrating tablet is as follows:

[0072] (1) 28.5 parts by weight of mannitol and 0.5 parts by weight of aspartame are passed through a 60-mesh sieve, mixed with 1.0 parts by weight of micropowder silica gel, and granulated;

[0073] (2) add the olanzapine of 5.0 weight parts, the anhydrous lactose of 11.5 weight parts, the cross-linked povidone of 8.5 weight parts and cross 80 mesh sieves, mix with the cross-linked sodium carboxymethyl cellulose of 3.0 weight parts, Whole grain;

[0074] (3) Add 1 part by weight of magnesium stearate to the mixture obtained in step (2) for total blending, and detect the particle content;

[0075] (4) The mixed material is directly compressed into tablets.

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Abstract

The invention relates to the field of pharmaceutical preparations, and in particular to an olanzapine orally disintegrating tablet for treating schizophrenia and psychosis with severe positive symptoms and / or negative symptoms and a preparation process thereof. The orally disintegrating tablet mainly comprises olanzapine, a filling agent, a disintegrating agent, a flavoring agent, a glidant, a lubricant and the like. Through regulating and controlling of components of the orally disintegrating tablet and a preparation process of the tablet, the defect of gravel feeling of the existing orally disintegrating tablet is eliminated. According to the preparation process provided by the invention, the layering phenomenon of medicines in a powder direct pressing preparation process is improved; and the prepared orally disintegrating tablet has the advantages of excellent mouthfeel, moderate sweetness, rapid disintegration, and good content uniformity, absorption and stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to olanzapine orally disintegrating tablets and a preparation method thereof. Background technique [0002] Olanzapine orally disintegrating tablets are suitable for the acute and maintenance treatment of schizophrenia and other psychosis with severe positive and / or negative symptoms, and can also alleviate the secondary affective symptoms of schizophrenia and related diseases. [0003] As a new type of pharmaceutical preparation, orally disintegrating tablets are very suitable for some special patients because they can quickly disintegrate into numerous particles on the tongue and taste sweet, and they disintegrate quickly and absorb quickly, and do not need to drink water after taking the medicine. (Mental illness, Alzheimer's disease, epilepsy patients, etc.) and the elderly and children. Tablet mouthfeel is therefore very important for clinical compliance. [0004] T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/32A61K47/38A61K47/04A61K47/12A61K47/36A61K47/18A61K31/551A61P25/18
CPCA61K9/0056A61K9/2018A61K9/2027A61K9/2054A61K9/2013A61K9/2009A61K9/2059A61K31/551A61P25/18
Inventor 牛秀梅唐亚芳陈中亚周炳城
Owner JIANGSU HANSOH PHARMA CO LTD
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