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Olanzapine orally disintegrating tablets and preparation method thereof

A technology of oral disintegrating tablets and olanzapine, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. problem, to achieve the effect of good tablet formability, good friability and low production cost

Active Publication Date: 2017-01-04
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the disintegration time is improved, due to the microcrystalline cellulose contained in the prescription, there will be residues on the tongue surface, a gritty feeling in the mouth, and poor human body compliance; and the tablet formability is poor

Method used

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  • Olanzapine orally disintegrating tablets and preparation method thereof
  • Olanzapine orally disintegrating tablets and preparation method thereof
  • Olanzapine orally disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053]

[0054]Preparation: Dissolve polyvinyl acetate and povidone K30 in 15ml of purified water and stir for 5 minutes; add olanzapine and crospovidone to the above solution and stir evenly; put mannitol into a pellet coating machine, and add the above-mentioned Spray the drug solution onto the surface of mannitol, atomize and dry to obtain olanzapine granules; centrally control the content of olanzapine granules; pass low-substituted hydroxypropyl cellulose LH-11 through a 30-40 mesh sieve, weigh and add olanzapine Mix in the granules; add the prescribed amount of magnesium stearate to the above granules and mix evenly; compress orally disintegrating tablets of olanzapine with different specifications according to the content of olanzapine in the middle control.

[0055] Obtain the orally disintegrating tablet that is especially suitable for medicinal olanzapine with the method that following composition weight is substantially the same as embodiment 1:

Embodiment 2

[0057]

[0058] Preparation: Dissolve polyvinyl acetate and povidone K30 in 20ml of purified water and stir for 5 minutes; add olanzapine and crospovidone to the above solution and stir evenly; put mannitol into a pellet coating machine, and mix the above-mentioned Spray the drug solution onto the surface of mannitol, atomize and dry to obtain olanzapine granules; centrally control the content of olanzapine granules; pass low-substituted hydroxypropyl cellulose LH-11 through a 30-40 mesh sieve, weigh and add olanzapine granules Mix in the granules of Olanzapine; Add the prescribed amount of magnesium stearate to the granules and mix evenly; According to the controlled content of Olanzapine, compress Olanzapine orally disintegrating tablets of different specifications.

Embodiment 3

[0060]

[0061] Preparation: dissolve polyvinyl acetate and povidone K90 in 7ml of purified water and stir for 5 minutes; add olanzapine and crospovidone to the above solution and stir evenly; put mannitol into a pellet coating machine, and mix the above-mentioned The drug solution is sprayed onto the surface of mannitol, atomized and dried to obtain olanzapine granules; the content of olanzapine granules is controlled in the middle; aspartame is passed through a sieve of 80-100 mesh, and croscarmellose sodium is passed through a 30-mesh sieve 40-mesh sieve, weighed and added to the olanzapine granules and mixed evenly; added the prescribed amount of sodium stearate fumarate to the above-mentioned granules and mixed evenly; according to the content of olanzapine in the middle control, pressed different specifications of olanzapine Orally disintegrating tablet.

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Abstract

The invention relates to olanzapine orally disintegrating tablets and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The novel pharmaceutical composition is prepared from olanzapine granules and an additive, wherein the olanzapine granules are prepared from olanzapine, mannitol, crospovidone and a water disperse system of polyvinyl acetate through granulation. The invention further relates to the olanzapine granules and the preparation method of the olanzapine orally disintegrating tablets.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a novel olanzapine orally disintegrating tablet and a preparation method thereof. Background technique [0002] Olanzapine is an antipsychotic with pharmacological effects on multiple receptor systems. Developed by Eli Lilly Company It was approved by the FDA in 2000, and its import application was approved by the CFDA in 2009. It is used for the treatment of acute and maintenance periods of schizophrenia and other psychosis with severe positive symptoms and / or negative symptoms, and can also relieve schizophrenia and related diseases. Secondary affective symptoms of illness. [0003] As a new type of antipsychotic drug, olanzapine has the advantages of good long-term curative effect and small side effects, and has been highly recognized by clinicians. At present, the dosage forms listed abroad include ordinary tablets, orally disintegrating tablets, intramuscular i...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/5513A61K47/26A61K47/32A61P25/18
CPCA61K9/0056A61K9/2018A61K9/2027A61K31/5513
Inventor 董礼袁恒立王小雷孙运栋郝好华
Owner JIANGSU HANSOH PHARMA CO LTD
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