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Olanzapine gastric soluble tablets and preparation method thereof

A stomach-dissolving, olanzapine technology, which is applied in the directions of pill delivery, pharmaceutical formulations, and inactive medical preparations, can solve the problems of unstable quality of finished products, numerous production steps, and many material losses, and achieves low cost. , The effect of short production cycle and stable quality of finished products

Active Publication Date: 2013-06-12
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When wet granulation is used to prepare olanzapine stomach-soluble tablets, there are many production steps, high energy consumption, high material loss, long production cycle, and the introduction of water during the production process, resulting in unstable quality of the finished product during long-term storage

Method used

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  • Olanzapine gastric soluble tablets and preparation method thereof
  • Olanzapine gastric soluble tablets and preparation method thereof
  • Olanzapine gastric soluble tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033] Preparation: The dosage form can be produced by conventional tablet pharmaceutical equipment, and prepared by direct tableting process. The specific preparation method is as follows: grind the main drug olanzapine and silicon dioxide separately, pass through a 100-mesh sieve, weigh the prescription amount, and The two are mixed evenly. Microcrystalline cellulose and mannitol were respectively passed through a 60-mesh sieve, weighed according to the amount, and added to the above-mentioned mixed medicine in sequence and mixed evenly, then added the prescribed amount of magnesium stearate, sieved and mixed evenly, and carried out intermediate Body content detection, after determining the weight of the tablet, use the direct compression technology to compress the tablet, that is to say. The obtained tablet core is coated with Opadry Y-1-7000 alcohol solution, and the weight gain of the coating is 2% to 4%.

Embodiment 2

[0035] Obtain the tablet that is particularly suitable for each tablet that contains 1,2.5,5,7.5,10mg olanzapine respectively with following component weight and the method that embodiment 1 is substantially identical:

[0036] 1 mg olanzapine per tablet

[0037] ingredient name

[0038] 2.5 mg olanzapine per tablet

[0039] ingredient name

[0040] 5 mg olanzapine per tablet

[0041] ingredient name

[0042] Olanzapine

[0043] 7.5mg olanzapine per tablet

[0044] ingredient name

[0045] 10 mg olanzapine per tablet

[0046] ingredient name

[0047] Get the olanzapine tablet finished product of every 5mg specification in embodiment 2, and the dissolution rate in 0.1N HCL solution is 97% in 10min.

experiment example 1

[0048] Experimental example 1 Influencing factors investigation

[0049] The finished olanzapine tablets of each 5mg specification in Example 2 were placed in a watch glass, and investigated under high temperature (60°C) and high humidity (RH92.5%) conditions. Specifically, the samples were placed in 60 ℃ incubator, RH92.5% environment and 4500LX light box, the final experimental results are as follows:

[0050]

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PUM

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Abstract

The invention relates to olanzapine gastric soluble tablets and a preparation method thereof. Particularly, the olanzapine gastric soluble tablets comprise the following components in percentage by weight: 2 to 15 percent of olanzapine, 40 to 82 percent of mannitol, 5 to 30 percent of microcrystalline cellulose, 0.5 to 2 percent of silicon dioxide, and 0.5 to 3 percent of magnesium stearate. The olanzapine gastric soluble tablets have the overall effects of quick dissolubility and stable preparation quality, and do not have the remarkable moisture absorption phenomenon when being placed in the air for a long time. The preparation method is simple in process steps, low in cost and energy consumption and short in production cycle, and thus is suitable for wide popularization and application.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an olanzapine stomach-soluble tablet and a preparation method thereof. Background technique [0002] Olanzapine is suitable for the acute and maintenance treatment of schizophrenia and other psychosis with severe positive and / or negative symptoms, and can also relieve the secondary affective symptoms of schizophrenia and related diseases. As a new type of antipsychotic drug, this product has the advantages of good long-term curative effect and less side effects, and has been highly recognized by clinicians. Olanzapine is relatively sensitive to humidity during storage. Olanzapine stomach-dissolving tablets currently on the market are mostly wet granulated. CN1179102A discloses "Olanzapine Oral Preparation", using about 1% to about 3% w / w olanzapine as the main drug, about 69.5% to about 87.5% w / w lactose as a filler, and 3.5% to about 4.5% w / w hydroxypropyl cellulose...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K31/5513A61K47/38A61K47/26A61P25/18
Inventor 张孟刘灵犀危军
Owner JIANGSU HANSOH PHARMA CO LTD
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