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Preparation method of olanzapine orally disintegrating tablet for treating depression

A technology of orally disintegrating tablets and olanzapine, which is applied in the field of preparation of orally disintegrating tablets of olanzapine, can solve problems such as inability to play a role for patients, achieve low content of related substances, increase disintegration speed, and improve stability Effect

Inactive Publication Date: 2015-04-22
刘新刚 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, bulky dosage forms such as tablets and capsules are often not effective in these patients, and easy-to-use dosage forms should be considered in patients with schizophrenia

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Step 2: Dissolve 2Kg of adhesive (povidone) in 20Kg of water; add 5Kg of olanzapine, 3Kg of phospholipid (dipalmitoylphosphatidylcholine) and 10Kg of filler (pregelatinized starch) into the fluidized bed In the process, the binder solution is sprayed into the fluidized bed with a spray gun for granulation, the temperature in the fluidized bed is 50°C, and the drying is carried out after the granulation is completed, and the drying temperature is 60°C;

[0024] The 3rd step, carry out the granule after drying with disintegrant (sodium carboxymethyl starch) 2Kg, corrective agent (mannitol) 0.5Kg, lubricant (magnesium stearate) 0.4Kg, mannitol 30Kg, lactose 5Kg carry out Mix and then compress into tablets.

[0025] Example 2

Embodiment 2

[0027] Step 2: Dissolve 10Kg of binder (povidone) in 40Kg of water; add 15Kg of olanzapine, 15Kg of phospholipid (dipalmitoylphosphatidylcholine) and 15Kg of filler (pregelatinized starch) into the fluidized bed In the process, use a spray gun to spray the binder solution into the fluidized bed for granulation. The temperature in the fluidized bed is 60°C, and then dry after the granulation is completed, and the drying temperature is 70°C;

[0028] The 3rd step, granule after drying is mixed with disintegrant (sodium carboxymethyl starch) 10Kg, correctives (mannitol) 4Kg, lubricant (magnesium stearate) 3Kg, mannitol 40Kg, lactose 15Kg, And then press tablet, you can.

[0029] Example 3

Embodiment 3

[0031] Step 2: Dissolve 5Kg of adhesive (povidone) in 30Kg of water; add 12Kg of olanzapine, 12Kg of phospholipid (dipalmitoylphosphatidylcholine) and 11Kg of filler (pregelatinized starch) into the fluidized bed In the process, spray the binder solution into the fluidized bed with a spray gun for granulation. The temperature in the fluidized bed is 55°C, and then dry after granulation, and the drying temperature is 65°C;

[0032] The 3rd step, granule after drying is mixed with disintegrant (sodium carboxymethyl starch) 8Kg, correctives (mannitol) 3Kg, lubricant (magnesium stearate) 2Kg, mannitol 35Kg, lactose 12Kg, And then press tablet, you can.

[0033] Comparative example 1

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Abstract

The invention discloses a preparation method of an olanzapine orally disintegrating tablet for treating depression and belongs to the field of pharmaceutical preparations. The preparation method of the olanzapine orally disintegrating tablet for treating depression comprises the following steps: smashing a binding agent, olanzapine, phospholipids, a disintegrating agent, a flavouring agent, a lubricating agent, mannitol and lactose, and sieving; dissolving the binding agent into water; then adding olanzapine, phospholipids and a filing agent into a fluidized bed, spraying binding agent solution into the fluidized bed for pelletizing, and drying after pelletizing is finished; and mixing the dried particles with the disinterring agent, the flavouring agent, the lubricating agent, mannitol and lactose, and then tabletting, thus obtaining the olanzapine orally disintegrating tablet. The preparation method of the olanzapine orally disintegrating tablet for treating depression has the advantages that olanzapine, phospholipids and the filling agent are coated by the binding agent in advance and then are mixed with other auxiliary materials, and tabletting is carried out, and thus disintegrating rate and breakage rate of the orally disintegrating tablet are effectively increased, stability of the tablet after long-term storage is well improved, and content of related substances is low.

Description

technical field [0001] The invention discloses a preparation method of olanzapine orally disintegrating tablets for treating depression, and belongs to the field of pharmaceutical preparations. Background technique [0002] Depression is a common mental illness characterized by pessimism, hopelessness, irritability, changes in eating habits, insomnia, decreased interest or distraction, suicidal thoughts, resistance to performing social responsibilities, extreme fatigue, unresponsiveness or Sensitive etc. [0003] Olanzapine, also known as Zyprexa and Olazapine, is the most commonly used atypical antipsychotic drug for the treatment of schizophrenia, and it is also the most expensive of the atypical antipsychotic drugs. The effect is worthy of recognition. [0004] In the acute phase of schizophrenic patients and the manic phase of bipolar disorder, patients often refuse to take medicine. Tibetan medicine and vomiting medicine in the mouth are the most common, and medicat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5513A61P25/24
CPCA61K9/0056A61K9/2013A61K9/2018A61K9/2095A61K31/551
Inventor 刘平
Owner 刘新刚
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