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Orally disintegrating tablet containing penfluridol and preparation method of orally disintegrating tablet

A technology of orally disintegrating tablets and penfluridol, which is applied in the field of pharmaceutical preparations, can solve the problems of poor drug compliance of patients, poor drug compliance of patients, and high requirements for production equipment, and achieve improved insoluble properties, rapid onset of action, and enhanced dissolution sexual effect

Inactive Publication Date: 2017-06-23
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Patent CN 104546784 A discloses a penfluridol tablet composition and its preparation method. The disintegration time limit of the coated tablet prepared by the composition disclosed in this document is about 16 minutes, and the patient’s medication compliance is poor.
Patent CN 101732311 A discloses an oral preparation containing penfluridol. The dosage forms included in the literature include capsules and granules, and the drug compliance of patients is also poor
Patent CN 104586780 A discloses a penfluridol oral freeze-dried tablet and its preparation method. The freeze-dried tablet described in the literature has reached the disintegration time limit of orally disintegrating tablets, but requires high production equipment and complicated technology

Method used

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  • Orally disintegrating tablet containing penfluridol and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing penfluridol and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing penfluridol and preparation method of orally disintegrating tablet

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Experimental program
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Effect test

Embodiment 1

[0024]

[0025] Preparation Process:

[0026] (1) Penfluridol and mannitol are co-micronized in proportion;

[0027] (2) Penfluridol, mannitol, microcrystalline cellulose, and sodium carboxymethyl starch are mixed uniformly in a mixer;

[0028] (3) Add 4% hydroxypropyl cellulose aqueous solution to the above mixture to make wet soft material, and granulate;

[0029] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0030] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

Embodiment 2

[0032]

[0033] Preparation Process:

[0034] (1) Penfluridol and mannitol are co-micronized in proportion;

[0035] (2) Penfluridol, mannitol, microcrystalline cellulose, and sodium carboxymethyl starch are mixed uniformly in a mixer;

[0036] (3) Add 4% hydroxypropyl cellulose aqueous solution to the above mixture to make wet soft material, and granulate;

[0037] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0038] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

Embodiment 3

[0040]

[0041] Preparation Process:

[0042] (1) Penfluridol and mannitol are co-micronized in proportion;

[0043] (2) Penfluridol, mannitol, microcrystalline cellulose, and sodium carboxymethyl starch are mixed uniformly in a mixer;

[0044] (3) Add 4% hydroxypropyl cellulose aqueous solution to the above mixture to make wet soft material, and granulate;

[0045] (4) The above-mentioned granules are dried until the water content is less than 3%. After the granules are sized, the dosages of magnesium stearate, peppermint essence and aspartame are converted and mixed evenly with the dried granules;

[0046] (5) Measure the particle content after total blending, convert the tablet weight, and control the hardness to 3-5kgf for tableting. Prepared in 1000 tablets.

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Abstract

The invention relates to an orally disintegrating tablet containing penfluridol and a preparation method of the orally disintegrating tablet, belonging to the technical field of medicines. The orally disintegrating tablet contains penfluridol, a hydrophilic filler, a water-soluble adhesive, a disintegrating agent, a lubricant, a corrigent and the like, the preparation process is simple, the taking is convenient, the effects are rapid, the time for reaching the peak is short, and the curative effects are obvious.

Description

technical field [0001] The invention relates to a rapidly disintegrating orally disintegrating tablet whose active ingredient is penfluridol and a method for producing the dosage form, belonging to the field of pharmaceutical preparations. Background technique [0002] The main manifestations of schizophrenia are mania, paranoia, depression, fear and anxiety, auditory hallucinations, sensitivity and suspicion, obsessive-compulsive impatience, disordered thinking, nonsense, throwing things, impulsive injury, and inability to control oneself. During the illness, the patient may have an unfounded erroneous idea, suspecting that someone is going to harm him, and other illusory perceptions, so that he finally commits suicide in pessimism and despair, causing great harm to the family and society. There is no single cause of schizophrenia, and possible contributing factors include genes (inheritance), imbalanced chemical balance, and complications during pregnancy and childbirth. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/451A61K47/26A61K47/36A61P25/18A61P25/24
CPCA61K9/2018A61K9/0056A61K9/2059A61K31/451
Inventor 易崇勤王海超冀蕾
Owner PEKING UNIV FOUNDER GRP CO LTD
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