Pimavanserin tablet and preparation method thereof

A technology of pimavanserin and tablets, which is applied in the field of pharmaceutical preparations and can solve the problems of poor stability of common preparations

Inactive Publication Date: 2019-04-05
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the study, it was found that the common preparation of pimavanserin was less stable, and the dissolution rate gradually decreased during the storage of the preparation. Therefore, a more stable pharmaceutical preparation of the compound was required

Method used

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  • Pimavanserin tablet and preparation method thereof
  • Pimavanserin tablet and preparation method thereof
  • Pimavanserin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Prescription composition:

[0019]

[0020] Preparation Process:

[0021] Pass pimavanserin and all auxiliary materials through 80-mesh sieve respectively for later use; weigh the colloidal silicon dioxide, polyethylene glycol and the main drug in the prescribed amount and add them to the granulation pot, and stir at a stirring speed of 500r / min, Dry mix for 5 minutes at a shear speed of 1000r / min; then add pregelatinized starch, microcrystalline cellulose and sodium starch glycolate and mix well; slowly add 15% hydroxypropyl cellulose aqueous solution to make a soft material; granulate with a 24-mesh sieve , dried at 55°C for 1 hour, sieved with a 24-mesh sieve, weighed and mixed with the prescribed amount of magnesium stearate, and pressed into tablets.

Embodiment 2

[0023] Prescription composition:

[0024]

[0025] Preparation Process:

[0026] Pass pimavanserin and all auxiliary materials through 80-mesh sieve respectively for later use; weigh the colloidal silicon dioxide, polyethylene glycol and the main drug in the prescribed amount and add them to the granulation pot, and stir at a stirring speed of 500r / min, Dry mix for 5 minutes at a shear speed of 1000r / min; then add pregelatinized starch, microcrystalline cellulose and sodium starch glycolate and mix well; slowly add 10% hydroxypropyl cellulose aqueous solution to make a soft material; granulate with a 24-mesh sieve , dried at 55°C for 1 hour, sieved with a 24-mesh sieve, weighed and mixed with the prescribed amount of magnesium stearate, and pressed into tablets.

Embodiment 3

[0028] Prescription composition:

[0029]

[0030] Preparation Process:

[0031] Pass pimavanserin and all auxiliary materials through 80-mesh sieve respectively for later use; weigh the colloidal silicon dioxide, polyethylene glycol and the main drug in the prescribed amount and add them to the granulation pot, and stir at a stirring speed of 500r / min, Dry mix for 5 minutes at a shear speed of 1000r / min; then add pregelatinized starch, microcrystalline cellulose and sodium starch glycolate and mix well; slowly add 5% hydroxypropyl cellulose aqueous solution to make a soft material; granulate with a 24-mesh sieve , dried at 55°C for 1 hour, sieved with a 24-mesh sieve, weighed and mixed with the prescribed amount of magnesium stearate, and pressed into tablets.

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PUM

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Abstract

The invention belongs to the field of pharmaceutic preparation, and particularly relates to a pimavanserin tablet and a preparation method thereof. The pimavanserin tablet is composed of active components of pimavanserin, colloidal silicon dioxide, polyethylene glycol, a filling agent selected from dextrin, corn starch, pregelatinized starch, cellulose microciystalline, mannitol and lactose, a disintegrating agent selected from carboxymethyl starch sodium, croscarmellose sodium, low-substituted hydroxypropyl cellulose and crospovidone, and a lubricating agent selected from magnesium stearate,talcum powder, and sodium stearyl fumarate. The pimavanserin tablet has good stability, and can significantly improve drug dissolution and bioavailability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to pimavanserin tablets and a preparation method thereof. Background technique [0002] At present, there are about 7 million to 10 million Parkinson's disease patients in the world, and China has 2.6 million people, ranking first in the world, and there will be an increase of 100,000 new patients every year. More than 50% of patients with Parkinson's disease have had psychotic symptoms (PDP). These psychiatric symptoms mainly manifest as hallucinations and delusions, which bring greater challenges to the treatment and care of patients with Parkinson's disease. Dopamine is the main target of Parkinson's disease treatment. Since most antipsychotic drugs block dopamine in the brain and lead to worsening of motor dysfunction in Parkinson's patients, they are currently not suitable for such patients. [0003] Pimavanserin (Pimavanserin), chemical name, 1-(4-fluorob...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4468A61K47/10A61K47/04A61P25/16
CPCA61K9/2009A61K9/2031A61K31/4468
Inventor 李春王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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