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A kind of rasagiline tablet and preparation method thereof

A technology of rasagiline tablets and tablets, which is applied in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve problems such as high production costs and complicated prescription processes, and achieve improved dissolution rates and lower prices. Effect of low cost and good dissolution properties

Active Publication Date: 2021-02-19
CHANGZHOU NO 4 PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, among the various prior art solutions disclosed, some have complex prescription processes, some have higher requirements on equipment, and some have strict process control, which all lead to higher production costs, so it is necessary to further improve the prescription process of this product , making it more suitable for industrialized mass production

Method used

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  • A kind of rasagiline tablet and preparation method thereof
  • A kind of rasagiline tablet and preparation method thereof
  • A kind of rasagiline tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The ingredients listed in Table 1 were used to prepare rasagiline mesylate tablets (1 mg / tablet), with a tablet weight of 100 mg.

[0035] Table 1:

[0036] Element Amount for one tablet (mg) Amount for one tablet (weight %) Rasagiline mesylate 1.56 1.56 microcrystalline cellulose 68.44 68.44 lactose 25 25 Sodium carboxymethyl starch 5 5 5% polyethylene glycol 6000 in water Appropriate amount ------ total 100 100

[0037] Preparation Process:

[0038] Mix rasagiline mesylate, microcrystalline cellulose and lactose evenly, add an appropriate amount of 5% polyethylene glycol 6000 aqueous solution for wet granulation, dry the wet granules in an oven at 60°C for about 2 hours, and then pass through a 20-mesh Sieve the granules, add sodium carboxymethyl starch and mix evenly, and finally compress the granules into tablets.

Embodiment 2

[0053] The ingredients listed in Table 4 were used to prepare rasagiline mesylate tablets (1 mg / tablet), with a tablet weight of 100 mg.

[0054] Table 4:

[0055]

[0056]

[0057] Preparation Process:

[0058] Mix rasagiline mesylate, microcrystalline cellulose and starch evenly, add an appropriate amount of 5% polyethylene glycol 4000 aqueous solution for wet granulation, dry the wet granules in an oven at 60°C for about 2 hours, and then pass through a 20-mesh Sieve the granules, add croscarmellose sodium and mix evenly, and finally compress the granules into tablets.

Embodiment 3

[0060] The ingredients listed in Table 5 were used to prepare rasagiline mesylate tablets (1 mg / tablet), with a tablet weight of 100 mg.

[0061] table 5:

[0062] Element Amount for one tablet (mg) Amount for one tablet (weight %) Rasagiline mesylate 1.56 1.56 Mannitol 67.44 67.44 lactose 25 25 Sodium carboxymethyl starch 5 5 5% polyethylene glycol 6000 in water Appropriate amount ------ total 100 100

[0063] Preparation Process:

[0064] Mix rasagiline mesylate, mannitol and lactose evenly, add an appropriate amount of 5% polyethylene glycol 6000 aqueous solution for wet granulation, dry the wet granules in an oven at 60°C for about 2 hours, and then pass through a 20-mesh sieve Granules, add sodium carboxymethyl starch and mix evenly, and finally compress the granules into tablets.

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PUM

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Abstract

The invention relates to a rasagiline tablet and a preparation method thereof. The rasagiline tablet of the present invention contains a pharmaceutically acceptable salt of rasagiline and pharmaceutically acceptable auxiliary materials, and the auxiliary materials include fillers and disintegrating agents. The tablet is obtained by using 0.1%-30% (mass concentration) polyethylene glycol aqueous solution as slurry to perform wet granulation and tablet compression. The particles prepared by the present invention have better fluidity and compressibility; the obtained product has better dissolution characteristics and better long-term stability, especially significantly reduces the concentration of the genotoxic impurity 2-Cl-AAI and the present invention has simple prescription, simple and convenient preparation process, low production cost, no need of special equipment, and is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and specifically designs a rasagiline tablet and a preparation method thereof. Background technique [0002] Parkinson's disease (PD), also known as Parkinson's disease, is the second most common neurodegenerative disease after Alzheimer's disease. The lesion is located in a part of the human brain called the midbrain. The substantia nigra neurons in this area synthesize a neurotransmitter called "dopamine", and its nerve fibers project to other areas of the brain, such as the striatum, to regulate the motor function of the brain. When the neurons in the substantia nigra of the midbrain degenerate and die to more than 80%, the neurotransmitter dopamine in the brain is reduced to the point that it cannot maintain the normal function of regulating the nervous system, and the symptoms of Parkinson's disease appear. The etiology of Parkinson's disease may involve aging, genetic and environ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/135A61K47/10A61P25/16
CPCA61K9/2031A61K9/2095A61K31/135
Inventor 王菊香周达祁琪严益民屠永锐孙永强曹月华冯晓晖
Owner CHANGZHOU NO 4 PHARMA FACTORY