Method for preparing pregabalin orally disintegrating tablet

A technology of pregabalin and orally disintegrating tablets, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problem of failure to meet the requirements of powder direct compression or dry granulation Problems such as pressure and poor fluidity

Inactive Publication Date: 2020-05-05
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(2) The raw material of pregabalin is crystalline powder particles with poor compressibility and fluidity, which cannot meet the requirements of conventional powder direct compression or dry granulation

Method used

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  • Method for preparing pregabalin orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] components Weight percentage (%) Pregabalin 10.00 Spray Dried Mannitol 100SD 50.00 Silicified Microcrystalline Cellulose 50 30.00 Sodium carboxymethyl starch 8.00 aspartame 1.000 Magnesium stearate 1.000

[0015] Preparation Process:

[0016] (1) Mix pregabalin and silicified microcrystalline cellulose 50 through a 60-mesh sieve for 3 times, and use it as premix 1 for later use;

[0017] (2) Mix premix 1 with the prescribed amount of spray-dried mannitol, sodium carboxymethyl starch, and aspartame through a 60-mesh sieve for 3 times, mix well, and use it as premix 2 for later use;

[0018] (3) Mix the premix 2 with magnesium stearate evenly, and press it into tablets.

Embodiment 2

[0020] components Weight percentage (%) Pregabalin 10.00 Spray Dried Mannitol 100SD 54.00 Silicified Microcrystalline Cellulose 90 30.00 Croscarmellose Sodium 4.00 aspartame 1.000 Magnesium stearate 1.000

[0021] Preparation Process:

[0022] (1) Mix pregabalin and silicified microcrystalline cellulose 90 through a 60-mesh sieve for 3 times, and use it as premix 1 for later use;

[0023] (2) Mix premix 1 with the prescribed amount of spray-dried mannitol 100SD, croscarmellose sodium, and aspartame through a 60-mesh sieve for 3 times, mix well, and use it as premix 2 for later use;

[0024] (3) Mix the premix 2 with magnesium stearate evenly, and press it into tablets.

Embodiment 3

[0026] components Weight percentage (%) Pregabalin 10.00 Spray Dried Mannitol 200SD 50.00 Silicified Microcrystalline Cellulose 90 15.00 Silicified Microcrystalline Cellulose 50 15.00 Sodium carboxymethyl starch 8.00 aspartame 1.000 Magnesium stearate 1.000

[0027] Preparation Process:

[0028] (1) Mix pregabalin and silicified microcrystalline cellulose 50 through a 60-mesh sieve for 3 times in equal increments, and use it as premix 1 for later use;

[0029] (2) Mix premix 1 and silicified microcrystalline cellulose 90 through a 60-mesh sieve for 3 times, and use it as premix 2 for later use;

[0030] (3) Mix premix 2 with the prescribed amount of spray-dried mannitol 200SD, sodium carboxymethyl starch, and aspartame through a 60-mesh sieve for 3 times, mix well, and use it as premix 3 for later use;

[0031] (4) Mix preblend 3 with magnesium stearate evenly, and press it into tablets.

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Abstract

The invention provides a pregabalin orally disintegrating tablet by adopting direct powder compression on silicified microcrystalline cellulose and a preparation method thereof. According to the method, pregabalin and silicified microcrystalline cellulose are premixed, the premix is uniformly mixed with other auxiliaries, and the orally disintegrating tablet is prepared by adopting the direct powder compression process. The method can remarkably improve the stability and compressibility of pregabalin and can improve the medication compliance of a patient.

Description

technical field [0001] The application belongs to the technical field of medicine, and in particular relates to a preparation method of an orally disintegrating tablet containing pregabalin. Background technique [0002] Pregabalin is a novel gamma-aminobutyric acid (GABA) receptor agonist with the molecular formula C 8 h 17 NO 2 , with a molecular weight of 159.23, is a white crystalline powder that is easily soluble in water, alkaline and acidic aqueous solutions. Pregabalin in this patent application refers specifically to S-pregabalin. Pregabalin was successfully developed by Pfizer. It is mainly used clinically for the treatment of peripheral neuralgia and adjuvant treatment of localized partial seizures. It can also be used for the treatment of pain and anxiety such as postherpetic neuralgia. [0003] Pregabalin is currently on the market in many countries and regions, and the marketed dosage forms mainly include capsules, oral solutions and orally disintegrating t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K31/197A61P25/02A61P25/08A61P29/00
CPCA61K9/0056A61K9/2054A61K9/2095A61K31/197A61P25/02A61P25/08A61P29/00
Inventor 张迪王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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