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Levetiracetam tablet and preparation method thereof

A technology for tablets and colloidal silicon dioxide, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with inactive ingredients, etc. The effect of saving process operation time, low production cost and simple process flow

Active Publication Date: 2021-06-01
HINYE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In order to solve the above-mentioned problems existing in the prior art, the present invention aims to provide a preparation method of levetiracetam tablet, which can well solve the stability of levetiracetam in the preparation development process , tablet molding, poor dissolution effect, etc., and the process is simple, the production cost is low, and it is suitable for commercial production

Method used

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  • Levetiracetam tablet and preparation method thereof
  • Levetiracetam tablet and preparation method thereof
  • Levetiracetam tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] A preparation method of levetiracetam tablet, described preparation method comprises the following steps:

[0038] (1) Weighing and preparing materials: carry out weighing and preparing materials according to the prescription ratio in the table below; Table 1

[0039]

[0040] (2) Preparation method

[0041] Table 2

[0042]

[0043]

Embodiment 2

[0045] Get the levetiracetam tablet that different prescriptions prepare among the embodiment 1, measure friability, investigate its composition

[0046] Formability; The experimental results are as follows: According to the measurement results, it can be known that the tablet is prepared by hydroxypropyl cellulose whose model is EXF, the friability of the plain tablet is small, and the formability is better.

[0047] table 3

[0048] Prescription 1 Prescription 2 Prescription 3 Prescription 4 Friability (%) 0.50 (with missing corner) 0.52 (with missing corner) 0.45 (with slight chipping) 0.33 (no chipped corner) Hardness (kg) 12-14 12-15 14-17 14-17

[0049] Note: During the testing of hardness and friability in this example, 10 preparations of the same batch were taken for each test, and the hardness data in Table 3 is the hardness distribution range of the 10 preparations.

Embodiment 3

[0051] Table 4

[0052]

[0053] Preparation

[0054] table 5

[0055]

[0056]

[0057] It can be seen from the above examples that the addition method of colloidal silicon dioxide has a great influence on the forming of the tablet. When colloidal silicon dioxide is added in the form of internal addition and external addition at the same time, the compressibility of the material is significantly improved, and the plain The hardness of the tablet increases obviously, and the friability decreases obviously.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a levetiracetam tablet and a preparation method thereof. The preparation method comprises the following steps: 1, sieving levetiracetam, hydroxypropyl cellulose, croscarmellose sodium and part of colloidal silicon dioxide together for later use; 2, mixing the granulated materials in the step 1, adding magnesium stearate, and uniformly mixing to obtain premixed powder; 3, the premixed powder in the step 2 being subjected to dry granulation and size stabilization, and obtaining a particle and powder mixture; 4, mixing the granules and powder mixture granulated in the step 3 with the residual colloidal silicon dioxide, and tabletting; and 5, coating. The preparation method provided by the invention has the characteristics of simple process flow, strong operability, low production cost and stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a levetiracetam tablet and a preparation method thereof. Background technique [0002] Levetiracetam is a pyrrolidone derivative whose chemical structure is not related to existing antiepileptic drugs. The antiepileptic effects of levetiracetam have been evaluated in various animal models of epilepsy. Levetiracetam has no inhibitory effect on isolated seizures induced by maximal stimulation with electric current or various convulsants, and shows only weak activity in submaximal stimulation and threshold tests. However, protection was observed against generalized seizures secondary to focal seizures induced by pilocarpine and kainic acid, two chemical convulsants that mimic the properties of complex partial seizures in some humans with secondary generalized seizures . Levetiracetam has inhibitory effects on both the ignition process and the ignition state in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/04A61K31/4015A61P25/08
CPCA61K9/2009A61K9/2054A61K9/2095A61K9/28A61K31/4015A61P25/08
Inventor 陶佑波高欣彭慧王宇杰王衡新宋志林
Owner HINYE PHARM CO LTD
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