Preparation method of lacosamide tablet

A technology of lacosamide and salamine tablets, which is applied in the direction of non-active ingredient medical preparations, pharmaceutical formulas, active ingredients of amides, etc., can solve the problems of poor dissolution uniformity, reduce dissolution, and reduce intra-batch variation , Improve the effect of dissolution uniformity

Active Publication Date: 2020-04-14
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problem of poor dissolution uniformity of commercially available lacosamide tablets, the invention provides a preparation method of lacosamide tablets, which can effectively improve the dissolution uniformity of lacosamide tablets

Method used

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  • Preparation method of lacosamide tablet
  • Preparation method of lacosamide tablet
  • Preparation method of lacosamide tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Example 1: Effects of Different Preparation Methods on the Dissolution Uniformity of the Same Prescription Tablet

[0067] According to the following prescriptions, 1000 tablets were prepared by different methods, and the influence of different preparation methods on the dissolution uniformity of the same prescription tablets was investigated.

[0068] 1. Embodiment 1 prescription is as follows:

[0069] Table 2 Example 1 prescription

[0070]

[0071] 2. The preparation method is as follows:

[0072] Method A:

[0073] (1) Preparation of raw and auxiliary materials: crush the raw materials and pass through an 80-mesh sieve. Lacosamide, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, crospovidone, silicon dioxide, and magnesium stearate were weighed in prescription quantities.

[0074] (2) Put lacosamide, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose in a wet mixing granulator, stir at 100 rp...

Embodiment 2

[0102] Embodiment 2: The effect of binder adding ratio in batches on dissolution uniformity

[0103] Adopt the process method of method C in embodiment 1, only change the addition ratio of adhesive twice (see Table 5 for the specific ratio, the percentage that accounts for the adhesive prescription amount), other process conditions are exactly the same, prepare 1000 pieces of tablets agent. Each group took 12 tablet samples respectively, and adopted the same method as in Example 1 to detect the dissolution rate. The results are shown in Table 6, and the results of the dissolution uniformity are shown in Table 7.

[0104] Table 5 Different ratios of binders

[0105] Example Binder for mixing in step (2) Step (3) water-soluble adhesive 2-1 30％ 70％ 2-2 40％ 60％ 2-3 50％ 50％ 2-4 60％ 40％ 2-5 70％ 30％

[0106] Table 6 Dissolution Data

[0107]

[0108] Table 7 Dissolution Uniformity Data

[0109]

[0110] As can be seen from Tabl...

Embodiment 3

[0111] Embodiment 3: the influence of different excipients on dissolution uniformity

[0112] Using different tablet prescriptions, 1000 tablets were prepared by the preparation process of Example 2-3, and 12 tablets were taken respectively, and the dissolution rate was detected by the same method as in Example 1. The specific prescription is shown in Table 8-10, and the dissolution results are shown in Table 11-12.

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Abstract

The invention provides a preparation method of a lacosamide tablet. According to the invention, by controlling the adding mode and adding amount of an adhesive, the dissolution uniformity of the drugis effectively improved, and the in-batch difference of the tablet is reduced, thereby being conducive to reducing the difference of in-vivo dissolution, absorption and bio-utilization of the quick-release drug.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of lacosamide tablets. Background technique [0002] Lacosamide (trade name Vimpat) is an immediate-release drug developed by UCB for the treatment of epilepsy and neuropathic pain. It is a new type of NMDA receptor glycine site-binding antagonist and belongs to a new class of functional amino acids. , is an anticonvulsant drug with a new dual mechanism of action. It selectively promotes slow inactivation of sodium channels and regulates collapse response mediator protein 22 (CRMP22), which may slow or even prevent seizures and alleviate neuropathic pain in diabetes. As an auxiliary drug, lacosamide is used in combination with other drugs for the treatment of partial epileptic seizures in patients aged 16 and over. It has a high curative effect in the treatment of epileptic seizures and is of great development value. [0003] According...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/26A61K31/16A61P25/08
CPCA61K9/2018A61K9/2054A61K9/2095A61K31/16A61P25/08
Inventor 冯福立李冬梅梁沛王咪岭牛艳婷金晓利
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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