Lacosamide tablet for treating epilepsy and preparation method for lacosamide tablet

A technology of lacosamide tablets and lacosamide, which is applied in the fields of pill delivery, sugar-coated pills, nervous system diseases, etc., can solve problems such as unstable properties and poor stability, and achieve good stability, stable source, and excipients safe and effective effect

Inactive Publication Date: 2013-01-23
YONG GUANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, because lacosamide is slightly soluble in water and has unstable properties, although the currently commercially available lacosamide tablet has a high dissolution rate, its stability is poor

Method used

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  • Lacosamide tablet for treating epilepsy and preparation method for lacosamide tablet
  • Lacosamide tablet for treating epilepsy and preparation method for lacosamide tablet
  • Lacosamide tablet for treating epilepsy and preparation method for lacosamide tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Prescription: (Specification 30mg, 1000 tablets)

[0064]

[0065]

[0066] Preparation Process:

[0067] 1. Dissolve 60g of cyclodextrin in 180ml of purified water, dissolve 30g of lacosamide in a small amount of purified water at 65-80°C, put the two solutions into a grinder and grind them into a paste, and dry them with air at 50-60°C to obtain Sample, mix the sample with 80g microcrystalline cellulose, 6g low-substituted hydroxypropyl cellulose, and 1.2g micropowder silica gel;

[0068] 2. Add an appropriate amount of purified water to the mixture obtained in 1 to prepare a soft material, pass through a 20-mesh sieve to granulate, dry, and granulate;

[0069] 3. Add 6g of crospovidone and 2g of magnesium stearate, mix well, and press into tablets;

[0070] 4. Coating, packaging, and full inspection.

Embodiment 2

[0072] Prescription: (Specification 50mg, 1000 tablets)

[0073]

[0074] Preparation Process:

[0075] 1. Dissolve 100g of cyclodextrin in 300ml of purified water, dissolve 50g of lacosamide in a small amount of purified water at 65-80°C, put the two solutions into a grinder and grind them into a paste, and dry them with air at 50-60°C to obtain Sample, this sample is mixed with 50g lactose, 50g starch, 5g micropowder silica gel;

[0076] 2. Add the mixture obtained in 1 into purified reclaimed water to prepare soft material, pass through a 20-mesh sieve to granulate, dry, and granulate;

[0077] 3. Add 10g of croscarmellose sodium and 3.0g of talc powder, mix well, and press into tablets;

[0078] 4. Coating, packaging, and full inspection.

Embodiment 3

[0080] Prescription: (Specification 70mg, 1000 tablets)

[0081]

[0082] Preparation Process:

[0083] 1. Dissolve 140g of cyclodextrin in 420ml of purified water, dissolve 70g of lacosamide in a small amount of purified water at 65-80°C, put the two solutions into a grinder and grind them into a paste, and dry them with air at 50-60°C to obtain Sample, mix the sample with 140g microcrystalline cellulose, 20g low-substituted hydroxypropyl cellulose, and 10g micropowder silica gel;

[0084] 2. Add the mixture obtained in 1 into purified reclaimed water to prepare soft material, pass through a 20-mesh sieve to granulate, dry, and granulate;

[0085] 3. Add 8g crospovidone and 2g magnesium stearate, mix evenly, and press into tablets;

[0086] 4. Coating, packaging, and full inspection.

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PUM

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Abstract

The invention relates to a tablet for treating epilepsy and a preparation method for the tablet, in particular to a lacosamide tablet for treating epilepsy and a preparation method for the lacosamide tablet. The lacosamide tablet comprises lacosamide, an inclusion material, filler, disintegrant, lubricant and / or wetting agent, adhesive and a coating material. The main medicine lacosamide is coated by the inclusion material, and other auxiliary materials are added into the lacosamide, so that a tablet core is obtained, and a finished product is obtained after the tablet core is coated by the coating material. The obtained lacosamide tablet is relatively high in dissolution rate, medicine stability is greatly improved, and medicine-using risks are reduced.

Description

technical field [0001] The invention relates to a tablet for treating epilepsy and a preparation method thereof, in particular to a lacosamide tablet for treating epilepsy and a preparation method thereof. Background technique [0002] Lacosamide (lacosamide), chemically named (R)-2-acetamido-N-benzyl-3-methoxypropionamide, is a new type of N-methyl-D-aspartic acid (NMDA ) The receptor glycine site binding antagonist belongs to a new class of functional amino acids and is an anticonvulsant drug with a new dual mechanism. It selectively promotes slow inactivation of sodium channels and regulates collapse response mediator protein-2 (CRMP-2), which may slow or even block epileptic seizures and reduce diabetic neuropathic pain. [0003] Lacosamide was developed by Schwarz Pharma, a subsidiary of UCB Pharma in Belgium, and was approved by EU Germany, UK and US FDA in August, September and October 2008 respectively. Approved to go on the market, trade name is Vimpat. Positive ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/165A61P25/08
Inventor 刘忠锋张秀生苏忆君蔡佩珍
Owner YONG GUANG PHARMA
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