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Maleic acid levo amido chloro diping oral disintegration tablet and preparation method thereof

A technology of levamlodipine and orally disintegrating tablets, which is applied in pharmaceutical formulas, medical preparations containing active ingredients, pill delivery, etc. It can solve the difficulties in taking medicine for patients with inconvenient water intake, difficulty in swallowing tablets and capsules, and inability to fully satisfy To meet the needs of patients with medication and other problems, to achieve the effect of shortening the dissolution time, refreshing and sweet taste, and heat stability

Active Publication Date: 2009-07-08
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the course of clinical medication, the incidence of difficulty in swallowing tablets and capsules is relatively high. Currently, the dosage form of levamlodipine maleate in clinical application is ordinary tablets, which will have certain difficulties in taking the medicine for patients with dysphagia or inconvenient water intake. ; Therefore, the ordinary tablet of levamlodipine maleate cannot fully meet the medication needs of all patients

Method used

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  • Maleic acid levo amido chloro diping oral disintegration tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Formula Dosage for 1000 tablets (g) Ratio of each component (%)

[0058] Levoamlodipine maleate 3.2 (equivalent to Levoamlodipine 4.3

[0059] Amlodipine 2.5)

[0060] Mannitol powder 53.5 71.3

[0061] Aspartame 0.375 0.5

[0062] Microcrystalline cellulose 15 20

[0063] Tartaric acid 0.75 1

[0064] Sodium bicarbonate 0.75 1

[0065] Menthol 0.375 0.5

[0066] Powder essence 0.75 1

[0067] Magnesium stearate 0.3750.5

[0068] Gross weight 75

[0069] Concrete preparation method is as follows:

[0070] Pass levamlodipine maleate through a 100-mesh sieve; weigh levamlodipine maleate, mix evenly with aspartame, tartaric acid, sodium bicarbonate, menthol and powder essence, then mix with mannitol powder, microcrystalline After the cellulose and lubricant are evenly mixed, the tablet is pressed, and the tablet pressure is controlled at 3-5 kg.

Embodiment 2

[0072] Formula Dosage for 1000 tablets (g) Ratio of each component (%)

[0073] Levoamlodipine maleate 3.2 (equivalent to Levoamlodipine 4.3

[0074] Amlodipine 2.5)

[0075] Mannitol 52 69.3

[0076] Aspartame 0.375 0.5

[0077] 5% povidone 95% ethanol solution 30 2

[0078] Low-substituted hydroxypropyl cellulose 3 4

[0079] Microcrystalline cellulose 12 16

[0080] Tartaric acid 0.75 1

[0081] Sodium bicarbonate 0.75 1

[0082] Menthol 0.375 0.5

[0083] Powder essence 0.75 1

[0084] Magnesium stearate 0.375 0.5

[0085] Gross weight 75

[0086] Concrete preparation method is as follows:

[0087] The raw and auxiliary materials were respectively pulverized and passed through a 100-mesh sieve; levamlodipine maleate was weighed and mixed with aspartame, and then mixed with mannitol in equal increments, and prepared by adding 5% povidone and 95% ethanol. Soft material, granulated through a 30-mesh sieve, dried at 50-55°C, and granulated;...

Embodiment 3

[0089] Formula 1000 dosage (g) weight ratio of each component

[0090] (%)

[0091] Levoamlodipine maleate 3.2 (equivalent to Levoammonia 2.1

[0092] Clodipine 2.5)

[0093] Erythrose 100 67.3

[0094] Sucralose 0.375 0.25

[0095] 50% ethanol 60 0

[0096] Low-substituted hydroxypropyl cellulose 7.5 5

[0097] Microcrystalline cellulose 30 20

[0098] Citric acid 3 2

[0099] Sodium bicarbonate 3 2

[0100] Menthol 0.75 0.5

[0101] Powder essence 1.5 1

[0102] Magnesium stearate 1.5 1

[0103] Gross weight 150

[0104] Concrete preparation method is as follows:

[0105] Crush the raw and auxiliary materials separately, and pass through a 100-mesh sieve; weigh levamlodipine maleate and mix them with sucralose evenly, and then mix them with erythrose in equal increments, add an appropriate amount of soft material made of 50% ethanol, pass through Mesh sieve granulation, dry at 50-55°C, and granula...

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Abstract

An oral disintegrating tablet of levo-amlodipine maleate is prepared from levo-amlodipine maleate, water-soluble filler, disintegrant, lubricant, and optional others.

Description

technical field [0001] The invention relates to a levoamlodipine maleate orally disintegrating tablet and a preparation method thereof. technical background [0002] Amlodipine is a new generation of calcium antagonist, which is clinically used to treat hypertension and stable angina pectoris. It effectively overcomes the shortcomings of the second-generation calcium ion antagonists diltiazem and nifedipine in the unstable blood pressure reduction and many adverse reactions, and is recognized as a safe and effective drug by the US FDA. In addition, it is convenient to take, and only needs to be taken once a day, and the patient's compliance with medication is good. It is precisely because of its unique pharmacology and efficacy that amlodipine has gradually been recognized by the majority of hypertensive patients and has become the drug of choice for the treatment of hypertension. [0003] Levoamlodipine maleate is the maleate of the left-handed form of amlodipine. Arrowsm...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4422A61K9/20A61P9/12
Inventor 刘立云陈素锐陈玉洁梁亚丽魏树辉韩卫占
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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