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Ramelteon composition and tablet thereof

A technology of ramelteon tablets and ramelteon, which is applied in the field of medicine, can solve the problems of unstable chemical properties of ramelteon, poor stability of ramelteon tablets, and difficulty in industrial production, and meet equipment requirements Not high, fast dissolution rate, good stability

Active Publication Date: 2014-12-24
BEIJING COLLAB PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But there is common problem in above-mentioned two kinds of methods, is exactly preparation technology loaded down with trivial details, high cost, is not easy to suitability for industrialized production, and because ramelteon chemical property is unstable, is easily oxidized and decomposed, the ramelteon prepared by above-mentioned two methods poor tablet stability

Method used

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  • Ramelteon composition and tablet thereof
  • Ramelteon composition and tablet thereof
  • Ramelteon composition and tablet thereof

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preparation example Construction

[0042] According to the present invention, the preparation method of the ramelteon tablet is preferably wet granulation compression, dry granulation compression or direct powder mixing compression; more preferably wet granulation compression. The wet granulation tablet preferably comprises the following steps:

[0043] Carry out micronization treatment of ramelteon, then mix the micronized ramelteon with filler and disintegrant evenly, then add the ethanol solution of copovidone to prepare soft material, then granulate, dry, The granules are sized, and then a lubricant is added to mix evenly, compressed into tablets, and finally coated to obtain ramelteon tablets.

[0044] According to the present invention, the micronization treatment controls the particle size of ramelteon to D90≤40 μm, which can ensure the rapid dissolution of the drug, and has low requirements on the equipment of the pulverizer.

[0045] The ethanol solution is an aqueous ethanol solution, and the volume ...

Embodiment 1

[0051] Micronize ramelteon to control its particle size to D90≤40 μm, then mix 8 g of ramelteon micronized with 110 g of lactose and 10 g of starch, and then add 30% ethanol with 5 wt% copovidone Solution 13g, prepare soft material, then granulate at 24 mesh, ventilate and dry at 70°C, granulate at 24 mesh, then add 1g of magnesium stearate and mix evenly, press into tablets with a punch with a diameter of 7mm, and finally coat to obtain Lemei For the amine tablet; the weight gain of the coating is 4g, wherein the coating powder formula is composed as follows: 100 parts by weight of hydroxypropyl methylcellulose, 40 parts by weight of titanium dioxide, and 10 parts by weight of iron oxide yellow.

Embodiment 2

[0053] Micronize ramelteon to control its particle size to D90≤40 μm, then mix 8 g of ramelteon micronized with 110 g of lactose and 10 g of starch, and then add 30% ethanol with 10 wt% copovidone 13g of the solution, wherein 0.02g of vitamin E is dispersed in the ethanol solution, and the soft material is prepared, then granulated at 24 mesh, ventilated and dried at 70°C, and granulated at 24 mesh, and then 1g of magnesium stearate is added to mix evenly, and a punch with a diameter of 7mm is used. Head compression tablet, carry out coating at last, obtain ramelteon tablet; Described coating increases in weight 4g, and wherein, coating powder formula is composed as follows: 100 parts by weight of hydroxypropyl methylcellulose, 40 parts by weight of titanium dioxide , 10 parts by weight of iron oxide yellow.

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Abstract

The invention provides a Ramelteon composition. The Ramelteon is composed of the following components, by weight part, 5-8 parts of Ramelteon and 0.5-3 parts of polyvidone. The invention also discloses a Ramelteon tablet. The Ramelteon tablet is composed of the following components including, by weight part, 5-8 parts of Ramelteon, 0.5-3 parts of polyvidone, 80-110 parts of filling agent, 3-10 parts of disintegrating agent and 0.5-1.5 parts of lubricant. The Ramelteon tablet is high in dissolution rate and stability and is prepared through a conventional method, which is simple in process, easy to operate, low in requirements on micronizing equipment, low in production cost and applicable to industrial mass production.

Description

technical field [0001] The present invention relates to the field of medicaments, in particular to a ramelteon composition and a tablet thereof. Background technique [0002] Ramelteon, chemical name N-{2-[(8S)-1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl}propane Amide, the English name is Ramelton, and the molecular formula is C 16 h 21 NO 2 , the molecular weight is 259.34, and the chemical structural formula is as follows: [0003] [0004] Ramelteon is a potent and highly selective melatonin receptor agonist that selectively stimulates melatonin type 1 receptors and type 2 receptors, increasing chronic wave sleep and rapid eye movement sleep without It can reduce rapid eye movement sleep in humans, and can be used to treat insomnia that is difficult to fall asleep. It also has a definite effect on chronic insomnia and short-term insomnia. Ramelteon Tablets was developed by Takeda Pharmaceutical Company of Japan, and it was launched in the United States and...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/20A61K31/343A61K47/32A61K47/22A61P25/20
Inventor 解兵亮邱敦有张秋佳王珂赵大龙邹德超曾庆娜
Owner BEIJING COLLAB PHARMA
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