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Ramelteon tablets and preparation process thereof

A technology of ramelteon tablets and ramelteon, applied in pill delivery, medical preparations of non-active ingredients, nervous system diseases, etc., can solve problems such as easy changes in the dissolution behavior of insoluble drugs, and achieve dissolution Improvement of degree change and good dissolution effect

Inactive Publication Date: 2015-04-29
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a new ramelteon tablet and its preparation method for the problem that the dissolution behavior of insoluble drugs is prone to change

Method used

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  • Ramelteon tablets and preparation process thereof
  • Ramelteon tablets and preparation process thereof
  • Ramelteon tablets and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

reference example 1

[0022] Preparation A of Example 1 in the patent CN101247805B.

[0023]

[0024] Preparation Process:

[0025] (1) Preparation of adhesive solution: weigh hydroxypropyl cellulose (viscosity 6-10mPa·s) to prepare an aqueous solution.

[0026] (2) Weigh ramelteon, lactose, and starch, mix them uniformly in a fluidized bed drier, spray the mixture with the prepared binder solution to granulate in a drier, and then granulate in the same drier. Dry in medium temperature, use 1.5mm sieve for sizing.

[0027] (3) Add magnesium stearate and mix well.

[0028] (4) Use a 7mm punch on the tablet press for tablet compression.

[0029] (5) Film coating.

[0030] (6) Repeat the above method for three batches (batch numbers are CZ02A01, CZ02A02, CZ02A03)

reference example 2

[0032] Preparation B of Example 1 in the patent CN101247805B.

[0033]

[0034] Preparation Process:

[0035] (1) Preparation of adhesive solution: weigh hydroxypropyl cellulose (viscosity 2-3mPa·s) to prepare an aqueous solution.

[0036] (2) Weigh ramelteon, lactose, and starch, mix them uniformly in a fluidized bed drier, spray the mixture with the prepared binder solution to granulate in a drier, and then granulate in the same drier. Dry in medium temperature, use 1.5mm sieve for sizing.

[0037] (3) Add magnesium stearate and mix well.

[0038] (4) Use a 7mm punch on the tablet press for tablet compression.

[0039] (5) Film coating.

[0040] (6) Repeat the above method for three batches (batch numbers are CZ02F01, CZ02F02, CZ02F03)

reference example 3

[0042]

[0043]

[0044] Preparation Process:

[0045] (1) Adhesive solution preparation: Weigh Povidone K30 and dissolve it in 40% ethanol. The mass concentration of Povidone K30 in 40% ethanol is 5%.

[0046] (2) Weigh ramelteon, lactose, and starch, place them in a high-efficiency wet granulator, mix them evenly, and use the prepared binder solution to granulate.

[0047] (3) Dry in a blast drying oven at 50° C., and use a 1.5 mm sieve for sizing.

[0048] (4) Add magnesium stearate and mix well.

[0049] (5) Use a 7mm punch on the tablet press for tablet compression.

[0050] (6) Film coating.

[0051] (7) Repeat the above method for three batches (batch numbers are CZ02G01, CZ02G02, CZ02G03).

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Abstract

The invention belongs to the field of medicinal preparations, and discloses ramelteon tablets and a preparation process thereof. According to the tablets, a polyvidone solution is used as an adhesive solution for granulating, and the weight ratio of polyvidone to ramelteon is 1:15-1:1. The preparation process effectively inhibits the changes of dissolution behavior of active ingredients in insoluble medicaments.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to ramelteon tablets and a preparation process thereof. Background technique [0002] Ramelteon (RozeremTM) is an oral hypnotic drug developed by Takeda Corporation of Japan, and it is the first melatonin receptor agonist used in the clinical treatment of insomnia. It has a high affinity with melatonin MT1 and MT2 receptors, and has a specific and complete agonistic effect on MT1 and MT2 receptors, but does not interact with MT3 receptors. In addition, it does not bind to neurotransmitter receptors such as GABA receptors, and does not interfere with the activities of most enzymes within a certain range, so it can avoid the distraction associated with GABA drugs (which may cause car accidents, falls and fractures, etc.) and drug addiction and dependence. Ramelteon has been launched in the United States and Japan in 2005 and 2010 respectively. It is mainly used...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/32A61P25/20
Inventor 吴小涛黄洋朱丽君霍立茹李纬李战汪礼权
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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