Orally disintegrating tablet containing ramelteon and preparation method of orally disintegrating tablet

A technology of ramelteon and orally disintegrating tablets is applied in the field of preparation of co-powder and orally disintegrating tablets, and can solve the problems of affecting the disintegration of orally disintegrating tablets, complicated process, time-consuming and labor-intensive and other problems

Inactive Publication Date: 2017-02-15
BEIJING VENTUREPHARM BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the process of the above patent is not suitable for the preparation of orally disintegrating tablets. Orally disintegrating tablets require rapid disintegration in the oral cavity after taking. Copovidone is often used as a binder in solid preparations. Adding it to the prescription may affect ora

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  • Orally disintegrating tablet containing ramelteon and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing ramelteon and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing ramelteon and preparation method of orally disintegrating tablet

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Embodiment

[0014] This embodiment is in the form of a tablet. (measured per 1000 pieces)

[0015] Name of raw material Percentage (%) Amount of raw materials and auxiliary materials for 1000 tablets (g) Ramelteon 8.00 8.00 Mannitol (co-powder) 7.20 7.20 Mannitol 44.80 44.80 Microcrystalline Cellulose PH101 28.40 28.40 Carboxymethyl Starch Sodium 2.00 2.00 Croscarmellose Sodium 6.00 6.00 Menthol 0.60 0.60 stevia 1.00 1.00 silica 1.00 1.00 Magnesium stearate 1.00 1.00 total 100.00 100.00

[0016] Preparation process: the active ingredient ramelteon in the prescription is mixed with the prescription amount of co-powder mannitol, and then micronized to obtain the blend, which is ready for use. Grind the remaining mannitol in the prescribed amount through a 100-mesh sieve for use. Mix co-powder, microcrystalline cellulose PH101, sodium carboxymethyl starch, croscarmellose sodium, menthol, stevia, si...

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Abstract

The invention provides a preparation method of a ramelteon orally disintegrating tablet. The orally disintegrating tablet, which takes ramelteon as an active ingredient, is a melatonin receptor agonist and is mainly used for treating insomnia of being hard to fall asleep, and the orally disintegrating tablet also has a concrete curative effect on chronic insomnia and short-term insomnia. The invention belongs to the novel technical field of medicines, and relates to the ramelteon orally disintegrating tablet and the preparation method thereof. The orally disintegrating tablet provided by the invention is good in taste and disintegrating effect and is good in stability; a sample is prepared by virtue of common equipment in accordance with a conventional process; and the preparation method is easy to operate, mature in process, low in production cost and is applicable to large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a co-powder containing ramelteon and a method for preparing orally disintegrating tablets thereof. Background technique [0002] Ramelteon, the Chinese alias is Ramelteon, and its chemical name is: (S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno(5,4-b) Furan-8-yl) ethyl) propionamide, the English name is Ramelteon, and the molecular formula is C 16 h 21 NO 2 , the molecular weight is 259.3434. Its chemical structure is as follows: [0003] [0004] Ramelteon was developed by Takeda Corporation of Japan and was approved by the US FDA in July 2005. It was launched in the US in September 2005 and in Japan in July 2010. It is the first application of prescription oral hypnotic drugs. Melatonin receptor agonists used in the clinical treatment of insomnia are mainly used to treat insomnia with difficulty falling asleep, and have definite curative effects ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/343A61K47/38A61K47/26A61K47/36A61K47/32A61P25/20
CPCA61K9/0056A61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K31/343
Inventor 常利丽张庭
Owner BEIJING VENTUREPHARM BIOTECH
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