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

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 ...

AI Technical Summary

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 orally disintegrating The disintegration of the tablet, or the unpleasant taste such as gritty feeling, affects the patient's compliance, and the preparation process of the ordinary tablet disclosed in the above patent is lengthy, cumbersome, time-consuming and labor-intensive, and the production cost is high

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