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Ramelteon oral disintegrating tablets and preparation method thereof

A technology for ramelteon and orally disintegrating tablets, applied in the field of ramelteon orally disintegrating tablets and their preparation, can solve problems such as difficulty in swallowing of patients

Inactive Publication Date: 2016-10-26
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the marketed dosage form of ramelteon is only ordinary tablets, which may cause difficulty in swallowing for some patients during the taking of ordinary tablets

Method used

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  • Ramelteon oral disintegrating tablets and preparation method thereof
  • Ramelteon oral disintegrating tablets and preparation method thereof
  • Ramelteon oral disintegrating tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]

[0033] Preparation process: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct compression process. The specific preparation method is as follows: the main drug is ground and passed through a 80-mesh sieve, low-substituted hydroxypropyl cellulose is passed through a 100-mesh sieve, starch and lactose are respectively Pass through a 40-mesh sieve, weigh the remaining excipients according to the amount, add them to the main drug and mix them in turn, then add the prescribed amount of magnesium stearate and flavoring agent, sieve and mix them, and test the intermediate content. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

Embodiment 2

[0035]

[0036] Preparation process: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct compression process. The specific preparation method is as follows: the main drug is ground and passed through an 80-mesh sieve, croscarmellose sodium is passed through a 100-mesh sieve, starch and lactose Pass through a 40-mesh sieve, weigh the remaining excipients according to the amount, add them to the main drug and mix them in turn, then add the prescribed amount of magnesium stearate and flavoring agent, sieve and mix them, and then test the intermediate content. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

Embodiment 3

[0038]

[0039] Preparation process: This dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by direct tableting process. The specific preparation method is as follows: the main drug research, cross-linked polyvinylpyrrolidone, starch, and lactose are respectively passed through a 100-mesh sieve, and weighed according to the amount. The remaining auxiliary materials are added in sequence, sieved and mixed, pressed into tablets, and passed through a 18-mesh sieve for dry granulation. Then add the prescribed amount of magnesium stearate and correctives, sieve and mix, and detect the intermediate content. After determining the weight of the tablet, the tablet is compressed by direct compression technology, and the product is obtained.

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Abstract

The invention belongs to the technical field of medicines and relates to ramelteon oral disintegrating tablets and a preparation method thereof. When being disintegrated, the ramelteon oral disintegrating tablets provided by the invention are wholly disintegrated within 60 seconds according to Chinese Pharmacopoeia Standards and have no hard cores. Raw drugs are sensitive to humidity so that dry-process granulation is used for replacing traditional wet-process granulation. The ramelteon oral disintegrating tablets provided by the invention are prepared from ramelteon and auxiliary components including a disintegrating agent, a filling agent, a binding agent, a sweetness flavoring agent and the like, and a dry-process granulation process is adopted. The ramelteon oral disintegrating tablets have the overall effects of high disintegrating speed, simple process steps, low cost, convenience for taking, good mouth feel, stable quality, reliable curative effect and the like; after the ramelteon oral disintegrating tablets are orally taken, the ramelteon oral disintegrating tablets are rapidly dispersed into fine particles or powder in an oral cavity, so that the ramelteon oral disintegrating tablets are particularly suitable for patients who cannot easily orally take the tablets and have insomnia; when the preparation reaches gastrointestinal tracts, the preparation exists in a form of fine particles, and thus the dissolving rate of the medicine is accelerated; and the medicine is widely distributed in the gastrointestinal tracts and a plurality of absorption points exist, so that the bioavailability can be improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to ramelteon orally disintegrating tablets and a preparation method thereof. Ramelteon is used as an active ingredient in oral formulations for the treatment of insomnia and bipolar disorder. Background technique [0002] Ramelteon ((S)-N-(2-(1,6,7,8-tetrahydro-2H-indeno(5,4-b)furan-8-yl)ethyl)propionamide) is Melatonin receptor agonist developed by Takeda Corporation of Japan. Ramelteon is currently the only melatonin receptor agonist on the market for the treatment of insomnia with difficulty falling asleep. It is used for the treatment of insomnia with difficulty falling asleep and bipolar affective disorder. It also has definite curative effect on chronic insomnia and short-term insomnia. It has no dependence and drug abuse tendency, and the FDA lists it as an unregulated hypnotic drug. [0003] Currently, the marketed dosage form of ramelteon is only ordi...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/343A61K47/36A61K47/26A61P25/20A61P25/18
CPCA61K9/0056A61K9/2018A61K9/2059A61K31/343
Inventor 付强马莉
Owner BEIJING VENTUREPHARM BIOTECH
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