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Ramelteon sustained-release preparation and preparation method thereof

A technology for ramelteon and sustained-release preparations, applied in the field of ramelteon sustained-release preparations and its preparation, can solve the problems of affecting the patient's mental state, short drug effect maintenance time, and reducing sleep quality, so as to achieve sufficient sleep time , avoid premature awakening, simple craft effect

Active Publication Date: 2021-12-07
广东科泰鼎润药业科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the traditional ramelteon drug releases rapidly and can make patients fall asleep in a short period of time, but at the same time, the duration of the drug effect is short, and patients are prone to wake up prematurely, and cannot fall asleep again after waking up, reducing the Sleep quality, which seriously affects the patient's mental state

Method used

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  • Ramelteon sustained-release preparation and preparation method thereof
  • Ramelteon sustained-release preparation and preparation method thereof
  • Ramelteon sustained-release preparation and preparation method thereof

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preparation example Construction

[0067] The present invention also provides a preparation method of the above-mentioned ramelteon sustained-release preparation, comprising the steps of:

[0068] Mix ramelteon, filler and extended release material, then add lubricant and mix.

[0069] In a specific example, the following step is further included after mixing: performing wet granulation with ethanol or water.

[0070] In a specific example, the blending is followed by compression into a tablet.

[0071] In a specific example, capsules are filled after mixing.

[0072] In a specific example, granules are prepared after mixing and filling sachets.

Embodiment 1

[0075] The present embodiment provides a sustained-release preparation of ramelteon, and the specific prescription is as follows:

[0076]

[0077] Concrete preparation method is as follows:

[0078] Mix ramelteon, lactose, microcrystalline cellulose PH101, hyprolose Klucel EXF PHARM, and silicon dioxide evenly. Slowly add 95% ethanol solution to the above mixture, stirring while adding. The soft material is suitable for softness and hardness, and it forms a ball when you hold it, and it disperses when you touch it lightly. The soft material was granulated through a 10-mesh sieve, and the prepared granules were dried in an oven at 60°C. After drying for 1 hour, measure the loss on drying of the granules, and stop drying when the loss on drying is less than 3%. The dried granules are then added with magnesium stearate and mixed evenly. Compressed tablet, tablet weight 250mg, hardness 3~10kg.

Embodiment 2

[0080] The present embodiment provides a sustained-release preparation of ramelteon, and the specific prescription is as follows:

[0081]

[0082] Concrete preparation method is as follows:

[0083] Mix ramelteon, lactose, microcrystalline cellulose PH102, hydroxypropyl methylcellulose K4M, and silicon dioxide evenly. Then add magnesium stearate and mix well. Compressed tablet, tablet weight 250mg, hardness 3~10kg.

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Abstract

The invention provides a sustained-release preparation of ramelteon, the dosage form of the sustained-release preparation of ramelteon is tablet, granule or capsule; in parts by weight, the sustained-release preparation of ramelteon Including the following raw materials: 1-30 parts of ramelteon, 50-250 parts of filler, 5-50 parts of slow-release material, 0.2-10 parts of lubricant; the slow-release material is selected from At least one of hypromellose, polyvinylpyrrolidone, hypromellose, sodium alginate, calcium alginate, guar gum and xanthan gum; the filler is selected from lactose, mannitol, sorbitol, At least one of sucrose, microcrystalline cellulose and calcium hydrogen phosphate. The ramelteon sustained-release preparation can maintain sufficient drug concentration for a long period of time, prolong the drug action time, and dissolve completely.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a ramelteon sustained-release preparation and a preparation method thereof. Background technique [0002] Ramelteon, 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, 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 drug for the treatment of insomnia developed by Japan's Takeda Pharmaceutical Company. It is the first melatonin receptor agonist used in the clinical treatment of insomnia. type receptors, but not with melatonin type 3 receptors, and has the characteristics of being potent and highly selective. In addition, ramelteon does not bind to neurotransmitter receptors such as GABA receptors, and does not interfere with the activities of most enzymes within a certain range. Therefore, it can av...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22A61K9/16A61K9/52A61K47/38A61K47/36A61K47/32A61K47/26A61K47/02A61K31/343A61P25/20
CPCA61K9/1611A61K9/1623A61K9/1635A61K9/1652A61K9/2009A61K9/2018A61K9/2027A61K9/205A61K9/2054A61K9/485A61K9/4858A61K9/4866A61K31/343A61P25/20
Inventor 郭德解健博李致伟乔飞
Owner 广东科泰鼎润药业科技有限公司
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