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Macimorelin film coated tablet and preparation method thereof

A technology for film-coated tablets and plain tablets, which is applied to the field of film-coated tablets of macyclorelin and their preparation, can solve the problems of rapid release of macyclorelin, influence on the absorption and bioavailability of macyclorelin, and the like, and achieve onset of effect. quick effect

Inactive Publication Date: 2017-01-11
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, when preparing maxirelin film-coated tablets according to the prior art, it was found that maxirelin aggregated into agglomerates during the granulation process, which resulted in the inability of maxirelin to release rapidly in an acidic medium, which seriously affected the quality of maxirelin. absorption and bioavailability of

Method used

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  • Macimorelin film coated tablet and preparation method thereof
  • Macimorelin film coated tablet and preparation method thereof
  • Macimorelin film coated tablet and preparation method thereof

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preparation example Construction

[0020] The invention provides a maxirelin film-coated tablet and a preparation method thereof.

[0021] The invention provides a film-coated tablet of macirelin, which comprises macirelin, a filler, a water-soluble acidic solid auxiliary material, a disintegrant, a lubricant and a coating material.

[0022] In a preferred embodiment of the present invention, the filler includes a water-soluble filler and a water-insoluble filler; wherein the water-soluble filler is one of lactose, sucrose, mannitol, sodium chloride, and sorbitol Or a combination of two or more; wherein the water-insoluble filler is microcrystalline cellulose PH 101, microcrystalline cellulose PH 102 or pregelatinized starch.

[0023] In a preferred embodiment of the present invention, the water-soluble acidic solid auxiliary material is organic weak acid and acidic amino acid; wherein, the organic weak acid is citric acid, tartaric acid, malic acid; wherein the acidic amino acid is glutamic acid, natural aspa...

Embodiment 1

[0046] Table 1: the prescription of macirelin tablet of embodiment 1

[0047] Element Dosage (g) Maxirelin 50 lactose 700 aspartic acid 100 Microcrystalline Cellulose (PH 101) 500 Low Substituted Hydroxypropyl Methyl Cellulose 75 Mannitol 200 Magnesium stearate 9

[0048] (a) Preparation of maxirelin granules

[0049]According to the amount in Table 1, the maxirelin, aspartic acid, lactose and mannitol were mixed evenly and dissolved in water. Set the air inlet temperature of the spray drying equipment at 80°C, the atomizer rotation speed at 25000rpm, and the atomization pressure at 0.4-0.88MPa for spray drying and granulation.

[0050] (b) Preparation of macirelin tablets: the macirelin granules obtained in step (a), microcrystalline cellulose, low-substituted hydroxypropyl methylcellulose, and magnesium stearate are mixed uniformly and then pressed into tablets, A total of 10,000 tablets were pressed. The average t...

Embodiment 2

[0053] Table 2: the prescription of macirelin tablet of embodiment 2

[0054] Element Dosage (g) Maxirelin 100 lactose 1050 glutamic acid 300 Microcrystalline Cellulose (PH 102) 200 citric acid 50 Crospovidone 60

[0055] Mannitol 250 Magnesium stearate 6

[0056] (a) Preparation of maxirelin granules

[0057] Mix maxirelin, glutamic acid, lactose, citric acid, and mannitol evenly and dissolve them in water. Set the air inlet temperature of the spray drying equipment to 80°C, the atomizer speed to 25,000rpm, and the atomization pressure to 0.4-0.88MPa for spraying. Dry and granulate.

[0058] (b) Preparation of macirelin tablets: the macirelin granules, microcrystalline cellulose, crospovidone, and magnesium stearate obtained in step (a) are uniformly mixed and compressed into tablets, and 10,000 tablets are compressed in total . The average tablet weight of the obtained plain tablet was 0.20 g.

[0...

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Abstract

The invention provides a macimorelin film coated tablet, which comprises macimorelin, a filling agent, a water soluble acidic solid auxiliary material, a disintegrating agent, a lubricant, and a coating material. Correspondingly, the invention also provides a preparation method of the macimorelin film coated tablet. The preparation method comprises the following steps: (a) preparing macimorelin particles; (b) pressing blank tablets; and (c) coating.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular, the invention relates to a film-coated maxirelin tablet and a preparation method thereof. Background technique [0002] Adults need growth hormone (growth hormone) to maintain normal body fat, muscle and bone content. However, some people, such as those who have undergone traumatic brain injury, pituitary tumor surgery, or craniopharyngioma surgery, do not produce enough growth hormone, and these people need growth hormone replacement therapy. Such a condition is called Adult Growth Hormone Deficiency (AGHD). AGHD is one of the hot diseases that the international medical community has paid attention to in recent ten years. [0003] AGHD refers to the clinical symptoms and corresponding biochemical characteristics related to growth hormone deficiency manifested in adults, which can be mainly divided into the following three categories: (1) GHD in children continues to ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/22A61K9/30A61K9/36A61P5/06
Inventor 郑春莲戴荣欢徐春莲陶安进马亚平袁建成
Owner HYBIO PHARMA