Apremilast oral solid preparation and preparation method thereof

A technology of solid preparations and fillers, applied in anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc., which can solve problems such as insufficient oral release, low dissolution of apremilast, and complicated operation processes, and achieve stable and reliable quality and reduce The effect of simple production cost and equipment operation

Inactive Publication Date: 2017-09-01
广州艾格生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims to provide an oral solid preparation of apremilast and its preparation method, which ef

Method used

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  • Apremilast oral solid preparation and preparation method thereof
  • Apremilast oral solid preparation and preparation method thereof
  • Apremilast oral solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example

[0025] Examples 1 to 6 Aprester oral solid preparation and preparation method thereof

[0026] The formulations of the oral solid preparations of aprester of Examples 1 to 6 are as described in Table 1.

[0027] Table 1 The formulations of the oral solid preparations of aprester of Examples 1 to 6 (unit: g)

[0028]

[0029] The preparation methods of the Aplast tablets of the above Examples 1 to 6 are as follows:

[0030] (1) Pass the active ingredients of the drug through a 120-mesh sieve for use; fillers and disintegrants through a 120-mesh sieve for use;

[0031] (2) Weighing and premixing: mix the prescription amount of API with filler and disintegrant in a mixer;

[0032] (3) Add lubricant to the above-mentioned mixed powder and press tablets;

[0033] (4) Put The powder is formulated into a solution, and the coating is carried out, and the coating temperature is controlled at 38°C to 42°C.

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Abstract

The invention discloses an apremilast oral solid preparation and a preparation method thereof. The invention belongs to the field of pharmaceutical preparations. The apremilast oral solid preparation is prepared by mixing, pressing and coating active components and excipients. The apremilast oral solid preparation comprises medicine active components, a filling agent, a disintegrating agent, a lubricating agent and a coating material. The compressibility and the flowability of the medicine can be improved by using auxiliary materials, and the oral solid preparation with high dissolvability and stable quality can be prepared by a powder direct tabletting process. The preparation method is simple in operation, low in production, high in efficiency, environment-friendly and suitable for industrialized mass production of the apremilast oral solid preparations.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, more specifically, the invention relates to a premilast oral solid preparation with apremilast as an active ingredient and a preparation method thereof. Background technique [0002] The English name of Apremilast is Apremilast, and the chemical name is S-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl)-4-acetylaminoiso Indoline-1,3-dione, the molecular formula is C22H24N207S, the molecular weight is 460.5, and the chemical structural formula is as follows: [0003] [0004] Apremilast is a small molecule phosphodiesterase 4 (PDE4) inhibitor, which can regulate the action of intracellular pro-inflammatory and anti-inflammatory factors, reduce joint swelling and improve the physiological functions of joints. Apremilast was developed by Celgene Biotechnology Company and was approved by the US FDA on March 21, 2014. The trade name is For the treatment of psoriasis and psoriati...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/38A61K47/26A61K31/4035A61P17/06A61P19/02A61P29/00
CPCA61K9/2866A61K9/0053A61K9/2018A61K9/2054A61K9/2095A61K31/4035
Inventor 汤文星余思琴谭斌
Owner 广州艾格生物科技有限公司
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