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Enzalutamide soft capsule quick-release preparation and preparation method thereof

A technology of enzalutamide and immediate-release preparations, which is applied in the field of medicine, can solve the problems of increasing the instability of raw materials, difficulty of filling, and low drug loading, and achieve increased drug dispersion, high bioavailability, and improved bioavailability. The effect of utilization

Pending Publication Date: 2020-12-29
REYOUNG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Patent CN104857517B mixes the contents of enzalutamide, caprylic acid macrogol glyceride, butylated hydroxyanisole, butylated hydroxytoluene and enzalutamide to prepare soft capsules. The method is to heat the carrier to dissolve the raw materials, and then fill it. This method has a low drug loading, increases the instability of raw materials and makes filling more difficult, and has already formed a solution, which may precipitate irregular raw material crystals as the storage time and temperature change

Method used

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  • Enzalutamide soft capsule quick-release preparation and preparation method thereof
  • Enzalutamide soft capsule quick-release preparation and preparation method thereof
  • Enzalutamide soft capsule quick-release preparation and preparation method thereof

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Embodiment 1-10

[0024] In Examples 1-10, the composition of the content and raw materials of the enzalutamide soft capsule immediate-release preparation is shown in Table 1.

[0025] The content raw material composition of table 1 embodiment 1-10 (in parts by weight)

[0026]

[0027]

[0028] The preparation method is as follows:

[0029] (1) heating the medium-chain triglyceride to 60° C., adding stearin and lecithin, and stirring evenly to obtain a pseudoplastic matrix fluid;

[0030] (2) Add enzalutamide to the pseudoplastic matrix fluid, stir evenly, and obtain a content suitable for soft capsule filling with certain fluidity;

[0031] (3) According to the mass ratio of gelatin, glycerin and purified water as 1:0.4:1, first add purified water and glycerin to the glue tank and heat to 70°C, stir until the solution is clear; then add gelatin to it, 70°C Stir to dissolve, and evacuate the air bubbles to obtain the capsule shell material;

[0032] (4) The contents and the capsule sh...

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Abstract

The invention relates to the technical field of medicines, in particular to an enzalutamide soft capsule quick-release preparation and a preparation method thereof. The enzalutamide soft capsule quick-release preparation is composed of a capsule shell and a content, wherein the content is a suspension containing enzalutamide. The enzalutamide soft capsule quick-release preparation is composed of the following raw materials in parts by weight of 40 parts of enzalutamide, 40-60 parts of medium chain triglyceride, 50-100 parts of a thickening agent, and 0.3-5 parts of a flow aid. According to theenzalutamide soft capsule quick-release preparation disclosed by the invention, aiming at the property characteristics of enzalutamide medicines, a soft capsule is prepared by adopting a suspension system, so that the dispersion and absorption of the enzalutamide are promoted, the chemical and physical stability of the medicines is good, the dissolution of effective components is quick, and the bioavailability is high. The invention also provides the preparation method of the enzalutamide soft capsule quick-release preparation.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an enzalutamide soft capsule quick-release preparation and a preparation method thereof. Background technique [0002] Enzalutamide is an androgen receptor antagonist that blocks androgen binding to the androgen receptor and prevents nuclear translocation and coactivator recruitment of the ligand-receptor complex and is used in the treatment of castration-resistant prostate cancer medicine. Enzalutamide is a poorly soluble drug, and its solubility in aqueous solution and solutions with different pHs is relatively low, which limits the preparation form of enzalutamide. At present, most of them are oral solid preparations, tablets or capsules on the market, but the drug dissolution is relatively slow, and the dissolution is incomplete, and the bioavailability is low, which limits the curative effect of oral preparations. [0003] Patent CN105030685A made enzalutamide into a soli...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K47/14A61K47/42A61K47/12A61K47/24A61K31/4166A61P13/08A61P35/00
CPCA61K9/4858A61K9/4825A61K9/4833A61K31/4166A61P13/08A61P35/00
Inventor 苗得足胡清文吕帅孔梁焦启扬王向华杨书华
Owner REYOUNG PHARMA
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