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Enzalutamide soft capsule and preparation method thereof

A technology of enzalutamide and soft capsule, applied in the field of medicine, can solve the problems of incompleteness, low bioavailability, low solubility and the like

Active Publication Date: 2015-08-26
NANJING HEALTHNICE MEDICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Enzalutamide is a poorly soluble drug with low solubility in aqueous solution and buffers with different pHs. If it is prepared into an ordinary oral solid preparation, such as tablet or capsule, the drug will dissolve slowly and incompletely, and the bioavailability low, which limits the efficacy of its oral formulations

Method used

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  • Enzalutamide soft capsule and preparation method thereof
  • Enzalutamide soft capsule and preparation method thereof
  • Enzalutamide soft capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019]

[0020]

[0021] Preparation:

[0022] (1) Preparation of the contents: heat caprylic capric acid macrogol glyceride to 60-70°C, add butylated hydroxyanisole, butylated hydroxytoluene and enzalutamide, and stir until the raw and auxiliary materials are completely dissolved;

[0023] (2) Preparation of capsule shell glue: add purified water, glycerin and sorbitol into the glue tank and heat to 60-80°C, stir until the solution is clear; add titanium dioxide, stir until the gelatin is evenly dispersed; add gelatin, then add prescription amount of gelatin. Turn on the vacuum pump, degas for ≥3 hours under the condition of ≤-0.08Mpa, keep warm at 70±5°C, and set aside;

[0024] (3) Preparation of soft capsules: take the prepared contents and capsule shells, make soft capsules by pressing, shape, dry, wash pills, pick pills, and pack.

Embodiment 2

[0026]

[0027] Preparation:

[0028] (1) Preparation of the contents: heat caprylic capric acid macrogol glyceride to 60-70°C, add butylated hydroxyanisole, butylated hydroxytoluene and enzalutamide, and stir until the raw and auxiliary materials are completely dissolved;

[0029] (2) Preparation of capsule shell glue: add purified water, glycerin and sorbitol into the glue tank and heat to 60-80°C, stir until the solution is clear; add titanium dioxide, stir until the gelatin is evenly dispersed; add gelatin, then add prescription amount of gelatin. Turn on the vacuum pump, degas for ≥3 hours under the condition of ≤-0.08Mpa, keep warm at 70±5°C, and set aside;

[0030] (3) Preparation of soft capsules: take the prepared contents and capsule shells, make soft capsules by pressing, shape, dry, wash pills, pick pills, and pack.

Embodiment 3

[0032]

[0033] Preparation:

[0034] (1) Preparation of the contents: heat caprylic capric acid macrogol glyceride to 60-70°C, add butylated hydroxyanisole, butylated hydroxytoluene and enzalutamide, and stir until the raw and auxiliary materials are completely dissolved;

[0035] (2) Preparation of capsule shell glue: add purified water, glycerin and sorbitol into the glue tank and heat to 60-80°C, stir until the solution is clear; add titanium dioxide, stir until the gelatin is evenly dispersed; add gelatin, then add prescription amount of gelatin. Turn on the vacuum pump, degas for ≥3 hours under the condition of ≤-0.08Mpa, keep warm at 70±5°C, and set aside;

[0036] (3) Preparation of soft capsules: take the prepared contents and capsule shells, make soft capsules by pressing, shape, dry, wash pills, pick pills, and pack.

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Abstract

The invention discloses an enzalutamide soft capsule and a preparation method thereof. The enzalutamide soft capsule comprises capsule content and a capsule shell, wherein the capsule content comprises enzalutamide and pharmaceutical adjuvants; the capsule shell is formed by gelatin, glycerin, sorbitol, titanium dioxide, purified water and the like. The soft capsule can be prepared with the method comprising following steps: Labrasol, butylated hydroxyanisole, butylated hydroxytoluene and enzalutamide are mixed to obtain the capsule content material of the soft capsule; the gelatin, the glycerin, the sorbitol, titanium dioxide and the purified water are mixed to obtain the capsule shell material of the soft capsule; the capsule content material and the capsule shell material of the soft capsule are pelleted on a soft capsule making machine to obtain the enzalutamide soft capsule. The enzalutamide soft capsule and the preparation method have the following advantages: the soft capsule is convenient to administrate and carry, the drug stability is good, effective components are dissolved quickly, and the bioavailability is high.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an enzalutamide soft capsule and a preparation method thereof. Background technique [0002] Enzalutamide, chemical name: 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-sulfur Oxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide, molecular formula: C 21 h 16 f 4 N 4 o 2 S, molecular weight: 464.44, structural formula as follows: [0003] Physical and chemical properties: This product is a white crystalline powder, easily soluble in N-methylpyrrolidone and acetonitrile, slightly soluble in methanol and absolute ethanol, almost insoluble in water. Enzalutamide is a new type of anticancer drug, which has been approved by the US FDA for the treatment of metastatic castration-resistant prostate cancer after docetaxel treatment. Patients treated with docetaxel were also effective. Enzalutamide is an androgen receptor inhibitor that acts on different steps in the a...

Claims

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Application Information

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IPC IPC(8): A61K47/34A61K31/4166A61K9/48A61P35/00
Inventor 曹林王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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