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A hard capsule preparation

A technology of hard capsules and preparations, which is applied in capsule delivery, medical preparations containing non-active ingredients, and medical preparations containing active ingredients. Excellent stability and uniform drug content

Active Publication Date: 2020-05-05
JIANGSU VCARE PHARMATECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can effectively improve the stability of lubiprostone, the liquid oil formed by dissolving the drug in medium-chain triglycerides is difficult to clean during the production process, and has high requirements for production equipment, which is not conducive to large-scale industrial production
This product is a highly active drug, and the commercially available specifications include 8 micrograms and 24 micrograms. Due to the low dosage, the development of conventional solid preparations is particularly difficult. The development risk is not only reflected in the uniformity of the mixture, but also includes stability, personnel protection, etc. , so there is no relevant report on the development of solid preparations of this product

Method used

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  • A hard capsule preparation
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation of mannitol particles:

[0020] After taking 4 kg of mannitol through a 200-mesh sieve, it is placed in a high-shear wet granulation pot with a stirring speed of 500 rpm / min, a cutting speed of 3000 rpm, and 800 g of water for granulation at a rate of 400 g / min. After the addition, continue to shear for 1 min, take out the wet mannitol granules and dry them at 65°C until the moisture content is less than 0.3%. The granules are sized through a 24-mesh sieve as the low-water active auxiliary material granules.

Embodiment 2

[0022] Preparation of mannitol particles:

[0023] Take 200SD direct pressure grade mannitol, dry it in a constant temperature drying oven at 65°C until the moisture content is less than 0.3%, and take it out through a 40-mesh sieve as the low-water activity auxiliary material particles.

Embodiment 3

[0025] Preparation of Lubiprostone Hard Capsules

[0026] Prepare according to the following prescription:

[0027]

[0028]

[0029] *Volatilized and removed during the preparation process.

[0030] Put the prescription amount of lubiprostone and medium-chain triglycerides in the prescription amount of acetone, stir and dissolve at 20 rpm, add mannitol particles, continue stirring, open the preparation tank and heat it at 40℃, turn on the vacuum device, and acetone The volatilization pipeline on the top of the preparation tank enters the acetone collection tank. When the collection continues until there is no fraction, the vacuum is continued for 1 hour, the particles are taken out, the organic solvent is detected, the prescription amount of glyceryl behenate is added, and the three-dimensional mixer is mixed for 3 minutes at 25 rpm. Control the drug content in the granules and then fill them into No. 3 hard capsules

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Abstract

The invention relates to a lubiprostone hard capsule preparation and a preparation method thereof, wherein the lubiprostone hard capsule preparation comprises a gelatin capsule shell, lubiprostone-containing particles, and a lubricant. According to the present invention, the lubiprostone hard capsule preparation has advantages of uniform drug content, excellent stability, rapid dissolution in vitro and simple operation, and is particularly suitable for the industrial production of solid preparation workshops.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to a hard capsule preparation of lubiprostone and a preparation method thereof. Background technique [0002] Lubiprostone is a selective chlorine channel activator. It has a novel mechanism of action. It can increase the secretion of intestinal juice and enhance intestinal peristalsis. It is beneficial to alleviate the symptoms of constipation. It has been approved by the FDA to treat adult chronic idiopathic constipation and adult chronic chronic constipation. Constipation caused by opioid use in non-cancerous pain patients and constipated irritable bowel syndrome in women over 18 years of age. [0003] Because this product is easily degraded in water and has low stability, the commercially available product dissolves the drug in medium-chain triglycerides to make a soft capsule preparation. The preparation method has been disclosed by patent CN101410097A. Although ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/558A61K31/5575A61K47/26A61P1/10A61P1/00
Inventor 赵炎磊刘小羽刘雪芳龚彦春刘永强
Owner JIANGSU VCARE PHARMATECH
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