Febuxostat soft capsule preparation and preparation technology thereof

A technology of soft capsule preparation and febuxostat, which is applied in the direction of capsule delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as adverse reactions, and achieve improved dissolution efficiency and good stability The effect of improving the cumulative dissolution rate

Inactive Publication Date: 2018-05-08
FOSHAN TENGRUI MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This also brings serious and even fatal adverse reactions due to drug accumulation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Prescription of content of febuxostat soft capsule preparation:

[0058] Febuxostat raw material 0.5g; caprylic capric acid macrogolglyceride 220g;

[0059] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0060] 0.035 g of 2,6-di-tert-butyl-p-cresol.

[0061] Softgel prescription:

[0062] Gelatin 160mg; Glycerin 80mg;

[0063] Yellow iron oxide 0.29mg; titanium dioxide 2mg.

[0064] Preparation:

[0065] (1) Preparation of contents: Take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of febuxostat raw material after heating up to 40°C drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1h until uniform, and then cool down to room temperature to obtain the content;

[0066](2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yello...

Embodiment 2

[0069] Prescription of content of febuxostat soft capsule preparation:

[0070] Febuxostat raw material 0.1g; caprylic capric acid macrogolglyceride 225g;

[0071] Polyglycerol oleate 50g; medium chain triglyceride 72g;

[0072] 0.038g of 2,6-di-tert-butyl-p-cresol.

[0073] Softgel prescription:

[0074] Gelatin 160mg; Glycerin 80mg;

[0075] Yellow iron oxide 0.25mg; titanium dioxide 2.2mg.

[0076] Preparation:

[0077] (1) Preparation of contents: Take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of febuxostat raw material after heating up to 40°C drug and 2,6-di-tert-butyl-p-cresol, continue to stir for 1h until uniform, and then cool down to room temperature to obtain the content;

[0078] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yel...

Embodiment 3

[0081] Prescription of content of febuxostat soft capsule preparation:

[0082] Febuxostat raw material 0.8g; caprylic capric acid macrogolglyceride 220g;

[0083] Polyglycerol oleate 45g; medium chain triglyceride 75g;

[0084] Softgel prescription:

[0085] Gelatin 161mg; Glycerin 85mg;

[0086] Yellow iron oxide 0.27mg; titanium dioxide 2mg.

[0087] Preparation:

[0088] (1) Preparation of contents: Take the prescription amount of caprylic capric acid macrogolglyceride, polyglycerol oleate and medium chain triglyceride and stir evenly, add the prescribed amount of febuxostat raw material after heating up to 40°C Continue to stir the medicine for 1 hour until it is uniform and then cool down to room temperature to obtain the content;

[0089] (2) Preparation of soft capsules: Take the prescribed amount of glycerin, add water, put it in a plastic tank, stir and mix evenly, then add titanium dioxide and yellow iron oxide passed through an 80-mesh sieve and mix evenly, th...

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PUM

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Abstract

The invention discloses a Febuxostat soft capsule preparation. The Febuxostat soft capsule preparation comprises a soft capsule and contents, wherein a prescription of the contents comprises 0.1-1g ofFebuxostat raw material, 200-250g of caprylic capric acid polyethylene glycol glyceride, 30-60g of polyglycerol oleate, 50-100g of medium chain triglyceride, and 0.02-0.05g of 2,6-butylated hydroxytoluene. The Febuxostat soft capsule has the advantages that the accumulative dissolution rate within 5 minutes of dissolution can be remarkably increased, and the dissolution efficiency of main drugs in the previous time period can be improved; and the stability is good, and the appearance quality of a product is good.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a febuxostat soft capsule preparation and a preparation process thereof. Background technique [0002] Febuxostat first applied for listing in Japan at the beginning of 2004 by Japan's Teijin Corporation, and at the end of the year it applied for listing in the United States, and IPSEN applied for listing in Europe; febuxostat is a new generation of xanthine oxidase inhibitors, clinically used Treat hyperuricemia (gout). [0003] Gout is caused by the deposition of crystalline uric acid in the joints, causing an inflammatory response. The goal of treatment is to reduce the serum uric acid level to below 6 mg / dL. The current standard treatment drug is allopurinol, which belongs to xanthine oxidase inhibitors. [0004] The occurrence of gout is due to the excessive production of uric acid in the body and the decline in the ability of the kidneys to clear it. T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/14A61K31/426A61P19/06
CPCA61K9/4858A61K9/4808A61K31/426
Inventor 欧泽桂
Owner FOSHAN TENGRUI MEDICINE TECH CO LTD
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