Oral disintegrating tablet of obeticholic acid, and preparation method thereof

A technology of obeticholic acid and orally disintegrating tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., can solve complex equipment, high production costs, fluidity of excipients, Issues such as large impact on compressibility

Inactive Publication Date: 2016-10-12
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Orally disintegrating tablets prepared by freeze-drying disintegrate quickly and taste good, but the production cost is high, the technology is difficult, and the equipment is complicated
The advantage of the tableting method is that the process is simple, and the existing oral solid preparation workshop can be used for production. The technical difficulty is small and the cost is low. However, it is greatly affected by the fluidity and compressibility of the excipients, and the requirements for the selection of excipients are high.

Method used

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  • Oral disintegrating tablet of obeticholic acid, and preparation method thereof
  • Oral disintegrating tablet of obeticholic acid, and preparation method thereof
  • Oral disintegrating tablet of obeticholic acid, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] To produce 1000 tablets of obeticholic acid orally disintegrating tablets with a specification of 10 mg, the dosage of raw and auxiliary materials is as follows:

[0058] Raw materials

Dosage (g)

Obeticholic acid

10

Calcium Carboxymethyl Cellulose

20

pregelatinized starch

120

Sorbitol

30

Stevioside

12

Magnesium stearate

8

[0059] Preparation:

[0060] (a) The main drug obeticholic acid is pulverized through a 100-mesh sieve, and the filler is passed through a 100-mesh sieve for subsequent use;

[0061] (b) The main ingredient is mixed with the pregelatinized starch, sieved, and the filler sorbitol is added and mixed;

[0062] (c) adding disintegrant, flavoring agent and lubricant to the mixture obtained in step (b) above and mixing;

[0063] (d) Tablets.

Embodiment 2

[0065] To produce 1000 tablets of obeticholic acid orally disintegrating tablets with a specification of 10 mg, the dosage of raw and auxiliary materials is as follows:

[0066] Raw materials

[0067] The preparation method is the same as in Example 1.

Embodiment 3

[0069] To produce 1000 tablets of obeticholic acid orally disintegrating tablets with a specification of 25 mg, the dosage of raw and auxiliary materials is as follows:

[0070] Raw materials

[0071] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and in particular relates to an orally disintegrating obeticholic acid tablet and a preparation method thereof. The orally disintegrating tablet of obeticholic acid of the present invention is composed of active ingredient obeticholic acid, filler, disintegrant, flavoring agent and lubricant, and its weight percentage is: 5‑12.5: 65‑75: 10‑20 : 1-6: 3-7. The invention adopts a powder direct tableting method to prepare obeticholic acid orally disintegrating tablets, and the process is simple and suitable for large-scale industrial production. The disintegration time, content uniformity, stability and the like of the obeticholic acid orally disintegrating tablet prepared by the present invention all meet the pharmacopoeia standards.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an orally disintegrating obeticholic acid tablet and a preparation method thereof. Background technique [0002] Acute and chronic liver diseases are one of the main causes of serious threats to human health, including viral hepatitis such as hepatitis B and C, and non-infectious liver diseases such as alcoholic liver disease and nonalcoholic fatty liver disease. my country currently has 20 million patients with chronic viral hepatitis and 120 million hepatitis B virus carriers, accounting for 1 / 3 of the global hepatitis B virus carriers. And with the improvement of modern people's living standards, the incidence of alcoholic fatty liver and non-alcoholic fatty liver is increasing, and people's demand for liver protection drugs is increasing. [0003] Obeticholic acid is a hepatoprotective drug whose mechanism of action is an agonist of the farnesoid X rece...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/575A61K47/26A61K47/36A61P1/16
CPCA61K9/0056A61K9/2018A61K9/2059A61K31/575A61K47/26A61K47/36
Inventor 谢媛王广基佘琳琳王梓霞张榜玲张一睿
Owner CHINA PHARM UNIV
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