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Dexibuprofen sustained-release tablet and preparation process thereof

A sustained-release tablet and process technology, applied in the field of dextro-ibuprofen sustained-release tablet and its preparation, can solve the problems such as the inability to improve the sticking and punching phenomenon of tablet pressing, lack of anti-sticking measures, etc. Good performance and efficiency

Inactive Publication Date: 2015-04-29
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the absence of anti-sticking measures, the sticking phenomenon during tablet compression cannot be improved.

Method used

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  • Dexibuprofen sustained-release tablet and preparation process thereof
  • Dexibuprofen sustained-release tablet and preparation process thereof
  • Dexibuprofen sustained-release tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The dry granulation of embodiment 1 Dexibuprofen

[0054] (1) See Table 1 for dry granulation prescription.

[0055] Table 1. Dry granulation prescription (mg / tablet)

[0056] Raw materials

Prescription 1

Prescription 2

Dexibuprofen

300 (average particle size 70μm)

300 (average particle size 30μm)

Microcrystalline Cellulose 102

45

45

[0057] colloidal silica

45

45

[0058] (2) Preparation method

[0059] Mix Dexibuprofen, microcrystalline cellulose 102 and colloidal silicon dioxide, pass through a 26-mesh sieve, and then use a high-speed rotary tablet press (GZPK3045 high-speed rotary tablet press, 45 punches, Shanghai Tianxiang Jiantai Pharmaceutical Co., Ltd. Co., Ltd.) pressed flakes, and the flakes passed through a swing granulator (26 mesh screen) to obtain dry granules. See the process flow figure 1 .

[0060] (3) Results

[0061] There is no sticking and punching phenomenon in ...

Embodiment 2

[0062] Embodiment 2 Preparation and dissolution behavior of Dexibuprofen sustained-release tablets of the present invention

[0063] The dry-process granules prepared by the two prescriptions in Example 1 were pressed into tablets respectively according to the following prescriptions, and the dissolution behavior of the Dexibuprofen sustained-release tablets prepared by raw materials with different particle sizes was investigated by dissolution tests.

[0064] (1) For the prescription of Dexibuprofen Sustained-release Tablets, see Table 2.

[0065] Table 2. Prescription of Dexibuprofen Sustained-release Tablets (mg / tablet)

[0066]

[0067]

[0068] (2) Preparation method

[0069] Weigh the dry-process granules obtained in Example 1 and other auxiliary materials according to the prescription of the immediate-release layer, and mix them uniformly; then weigh the dry-process granules obtained in Example 1 and other auxiliary materials according to the prescription of the ...

Embodiment 3

[0083] Embodiment 3 Dissolution behavior of Dexibuprofen sustained-release tablets of the present invention in different dissolution media

[0084] With the dry-process granules prepared by prescription 2 in Example 1, according to the prescription of sustained-release tablets described in Example 2, scale-up production of Dexibuprofen sustained-release tablets of the present invention (hereinafter referred to as "self-made samples") in a workshop , compared with the similar product (trade name Maxibupen ER, specification 300mg, batch number 11003, manufacturer: Korea Hanmi Pharmaceutical Co., Ltd.; hereinafter referred to as "reference preparation") in different dissolution media Research:

[0085] Dissolution medium:

[0086] 1. pH 1.0 hydrochloric acid solution: 9ml hydrochloric acid, dilute with water to 1000ml, shake well, and you get it;

[0087] 2. Phosphate buffer solution of pH 6.8: 6.8g potassium dihydrogen phosphate and 0.9583g sodium hydroxide, add water to disso...

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Abstract

The invention discloses a dexibuprofen sustained-release tablet and a preparation process thereof. According to the preparation process, colloidal silicon dioxide is used as an antiplastering aid, and dry granulation is carried out by using a high-speed rotary tablet press; the prepared dry granules are respectively mixed with auxiliaries in specific quick-release and sustained-release layers to press a dual-layer tablet which is the dexibuprofen sustained-release tablet. The preparation process can be used for effectively reducing the sticking phenomenon caused by temperature increase when tabletting is carried out for a long time, and has simple process and relatively high efficiency; and the prepared sustained-release tablet has high bioavailability and good stability.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a Dexibuprofen sustained-release tablet and a preparation process thereof. Background technique [0002] Mixed ibuprofen is composed of equal amounts of ibuprofen and ibuprofen. It has been used clinically as an anti-inflammatory and analgesic for 30 years and is considered to be the safest non-steroidal anti-inflammatory drug (NSAID) ), and is an over-the-counter drug. However, mixed ibuprofen still has a variety of side effects including gastrointestinal toxicity, water and sodium retention, decreased renal perfusion, and allergic reactions, with an incidence rate of 15% to 30%. For the development of safer NSAIDs, two drugs have been proposed: cyclooxygenase-2 inhibitors and pure steric counterparts of NSAIDs, especially dexibuprofen. In 1996, Dexibuprofen began to be widely used in the treatment of rheumatoid arthritis in Austria. experience, so it is quickly accepted and...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/22A61K31/192A61K47/04A61P19/02A61P29/00
Inventor 闫学文方翼杨慧君成仁基
Owner BEIJING HANMI PHARMA CO LTD
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