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Moxifloxacin dispersible tablet and preparation method thereof

A technology of moxifloxacin hydrochloride and dispersible tablets, applied in the field of chemical pharmacy, can solve the problems of inconvenience for patients to take, less adverse reactions, etc., and achieve rapid drug dissolution, short disintegration time, good fluidity and compressibility Effect

Active Publication Date: 2015-09-16
CHONGQING SHENGHUAXI PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Currently commercially available moxifloxacin oral preparations are mainly tablets, which are inconvenient to be taken by the elderly, young and patients who have difficulty swallowing solids. It is urgent to develop a new drug that is convenient to take, fast to absorb, high in bioavailability and less in adverse reactions. dosage form

Method used

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  • Moxifloxacin dispersible tablet and preparation method thereof
  • Moxifloxacin dispersible tablet and preparation method thereof
  • Moxifloxacin dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-12

[0031] Test the selection of various excipients in the prescription, take each component according to the amount in Table 1 and 2, pass moxifloxacin hydrochloride through an 80 mesh sieve, filler, disintegrant (accounting for 65% of the total disintegration dose), Adhesives, flavoring agents, etc. are passed through a 60-mesh sieve, and the above components are mixed evenly. Subsequently, with an appropriate amount of 4% povidone K 30 The ethanol solution is prepared into a soft material, granulated through a 30-mesh sieve, dried at 55°C, and then granulated through a 24-mesh sieve. Then add a lubricant and a disintegrant (accounting for 35% of the total disintegrating dose), mix evenly and press into tablets to prepare dispersible tablets each containing 200 mg of moxifloxacin hydrochloride.

[0032] Table 1 The composition and investigation results of each component in Examples 1-6

[0033]

[0034] Table 2 The composition and investigation results of each component in ...

Embodiment 13-21

[0038] According to the preferred auxiliary materials in Example 9 above, the proportions of the various components of the auxiliary materials were studied in Examples 13-21, and each component was measured according to Table 3. Pass moxifloxacin hydrochloride through a 80-mesh sieve, microcrystalline cellulose, crospovidone (accounting for 65% of the total), hydroxypropyl cellulose, stevioside, etc. through a 60-mesh sieve, and mix the above components evenly . Subsequently, with an appropriate amount of 4% povidone K 30 The ethanol solution is prepared into a soft material, granulated through a 30-mesh sieve, dried at 55°C, and then granulated through a 24-mesh sieve. Magnesium stearate and crospovidone (accounting for 35% of the total amount) were then added, mixed uniformly and pressed into tablets to prepare dispersible tablets each containing 200 mg of moxifloxacin hydrochloride.

[0039] Table 3 Embodiment 13-21 each component weight composition and investigation resu...

Embodiment 22

[0043] Prepare each dispersible tablet containing 50mg of moxifloxacin hydrochloride active substance, each active substance content is about 33%, take each component according to the following weight:

[0044] Moxifloxacin hydrochloride 50g

[0045] Crospovidone 20g

[0046] Microcrystalline Cellulose 50g

[0047] Hypromellose 23g

[0048] Magnesium Stearate 3g

[0049] Stevioside 4g

[0050] 4% Povidone K 30 Proper amount of ethanol solution

[0051] Pass 50 g of the above-mentioned moxifloxacin hydrochloride through a 80-mesh sieve, 13 g of crospovidone, 50 g of microcrystalline cellulose, 23 g of hydroxypropyl cellulose, and 4 g of stevioside through a 60-mesh sieve, and mix the above components evenly. Subsequently, with an appropriate amount of 4% povidone K 30 The ethanol solution is prepared into a soft material, granulated through a 30-mesh sieve, dried at 55°C, and then granulated through a 24-mesh sieve. Then 7 g of crospovidone and 3 g of magnesium stearate...

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Abstract

The invention discloses a dispersible tablet of moxifloxacin or a salt thereof or / and hydrate thereof and a preparation method of the dispersible tablet. The prescription of dispersible tablet comprises the following components in percentage by weight: 15%-65% of filler, 5%-10% of adhesive, 5%-25% of disintegrating agent, 1%-5% of lubricating agent, and a proper amount of wetting agent and other auxiliary materials. The preparation method of the moxifloxacin dispersible tablet comprises the following steps of: respectively screening the main material and the auxiliary materials; uniformly mixing the main material and the auxiliary materials according to a prescription ratio; using a proper amount of povidone K30 alcohol solution to prepare a soft material; sieving and pelletizing, drying, and sieving the dry particles; adding a disintegrating agent cross-linked povidone and a lubricating agent magnesium stearate, uniformly mixing and tabletting to obtain the dispersible tablet. The dispersible tablet of moxifloxacin or the salt thereof or / and hydrate thereof provided by the invention is short in disintegrating time, good in dispersing status, quick in dissolving out of medicines, convenient and flexible to take, and can be swallowed, also can be taken after being dispersed in water.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy and relates to a preparation method of medicines and medicine preparations. It specifically relates to a dispersible tablet of moxifloxacin or its salt and / or its hydrate and a preparation method thereof. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone broad-spectrum fully synthetic antibacterial drugs. Clinically, it is mainly used to treat upper and lower respiratory tract infections, such as acute sinusitis, chronic bronchial exacerbation, community-acquired pneumonia, and skin and soft tissue infections. Studies have shown that moxifloxacin is effective in the treatment of community-acquired pneumonia and can be used as the drug of choice for community-acquired pneumonia. [0003] Moxifloxacin hydrochloride is the fourth-generation fluoroquinolone broad-spectrum antibacterial drug developed by Bayer Company in Germany. It was first launched in Germany in 199...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4709A61P31/04
Inventor 何亮曾秀秀
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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