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Amoxicillin clavulanate potassium 4:1 dispersible tablet and production technology thereof

A technology of amoxicillin-clavulanate potassium and dispersible tablets, which is applied in the direction of active ingredients of heterocyclic compounds, pill delivery, antibacterial drugs, etc. It can solve the problems that the fluidity is not as good as that of granules, and it is easy to produce capping, so as to achieve fluidity Good resistance, not easy to absorb water, excellent disintegration performance

Inactive Publication Date: 2008-06-04
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The material used in direct compression is powdery fine powder, its fluidity is not as good as that of granules, and there is more air in the powder than in the granules, and capping is prone to occur during tablet compression
[0006] At present, although many pharmaceutical companies in my country have produced amoxicillin and clavulanate potassium 4:1 dispersible tablets, because potassium clavulanate is easily degraded when exposed to water, wet granulation process cannot be used for production, and direct compression can only be used. craft
Therefore, there are fluidity and compressibility problems in the process, and it is necessary to study the selection of auxiliary materials and the improvement of the process

Method used

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  • Amoxicillin clavulanate potassium 4:1 dispersible tablet and production technology thereof
  • Amoxicillin clavulanate potassium 4:1 dispersible tablet and production technology thereof
  • Amoxicillin clavulanate potassium 4:1 dispersible tablet and production technology thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Feeding:

[0044] 1. Potassium Amoxicillin and Clavulanate 4:1 Mixed Powder 156.25g

[0045] 2. Lactose 35g

[0046] 3. Microcrystalline cellulose 65g

[0047] 4. Crystalline Mannitol 170g

[0048] 5. Cross-linked polyvinylpyrrolidone (XL type) 60g

[0049] 6. Micropowder silica gel (solid phase) 10.4g

[0050] 7. Magnesium stearate 5.2g

[0051] 8. Powdered mint essence 6.2g

[0052] 9. Aspartame 3.4g

[0053]

[0054] Total weight 511.45g

[0055] a) Dry lactose, microcrystalline cellulose, crystalline mannitol, cross-linked PVP, and micropowder silica gel at 90°C for 14 hours;

[0056]b) Mix the full amount of lactose, crystalline mannitol, cross-linked PVP, micropowder silica gel and 48g of microcrystalline cellulose according to the above prescription, and put them into the mixer together with the main ingredients and mix for 30 minutes to control the moisture content of the mixed powder < 3.0%;

[0...

Embodiment 2

[0063] Feeding:

[0064] 1. Potassium Amoxicillin and Clavulanate 4:1 Mixed Powder 160g

[0065] 2. Lactose 45g

[0066] 3. Microcrystalline cellulose 68g

[0067] 4. Crystalline Mannitol 183g

[0068] 5. Cross-linked polyvinylpyrrolidone (XL type) 62.5g

[0069] 6. Micropowder silica gel (solid phase) 11.8g

[0070] 7. Magnesium stearate 7.3g

[0071] 8. Powdered peppermint essence 11.6g

[0072] 9. Aspartame 6.9g

[0073]

[0074] Total weight 556.1g

[0075] a) Dry lactose, microcrystalline cellulose, crystalline mannitol, cross-linked PVP, and micronized silica gel at 95° C. for 12 hours;

[0076] b) Mix the full amount of lactose, crystalline mannitol, cross-linked PVP, micropowder silica gel and 35g of microcrystalline cellulose according to the above prescription, and put them into the mixer together with the main ingredients and mix for 40 minutes to control the moisture content of the mixed powder < 3.0%;

...

Embodiment 3

[0083] Feeding:

[0084] 1. Potassium Amoxicillin and Clavulanate 4:1 Mixed Powder 142g

[0085] 2. Lactose 30g

[0086] 3. Microcrystalline cellulose 52g

[0087] 4. Crystalline Mannitol 168g

[0088] 5. Cross-linked polyvinylpyrrolidone (XL type) 53.5g

[0089] 6. Micropowder silica gel (solid phase) 7.8g

[0090] 7. Magnesium stearate 4.2g

[0091] 8. Powdered peppermint essence 7.8g

[0092] 9. Aspartame 3.6g

[0093]

[0094] Total weight 468.9g

[0095] The production process and production environment are the same as in Example 1, wherein the added amount of microcrystalline cellulose is 36g.

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Abstract

The invention provides an amoxillin-potassium clavulanatein 4:1 dispersible tablet. The dispersible tablet adopts lactose, crystallite fibrin and crystal mannitol as thinner, and adopts crosslinked polyvinyl pyrrolidone (XL type) as disintegrant and also adopts micro-powder silica gel and magnesium stearate as lubricant. The dispersible tablet of the invention adopts the lactose and mannitol with better fluidity, which is good for directly pressing the powder into tablet. The invention also provides a technique of the dispersible tablet: subsidiary substances are dried for 12 to 16 hours at the temperature of 80 to 100 DEG C; the two-time tablet pressing technique is adopted and the crystallite fibrin is added both internally and externally. The environment-humidity is less than 28 percent, and the environment-temperature is below 30 DEG C in the whole preparation process. The method of the invention thoroughly dries the subsidiary substances and the process environment-humidity is controlled, so as to guarantee the stability of the product; the mixing between the subsidiary substances and the medicines, the internal and external adding method is adopted, so as to enhance the disintegrating speed of the dispersible tablet; by adopting the two-time tablet-pressing method, the dispersing equality and hardness of the dispersible tablet can be improved.

Description

technical field [0001] The invention relates to the field of preparations, in particular to dispersible tablet preparations, and more specifically to a production process for amoxicillin-clavulanate potassium 4:1 dispersible tablets. Background technique [0002] Amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has a strong broad-spectrum β-lactamase inhibitory effect, and combined with amoxicillin can protect amoxicillin from β-lactamase hydrolysis. The in vitro antibacterial study of amoxicillin and clavulanic acid found that clavulanic acid can increase the antibacterial effect of amoxicillin against Klebsiella spp. 32 times the antibacterial activity of Haemophilus influenzae. For Canamora, clavulanic acid can increase the antibacterial activity of amoxicillin by 4-32 times. Therefore, compound preparations made of amoxicillin and potassium clavulanate have been recognized by industry insi...

Claims

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Application Information

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IPC IPC(8): A61K31/43A61K9/20A61K47/38A61P31/04A61K31/424
Inventor 赵东明仇林元王佩芳薛曌
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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