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Oral disintegrant of compound paracetamol

A technology for acetaminophen and orally disintegrating tablets, applied in anti-infective drugs, pill delivery, non-central analgesics, etc., can solve problems such as high hardness, poor stability of preparations, and difficulty in covering the bad taste of compound preparations

Inactive Publication Date: 2005-10-12
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Children, especially infants, often have difficulty swallowing the tablet whole
Although the oral solution is convenient to take, it is difficult to cover the bad taste of the compound preparation, and the stability of the preparation is relatively poor
Chewable tablets can overcome the above shortcomings, but their hardness is large, and the compliance of children to take medicine is poor

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] prescription

[0020] Acetaminophen 80mg

[0021] Pseudoephedrine Hydrochloride 7.5mg

[0022] Dextromethorphan Hydrobromide 2.5mg

[0023] Chlorpheniramine Maleate 0.5mg

[0024] Microcrystalline Cellulose (MCC) 200mg

[0025] Low-substituted hydroxypropyl cellulose (L-HPC) 23.1mg

[0026] Aspartame 1.6mg

[0027] Orange Juice Flavor 1.6mg

[0028] Magnesium Stearate 3.2mg

[0029] Preparation: Weigh the ingredients. The main drug and the auxiliary materials are mixed uniformly according to the equal amount incremental method, passed through a 40-mesh sieve twice, added with magnesium stearate, mixed uniformly, and pressed into tablets.

[0030] Tablet hardness: 3-3.5kg, tablet weight difference: -2.59% to 2.55%.

[0031] The in vitro disintegration time limit of the orally disintegrating tablet was determined by a static method: the tablet was placed in a small beaker filled wit...

Embodiment 2

[0036] prescription

[0037] Acetaminophen 40mg

[0038] Pseudoephedrine Hydrochloride 3.75mg

[0039] Dextromethorphan Hydrobromide 1.25mg

[0040]Chlorpheniramine Maleate 0.25mg

[0041] Microcrystalline Cellulose (MCC) 56mg

[0042] Mannitol 83.8mg

[0043] Crospovidone (PVPP) 10mg

[0044] Aspartame 2mg

[0045] Fresh Milk Flavor 1mg

[0046] Micronized silica gel 2mg

[0047] Preparation: Weigh the ingredients. After mixing the main drug and the auxiliary materials uniformly, use an 8mm punch to directly press the tablet.

[0048] Tablet hardness: 2.5kg, friability: 0.47%, in vitro disintegration time limit: 32s

[0049] Mouthfeel: The gritty feeling is not obvious, sweet and fragrant at first, and bitter taste can be tasted after the tablet is completely dispersed.

Embodiment 3

[0051] prescription

[0052] Acetaminophen 25%

[0053] Pseudoephedrine Hydrochloride 2.34%

[0054] Dextromethorphan hydrobromide 0.78%

[0055] Chlorpheniramine Maleate 0.16%

[0056] Microcrystalline Cellulose (MCC) 25%

[0057] Mannitol 25.5%

[0058] Lactose 12.7%

[0059] Croscarmelloxymethyl starch sodium (CCMS-Na) 2%

[0060] Crospovidone (PVPP) 3%

[0061] Stevioside 2%

[0062] Peppermint Flavor 0.5%

[0063] Magnesium Stearate 1%

[0064] Preparation: Weigh the ingredients. After mixing the main drug and the auxiliary materials uniformly, directly press the tablet.

[0065] Tablet hardness: 2.8~3.0kg, tablet weight difference: -3.27%~2.55%

[0066] Disintegration time in vitro: 40s, disintegration time in oral cavity: 38.3±4.7s

[0067] Mouthfeel: Sweet enough, cool after rinsing, not easy to taste bitter.

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Abstract

An oral disintegrating tablet of compound paracetamol is prepared from paracetamol, pseudoephedrine hydrochloride, dextromethorphan HBr, chlorphenamine maleate, filler, disintegrant, adhesive or moistening agent, lubricant, flavouring and pigment through direct tabletting.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet type, in particular to a compound paracetamol orally disintegrating tablet with quick-release effect and good taste. Background technique [0002] Cold is the most common frequently-occurring disease. According to statistics, 36% of employees and 67% of students absent from school are caused by colds. Colds seriously affect the normal life and health of human beings, especially children. If they are not treated in time, they will not only bring pain to children, but also easily induce other serious diseases. However, at present, there are few varieties of antipyretic and analgesic drugs specially used for children in China, and the dosage forms are monotonous. More varieties need to be added in clinical practice to meet the requirements of different patients for choosing drugs. [0003] Acetaminophen is an antipyretic and analgesic drug co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/167A61K31/485A61P29/00A61P31/00
Inventor 张奇志蒋新国梅妮
Owner FUDAN UNIV
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