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Pediatric acetaminophen composition

A technology of acetaminophen and its composition, which is applied in the field of pediatric acetaminophen freeze-dried orally disintegrating tablets and its preparation, can solve the problems of inconvenient taking for children, unsuitability for children, and high hardness of tablets, etc. Effects of bioavailability, shortening dissolution time, and accelerating absorption

Active Publication Date: 2012-07-25
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, most of the oral preparations need to be taken with water or the tablets are very hard, which will be difficult for patients who have difficulty swallowing or have trouble getting water, especially for children. It is very inconvenient to take. The tablet is made of a variety of excipients and disintegrants, and is compressed with a traditional tablet machine. It takes at least 30 seconds to disintegrate in the human oral cavity, and there is a sandy feeling in the mouth, which is not suitable for children. In view of this , propose the present invention

Method used

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  • Pediatric acetaminophen composition
  • Pediatric acetaminophen composition
  • Pediatric acetaminophen composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Preparation of children's acetaminophen composition freeze-dried orally disintegrating tablets,

[0047] Prescription: 1000 tablets

[0048]

[0049] Preparation Process:

[0050]Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin with a medium degree of substitution in purified water of 80% of the total amount of prescribed water, heat to 55°C while stirring, slowly add the prescribed amount of acetaminophen, and continue stirring After 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin encapsulates the acetaminophen, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin and xanthan gum in the prescribed amount of water 20% purified water, heated until completely dissolved, combined the above two solutions and stirred evenly, adjusted the pH value to 5.5-6.5 with sodium bicarbonate, and determined the packaging according to the specifications of the children's acetaminophen composition freeze-...

Embodiment 2

[0052] Preparation of children's acetaminophen composition freeze-dried orally disintegrating tablets,

[0053] Prescription: 1000 tablets

[0054]

[0055] Preparation Process:

[0056] Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin with a medium degree of substitution in purified water of 80% of the total amount of prescribed water, heat to 55°C while stirring, slowly add the prescribed amount of acetaminophen, and continue stirring After 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin encapsulates the acetaminophen, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin and xanthan gum in the prescribed amount of water 20% purified water, heated until completely dissolved, combined the above two solutions and stirred evenly, adjusted the pH value to 5.5-6.5 with sodium bicarbonate, and determined the packaging according to the specifications of the children's acetaminophen composition freeze...

Embodiment 3

[0058] Preparation of children's acetaminophen composition freeze-dried orally disintegrating tablets,

[0059] Prescription: 1000 tablets

[0060]

[0061] Preparation Process:

[0062] Dissolve the prescribed amount of hydroxypropyl-β-cyclodextrin with a medium degree of substitution in purified water of 80% of the total amount of prescribed water, heat to 55°C while stirring, slowly add the prescribed amount of acetaminophen, and continue stirring After 10 hours, after the medium-substituted hydroxypropyl-β-cyclodextrin encapsulates the acetaminophen, add the prescribed amount of mannitol and sucralose, and dissolve the prescribed amount of gelatin and xanthan gum in the prescribed amount of water 20% purified water, heated until completely dissolved, combined the above two solutions and stirred evenly, adjusted the pH value to 5.5-6.5 with sodium bicarbonate, and determined the packaging according to the specifications of the children's acetaminophen composition freeze...

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Abstract

The invention discloses a pediatric acetaminophen composition and relates to the technical field of pharmaceutic preparations. The composition comprises the following components by weight: 13-32% of acetaminophen, 32-40% of mannitol, 2-4% of gelatin, 0.2-1.0% of xanthan gum, 32-40% of hydroxypropyl-beta-cyclodextrin with a medium degree of substitution and 0.1-0.15% of sucralose. A prepared pediatric acetaminophen freeze-drying oral disintegrating tablet containing above components is simple in components, needs no water when being taken, do not need to be chewed, works rapidly, has few residues in intestinal tract, is full in absorption and less in side effect and good in taste; the disintegration time of the tablet is no more than 2 minutes in an oral cavity of a human body, so that pediatric acetaminophen freeze-drying oral disintegrating tablet is especially suitable for being taken by infant patients.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a pediatric acetaminophen composition, a pediatric acetaminophen freeze-dried orally disintegrating tablet made from the composition and a preparation method thereof. Background technique [0002] Acetaminophen is an antipyretic and analgesic drug of the acetanilide class. By inhibiting cyclooxygenase, selectively inhibiting the synthesis of prostaglandins in the hypothalamic thermoregulation center, resulting in peripheral blood vessel dilation and sweating to achieve antipyretic effect, and its antipyretic effect is similar to that of aspirin; by inhibiting the synthesis of prostaglandins, etc. It is a peripheral analgesic, its effect is weaker than that of aspirin, and it is only effective for mild and moderate pain. At present, among the antipyretic and analgesic drugs, it is considered that the first choice drug should be acetaminophen, because of its sm...

Claims

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Application Information

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IPC IPC(8): A61K31/167A61K47/46A61P29/00
Inventor 汪六一汪金灿李祖红
Owner HAINAN WEI KANG PHARMA QIANSHAN
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