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Soft capsule composition containing acetaminophen

A technology of acetaminophen and composition, applied in the field of soft capsule compositions containing acetaminophen, can solve the problems of poor solubility of acetaminophen, enlarged dispersion medium, unclear solution and the like

Inactive Publication Date: 2006-08-30
ZHEJIANG WANLIAN PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to the poor solubility of paracetamol in water, technical difficulties have been encountered in some dosage form research, which limits its wide application. For example, when it is prepared into soft capsules, due to the small solubility of paracetamol, Often there will be a small amount of undissolved acetaminophen powder in the contents of the soft capsule, making the solution unclear
And if the amount of dispersion medium is increased, the number of drug particles taken by the patient during clinical use is just too much
US5505961 discloses a soft capsule composition containing high-concentration paracetamol, which uses polyethylene glycol as a dispersion medium, and increases the solubility of paracetamol by adding acetate, which solves the problem of unclear solution. However, the soft capsule prepared according to the patent method is prone to leakage after being placed for a period of time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Component Content (mg / grain)

[0028] Acetaminophen 162.5

[0029] Pseudoephedrine hydrochloride 15.0

[0030] Dextromethorphan Hydrobromide 7.5

[0031] Polyethylene glycol 400 300.0

[0032] Potassium acetate 40.0

[0033] PvP 17.5

[0034] Total 542.5mg

[0035] Preparation method: heat the dispersion medium to 50°C, weigh povidone (PVP) according to the required weight unit, slowly stir and add to mix evenly, then add acetaminophen and other active pharmaceutical ingredients in proportion, stir evenly, and finally add Potassium acetate, stirring continuously until the solution is clear and a uniform and stable medicinal solution is formed; add about 9g of citric acid to 1kg of medicinal solution to adjust the pH value to about 6.8. The medicinal liquid is introduced into a soft capsule pill press, and soft capsules are prepared according to a conventional soft capsule preparation method.

Embodiment 2

[0037] Component Content (mg / grain)

[0038] Acetaminophen 81.25

[0039] Pseudoephedrine hydrochloride 7.5

[0040] Dextromethorphan Hydrobromide 3.75

[0041] Polyethylene glycol 400 150.0

[0042] Sodium acetate 17.5

[0043] PvP 8.75

[0044] Total 268.75mg

[0045] The above components were prepared into a solution by the same method as in Example 1, and then the pH was adjusted to 6.8 with citric acid, and then introduced into a soft capsule pill press, and soft capsules were prepared according to the conventional soft capsule preparation method.

Embodiment 3

[0047] Component Content (mg / grain)

[0048] Acetaminophen 162.5

[0049] Pseudoephedrine hydrochloride 15.0

[0050] Dextromethorphan Hydrobromide 7.5

[0051] Polyethylene glycol 400 300.0

[0052] Sodium acetate 35.0

[0053] PvP 20

[0054] Total 540.0mg

[0055] The above components were prepared into a solution by the same method as in Example 1, and then the pH value was adjusted to 7.2 with citric acid, introduced into a soft capsule pellet machine, and prepared into soft capsules according to the conventional soft capsule preparation method.

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PUM

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Abstract

A composite soft capsule contains proportionally the active component chosen from paracetranol and one or more of pseudoephedrine hydrochloride, chlorpheniramine maleate, dextromethorphen hydrobromate, bagodryl hydrochloride and coffin, polyethanediol, sodium (or potassium) acetate, and polyvidone.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a soft capsule composition containing acetaminophen. Background technique [0002] Cold is a common respiratory disease, its symptoms are headache, fever, sneezing, nasal congestion, runny nose, coughing, etc., seriously affecting the normal work and life of patients. Acetaminophen is a good medicine for treating colds and has been used clinically for many years. Most of the anti-cold medicines currently used clinically contain acetaminophen, and some are supplemented by other drugs that shrink nasal mucosa capillaries, antihistamines, and central antitussives. [0003] Due to the poor solubility of paracetamol in water, technical difficulties have been encountered in some dosage form research, which limits its wide application. For example, when it is prepared into soft capsules, due to the small solubility of paracetamol, Often there will be a small amount of undiss...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/167A61K31/4402A61K31/485A61K31/522A61K31/138A61K9/48A61P29/00A61P11/02A61P11/14
Inventor 江磊陈云芳
Owner ZHEJIANG WANLIAN PHARMA IND
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