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Ibuprofen oral suspension and preparation method thereof

An oral suspension and dispersibility technology, applied in liquid delivery, pharmaceutical formula, emulsion delivery, etc., can solve the problem of high viscosity and agglomerated dumping of the drug solution, which affects the safety and effectiveness of the drug, and affects the dosage Accuracy and other issues, to achieve the effect of improving high viscosity and caking problems, improving safety and effectiveness, and good tolerance

Active Publication Date: 2011-03-30
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, we found that after long-term storage of the commercially available ibuprofen oral suspension, unpredictable high viscosity and agglomeration will occur, making the liquid difficult to flow
The high viscosity and agglomeration of the liquid medicine lead to difficulties in pouring, which will affect the accuracy of the dosage, especially for children, affecting the safety and effectiveness of their medication

Method used

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  • Ibuprofen oral suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The composition and dosage of 100mL ibuprofen oral suspension:

[0031] Ibuprofen (particle size 4-10μm) 2.00g,

[0032] Avicel RC-591 (purchased from U.S. FMC company, wherein, the ratio of sodium carboxymethylcellulose and microcrystalline cellulose is 1: 8.09) 1.30g,

[0033] Sodium benzoate 0.20g,

[0034] Citric acid 0.18g,

[0035] Glycerin 10.00g,

[0036] Sucrose 20.00g,

[0037] Sorbitol 0.03g,

[0038] Polysorbate 800.10g,

[0039] Lemon essence 0.30g,

[0040] water balance.

[0041] Preparation:

[0042] (1) Add 0.20g of sodium benzoate and 0.18g of citric acid into 10.00g of glycerin heated to 50-55°C until fully dissolved;

[0043] (2) Add 1.30g of Avicel RC-591 into water, and use high-shear equipment to disperse it evenly, presenting a uniform suspension system;

[0044] (3) Mix purified water heated to 50-55°C with 0.10 g polysorbate 80 to prepare a dispersion;

[0045] (4) Mix 20.00g sucrose, 0.03g sorbitol, 0.30g lemon essence and the solut...

Embodiment 2

[0048] The composition and dosage of 100mL ibuprofen oral suspension:

[0049] Ibuprofen (particle size 4-10μm) 2.00g

[0050] Avicel CL-611 (purchased from FMC Corporation of the United States, wherein the ratio of sodium carboxymethylcellulose to microcrystalline cellulose is 1: 5.67) 3.00g

[0051] Sodium Benzoate 0.20g

[0052] Citric acid 0.18g

[0053] Glycerin 7.00g

[0054] Sucrose 25.00g

[0055] Sorbitol 0.03g

[0056] Polysorbate 800.10g

[0057] Lemon essence 0.25g

[0058] water balance

[0059] Preparation:

[0060] (1) Add 0.20g of sodium benzoate and 0.18g of citric acid to 7.00g of glycerin heated to 50-55°C until fully dissolved;

[0061] (2) Add 3.00g of Avicel CL-611 into water, and use high-shear equipment to disperse it evenly, presenting a uniform suspension system;

[0062] (3) Mix purified water heated to 50-55°C with 0.10 g polysorbate 80 to prepare a dispersion;

[0063] (4) Mix 25.00g sucrose, 0.03g pitol, 0.25g lemon essence and the solu...

Embodiment 3

[0066] The composition and dosage of 100mL ibuprofen oral suspension:

[0067] Ibuprofen (particle size 4-10μm) 2.00g

[0068] Avicel CL-611 (purchased from FMC, USA) 1.30g

[0069] Sodium Benzoate 0.20g

[0070] Citric acid 0.20g

[0071] Glycerin 12.00g

[0072] Sucrose 25.00g

[0073] Sorbitol 0.05g

[0074] Polysorbate 800.10g

[0075] Lemon essence 0.30g

[0076] water balance

[0077] Preparation:

[0078] (1) Add 0.20g of sodium benzoate and 0.20g of citric acid to 12.00g of glycerin heated at 50-55°C until fully dissolved;

[0079] (2) Add 1.30g of Avicel CL-611 into water, and use high-shear equipment to disperse it evenly, presenting a uniform suspension system;

[0080] (3) Mix purified water heated at 50-55°C with 0.10 g of polysorbate 80 to prepare a dispersion;

[0081] (4) Mix 25.00g sucrose, 0.05g sorbitol, 0.30g lemon essence and the solution prepared in step (1) with the suspension obtained in step (2), and set aside;

[0082] (5) Mix the micronized...

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Abstract

The invention provides an ibuprofen oral suspension comprising the following ingredients based on the concentration: ibuprofen of 20 to 40 g / L and dispersion cellulose of 13 to 30 g / L. The preparation method of ibuprofen oral suspension comprises the following steps: (1) heating glycerine, adding a preservative; (2) adding the dispersion cellulose into water, then dispersing uniformly; (3) mixing pure water with a wetting agent; (4) thoroughly mixing a sweetener, a flavouring agent and the preservative solution which is prepared in the first step with the suspension system which is obtained in the second step; (5) mixing a micronized ibuprofen with the dispersion solution which is obtained in the third step uniformly, then adding the mixture obtained therein into the mixture obtained in the fourth step, and then stirring at high speed and simultaneously infusing nitrogen to obtain an ibuprofen oral suspension. The ibuprofen oral suspension provided by the invention is a thixotropic colloid comprising ibuprofen particles which are arranged evenly, and is characterized in that the ibuprofen oral suspension can be changed to a low-viscosity liquid by shaking before taking, the problem of common suspension which has high viscosity and agglomeration after placing for a long time is improved, the accuracy of dosage is ensured and the stability of the ibuprofen oral suspension is good.

Description

technical field [0001] The invention relates to an ibuprofen oral suspension and a preparation method thereof. Background technique [0002] Ibuprofen (2-methyl-4-(2-methylpropyl) phenylacetic acid) is a good non-steroidal antipyretic, analgesic and anti-inflammatory drug, which is commonly used clinically for patients with fever and mild to moderate pain. treat. [0003] Compared with other forms of preparations, the oral suspension form of ibuprofen has the advantages of convenient administration and good drug absorption effect, and it is mainly developed for children and patients who have difficulty swallowing oral solid preparations. However, we have found that the commercially available ibuprofen oral suspension will have unpredictable high viscosity and agglomeration after long-term storage, making the liquid medicine difficult to flow. The high viscosity and agglomeration of the liquid medicine lead to difficulties in pouring, which will affect the accuracy of the d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/192A61K47/38A61P29/00
Inventor 卢山刘红华陆毅
Owner 武汉人福药业有限责任公司
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