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Ibuprofen-containing oral pharmaceutical formulation

A pharmaceutical preparation and oral technology, which is applied in the field of oral pharmaceutical preparations containing ibuprofen, can solve the problems of irritating mucous membranes and unpleasant taste, and achieve the effect of reducing taste

Pending Publication Date: 2021-06-25
SS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although ibuprofen has an excellent anti-inflammatory analgesic effect, it has a disadvantage in that it has an unpleasant taste: when orally ingested, it is bitter in the mouth and irritates mucous membranes, etc.

Method used

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  • Ibuprofen-containing oral pharmaceutical formulation
  • Ibuprofen-containing oral pharmaceutical formulation
  • Ibuprofen-containing oral pharmaceutical formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] Make ibuprofen pass through 30 mesh sieves completely, and gained ibuprofen adds magnesium oxide (embodiment 1) or magnesium chloride hexahydrate (comparative example 1) and weighs in the glass bottle according to the corresponding ratio shown in table 1 below . Next, the glass bottle was sealed with a metal cap and mixed in a vortex mixer for 3 minutes.

[0107] Immediately after mixing, a sample equivalent to 200 mg of ibuprofen was put in the mouth, kept in the mouth for 3 minutes without swallowing, and sensory evaluation was performed for the unpleasant taste (pungent and bitter) of the ibuprofen over time. For the sample used in Reference Example 1 shown in Table 1 (ibuprofen that completely passed through a 30-mesh sieve), sensory evaluation was performed according to the above operation using the following evaluation criteria, and the evaluations of Example 1 and Comparative Example 1 were performed based on Relative evaluation of the evaluation results of the ...

Embodiment 2

[0118] Make ibuprofen pass through 30 mesh sieves completely, and gained ibuprofen adds magnesium oxide (embodiment 2 to 7 and comparative example 4) or magnesium chloride hexahydrate (comparative example 3) corresponding ratio shown in following table 2 Weigh into glass jars. Next, the glass bottle was sealed with a metal cap and mixed in a vortex mixer for 3 minutes. The sealed bottle was then stored at 65° C. for 15 hours, and then cooled; thereby obtaining samples of Examples 2 to 7 and Comparative Examples 3 to 4.

[0119] Separately, ibuprofen was completely passed through a 30-mesh sieve, and 200 mg of the resulting ibuprofen was introduced into a glass bottle, which was then sealed using a metal cap, and the sealed bottle was stored at 65° C. for 15 hours, and then cooled A sample of Comparative Example 2 was obtained.

[0120] According to the operation and evaluation criteria used in Test Example 1, the samples of Examples 2 to 7 and Comparative Examples 2 to 4 wer...

Embodiment 3

[0128] Weigh ibuprofen, magnesium oxide, and low-substituted hydroxypropylcellulose (L-HPC (LH31) manufactured by Shin-Etsu Chemical Co., Ltd.) to a total of 50 g according to the corresponding ratios shown in Table 3 below . This was introduced into the Mechanomill and mixed for 3 minutes at 900 rpm. Next, the amount of purified water shown in Table 3 below was added, kneading was performed for 3 minutes, and then extrusion granulation was performed. The resulting granulated material was dried (overnight at 65° C.) using a box dryer. Its size was set to obtain the granules of Examples 8 to 12 and Comparative Example 5 (16 to 60 mesh).

[0129] According to the operation and evaluation standard used in Test Example 1, the sensory evaluation of ibuprofen's unpleasant taste (pungent and bitter taste) was carried out to the granules equivalent to 200 mg of ibuprofen (based on the comparison of the evaluation results of the samples of Reference Example 1 evaluate). The results...

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Abstract

The provision of technology for reducing the unpleasant taste of ibuprofen in ibuprofen-containing oral pharmaceutical formulations. An oral pharmaceutical formulation in which the unpleasant taste of ibuprofen is reduced, which contains (A) ibuprofen or salt thereof or solvate of these, and (B) magnesium oxide, wherein the mass ratio [(B) / (A)] of component (A) and component (B) is 0.2-1.5.

Description

technical field [0001] The present invention relates to an ibuprofen-containing oral pharmaceutical preparation, a method for producing the oral pharmaceutical preparation, a method for reducing the unpleasant taste of ibuprofen, and the like. Background technique [0002] Non-steroidal antipyretic analgesic anti-inflammatory agents are used to relieve fever and pain; among them, drugs containing ibuprofen (chemical name: 2-(4-isobutylphenyl)propionic acid) are widely prescribed and Commercially available. However, although ibuprofen has excellent anti-inflammatory and analgesic effects, it has a disadvantage in that it has an unpleasant taste: when orally ingested, it is bitter in the mouth and irritates mucous membranes and the like. Therefore, incorporation of magnesium chloride has been proposed as a technique for reducing the unpleasant taste of ibuprofen-containing liquid agents (Patent Document 1). [0003] Citation list [0004] patent documents [0005] PTL 1: J...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/10A61K9/14A61K9/16A61K9/20A61K31/192A61K47/02
CPCA61K9/0053A61K9/2009A61K9/10A61K9/0056A61K9/1611A61K9/143A61K47/02A61K31/192A61K9/0095
Inventor 小贯洋一吉村理
Owner SS PHARMA CO LTD