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A pharmaceutical composition for treating gastrointestinal diseases

A technology for gastrointestinal diseases and compositions, which is applied in the field of pharmaceutical compositions for the treatment of gastrointestinal diseases, and can solve problems such as reducing the stability of ranitidine, uncomfortable swallowing by patients, and complicated preparation processes, etc.

Active Publication Date: 2017-09-26
DAEWOONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is a problem that when the core tablet containing ranitidine is film-coated to produce a tablet within a tablet, the production process becomes complicated and the production cost increases
Also, since the tablet-in-tablet has a larger tablet size than a matrix tablet with the same dose, if the drug dose increases, the tablet size increases excessively and is less comfortable for the patient to swallow
[0006] Therefore, need to prepare a kind of combination medicine that can solve the following problems: 1) the hygroscopicity problem of ranitidine itself; 2) reduce the stability problem of ranitidine due to mixing with bismuth subcitrate; and 3) When preparing a combination drug of ranitidine, bismuth subcitrate and sclaffil, the problem of lower drug absorption rate due to mixing the three drugs

Method used

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  • A pharmaceutical composition for treating gastrointestinal diseases
  • A pharmaceutical composition for treating gastrointestinal diseases
  • A pharmaceutical composition for treating gastrointestinal diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Example 1: SK Adjustment of Particle Size of Lafite and Bismuth Subcitrate

[0080] Ranitidine, sclaffil, and bismuth subcitrate having the raw material particle sizes before micronization in Table 1 were used in the experiment.

[0081] 【Table 1】

[0082] Raw material particle size before micronization

[0083] Particle size distribution

Ranitidine

Scraffi

bismuth subcitrate

d(10)

2.59μm

21.172μm

18.565μm

d(50)

8.55μm

75.135μm

72.380μm

d(90)

20.74μm

176.62μm

195.559μm

average

10.54μm

89.154μm

95.563μm

[0084] The raw material particle diameter was measured according to a wet method using a particle diameter measuring device (Malvern Mastersizer 2000 / Hydro S) under the following conditions.

[0085]

[0086] Device: laser diffraction particle size distribution measurement device Malvern Mastersizer 2000 / Hydro S (Malvern)

[0087] Wet unit: Hydro 2000S

[0088] Sam...

experiment example 1

[0112] Experimental Example 1: Adjustment of the particle size of scrafil

[0113] In order to verify the change of the dissolution rate of scrafil according to the particle size adjustment of sclafil, as shown in Table 5, use and prepare raw materials with particle size combinations according to the composition of table 4, wherein only the particle size of sclafil is changed, At the same time the particle sizes of ranitidine and bismuth subcitrate were fixed, and then the experiment was performed.

[0114] 【table 5】

[0115] Combination of Particle Sizes of Ranitidine, Sclafin and Bismuth Subcitrate

[0116]

[0117] Except that the raw materials have different particle sizes, according to the same composition as shown in Table 4, use pure water (or a mixed solvent of pure water and ethanol) to prepare dry granules or wet granules according to the usual method, and dry at 50 ° C. And then pass through a 18-mesh sieve. Then, the prepared granules were compressed and co...

experiment example 2

[0136] Experimental Example 2: Adjustment of Particle Size of Bismuth Subcitrate

[0137] Based on the results of Experimental Example 1, it was defined that the raw materials having the particle diameters represented by scrafil 4 to sclafil 6 in Table 2 are preferably used as sclafil. Therefore, the particle size of sclafil was fixed to the particle size of "sclafil 6", and then the particle size of bismuth subcitrate was adjusted to evaluate the stability of the tablet according to the particle size of bismuth.

[0138] Raw materials with particle size combinations in Table 7 were used and formulated according to the composition in Table 4, and then experiments were performed.

[0139] 【Table 7】

[0140] Combination of Particle Sizes of Ranitidine, Sclafin and Bismuth Subcitrate

[0141]

[0142] Except that the raw materials have different particle sizes, according to the same composition as shown in Table 4, ranitidine, sclaffil and hypocitrate were prepared by usin...

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Abstract

The present invention provides a pharmaceutical composition for treating gastrointestinal diseases comprising ranitidine, sucralfate and bismuth subcitrate as active ingredients and a preparation method thereof. According to the present invention, when a combination drug of ranitidine, sucralfate and bismuth subcitrate is prepared, it is possible to address a hygroscopicity problem of ranitidine and increase formulation stability and drug bioavailability by controlling particle sizes of sucralfate and bismuth subcitrate.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating gastrointestinal diseases, which comprises ranitidine, sucralfate and bismuth subcitrate as active ingredients. Background technique [0002] Ranitidine is a drug that suppresses the production of gastric acid through H2 receptor blockade, and it is used in the treatment of gastric ulcer or reflux esophagitis. In fact, it is known that ranitidine exhibits excellent therapeutic effects on gastric ulcer and duodenal ulcer when it is taken together with bismuth subcitrate and sclaffil as combination therapy (Patent Document 1: Korean Patent Publication No. 1997-006083). Therefore, combination drugs comprising these three drugs as active ingredients are currently commercially available. [0003] However, ranitidine is highly hygroscopic and thus causes moisture absorption during storage and causes changes in tablet weight and properties (PDA J.Pharm.Sci.Tech.2009May-Jun:63(3):223- 33). ...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K33/24A61K47/32A61P1/04A61K31/341A61K31/7024
CPCA61K9/2054A61K9/284A61K31/341A61K31/7024A61K33/245A61K2300/00A61P1/04A61K9/1688
Inventor 曺英浩李俊雨
Owner DAEWOONG PHARM CO LTD
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