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Therapeutic formulation for mainly of diarrhea large intesitine irritation syndrome

A syndrome and large intestine technology, applied in preparations for improving diarrhea symptoms of irritable bowel syndrome, in the field of preparations for irritable bowel syndrome, to achieve the effect of improving diarrhea symptoms

Inactive Publication Date: 2006-04-26
ASTELLAS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

More specifically, the results of a clinical study of alosetron (alosetron) administered 1 to 8 mg twice daily in patients with non-constipating irritable bowel syndrome showed that the drug significantly improved pain and Discomfort, stool consistency, frequency of bowel movements, and proportion of days of urgent treatment, however, no significant improvement was seen in male patients compared to placebo other than stool consistency

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Ramosetron hydrochloride 0.02 part

[0040] Lactose 86 parts

[0041] 3 parts hydroxypropyl cellulose

[0042] 1 part tartaric acid

[0043] Yellow ferric oxide 0.2 parts

[0044] Titanium oxide 10 parts

[0045] 0.3 parts of light silicic anhydride

[0046] Dissolve hydroxypropyl cellulose (3 parts), 0.02 parts of ramosetron hydrochloride and 1 part of tartaric acid in 35 parts of water, stir with a magnetic stirrer, and use a grinder with 10 parts of titanium oxide and 0.2 parts of yellow ferric oxide Kneading was performed with a mill to prepare a spray liquid (hydroxypropylcellulose concentration: 8% by weight). Thereafter, 86 parts of lactose were charged into a liquid layer granulator (Flow Coater; manufactured by Freund), and the above-mentioned spray liquid was sprayed at a spray speed of 5 g / min to perform liquid granulation. The granules were dried at an air inlet temperature of 40° C. for 5 minutes, and then mixed with 0.3 parts of light silicic anhydri...

Embodiment 2

[0048] Ramosetron hydrochloride 0.0008 part

[0049] Mannitol 89 parts

[0050] Citric anhydride 0.1 parts

[0051] Maltose 10 parts

[0052] 1 part red ferric oxide

[0053] 1 part magnesium stearate

[0054] Suspend maltose (10 parts), 0.0008 parts of ramosetron hydrochloride, 0.1 part of citric anhydride and 1 part of red ferric oxide in 67 parts of water, and stir with a magnetic stirrer to prepare a spray liquid (concentration: 15% by weight). Thereafter, 89 parts of mannitol were charged into a fluidized bed type fluidized bed granulator (Flow Coater; manufactured by Freund), and the above sprayed liquid was sprayed at a spray rate of 10 g / min to perform liquid granulation. After granulation, the granules were dried at an inlet temperature of 40°C for 5 minutes, and then mixed with 1 part of magnesium stearate. The blended powder was tableted with a rotary tablet machine at a rate of 120 mg / tablet to obtain tablets with an initial hardness of about 1 kp. These tabl...

Embodiment 3

[0056] The same production method as in Example 2 was carried out, except that the amount of citric anhydride added was changed to 0.2 parts, to obtain a tablet disintegrating in the mouth.

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PUM

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Abstract

A pharmaceutical composition for treating male and female patients with diarrhea-type irritable bowel syndrome, the daily dose of the pharmaceutical composition contains ramosetron hydrochloride (ramosetron) of 0.001 to 0.05 mg, or ramosetron in equimolar amounts or its pharmaceutical composition Other acceptable salts are used as active ingredients.

Description

technical field [0001] The present invention relates to a medicine, or more specifically, the present invention relates to a preparation for treating irritable large bowel syndrome mainly caused by diarrhea, or a preparation for improving diarrhea symptoms of irritable large bowel syndrome. Background technique [0002] The chemical name of Ramosetron is (-)-(R)-5-((1-methyl-1H-indol-3-yl)carbonyl)-4,5,6,7-tetrahydro -1H-benzimidazole. [0003] Ramosetron hydrochloride is sold as a preparation to improve gastrointestinal symptoms (nausea and vomiting) associated with anticancer drug therapy (such as cisplatin), and its adult dosage is usually oral once a day, 0.1 mg each time, or intravenous injection Once a day, 0.3mg each time ("Nasea OD Tablet 0.1mg", "Nasea Injection 0.3mg", see "Japanese Pharmaceutical Reference, Japanese Products and Administration" (JAPAN PHARMACEUTICAL REFERENCE, PRODUCTS AND ADMINISTRATION in JAPAN), fifth edition (1999), published by the Japan Me...

Claims

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Application Information

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IPC IPC(8): A61K31/4184C07D403/06A61P1/00A61P1/04A61P1/08A61P1/12A61P25/02A61P25/06A61P25/22A61P43/00
CPCA61K31/4184A61P1/00A61P1/04A61P1/08A61P1/12A61P25/02A61P25/06A61P25/22A61P43/00
Inventor 西田明登丹羽章热田丰
Owner ASTELLAS PHARMA INC
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