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Solid preparation composition for oral administration of colonic purgative containing anhydrous sodium sulfate, potassium sulfate, anhydrous magnesium sulfate and simethicone

A technology of anhydrous magnesium sulfate and anhydrous sodium sulfate, which can be used in pharmaceutical combinations, active ingredients of silicon compounds, and medical preparations containing active ingredients, etc. Unpleasant odor, efficacy in improving medication adherence

Pending Publication Date: 2021-01-29
韩国碧奥生物药业
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, drug adherence is not very high as it is recommended to drink 250 mL of water per hour after taking the second dose to prevent dehydration

Method used

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  • Solid preparation composition for oral administration of colonic purgative containing anhydrous sodium sulfate, potassium sulfate, anhydrous magnesium sulfate and simethicone
  • Solid preparation composition for oral administration of colonic purgative containing anhydrous sodium sulfate, potassium sulfate, anhydrous magnesium sulfate and simethicone
  • Solid preparation composition for oral administration of colonic purgative containing anhydrous sodium sulfate, potassium sulfate, anhydrous magnesium sulfate and simethicone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] A comparison between Examples 1 and 2 reveals the effect of water. Example 1 of the present invention, even without water, is superior to Comparative Example 2 in properties related to blocking, capping, and fluidity, and thus is considered to be industrially feasible as required. However, adding only a small amount of water as in Example 2 increased flowability and reduced capping defects.

[0088] According to the addition amount of water, embodiment 2 and 3 have carried out process method comparison. Excess water caused no capping defects, but slightly more blocking defects (however, less than Comparative Example 2). For better productivity, the appropriate water content is 0.1wt%-2.0wt% per piece, preferably 0.5wt%-1.0wt% per piece.

[0089] In addition, there was no difference in disintegration time between Comparative Examples and Examples.

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Abstract

The present invention relates to a solid colonic purgative for oral administration, containing anhydrous magnesium sulfate, potassium sulfate and anhydrous sodium sulfate and additionally containing simethicone. The present invention exhibits, even when dosage is reduced by up to approximately 20%, a colon cleansing effect that is more satisfactory than that of a conventional colonic purgative consisting of anhydrous magnesium sulfate, potassium sulfate and anhydrous sodium sulfate. In addition, since the dosage of the present invention is decreased to be less than that of a conventional product, a foul taste or odor caused by a main ingredient is reduced and ingestion amount of the preparation and water is small such that the drug compliance is significantly improved. Furthermore, unlikea conventional solid colonic purgative, the present invention can be prepared as a tablet even without containing a water-soluble lubricant. In other words, the present invention can be prepared as asolid preparation for oral administration by containing a water-soluble lubricant, but can be prepared as a solid preparation for oral administration even when a water-soluble lubricant is excluded.

Description

technical field [0001] The present invention relates to a kind of solid preparation composition for oral administration of colonic purgative (colonic purgative), and this colonic purgative contains anhydrous sodium sulfate, potassium sulfate and anhydrous magnesium sulfate as main component, and contains simethicone (simethicone, Simethicone), and also relates to solid formulations of new drugs hitherto unprecedented. Background technique [0002] A colon cleanse completely removes fecal debris from the colon (also known as the large bowel or large intestine) without damaging the colonic mucosa or blood vessels, allowing for a clear appearance of the colonic mucosa from which the fecal debris has been removed. Existing colon cleansers are mainly divided into osmotic agents and stimulants. [0003] An example of an osmotic agent is a polyethylene glycol (PEG) solution. PEG has little effect on plasma and electrolyte levels and is suitable for patients with comorbid diseases...

Claims

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Application Information

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IPC IPC(8): A61K33/04A61K33/06A61K31/695A61K9/20A61P1/10
CPCA61P1/10A61K33/04A61K33/06A61K9/2009A61K9/2036A61K31/80A61K33/00A61K2300/00A61K31/695A61K9/20A61K9/0053A61K9/2013A61K9/2027A61K9/2095A61K9/2853
Inventor 郑贤静朴宗洙李庆洙李桓赫
Owner 韩国碧奥生物药业
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