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Lubiprostone solid dispersion and preparation method thereof

A technology of solid dispersion and lubiprostone, which is applied in the field of lubiprostone solid dispersion and its preparation, can solve the problems related to the undiscovered solid dispersion of lubiprostone, etc., and solve the problem of organic solvent residue , the effect of improving the dissolution rate

Inactive Publication Date: 2018-06-22
PEKING UNIV FOUNDER GRP CO LTD +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] So far, no relevant reports on solid dispersions of lubiprostone have been found

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1 lubiprostone solid dispersion and preparation method thereof

[0019] Put 8 mg of lubiprostone, 24,000 mg of poloxamer 188 and 240,000 mg of polyethylene glycol 4000 melted in a water bath at 50-60°C in an evaporating dish, add appropriate amount of distilled water and stir until lubiprostone and poloxamer 188 and polyethylene glycol 4000 were dissolved in water to form a clear solution, which was freeze-dried until the sample was completely dried, and packed into 1000 capsules.

Embodiment 2

[0020] Embodiment 2 lubiprostone solid dispersion and preparation method thereof

[0021] Put 24 mg of lubiprostone, 72,000 mg of poloxamer 188 and 720,000 mg of polyethylene glycol 4000 melted in a water bath at 50-60°C in an evaporating dish, add an appropriate amount of distilled water and stir until lubiprostone and poloxamer 188 and polyethylene glycol 4000 were dissolved in water to form a clear solution, which was freeze-dried until the sample was completely dried, and packed into 1000 capsules.

Embodiment 3

[0022] Embodiment 3 lubiprostone solid dispersion and preparation method thereof

[0023] Put 8 mg of lubiprostone and 240,000 mg of polyethylene glycol 4000 melted in a water bath at 50-60°C in an evaporating dish, add an appropriate amount of distilled water and stir until both lubiprostone and polyethylene glycol 4000 are dissolved in water and form a clear The solution was freeze-dried until the sample was completely dried, and packed into 1000 capsules.

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PUM

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Abstract

The present invention provides a lubiprostone solid dispersion and a preparation method thereof, wherein the lubiprostone solid dispersion comprises lubiprostone and a carrier, the carrier is a hydrophilic polymer carrier, a weight ratio of the lubiprostone to the carrier is 8:200000-400000, optionally the solid dispersion further comprises a surfactant, and a weight ratio of the lubiprostone to the carrier to the surfactant is 8:200000-400000:20000-40000. The preparation method comprises: dissolving lubiprostone, a carrier and / or a surfactant in an aqueous solvent, stirring to form a clarified solution, and carrying out freeze-drying or spray-drying to completely remove the aqueous solvent so as to prepare the solid dispersion. According to the present invention, the lubiprostone solid dispersion has advantages of improved water solubility, improved dissolution rate, promoted absorption by gastrointestinal tract and improved bioavailability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lubiprostone solid dispersion and a preparation method thereof. Background technique [0002] Lubiprostone (lubiprostone) is a chloride ion channel activator, a new pharmacological mechanism developed by Sucampo for the treatment of chronic idiopathic constipation drug, FDA approved lubiprostone in 2006 for the treatment of chronic idiopathic constipation Epidemic constipation, followed by new indications for constipation-induced irritable bowel syndrome (only for female patients over 18 years old), constipation caused by opioids for adults with chronic non-cancer pain, etc. [0003] So far, no relevant reports on the solid dispersion of lubiprostone have been found. Contents of the invention [0004] The object of the present invention is to provide a solid dispersion of lubiprostone to increase the dissolution rate of the drug, promote absor...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/558A61K31/5575A61K47/10A61P1/10
CPCA61K31/558A61K9/4866A61K31/5575
Inventor 邹明琛易崇勤谢小飞姚定丽
Owner PEKING UNIV FOUNDER GRP CO LTD
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