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Glibenclamide solid dispersion agent , oral single-ingredient or compound formulation and its preparation method

A solid dispersion and preparation technology, applied in the field of glyburide solid dispersion and preparation thereof, can solve the problems of not improving the bioavailability of glyburide and the like

Active Publication Date: 2010-05-12
TIANJIN HUAJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The Chinese invention patent with application number 200410065993.7 relates to a solid dispersion of Glibenclamide (Glibenclamide), as well as the oral pharmaceutical composition of the dispersion and the preparation method of the dispersion. The solid Glibenclamide involved in this patent The preparation method of the dispersion is grinding, melting method or spray drying method, and does not involve solvent method. And the experimental results of bioavailability are given in the experimental examples of the patent disclosure, and the results show that the two pharmaceutical ingredients and the two reference Tablets are bioequivalent when administered in equal doses. It is proved from the data that this patented technology does not improve the bioavailability of glibenclamide, but is equivalent to ordinary tablets.

Method used

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  • Glibenclamide solid dispersion agent , oral single-ingredient or compound formulation and its preparation method
  • Glibenclamide solid dispersion agent , oral single-ingredient or compound formulation and its preparation method
  • Glibenclamide solid dispersion agent , oral single-ingredient or compound formulation and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Weigh glibenclamide 10g, povidone K 30 20g, add 625ml of dichloromethane, ultrasonically dissolve and clarify, 55°C water bath, rotary evaporation, evaporate the solvent to dryness under reduced pressure until white solid dispersion is precipitated, crush the solid dispersion, pass through a 200-mesh sieve, and place in a blast drying oven at 40°C Dry for more than 48 hours.

Embodiment 2

[0095] Weigh 14 g of glibenclamide and 14 g of polyethylene glycol 4000, add 330 ml of ethyl acetate, dissolve and clarify by ultrasonic, 45 ° C water bath, rotary evaporation, and evaporate the solvent under reduced pressure until the white solid dispersion is precipitated, and the solid dispersion is crushed, Pass through a 200-mesh sieve, and dry in a blast drying oven at 50°C for more than 48 hours.

Embodiment 3

[0097] Weigh glibenclamide 2g, ethyl cellulose 20cp 28g, add acetone 900ml, ultrasonically dissolve and clarify, 40°C water bath, rotary evaporation, evaporate the solvent to dryness under reduced pressure until white solid dispersion is precipitated, crush the solid dispersion, pass 150 Mesh sieve, and dry in a blast drying oven at 50°C for more than 24 hours.

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Abstract

The invention relates to a Glibenclamide solid dispersion prepared through solvent method, which comprises Glibenclamide 2-14 parts, carrying agent 4-28 parts, organic solvent 100-900 parts. The compound preparation provided by the invention contains 0.399-1.035mg of Glibenclamide solid dispersion, 250mg of metformin hydrochloride, and one or more pharmaceutically acceptable carrying agents.

Description

technical field [0001] The present invention relates to a solid dispersion of glibenclamide prepared by a solvent method and a preparation method thereof, as well as solid oral tablets and capsules prepared by using the dispersion; and a drug containing solid dispersion of glibenclamide and metformin hydrochloride pharmaceutical composition. Background technique: [0002] Glibenclamide is a second-generation sulfonylurea oral hypoglycemic drug, also known as glibenclamide, and its chemical name is N-[2-[4-[[[(cyclohexylamino)carbonyl]amino]sulfonyl] phenyl]ethyl]-2-methoxy-5-chlorobenzamide. It strongly lowers blood sugar by stimulating insulin release, and its effect is based on enabling the beta cells of the pancreatic islets to perform their functions. Glibenclamide was listed in my country in the mid-1970s. In the past 30 years, glibenclamide has become an indispensable drug for the majority of diabetic patients, especially the drug of choice for low- and middle-incom...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/17A61K9/20A61P3/10A61K31/155
Inventor 苏慕君臧可昕吴赟张胜利
Owner TIANJIN HUAJIN PHARMA