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Drug combination containing glucokinase activator (GKA) and biguanide antidiabetic drug, composition and combination preparation and preparation methods and application thereof

A glucose-lowering technology of glucokinase and biguanides, which is applied in the field of oral solid preparations to treat and/or prevent one or more diseases and medical conditions, and can solve the problem of a single glucose-controlling organ, which cannot effectively treat the imbalance of blood glucose homeostasis balance system To achieve short disintegration time limit, treat diabetes and accompanying diseases and complications, and improve compliance

Active Publication Date: 2019-12-10
HUA MEDICINE (SHANGHAI) LIMITED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The existing oral hypoglycemic drugs for diabetes usually act on a single sugar-controlling organ and cannot effectively treat the problem of blood sugar homeostasis balance system imbalance

Method used

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  • Drug combination containing glucokinase activator (GKA) and biguanide antidiabetic drug, composition and combination preparation and preparation methods and application thereof
  • Drug combination containing glucokinase activator (GKA) and biguanide antidiabetic drug, composition and combination preparation and preparation methods and application thereof
  • Drug combination containing glucokinase activator (GKA) and biguanide antidiabetic drug, composition and combination preparation and preparation methods and application thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0352] Scheme 44. The method for preparing the pharmaceutical combination, pharmaceutical composition or fixed dose combination preparation according to scheme 43, wherein it is prepared by wet granulation (high shear and / or fluidized bed), or by dry processing (direct compression or dry process) pellets) preparation.

[0353] Item 45. The method for preparing a pharmaceutical combination, pharmaceutical composition or fixed dose combination according to any one of items 43-44, wherein the glucokinase activator is prepared in the form of a solid dispersion.

[0354] Scheme 46. The method for preparing a pharmaceutical combination, a pharmaceutical composition or a fixed-dose compound preparation according to any one of Scheme 43-45, wherein the glucokinase activator and the second or more active ingredients can also be prepared together into a compound solid Dispersion forms (ie solid dispersions containing 2 or more active ingredients).

[0355] Scheme 47. The pharmaceutical...

Embodiment

[0360] Preparation of compound tablet of glucokinase activator

[0361] The chemicals used in the present invention can be purchased from companies such as Shin-Etsu Japan, Evonik Germany, J.T. Baker US, SCR China, Ashland US, FMC US, JRS Germany, Colorcon US, Capsugel, BASF, revitalizing reagents, etc. Production equipment and analytical testing instruments etc. can be purchased from such companies as Sartorius, Nikon, Sympatec, Bruker, Gea Niro, Korsch, Erweka, Agilent, Quadro Engineering, Canada; Warters, US; TA, US; SOTAX, Switzerland; Mettler Toledo Instrument Newark, DE.

[0362] I. Preparation of Solid Dispersion of Glucokinase Activator

[0363] 1.1 Preparation of solid dispersion solution before spray drying

[0364] Example 1A (the weight ratio of active ingredient to polymer is 1:9)

[0365] Weigh 6.75 grams of Eudragit L100 (Evonik L100, Evonik Germany), add it to absolute ethanol (J.T.Baker) under stirring conditions, add 0.75 grams of compound HMS5552 after it...

Embodiment 2A

[0366] Example 2A (the weight ratio of active ingredient to polymer is 3:7)

[0367] Weigh 5.25 grams of Eudragit L100 (Evonik L100, Evonik Germany), add it into dehydrated ethanol (J.T.Baker) under stirring conditions, add 2.25 grams of compound HMS5552 after it is completely dissolved, add a sufficient amount of dehydrated ethanol and continue stirring to obtain 50ml solution.

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PUM

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Abstract

The invention relates to a drug combination. The drug combination comprises a glucokinase activator (GKA), a pharmaceutical salt, an isotope marker and a crystalline form of the GKA, a hydrate, a solvate, a diastereoisomer or an enantiomer form and a biguanide antidiabetic drug. The invention further relates to a drug composition, a fixed dose combination (FDC) preparation and a preparation methods and application of the drug combination and the FDC preparation.

Description

[0001] priority claim [0002] This application claims the priority of Chinese Invention Patent Application No. 201810556685.6 with the filing date of May 31, 2018, the entire disclosure of which is incorporated herein by reference. technical field [0003] The present invention relates to a drug combination comprising a glucokinase activator (GKA) drug and a partner drug (partner drug), a drug composition and a fixed dose compound (fixed dose combination, FDC) preparation, a preparation method thereof and its use in the treatment of Uses for Certain Diseases. [0004] In a more detailed aspect, the present invention relates to a pharmaceutical combination, a pharmaceutical composition or an oral solid dosage form of a fixed dose combination comprising a glucokinase activator drug and a combination drug, and methods for the preparation thereof. The present invention also relates to the use of a pharmaceutical combination, a pharmaceutical composition or a fixed dose compound ...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K31/4155A61K31/155A61K9/36A61P3/10A61P3/04A61P9/12A61P5/50A61P3/00
CPCA61K31/4155A61P3/10A61P3/04A61P9/12A61P5/50A61P3/00A61K45/06A61K31/7036A61K9/2027A61K9/28A61K2300/00A61P3/08A61P1/16A61P25/28A61K31/7048A61K9/2054A61K9/2009A61K31/70A61K31/7042A61K31/133A61K31/155A61K31/17A61K31/351A61K31/381A61K31/382A61K31/40A61K31/403A61K31/415A61K31/426A61K31/427A61K31/437A61K31/4439A61K31/444A61K31/445A61K31/451A61K31/4965A61K31/497A61K31/4985A61K31/506A61K31/64A61K47/38A61K9/14A61K9/20A61K9/2866A61K9/48A61K9/1635A61K9/2077A61K9/1652A61P9/10A61P13/12A61K31/702A61K31/7008A61K9/2013A61K9/2086A61K9/2095A61K9/2813A61K9/1611A61K9/1617A61K9/1694A61K31/522A61K31/4035A61K9/284A61K31/7034C07D403/12C07D231/38
Inventor 陈力李永国王高森
Owner HUA MEDICINE (SHANGHAI) LIMITED
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