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Medicinal complex for treating type 2 diabetes and diabetic dyslipidemia

A pharmacy and dosage form technology, applied in the field of combined preparations of type 2 diabetes and dyslipidemia, can solve problems such as increasing the risk of cardiovascular disease, and achieve the effect of improving drug compliance and treating dyslipidemia

Inactive Publication Date: 2019-07-09
LG CHEM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Hypertension and dyslipidemia are also major contributors to cardiovascular disease, thereby significantly increasing the risk of cardiovascular disease

Method used

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  • Medicinal complex for treating type 2 diabetes and diabetic dyslipidemia
  • Medicinal complex for treating type 2 diabetes and diabetic dyslipidemia
  • Medicinal complex for treating type 2 diabetes and diabetic dyslipidemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: the preparation of fixed dosage

[0036] According to the composition of Table 1, fixed-dose combinations of 3 formulations were prepared, in which the content of rosuvastatin was different.

[0037] [Table 1]

[0038]

[0039] 1) Supertab 21AN: lactose anhydrous

[0040] 2) Prosolv SMCC 50: Silicified microcrystalline cellulose

[0041] 3) DI-TAB: Calcium hydrogen phosphate dihydrate

[0042] 4) Kollidon VA64: vinylpyrrolidone-vinyl acetate copolymer

Embodiment 2

[0043] Embodiment 2: the preparation of bilayer tablet

[0044] According to the composition of Table 2, two-layer tablets of 3 kinds of preparations were prepared, and in the 3 kinds of preparations, the content of rosuvastatin was different. The preparation method is presented in Table 3.

[0045] [Table 2]

[0046]

[0047]

[0048] 1) Flowlac 100: lactose monohydrate

[0049] 2) DI-TAB: Calcium hydrogen phosphate dihydrate

[0050] 3) Kollidon VA63: vinylpyrrolidone-vinyl acetate copolymer

[0051] [table 3]

[0052]

[0053]

Embodiment 3

[0054] Embodiment 3: stability test

[0055] The stability test of the bilayer tablet formulation prepared in Example 2 was carried out under accelerated conditions (40° C., 75% humidity) for 6 months. The results are presented in Table 4.

[0056] [Table 4]

[0057]

[0058] DP-IMP-1:

[0059] 2-[(2S)-6,6-Difluoro-2,3,5,6,7,8-hexahydroimidazo[1,2-a]pyridin-2-yl]-1-[2,4 -Bis(trifluoromethyl)-5,6,7,8-tetrahydropyrido[3,4-d]pyrimidin-7-yl]-1-ethanone

[0060] DP-IMP-2:

[0061] 2,4-bis(trifluoromethyl)-5,6,7,8-tetrahydropyrido[3,4-d]pyrimidin-8-one

[0062] DP-IMP-3:

[0063] (3S)-3-amino-4-(5,5-difluoro-2-oxopiperidinyl)-1-[8-hydroxy-2,4-bis(trifluoromethyl)-5,6, 7,8-Tetrahydropyrido[3,4-d]pyrimidin-7-yl]butan-1-one tartrate

[0064] 5-oxo:

[0065] Bis(6E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R)-3-hydroxy -5-oxohept-6-enoic acid

[0066] Lactone:

[0067] N-(4-(4-fluorophenyl)-5-(1E)-2-[(2S,4R)-4-hydroxy-6-oxotetrah...

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PUM

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Abstract

The present invention relates to a medicinal complex for effectively treating type 2 diabetes and dyslipidemia of diabetic patients, more specifically, the present invention provides a medicinal complex comprising a peptidase IV inhibitor gemigliptin or a pharmaceutically acceptable salt thereof, and a HMG-CoA reductase inhibitor rosuvastatin or a pharmaceutically acceptable salt thereof, to effectively control blood sugar levels and improve cardiovascular disease risk factors.

Description

technical field [0001] The present invention relates to a combined preparation for the effective treatment of type 2 diabetes and dyslipidemia in diabetic patients. More specifically, the present invention provides a combined preparation comprising gemagliptin or a pharmaceutically acceptable salt thereof as a dipeptidyl peptidase IV inhibitor and rhodium as an HMG-CoA reductase inhibitor. Suvastatin or a pharmaceutically acceptable salt thereof can effectively control blood sugar and improve risk factors of cardiovascular diseases. Background technique [0002] In 2011, the International Diabetes Federation (IDF) estimated that 366 million people worldwide had diabetes. In addition, according to IDF, 80% of diabetic patients live in low- and middle-income countries, and about 36% of diabetic patients live in the Western Pacific region including Korea. However, considering that approximately 183 million people have undiagnosed diabetes, the IDF estimates that there are mor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K31/505A61K31/225
CPCA61K31/225A61K31/505A61K31/519A61K2300/00A61P3/10A61P31/06
Inventor 朴基淑尹慧真郑钟赫金成垣金志玧刘锡澈金利宣安在淳
Owner LG CHEM LTD
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