Pharmaceutical composition comprising a combination of metformin and a statin

The technology of a metformin and a composition is applied in the field of pharmaceutical compositions comprising the combination of metformin and statin, and can solve the problems of not recording the combination of metformin and statin, etc.

Inactive Publication Date: 2006-09-27
FOURNIER LAB IRELAND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The combination of metformin and statin has not been described in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Animal models were used to demonstrate synergy. Zucker obese (fa / fa) rats were used as a model of non-insulin-dependent diabetes mellitus (NIDD). The effects of lovastatin alone, metformin alone and the lovastatin+metformin combination were evaluated in terms of triglycerides, total cholesterol, high-density lipoprotein cholesterol (HDL C), glucose and insulin. Rats were treated for 5 consecutive days. Blood samples were collected 3 days before and 5 days after starting treatment to measure triglycerides, total cholesterol, HDL C, glucose, and insulin levels.

[0064] The procedure is as follows:

[0065] Divided into 4 groups of 8 rats each:

[0066] - vector set,

[0067] - the group receiving lovastatin orally at a dose of 1 mg / kg / day,

[0068] - the group receiving metformin orally at a dose of 50 mg / kg twice daily,

[0069] - Group receiving lovastatin at a dose of 1 mg / kg / day + metformin 50 mg / kg twice a day orally.

[0070] Statistical analysis included on...

Embodiment 2

[0076]The effects of simvastatin alone, metformin alone, and the combination of simvastatin + metformin were evaluated in terms of triglycerides, total cholesterol, high-density lipoprotein cholesterol (HDL C), glucose, and insulin.

[0077] Male 10 / 11 week old ZUCKER fa / fa rats (Charles River, France) were used in this study. They were housed in cages, 2 per cage, in a temperature (21°C–24.5°C) and relative humidity (45%–65%) controlled room with a 12-h light / dark cycle throughout During the experiment, they had ad libitum access to filtered tap water and standard pelletized laboratory rat chow (SAFE, France). After adapting to the environment, they were randomly divided into 6 groups according to their blood triglycerides, with 8 animals in each group:

[0078] Group 1: Carriers

[0079] Group 2: Simvastatin 0.5mg / kg

[0080] Group 3: Simvastatin 1mg / kg

[0081] Group 4: Metformin 50mg / kg (twice a day)

[0082] Group 5: Simvastatin 0.5mg / kg+ Metformin 50mg / kg (twice a d...

Embodiment 3

[0093] The effects of simvastatin alone, metformin alone and the combination of simvastatin + metformin were evaluated in terms of triglycerides, total cholesterol, non-esterified fatty acids (NEFA), glucose and insulin.

[0094] Male 12-week-old C57BL / Ks J Rj-db (db / db) mice (Janvier, France) with a body weight within the target range of 30-50 g were used in this study. Put them in cages, 5 per cage, and place them in a room with controlled temperature (19.5°C-24.5°C) and relative humidity (45%-65%), using a 12-hour light / dark cycle. During the procedure, they had ad libitum access to filtered tap water and irradiated pelletized laboratory rat chow (ref. A04, SAFE, France). After adapting to the environment, they were randomly divided into groups according to their homogeneous blood sugar, 10 in each group:

[0095] Group 1: Carriers

[0096] Group 2: Metformin 150mg / kg

[0097] Group 3: Simvastatin 30mg / kg

[0098] Group 4: Metformin 150mg / kg+ Simvastatin 30ng / kg

[009...

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PUM

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Abstract

A pharmaceutical composition comprising: (i) metformin, optionally in the form of one of its pharmaceutically acceptable salts, (ii) a statin, optionally in the form one of its pharmaceutically acceptable salts, and optionally one or more pharmaceutically acceptable excipients, is suitable for use in the treatment of hyperglycemia non-insulin-dependent diabetes, dyslipidemia, hyperlipidemia, hypercholesterolemia, and obesity.

Description

technical field [0001] The present invention relates to therapeutically effective compositions and methods for treating patients suffering from dyslipidemia, hyperlipidemia, hypercholesterolemia, hyperglycemia, obesity and related diseases, comprising metformin With hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors or statins (such as pravastatin, lovastatin, simvastatin, atorvastatin, cerivastatin, or fluvastatin ) that are formulated together to simultaneously provide a therapeutically effective amount of a hydroxymethylglutaryl-CoA reductase inhibitor and a therapeutically effective amount of metformin to be absorbed into the blood of a patient in need thereof. The compositions of the present invention are useful for reducing hyperglycemia associated with non-insulin dependent diabetes and for treating dyslipidemia, hyperlipidemia, hypercholesterolemia and / or obesity. Background technique [0002] In humans, cholesterol and triglycerides (TG) are part of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/155A61K31/366A61K31/404A61K31/40A61K31/506A61P3/06A61P3/10A61P9/00
CPCA61K31/366A61K31/506A61K31/40A61K31/404A61K31/155A61P3/00A61P3/04A61P3/06A61P3/10A61P9/00A61K2300/00
Inventor 吉恩-路易斯·朱尼安阿兰·埃德加
Owner FOURNIER LAB IRELAND
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