Pharmaceutical composition, methods for treating and uses thereof

a technology of pharmaceutical compositions and compositions, applied in the direction of drug compositions, medical preparations, pill delivery, etc., can solve the problems of unmet medical needs, decreased kidneys' ability to excrete waste products,

Inactive Publication Date: 2018-05-10
BOEHRINGER INGELHEIM INT GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0214]The pharmaceutical compositions and methods according to this invention show advantageous effects in the treatment and prevention of those diseases and conditions as described hereinbefore. Advantageous effects may be seen for example with respect to efficacy, dosage strength, dosage frequency, pharmacodynamic properties, pharmacokinetic properties, fewer adverse effects, convenience, compliance, etc.
[0215]Methods for the manufacture of empagliflozin are known to the one skilled in the art. Advantageously, the compounds according to this invention can be prepared using synthetic methods as described in the literature, including patent applications as cited hereinbefore. Preferred methods of manufacture are described in the WO 2006 / 120208 and WO 2007 / 031548. With regard to empagliflozin an advantageous crystalline form is described in the international patent application WO 2006 / 117359 which hereby is incorporated herein in its entirety.
[0216]Further embodiments, features and advantages of the present invention may become apparent from the following examples. The following examples serve to illustrate, by way of example, the principles of the invention without restricting it.EXAMPLES

Problems solved by technology

Higher levels of creatinine indicate a lower glomerular filtration rate and as a result a decreased capability of the kidneys to excrete waste products.
Therefore, there is an unmet medical need for methods, medicaments and pharmaceutical compositions able to slow the worsening or progression of chronic kidney disease and reduce the risk of CV events in patients, in particular patients with chronic kidney disease.

Method used

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  • Pharmaceutical composition, methods for treating and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1a

of Patients with Chronic Kidney Disease

[0217]Empagliflozin is administered to patients in a randomised, double-blind, placebo controlled, parallel group study to compare treatment with empagliflozin 10 mg once daily with placebo as add-on therapy to standard of care in patients with chronic kidney disease. The duration of the patients is preferably a long term treatment, for example between 30 and 48 months.

[0218]Patients include individuals with presence of chronic kidney disease with high risk of cardiorenal events defined by at least one of the following:[0219]A) Very high levels of albuminuria (i.e. macroalbuminuria) defined as UACR 200 mg / g creatinine and / or[0220]B) Impaired renal function with estimated GFR2.

[0221]Furthermore patients include those with stable single RAS blockade background therapy (i.e. either ACE-inhibitor or ARB with unchanged daily dose.

[0222]The composite primary endpoint of the study is time to the first occurrence of any of the following components:[022...

example 1b

of Patients with Chronic Kidney Disease

[0253]Empagliflozin is administered to patients in a randomised, double-blind, placebo controlled, parallel group study to compare treatment with empagliflozin 10 mg once daily with placebo as add-on therapy to standard of care in patients with chronic kidney disease. The duration of the patients is preferably a long term treatment, for example between 30 and 48 months.

[0254]Patients include individuals with presence of chronic kidney disease with high risk of cardiorenal events defined by at least one of the following:[0255]A) Impaired renal function with estimated GFR 20 and 2 or[0256]B) Estimated GFR 45 and 2 and very high levels of albuminuria (i.e. macroalbuminuria) defined as UACR 200 mg / g creatinine

[0257]Furthermore patients include those with a clinically appropriate dose of single agent RAS blockade background therapy (i.e. either ACE-inhibitor or ARB). Those participants for whom RAS blockade is not considered indicated (e.g. due to c...

example 2

tical Composition and Dosage Form

[0283]The following example of solid pharmaceutical compositions and dosage forms for oral administration serves to illustrate the present invention more fully without restricting it to the contents of the example. Further examples of compositions and dosage forms for oral administration, are described in WO 2010 / 092126. The term “active substance” denotes empagliflozin according to this invention, especially its crystalline form as described in WO 2006 / 117359 and WO 2011 / 039107.

[0284]Tablets containing 2.5 mg, 5 mg, 10 mg or 25 mg of the active substance empagliflozin. Amounts of the ingredients are provided in mg per film-coated tablet.

2.5 mg / 5 mg / 10 mg / 25 mg / Active substanceper tabletper tabletper tabletper tabletWet granulationEmpagliflozin2.50005.00010.0025.00Lactose40.625081.250162.50113.00MonohydrateMicrocrystalline12.500025.00050.0040.00CelluloseHydroxypropyl1.87503.7507.506.00CelluloseCroscarmellose1.25002.5005.004.00SodiumPurified Waterq.s....

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Abstract

The present invention relates to methods for treating or preventing chronic kidney disease and cardiovascular disease in patients with chronic kidney disease comprising administering empagliflozin to the patient.

Description

TECHNICAL FIELD OF THE INVENTION[0001]The present invention relates to methods for treating or preventing chronic kidney disease and cardiovascular disease in patients with chronic kidney disease.BACKGROUND OF THE INVENTION[0002]Chronic kidney disease (CKD), also known as chronic renal disease, is a progressive loss in renal function over a period of months or years. The symptoms of worsening kidney function are non-specific, and chronic kidney disease is often diagnosed as a result of screening of people known to be at risk of kidney problems. CKD is a highly prevalent disease, afflicting more than one out of ten individuals worldwide.[0003]Chronic kidney disease may be identified by a blood test, for example for creatinine. Higher levels of creatinine indicate a lower glomerular filtration rate and as a result a decreased capability of the kidneys to excrete waste products.[0004]CKD has been classified into 5 stages, where stage 1 is kidney damage with normal GFR (mL / min / 1.73 m2) ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/351A61K45/06
CPCA61K31/351A61K45/06A61K9/2018A61K31/7048A61P13/12A61K2300/00
Inventor VON EYNATTEN, MAXIMILIANBROEDL, ULI CHRISTIANWOERLE, HANS-JUERGEN
Owner BOEHRINGER INGELHEIM INT GMBH
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