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A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an HMG-CoA reductase inhibitor

A reductase inhibitor, fenofibrate technology, applied in the field of statin compound composition, single solid dosage form

Inactive Publication Date: 2008-01-30
LIFECYCLE PHARMA AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, certain statins are known to be prone to degradation and / or oxidation when subjected to adverse physical and / or chemical conditions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0165] Preparation of fenofibrate granules

[0166] Fenofibrate granules represented by 1A below were prepared as described in the Methods section above and as described in WO-A-2005 / 034920 (which is incorporated by reference in its entirety). 'mg / tablet' indicates the amount present in a single solid dosage form (tablet) of the pharmaceutical composition of the invention:

[0167] substance

Element

1A

％

mg / tablet

drug

Fenofibrate

19.6

160.00

carrier

lactose

43.6

356.50

excipient

PEG 6000

25.4

208.20

excipient

Poloxamer 188

10.9

89.20

Accessories

Magnesium stearate

0.5

4.10

100.0

818.00

[0168] Fenofibrate granules represented by 1B, 1C, 1D and 1E below were prepared as described in the Methods section above and as described in WO-A-2005 / 034920 (which is incorporated by reference in its entirety). 'mg / tablet' indicates the a...

Embodiment 2

[0171] Preparation of Simvastatin Granules

[0172] The simvastatin granules represented by 2A below were prepared using a conventional wet granulation method.

[0173] 'mg / tablet' indicates the amount present in a single solid dosage form (tablet) of the pharmaceutical composition of the invention:

[0174] substance

Embodiment 3

[0176] Preparation of Atorvastatin Granules

[0177] The atorvastatin granules represented by the following 3A were prepared by the conventional method of wet granulation, that is, mixing atorvastatin, lactose (carrier) and calcium carbonate (stabilizer), adding an appropriate amount of hydroxypropyl cellulose (Klucel; binder) and sodium carboxymethylcellulose (Ac-di-sol; disintegrant), add sterile water to the mixture, mix and dry out the water, sieve the dried mixture and add magnesium stearate ( lubricant) and microcrystalline cellulose (Avicel).

[0178] The following atorvastatin granules represented by 3B are prepared by the conventional method of wet granulation: hydroxypropyl cellulose (binding agent) and tromethamine (stabilizer) are dissolved in water (surfactant can be added, e.g. The binder solution was prepared in polysorbate 80). Atorvastatin, mannitol (vehicle), hydroxypropylcellulose (binder) and microcrystalline cellulose (Avicel; filler) were transferred to...

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PUM

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Abstract

A pharmaceutical composition for oral administration comprising a fixed dose combination of a first solid pharmaceutical composition containing fenofibrate as the active substance and second solid pharmaceutical composition containing an HMG-CoA reductase inhibitor such as a statin as the active substance, wherein the first and the second pharmaceutical compositions are present in separate entities in a single solid dosage form. For example a multilayer tablet, a two-layer tablet, or capsules or sachets containing the active ingredients in separate granulates or beads, either granulate or bead optionally being coated with a protective coating or an entero-coating.

Description

[0001] The present invention relates to a stable pharmaceutical composition comprising at least two active pharmaceutical ingredients, namely fenofibrate as a first ingredient and an HMG CoA reductase inhibitor or a derivative thereof as a second ingredient. More particularly, the present invention relates to a single solid dosage form for oral administration comprising the active substance present in separate entities: a solid fenofibrate composition and a solid HMG-CoA reductase inhibitor composition, preferably Statin composition. Background of the invention [0002] Clinical guidelines indicate that not only treatment with fibrates but also combined treatment with eg fenofibrate and statins should be the most effective way to manage cholesterol and lipids. In fact, treatment with fenofibrate is often prescribed together with statins, as clinicians seem to prefer using eg fenofibrate due to its triglyceride-lowering and HDL-C increasing effects, while statins are due to the...

Claims

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Application Information

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IPC IPC(8): A61K31/216A61K9/16A61K31/366A61K9/24A61K31/40A61K9/26
Inventor P·霍尔姆T·诺林
Owner LIFECYCLE PHARMA AS
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