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Pharmaceutical composition comprising HMG-CoA reductase inhibitor and fenofibrate

A technology of fenofibrate and composition, which is applied in the field of pharmaceutical compositions comprising HMG-CoA reductase inhibitor and fenofibrate, and can solve the problems of no display and the like

Pending Publication Date: 2022-03-11
INTAS PHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0024] Furthermore, none of the prior art literature has shown that by providing in vivo bioequivalent to concomitant administration of monotherapy SECALIP and Fixed-dose combination of fenofibrate and rosuvastatin effectively improves treatment adherence

Method used

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  • Pharmaceutical composition comprising HMG-CoA reductase inhibitor and fenofibrate
  • Pharmaceutical composition comprising HMG-CoA reductase inhibitor and fenofibrate
  • Pharmaceutical composition comprising HMG-CoA reductase inhibitor and fenofibrate

Examples

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example

[0110] To further illustrate the present invention, the following examples are provided for purposes of clarity of understanding. However, it is not intended to limit the scope of the present invention in any way, and it is easy for those skilled in the art to make certain changes and modifications without departing from the scope of the present invention based on the teaching of the present invention.

[0111] Preparation of Fenofibrate (micronized):

[0112] For Comparative Example 1 and Examples 2-4, fenofibrate was micronized to have the following particle distribution, characterized by the PSD parameters listed in Table 1 below.

[0113] Table 1 : Particle size distribution parameters of micronized fenofibrate, where NMT means "not larger than".

[0114] parameter limit D(v,10) NMT 2μm D(v,50) NMT 4μm D(v,90) NMT 10μm

example 2

[0122] Example 2: Rosuvastatin and fenofibrate bilayer tablet (according to the invention)

[0123] Table 3: Weight ratios of ingredients in the two layers of the rosuvastatin / fenofibrate multilayer tablet of the present invention. For example, a combined dose of 5+160 mg / tablet, 10+160 mg / tablet or 20+160 mg / tablet of the multilayer tablet of the invention is useful.

[0124]

[0125] ** - Not present in final composition.

[0126] Manufacturing method:

example 3

[0128] Example 3: Rosuvastatin and fenofibrate bilayer tablet (according to the invention)

[0129] Table 4: Absolute amounts of ingredients in the two layers of different doses of rosuvastatin / fenofibrate multilayer tablet according to the invention.

[0130]

[0131]

[0132] ** - Not present in final composition.

[0133] *- 5.21 / 10.42 / 20.84mg rosuvastatin calcium is equivalent to 5 / 10 / 20mg rosuvastatin.

[0134] Manufacturing method:

[0135] Layer 1 (fenofibrate layer):

[0136] The fenofibrate blend is prepared by sieving the intragranular ingredients with serial numbers Sr. No 1 to 7 as listed above through a suitable sieve and by charging it to a suitable granulator. The adhesive solution was prepared by dissolving povidone (Sr. No 8) in purified water added with isopropanol to obtain a suitable mixture. Fenofibrate granules are obtained by granulating the fenofibrate blend (Sr. No 1-7) and granulation solvent in a suitable granulator. Subsequently, the ob...

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Abstract

The present invention provides a multilayer pharmaceutical composition comprising a fixed dose combination of rosuvastatin or a pharmaceutically acceptable salt thereof and fenofibrate or a pharmaceutically acceptable salt thereof wherein the fenofibrate or the pharmaceutically acceptable salt thereof and the rosuvastatin or the pharmaceutically acceptable salt thereof are present in separate layers, the present invention relates to a composition comprising a fenofibrate layer and a rosuvastatin layer, in which fenofibrate and rosuvastatin are immediately released from the fenofibrate layer and the rosuvastatin layer, respectively, and in which the fenofibrate layer comprises micronized fenofibrate. In addition, the present invention provides a method for preparing the composition.

Description

[0001] Cross References to Related Applications [0002] This application is related to Indian Provisional Application No. IN 201921030870 filed on 31 July 2019 and European Patent Provisional Application No. EP 19201186.4 filed on 2 October 2019, which applications are incorporated herein in their entirety. technical field [0003] The present invention provides a multilayer pharmaceutical composition comprising a fixed dose combination of rosuvastatin or a pharmaceutically acceptable salt thereof and fenofibrate or a pharmaceutically acceptable salt thereof, wherein The fenofibrate or a pharmaceutically acceptable salt thereof and the rosuvastatin or a pharmaceutically acceptable salt thereof are present in separate layers, namely a fenofibrate layer and a rosuvastatin layer, wherein fenofibrate Fibrate and rosuvastatin are released immediately from the fenofibrate layer and the rosuvastatin layer, respectively, and wherein the fenofibrate layer comprises micronized fenofibr...

Claims

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Application Information

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IPC IPC(8): A61K31/505A61K9/24A61K47/38A61P3/06A61K31/216
CPCA61K31/505A61K31/216A61K9/2054A61K9/209A61P3/06A61K2300/00A61K9/2095
Inventor 希滕德拉·内特拉尔·拉汉代尔纳伦德拉·巴格瓦特拜·普拉贾帕蒂萨蒂亚万·希瓦吉拉奥·达瓦莱文卡塔拉曼纳·奈杜
Owner INTAS PHARM LTD
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