Multi-phasic, nano-structured compositions containing a combination of a fibrate and a statin

A composition, fibrate technology, applied in the direction of drug combination, drug delivery, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2010-10-06
NOVAVAX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, even after micronization, fibrates still have high fed-fasted variability in their bioabsorption and bioavailability

Method used

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  • Multi-phasic, nano-structured compositions containing a combination of a fibrate and a statin
  • Multi-phasic, nano-structured compositions containing a combination of a fibrate and a statin
  • Multi-phasic, nano-structured compositions containing a combination of a fibrate and a statin

Examples

Experimental program
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Embodiment

[0100] Preparation I: Control Substance

[0101] Non-micronized fenofibrate powder was suspended in hydroxypropylmethylcellulose (HPMC, grade E4M) to obtain a suspension with a concentration of 0.5 wt% (48 mg fenofibrate / g suspension). The suspension is mixed very well to obtain a homogeneous suspension free of lumps and / or aggregates.

[0102] Formulation II: Standard

[0103] TriCor tablets (48 mg fenofibrate / tablet) (from Abbott Pharma) were ground using a mortar and pestle until a mass free of aggregates was obtained. Then, the material was suspended in 1 ml of purified water to obtain a homogeneous suspension.

[0104] Formulation III: Test Article I

[0105] Fenofibrate (4.8 g) was mixed with ethanol (8.8 g), polysorbate 80 (9.4 g) and soybean oil (50.2 g). Water (26.8 grams) was added and the whole mixture was emulsified using a paddle stirrer. The resulting emulsion was then subjected to three rounds of high-pressure homogenization (APV-1000) at 10,000 psi (...

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Abstract

The present invention discloses a pharmaceutical formulation containing a multi-phasic pharmaceutical composition in an oral dosage form. The multi-phasic pharmaceutical composition contains: (a) a fibrate, or a pharmaceutically acceptable salt, ester, hydrate, or prodrug thereof; (b) a statin, or a pharmaceutically acceptable salt, ester, hydrate, or prodrug thereof; (c) a solvent; (d) a non-miscible liquid; (e) a stabilizer; and (f) water. The fibrate or the statin or both is in a particulate state and / or a solubilized state. Such pharmaceutical formulations are capable of reducing the fed / fast variability and improving oral bioavailability to which a number of active pharmaceutical ingredients are susceptible. The pharmaceutical formulations of the invention, therefore are bioequivalent in fed and fasted states and have improved oral bioavailability.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to U.S. Provisional Patent Application Serial No. 60 / 970,684, filed September 7, 2007, entitled "Multi-phasic, Nano-structured Compositions Containing a Combination of a Fibrate and a Statin," which is adopted in its entirety by Incorporated by reference herein for all purposes. This application is also related to U.S. Provisional Patent Application Serial No. 60 / 881,470, filed January 22, 2007, and entitled "Multi-phasic Pharmaceutical Formulations of Poorly Water-soluble Drugs for Reduced Fed / Fasted Variability and Improved Oral Bioavailability" and filed on 11 January 2006 U.S. Provisional Patent Application Serial No. 60 / 857,511, entitled "Method of Preparing Solid Dosage Forms of Multi-phasic Pharmaceutical Compositions," filed on March 8, is hereby incorporated by reference in its entirety for all purposes. technical field [0003] The present invention generally relates to multiph...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00
CPCA61K47/14A61K31/00A61K47/38A61K9/107A61K9/4866A61K47/26A61K9/0095A61K47/10A61K9/0056A61K31/401A61K9/10A61K45/06A61P3/06A61K2300/00
Inventor 迪尼什·谢诺伊罗伯特·李
Owner NOVAVAX
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