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Oral formulations of a HEDGEHOG pathway inhibitor

A preparation and a technology for pharmaceutical preparations, applied in the field of preparation and use of the preparations, can solve problems such as the reduction of the actual amount of drug substances

Inactive Publication Date: 2012-10-03
INFINITY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The foregoing can sometimes have a considerable effect on pharmacokinetics and can lead to a reduction in the actual amount of drug substance absorbed

Method used

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  • Oral formulations of a HEDGEHOG pathway inhibitor
  • Oral formulations of a HEDGEHOG pathway inhibitor
  • Oral formulations of a HEDGEHOG pathway inhibitor

Examples

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Embodiment Construction

[0108] The application provides pharmaceutical formulations (eg, solid dosage forms) useful for oral administration of a compound of formula (I) (shown below) or a pharmaceutically acceptable salt thereof (eg, IPI-926) to a human or animal subject.

[0109]

[0110] As used herein, the term "pharmaceutically acceptable salt" or "salt" refers to a salt which, within the scope of sound medical judgment, is suitable for use in contact with the tissues of humans and lower animals without producing undue Toxicity, irritation, allergic response, etc. and commensurate with a reasonable benefit / risk ratio. Pharmaceutically acceptable salts are well known in the art. For example, S.M. Berge et al. describe pharmaceutically acceptable salts in detail in J. Pharmaceutical Sciences (1977) 66:1-19. Pharmaceutically acceptable salts of the compounds of this invention include those derived from suitable inorganic and organic acids. Examples of pharmaceutically acceptable, non-toxic acid...

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Abstract

Oral formulations of the drug product IPI-926 are described. Pharmaceutical formulations (e.g., solid dosage forms) that are useful for the oral administration of a compound of formula (I), or a pharmaceutically acceptable salt thereof (e.g., IPI-926), to a human or animal subject are disclosed. The formulations can further include, for example and without limitation, one or more other pharmaceutically-acceptable filler(s), binder(s), surfactant(s), and disintegrant(s); as well as one or more other therapeutic agent(s). Methods of preparing and using said formulations are also disclosed.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Patent Application No. 61 / 280,628, filed November 6, 2009, which is hereby incorporated by reference in its entirety. Background of the invention [0003] Malignant activation of (Hh) channels plays a crucial role in cancer (Jiang and Hui, "Hedgehog Signaling in Development and Cancer" Developmental Cell Review (2008) 15:801-812). This channel includes two cell membrane proteins, Patched (PTC) and Smoothened (SMO), and is regulated by the presence or absence of Hh ligands. In most mature cells, Hh channels are inactive. In the absence of ligand, Smo is kept inactive by Ptc, and Gli transcription factors do not enter the nucleus to promote transcription. When Hh ligand is present, it binds to Ptc to allow Smo to initiate a signaling cascade that regulates Gli transcription factors and leads to Gli translocation into the nucleus. This results in the transcription of ...

Claims

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Application Information

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IPC IPC(8): A01N45/00
CPCA61K9/1652A61K31/343A61K9/2054A61P35/00A61K31/34A61K9/16A61K9/14
Inventor B·卡特J·J·李H·谢赫
Owner INFINITY PHARMA