Rifaximin ready-to-use suspension

Patent metadata

Field	Value
Publication number	US-2016136141-A1
Application number	US-201514937730-A
Country	US
Kind code	A1
Filing date	Nov 10, 2015
Priority date	Mar 10, 2010
Publication date	May 19, 2016
Grant date	—

Abstract

A stable, taste-masked, ready-to-use suspension comprising rifaximin dispersed in a suspension base and one or more pharmaceutically acceptable additive(s). Also provided is a process for preparing a stable, taste-masked, ready-to-use suspension of rifaximin comprising the steps of mixing rifaximin with the suspension base and further sizing the particles of rifaximin by milling the suspension to obtain a homogenously dispersed rifaximin suspension.

First claim

1 ) A stable, taste-masked, ready-to-use suspension comprising rifaximin dispersed in a suspension base and one or more pharmaceutically acceptable additive(s).

2 ) The stable, taste—masked, ready-to-use suspension as of claim 1 wherein one or more pharmaceutically acceptable additive(s) is selected from flavoring agent(s), sweetening agent(s), buffering agents(s), preservative(s), suspending agents(s), antioxidant(s), wetting agent(s), dispersing agent(s), pH stabilizing agent(s), taste enhancing agent(s), antifoaming agent(s) or mixtures thereof.

3 ) The stable, taste—masked, ready-to-use suspension as of claim 1 wherein the pH of the suspension is from about 2 to about 8.

4 ) The stable, taste—masked, ready-to-use suspension as of claim 1 wherein the viscosity of the suspension is from about 20 to about 200 Cps.

5 ) A stable taste—masked, ready-to-use suspension as of claim 1 wherein the d90 of rifaximin is less than about 40 μm.

6 ) A process for preparing stable, taste-masked, ready-to-use suspension of rifaximin wherein the said process comprises the steps of dispersing rifaximin in the suspension base comprising one or more pharmaceutically acceptable additive(s) and further milling the suspension to obtain a homogenously dispersed rifaximin suspension.

Assignees

• Jahagirdar Harshal Anil
• Konda Kishore Kumar
• Dalal Satish Kumar
• Kulkarni Shirishkumar
• Lupin Ltd

Inventors

• Jahagirdar Harshal Anil
• Konda Kishore Kumar
• Dalal Satish Kumar
• Kulkarni Shirishkumar

Classifications

• A61K31/437 Primary

  the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline · CPC title

• A23L27/00

  Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof · CPC title

• A61K9/10

  Dispersions; Emulsions · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• A61K31/428

  condensed with carbocyclic rings · CPC title