IS7464A

Azithromycin dosage forms with reduced side effects

Abstract

An oral dosage form comprising azithromycin and an effective amount of an alkalizing agent. Preferably, said oral dosage form comprises an effective amount of an alkalizing agent and an azithromycin multiparticulate wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer. Typically, the oral dosage form includes any suitable oral dosing means such as a powder for oral suspension, a unit dose packet or sachet, a tablet or a capsule. Additionally disclosed is an oral suspension comprising azithromycin, an effective amount of an alkalizing agent and a vehicle. Preferably, the azithromycin is in multiparticulate form wherein said multiparticulate comprises azithromycin, a mixture of glyceryl monobehenate, glyceryl dibehenate and glyceryl tribehenate, and a poloxamer. Also disclosed is a method for reducing gastrointestinal side effects, associated with administering azithromycin to a mammal, comprising contiguously administering azithromycin and an effective amount of alkalizing agent to said mammal wherein the frequency of gastrointestinal side effects is lower than that experienced by administering an equal dose of azithromycin without said alkalizing agent. Further disclosed is a method of treating a bacterial or protozoal infection in a mammal in need thereof comprising contiguously administering to said mammal a single dose of an oral dosage form wherein said oral dosage form comprises azithromycin and an effective amount of an alkalizing agent. Additionally disclosed are azithromycin multiparticulates comprising azithromycin, a surfactant; and a pharmaceutically acceptable carrier.

Term

Term ended

Projected expiry passed 20 September 2024, 2 years ago.

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68 members in 44 offices

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Priority claims10

Priority claims
DocumentOfficeKindDate
52708403United States of AmericaP
52708403United States of AmericaP
76334004United States of AmericaA
76334004United States of AmericaA
2004001654International Bureau of the World Intellectual Property Organization (WIPO)W
2004001654International Bureau of the World Intellectual Property Organization (WIPO)W
PCTIB04001654
US20030527084P
US20040763340
WO2004IB01654

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IS7464AThis recordIcelandA
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EP1537859A2European Patent Office (EPO)A2
US2005123627A1United States of AmericaA1
TW200518784ATaiwan Province of ChinaA
WO2005053650A1World Intellectual Property Organization (WIPO)A1
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