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 6 May 2024, 2.4 years ago.
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1 sheet
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Every citation, both ways
| Document | Relation | Office | Category | Cited during | Relevant claims |
|---|---|---|---|---|---|
| EP0298650A2 | Cites | European Patent Office (EPO) | A | Search report | 38 |
| WO03053399A2 | Cites | World Intellectual Property Organization (WIPO) | X | Search report | 38 |
| WO03063838A1 | Cites | World Intellectual Property Organization (WIPO) | X | Search report | 38,39 |
| EP0679400A1 | Cites | European Patent Office (EPO) | X | Search report | 1-7,21,22,24,30 |
| US5633006A | Cites | United States of America | X | Search report | 1,2,4,5 |
| US6068859A | Cites | United States of America | DA | Search report | 1 |
68 members in 44 offices
Priority claims10
| Document | Office | Kind | Date |
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| 527084P | United States of America | – | |
| 52708403 | United States of America | P | |
| 52708403 | United States of America | P | |
| 763340 | United States of America | – | |
| 76334004 | United States of America | A | |
| 76334004 | United States of America | A | |
| 527084P | – | – | – |
| 763340 | – | – | – |
| US20030527084P | – | – | – |
| US20040763340 | – | – | – |
Members68
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| ECSP045351A | Ecuador | A | |
| CL2004001501A1 | Chile | A1 | |
| CA2467611A1 | Canada | A1 | |
| IS7464A | Iceland | A | |
| NL1026315A1 | Netherlands (Kingdom of the) | A1 | |
| EP1537859A2 | European Patent Office (EPO) | A2 | |
| US2005123627A1 | United States of America | A1 | |
| TW200518784A | Taiwan Province of China | A | |
| WO2005053650A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2004216676A1 | Australia | A1 | |
| JP2005162733A | Japan | A | |
| DOP2004000994A | Dominican Republic | A | |
| EP1537859A3This record | European Patent Office (EPO) | A3 | |
| MXPA04009424A | Mexico | A | |
| UY28509A1 | Uruguay | A1 | |
| PA8611501A1 | Panama | A1 | |
| BRPI0403935A | Brazil | A | |
| PE20050573A1 | Peru | A1 | |
| GT200400183A | Guatemala | A | |
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| WO2005053650A8 | World Intellectual Property Organization (WIPO) | A8 | |
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| US6984403B2 | United States of America | B2 | |
| NL1026315C2 | Netherlands (Kingdom of the) | C2 | |
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| US2006039988A1 | United States of America | A1 | |
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| MA27848A1 | Morocco | A1 | |
| KR20060033851A | Republic of Korea | A | |
| HK1080367A1 | Hong Kong, China | A1 | |
| OA12858A | African Intellectual Property Organization (OAPI) | A | |
| PL379984A1 | Poland | A1 | |
| ZA200408075B | South Africa | B | |
| RS84704A | Serbia | A | |
| GEP20074056B | Georgia | B | |
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| TNSN05319A1 | Tunisia | A1 | |
| CR7500A | Costa Rica | A | |
| US2008015343A1 | United States of America | A1 | |
| EA010110B1 | Eurasian Patent Organization (EAPO) | B1 | |
| EP1537859B1 | European Patent Office (EPO) | B1 | |
| AT407663T | Austria | T | |
| ATE407663T1 | Austria | T1 | |
| DE602004016444D1 | Germany | D1 | |
| DK1537859T3 | Denmark | T3 | |
| PT1537859E | Portugal | E | |
| SI1537859T1 | Slovenia | T1 | |
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| HK1080367B | Hong Kong, China | B | |
| JP4602711B2 | Japan | B2 | |
| AP2218A | African Regional Intellectual Property Organization (ARIPO) | A | |
| AU2004216676B2 | Australia | B2 | |
| TWI351969B | Taiwan Province of China | B | |
| IL164165A | Israel | A | |
| CY1108486T1 | Cyprus | T1 | |
| BRPI0403935B1 | Brazil | B1 | |
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Numbers
- Publication
- 1537859
- Publication, DOCDB
- 1537859
- Publication, EPODOC
- EP1537859
- Application
- 4252643
- Application, DOCDB
- 04252643
- Application, EPODOC
- EP20040252643
Titles3
- German
- Azithromycin enthaltende pharmazeutische Zusammensetzungen mit verringerten Nebenwirkungen
- English
- Azithromycin dosage forms with reduced side effects
- French
- Formes posologiques contenant de l'azithromycin à effets secondaires réduits
Classification
- CPC, 18
- A61K9/1611
- A61K31/7052
- A61K9/143
- A61K9/1617
- A61K9/1623
- A61K9/1635
- A61K9/1641
- A61K9/1694
- A61K9/2009
- A61K9/2013
- A61K9/2031
- A61P31/00
- A61P31/04
- A61P33/00
- A61P33/02
- A61K9/16
- A61K9/20
- A61K31/7042
- IPC, 10
- C07H17 00
- A61K9 00
- A61K9 16
- A61K9 20
- A61K31 7052
- A61K47 02
- A61K47 14
- A61K47 18
- A61K47 44
- A61P31 04
Designated states33
- Contracting states, 28
- Austria
- Belgium
- Bulgaria
- Switzerland
- Cyprus
- Czechia
- Germany
- Denmark
- Estonia
- Spain
- Finland
- France
- United Kingdom
- Greece
- Hungary
- Ireland
- Italy
- Liechtenstein
- Luxembourg
- Monaco
- Netherlands (Kingdom of the)
- Poland
- Portugal
- Romania
and 4 moreShow fewer
- Sweden
- Slovenia
- Slovakia
- Türkiye
- Extension states, 5
- Albania
- Croatia
- Lithuania
- Latvia
- North Macedonia