PT1446010E - Composições de azitromicina estabilizadas - Google Patents

Composições de azitromicina estabilizadas Download PDF

Info

Publication number
PT1446010E
PT1446010E PT02801784T PT02801784T PT1446010E PT 1446010 E PT1446010 E PT 1446010E PT 02801784 T PT02801784 T PT 02801784T PT 02801784 T PT02801784 T PT 02801784T PT 1446010 E PT1446010 E PT 1446010E
Authority
PT
Portugal
Prior art keywords
azithromycin
compositions
stabilized
stabilized azithromycin
antioxidant
Prior art date
Application number
PT02801784T
Other languages
English (en)
Inventor
Ruth Tenengauzer
Joseph Schwarz
Julia Hrakovsky
Tania Lessen
Lev Khondo
Mathi Mathivanan
Claude Singer
Michael Pesachovich
Original Assignee
Teva Pharma
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharma filed Critical Teva Pharma
Publication of PT1446010E publication Critical patent/PT1446010E/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)
PT02801784T 2001-10-18 2002-10-18 Composições de azitromicina estabilizadas PT1446010E (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33634601P 2001-10-18 2001-10-18
US33193101P 2001-11-21 2001-11-21
US34129501P 2001-12-17 2001-12-17

Publications (1)

Publication Number Publication Date
PT1446010E true PT1446010E (pt) 2009-06-08

Family

ID=27406829

Family Applications (1)

Application Number Title Priority Date Filing Date
PT02801784T PT1446010E (pt) 2001-10-18 2002-10-18 Composições de azitromicina estabilizadas

Country Status (13)

Country Link
US (3) US6764997B2 (pt)
EP (1) EP1446010B1 (pt)
AT (1) ATE428403T1 (pt)
AU (1) AU2002335087A1 (pt)
CA (1) CA2463619C (pt)
DE (1) DE60232005D1 (pt)
DK (1) DK1446010T3 (pt)
ES (1) ES2324527T3 (pt)
HK (1) HK1067278A1 (pt)
HU (1) HUP0402291A2 (pt)
IL (1) IL161398A0 (pt)
PT (1) PT1446010E (pt)
WO (1) WO2003032922A2 (pt)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6861413B2 (en) 2001-05-22 2005-03-01 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
JP2004530703A (ja) 2001-05-22 2004-10-07 ファイザー・プロダクツ・インク 結晶形アジスロマイシン
US20080149521A9 (en) * 2001-10-18 2008-06-26 Michael Pesachovich Methods of stabilizing azithromycin
EP1455758A1 (en) * 2001-12-21 2004-09-15 Pfizer Products Inc. Directly compressible formulations of azithromycin
WO2003053399A2 (en) * 2001-12-21 2003-07-03 Pfizer Products Inc. Methods for wet granulating azithromycin
BR0307331A (pt) * 2002-02-01 2004-12-07 Pfizer Prod Inc Formulações granuladas a seco de azitromicina
CA2517004A1 (en) * 2003-02-19 2004-09-02 Teva Pharmaceutical Industries Ltd. Methods of stabilizing azithromycin during storage by packaging in a gas impermeable container
US20040266997A1 (en) * 2003-03-25 2004-12-30 Michael Pesachovich Degradation products of azithromycin, and methods for their indentification
CA2521462A1 (en) * 2003-04-17 2004-10-28 Sandoz Ag Derivatives of azithromycin
EP1648472A2 (en) * 2003-07-01 2006-04-26 Ranbaxy Laboratories, Ltd. Stable oral compositions of azithromycin monohydrate
US20050013835A1 (en) * 2003-07-15 2005-01-20 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
JP2007507489A (ja) * 2003-09-30 2007-03-29 ソルベスト リミテッド 水可溶性ナノ粒子封入複合体
US7468428B2 (en) * 2004-03-17 2008-12-23 App Pharmaceuticals, Llc Lyophilized azithromycin formulation
US20060116336A1 (en) * 2004-03-17 2006-06-01 American Pharmaceutical Partners, Inc. Lyophilized azithromycin formulation
EP1830860A2 (en) * 2004-12-21 2007-09-12 Pfizer Products Incorporated Stable non-dihydrate azithromycin oral suspensions
US20060198895A1 (en) * 2005-03-07 2006-09-07 Kotliar Eleonora M Azithromycin powder for oral suspension compositions
US8906823B2 (en) * 2007-09-24 2014-12-09 Basf Corporation Pollutant emission control sorbents and methods of manufacture and use
TWI468167B (zh) 2007-11-16 2015-01-11 威佛(國際)股份有限公司 藥學組成物
US8106111B2 (en) 2009-05-15 2012-01-31 Eastman Chemical Company Antimicrobial effect of cycloaliphatic diol antimicrobial agents in coating compositions
WO2011015219A1 (en) 2009-08-06 2011-02-10 Shifa Pharmed Industrial Group Co. Process for the purification of azithromycin by separation from its thermal degradation products and/or isomers
RU2512683C2 (ru) * 2012-06-08 2014-04-10 Общество с ограниченной ответственностью "ВИК-здоровье животных" Антибактериальная инъекционная фармацевтическая композиция
EP3615032A4 (en) * 2017-04-28 2020-12-23 Asana BioSciences, LLC FORMULATIONS, PROCEDURES, KITS AND DOSING FORMS FOR TREATMENT OF ATOPIC DERMATITIS AND IMPROVED STABILITY OF AN ACTIVE INGREDIENT
RU2666607C1 (ru) * 2017-05-03 2018-09-11 Общество С Ограниченной Ответственностью "Вик - Здоровье Животных" Способ повышения стабильности инъекционной фармацевтической композиции
US11654124B2 (en) 2019-07-29 2023-05-23 Amneal Pharmaceuticals Llc Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
US10792262B1 (en) * 2019-07-29 2020-10-06 Saol International Limited Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
CN111450065B (zh) * 2020-04-22 2022-04-01 南京嘉晨医药科技有限公司 一种阿奇霉素干混悬剂的制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
YU43006B (en) * 1981-03-06 1989-02-28 Pliva Pharm & Chem Works Process for preparing n-methyl-11-aza-10-deoxo-10-dihydro erythromycin and derivatives thereof
US4474768A (en) * 1982-07-19 1984-10-02 Pfizer Inc. N-Methyl 11-aza-10-deoxo-10-dihydro-erytromycin A, intermediates therefor
WO1989002271A1 (en) * 1987-09-10 1989-03-23 Pfizer Azithromycin and derivatives as antiprotozoal agents
US5605889A (en) * 1994-04-29 1997-02-25 Pfizer Inc. Method of administering azithromycin
AU4399396A (en) * 1994-12-19 1996-07-10 Russinsky Limited Compounds
US5872104A (en) 1994-12-27 1999-02-16 Oridigm Corporation Combinations and methods for reducing antimicrobial resistance
TW546302B (en) * 1998-05-08 2003-08-11 Biochemie Sa Improvements in macrolide production
CN1205338A (zh) * 1998-05-08 1999-01-20 刘万忠 阿奇霉素水溶性盐的合成新方法及其在医药上的用途
US6239112B1 (en) 1998-07-09 2001-05-29 Merial, Inc. Water miscible macrolide solutions
EP1484062A1 (en) * 1998-11-30 2004-12-08 Teva Pharmaceutical Industries Limited Crystalline azithromycin, process for manufacture and pharmaceutical compositions thereof
US6239113B1 (en) * 1999-03-31 2001-05-29 Insite Vision, Incorporated Topical treatment or prevention of ocular infections
IT1313610B1 (it) * 1999-08-09 2002-09-09 S I F I Societa Ind Farmaceuti Processo per la preparazione di formulazioni acquose per uso oftalmico

Also Published As

Publication number Publication date
ES2324527T3 (es) 2009-08-10
AU2002335087A1 (en) 2003-04-28
CA2463619A1 (en) 2003-04-24
CA2463619C (en) 2008-05-06
IL161398A0 (en) 2004-09-27
EP1446010A4 (en) 2007-06-13
DK1446010T3 (da) 2009-06-22
HK1067278A1 (en) 2005-04-08
DE60232005D1 (de) 2009-05-28
US20050106239A1 (en) 2005-05-19
US20040192622A1 (en) 2004-09-30
EP1446010B1 (en) 2009-04-15
HUP0402291A2 (hu) 2005-03-29
WO2003032922A2 (en) 2003-04-24
US6764997B2 (en) 2004-07-20
WO2003032922A3 (en) 2003-10-16
US20030176369A1 (en) 2003-09-18
ATE428403T1 (de) 2009-05-15
EP1446010A2 (en) 2004-08-18

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