PA8562101A1 - Metodos para granulacion humeda de azitromicina - Google Patents

Metodos para granulacion humeda de azitromicina

Info

Publication number
PA8562101A1
PA8562101A1 PA20028562101A PA8562101A PA8562101A1 PA 8562101 A1 PA8562101 A1 PA 8562101A1 PA 20028562101 A PA20028562101 A PA 20028562101A PA 8562101 A PA8562101 A PA 8562101A PA 8562101 A1 PA8562101 A1 PA 8562101A1
Authority
PA
Panama
Prior art keywords
azitromycin
dihydrate
granules
refers
methods
Prior art date
Application number
PA20028562101A
Other languages
English (en)
Inventor
Barbara Alice Johnson
Michael Bruce Fergione
Original Assignee
Pfizer Prod Inc
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 Pfizer Prod Inc filed Critical Pfizer Prod Inc
Publication of PA8562101A1 publication Critical patent/PA8562101A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Abstract

ESTA INVENCION SE REFIERE A UN METODO DE FORMACION DE GRANULOS DE AZITROMICINA NO DIHIDRATO, QUE COMPRENDE MEZCLAR PARTICULAS DE AZITROMICINA NO DIHIDRATO, CON UNA CANTIDAD DE GRANULACION DE UN LIQUIDO DE GRANULACION, Y OPCIONALMENTE, CON PARTICULAS DE UNO O MAS EXCIPIENTES, PARA FORMAR GRANULOS HUMEDOS QUE COMPRENDEN AZITROMICINA NO DIHIDRATO Y EL LIQUIDO DE GRANULACION. LOS GRANULOS SE SECAN DESPUES PARA SEPARAR EL LIQUIDO DE GRANULACION. LA INVENCIÓN ADEMAS SE REFIERE A UNA COMPOSICION FARMACEUTICA QUE COMPRENDE GRANULOS DE UNA AZITROMICINA NO DIHIDRATO Y AL MENOS UN EXCIPIENTE FARMACEUTICAMENTE ACEPTABLE. LA INVENCION TAMBIEN SE REFIERE A FORMULACIONES FARMACEUTICAS QUE COMPRENDEN GRANULOS DE AZITROMICINA NO DIHIDRATO. LA INVENCION ADEMAS SE REFIERE A GRANULOS DE AZITROMICINA DIHIDRATO EN QUE LOS GRANULOS COMPRENDEN 98% O MAS DE AZITROMICINA DIHIDRATO Y DESDE APROXIMADAMENTE 2% A 0%, EN PESO TOTAL, DE UNO O MAS EXCIPIENTES FARMACEUTICAMENTE ACEPTABLES.
PA20028562101A 2001-12-21 2002-12-20 Metodos para granulacion humeda de azitromicina PA8562101A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US34346901P 2001-12-21 2001-12-21

Publications (1)

Publication Number Publication Date
PA8562101A1 true PA8562101A1 (es) 2005-02-04

Family

ID=23346249

Family Applications (1)

Application Number Title Priority Date Filing Date
PA20028562101A PA8562101A1 (es) 2001-12-21 2002-12-20 Metodos para granulacion humeda de azitromicina

Country Status (21)

Country Link
US (1) US20030190365A1 (es)
EP (1) EP1455757A2 (es)
JP (1) JP2005515212A (es)
KR (1) KR100669279B1 (es)
CN (1) CN1606433A (es)
AR (1) AR037931A1 (es)
AU (1) AU2002353316A1 (es)
BR (1) BR0215175A (es)
CA (1) CA2470055A1 (es)
HN (1) HN2002000376A (es)
IL (1) IL161259A0 (es)
MX (1) MXPA04003027A (es)
NO (1) NO20042575L (es)
NZ (1) NZ532063A (es)
PA (1) PA8562101A1 (es)
PE (1) PE20030588A1 (es)
PL (1) PL371125A1 (es)
RU (1) RU2283651C2 (es)
TW (1) TW200301260A (es)
WO (1) WO2003053399A2 (es)
ZA (1) ZA200402586B (es)

Families Citing this family (26)

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HRP20020231A2 (en) 2002-03-18 2003-12-31 Pliva D D ISOSTRUCTURAL PSEUDOPOLYMORPHS OF 9-DEOXO-9a-AZA-9a-METHYL-9a-HOMOERYTHROMYCIN A
IL161996A0 (en) * 2001-12-21 2005-11-20 Pfizer Prod Inc Directly compressible formulations of azithromycin
HRP20020614A2 (en) * 2002-07-22 2004-06-30 PLIVA-ISTRAŽIVAČKI INSTITUT d.o.o. Rhombic pseudopolymorph of 9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin a
WO2005002592A2 (en) * 2003-07-01 2005-01-13 Ranbaxy Laboratories Limited Stable oral compositions of azithromycin monohydrate
JP2007513139A (ja) 2003-12-04 2007-05-24 ファイザー・プロダクツ・インク 安定性の改善した多粒子組成物
CA2549225A1 (en) 2003-12-04 2005-06-16 Pfizer Products Inc. Spray-congeal process using an extruder for preparing multiparticulate crystalline drug compositions containing preferably a poloxamer and a glyceride
JP2007513145A (ja) 2003-12-04 2007-05-24 ファイザー・プロダクツ・インク 医薬用多微粒子の製造方法
US6984403B2 (en) * 2003-12-04 2006-01-10 Pfizer Inc. Azithromycin dosage forms with reduced side effects
WO2005053652A1 (en) 2003-12-04 2005-06-16 Pfizer Products Inc. Multiparticulate crystalline drug compositions containing a poloxamer and a glyceride
US7943585B2 (en) 2003-12-22 2011-05-17 Sandoz, Inc. Extended release antibiotic composition
KR20060129303A (ko) * 2003-12-23 2006-12-15 템렐 리미티드 약제학적 조성물을 위한 펠렛을 생산하는 방법
US7468428B2 (en) 2004-03-17 2008-12-23 App Pharmaceuticals, Llc Lyophilized azithromycin formulation
UA95093C2 (uk) * 2005-12-07 2011-07-11 Нікомед Фарма Ас Спосіб одержання кальцієвмісної сполуки
CN100441196C (zh) * 2006-12-15 2008-12-10 北京化工大学 一种制备微粉化阿奇霉素的方法
GB0715628D0 (en) * 2007-08-10 2007-09-19 Generics Uk Ltd Solid valsartan composition
CA2744377A1 (en) * 2008-11-20 2010-05-27 Avantor Performance Materials, Inc. Directly compressible high functionality granular dibasic calcium phosphate based co-processed excipient
US8106111B2 (en) 2009-05-15 2012-01-31 Eastman Chemical Company Antimicrobial effect of cycloaliphatic diol antimicrobial agents in coating compositions
RU2403049C1 (ru) * 2009-06-04 2010-11-10 Государственное образовательное учреждение высшего профессионального образования Московская медицинская академия им. И.М. Сеченова Федерального агентства по здравоохранению и социальному развитию (ГОУВПО ММА им. И.М. Сеченова Росздрава) Способ получения таблеток эритромицина
EP2295037A1 (en) * 2009-09-11 2011-03-16 Ratiopharm GmbH Pharmaceutical formulation containing Ribavirin
RU2480689C1 (ru) * 2011-10-26 2013-04-27 Александр Михайлович Муртищев Способ получения порошкообразных продуктов
DK3378479T3 (da) * 2016-01-27 2020-08-03 Jiangsu Hengrui Medicine Co Fremgangsmåde til forberedelse af farmakologisk sammensætning, der omfatter qionolinderivat eller salt deraf
WO2017163170A1 (en) * 2016-03-21 2017-09-28 Sun Pharmaceutical Industries Limited Pharmaceutical composition comprising apixaban
CN110292567B (zh) * 2019-05-17 2022-02-18 北京悦康科创医药科技股份有限公司 一种阿奇霉素胶囊的制备方法
CN113088422A (zh) * 2021-05-18 2021-07-09 耿艳飞 一种荞麦果醋
CN113559073A (zh) * 2021-07-20 2021-10-29 海南海神同洲制药有限公司 阿奇霉素片剂及其制备方法
CN116930013A (zh) * 2023-07-28 2023-10-24 海南卫康制药(潜山)有限公司 一种阿奇霉素干混悬剂中原料粒度的测定方法

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Also Published As

Publication number Publication date
NZ532063A (en) 2006-03-31
WO2003053399A3 (en) 2004-05-21
PE20030588A1 (es) 2003-07-08
IL161259A0 (en) 2004-09-27
CN1606433A (zh) 2005-04-13
NO20042575L (no) 2004-06-18
MXPA04003027A (es) 2004-07-05
CA2470055A1 (en) 2003-07-03
PL371125A1 (en) 2005-06-13
AU2002353316A1 (en) 2003-07-09
AR037931A1 (es) 2004-12-22
TW200301260A (en) 2003-07-01
BR0215175A (pt) 2004-12-28
RU2283651C2 (ru) 2006-09-20
JP2005515212A (ja) 2005-05-26
WO2003053399A2 (en) 2003-07-03
ZA200402586B (en) 2005-04-01
KR20040073504A (ko) 2004-08-19
US20030190365A1 (en) 2003-10-09
KR100669279B1 (ko) 2007-01-16
HN2002000376A (es) 2003-02-21
RU2004118502A (ru) 2005-04-10
EP1455757A2 (en) 2004-09-15

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