BR112014027885A2 - produção de ingredientes farmacêuticos ativos estéreis - Google Patents

produção de ingredientes farmacêuticos ativos estéreis

Info

Publication number
BR112014027885A2
BR112014027885A2 BR112014027885A BR112014027885A BR112014027885A2 BR 112014027885 A2 BR112014027885 A2 BR 112014027885A2 BR 112014027885 A BR112014027885 A BR 112014027885A BR 112014027885 A BR112014027885 A BR 112014027885A BR 112014027885 A2 BR112014027885 A2 BR 112014027885A2
Authority
BR
Brazil
Prior art keywords
active pharmaceutical
pharmaceutical ingredients
production
sterile active
sterile
Prior art date
Application number
BR112014027885A
Other languages
English (en)
Other versions
BR112014027885B1 (pt
Inventor
Leone Mario
Morosini Pierfrancesco
Original Assignee
Icrom Spa
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 Icrom Spa filed Critical Icrom Spa
Publication of BR112014027885A2 publication Critical patent/BR112014027885A2/pt
Publication of BR112014027885B1 publication Critical patent/BR112014027885B1/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029—Radiation
    • A61L2/0035—Gamma radiation
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

resumo “produção de ingredientes farmacêuticos ativos estéreis” a invenção refere-se a um processo para preparar ingredientes farmacêuticos ativos estéreis (apis) úteis na preparação de produto estéril para o uso oftálmico. o processo compreende o tratamento por esterilização de raios gama do pó de apis em uma atmosfera protetora.
BR112014027885-7A 2012-05-09 2012-05-09 Processo para a preparação de um pó a granel de brinzolamida estéril BR112014027885B1 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2012/000136 WO2013168186A1 (en) 2012-05-09 2012-05-09 Production of sterile active pharmaceutical ingredients

Publications (2)

Publication Number Publication Date
BR112014027885A2 true BR112014027885A2 (pt) 2017-06-27
BR112014027885B1 BR112014027885B1 (pt) 2022-07-26

Family

ID=46321406

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014027885-7A BR112014027885B1 (pt) 2012-05-09 2012-05-09 Processo para a preparação de um pó a granel de brinzolamida estéril

Country Status (16)

Country Link
US (1) US10953115B2 (pt)
EP (1) EP2846845B1 (pt)
JP (1) JP6122485B2 (pt)
KR (1) KR101966830B1 (pt)
CN (1) CN104487099B (pt)
BR (1) BR112014027885B1 (pt)
CA (1) CA2872336C (pt)
EA (1) EA028596B1 (pt)
ES (1) ES2624250T3 (pt)
HR (1) HRP20170529T1 (pt)
HU (1) HUE034356T2 (pt)
IN (1) IN2014DN09993A (pt)
MX (1) MX349920B (pt)
PL (1) PL2846845T3 (pt)
PT (1) PT2846845T (pt)
WO (1) WO2013168186A1 (pt)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210145836A1 (en) * 2012-05-09 2021-05-20 Icrom Spa Production of sterile active pharmaceutical ingredients
HUE053952T4 (hu) * 2016-02-05 2021-09-28 Innopharma Inc Eljárás oxidációra érzékeny készítményhez stabil, alkalmazásra kész infúziós tasak elõállítására
BE1024110B1 (fr) * 2016-10-18 2017-11-16 Auxin Surgery Sa Dispositif, procédé et formulation pour dissection assistée de manière chimique
US20200289144A1 (en) * 2016-03-14 2020-09-17 Auxin Surgery Sa Device, method and formulation for chemically assisted dissection
DE102017107124A1 (de) * 2017-04-03 2018-10-04 Ferton Holding S.A. Pulver zur Reinigung eines inneren Körperteils und/oder eines Implantats, Verfahren zur Herstellung eines solchen Pulvers und geeignete Verwendungen
EP4153494A4 (en) * 2020-05-21 2024-10-09 Coherus Ophthalmology Llc SYSTEMS AND METHODS FOR MANUFACTURING STERILE INJECTION DEVICES
IT202100006794A1 (it) 2021-03-22 2022-09-22 Icrom Srl Processo per preparare il verde indocianina

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2004553B1 (de) * 1970-02-02 1971-05-19 Fa B Braun, 3508 Melsungen Verfahren zur Herstellung von Leit schienen aus menschlichen oder tierischen Geweben zur Wiederherstellung beschädigter oder zerstörter spezifischer Gewebsteile im menschlichen und tierischen Korper
US6071904A (en) 1996-12-11 2000-06-06 Alcon Laboratories, Inc. Process for manufacturing ophthalmic suspensions
US20030095890A1 (en) * 2001-09-24 2003-05-22 Shirley Miekka Methods for sterilizing biological materials containing non-aqueous solvents
US8080682B2 (en) * 2006-08-24 2011-12-20 University Of Tennessee Research Foundation Substituted acylanilides and methods of use thereof
EP1904114A2 (en) * 2005-05-19 2008-04-02 Albiorex, LLC Terminal sterilization of injectable collagen products
AU2007248949B2 (en) * 2006-05-09 2010-04-08 Astrazeneca Ab Parenteral formulation comprising proton pump inhibitor sterilized in its final container by ionizing radiation
GB0626021D0 (en) * 2006-12-29 2007-02-07 Insense Ltd The stabilisation of proteins
US20090258850A1 (en) * 2007-08-21 2009-10-15 Frincke James M Stabilized therapeutic compositions and formulations
EP2394637A1 (en) * 2010-05-21 2011-12-14 Zaklady Farmaceutyczne Polpharma SA Process for obtaining sterile brinzolamide suspensions

Also Published As

Publication number Publication date
MX2014013238A (es) 2015-04-08
PT2846845T (pt) 2017-06-02
JP2015523327A (ja) 2015-08-13
EP2846845A1 (en) 2015-03-18
US20150141412A1 (en) 2015-05-21
EA028596B1 (ru) 2017-12-29
PL2846845T3 (pl) 2017-07-31
KR101966830B1 (ko) 2019-04-08
WO2013168186A1 (en) 2013-11-14
EA201491845A1 (ru) 2015-02-27
BR112014027885B1 (pt) 2022-07-26
MX349920B (es) 2017-08-21
KR20150024821A (ko) 2015-03-09
HUE034356T2 (en) 2018-02-28
EP2846845B1 (en) 2017-03-01
IN2014DN09993A (pt) 2015-08-14
CN104487099A (zh) 2015-04-01
CN104487099B (zh) 2017-06-20
ES2624250T3 (es) 2017-07-13
CA2872336A1 (en) 2013-11-14
CA2872336C (en) 2019-08-13
US10953115B2 (en) 2021-03-23
HRP20170529T1 (hr) 2017-06-16
JP6122485B2 (ja) 2017-04-26

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/05/2012, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.