BR112020012113A2 - processo e dispositivo para determinaçao de um produto farmacêutico acabado - Google Patents

processo e dispositivo para determinaçao de um produto farmacêutico acabado

Info

Publication number
BR112020012113A2
BR112020012113A2 BR112020012113-4A BR112020012113A BR112020012113A2 BR 112020012113 A2 BR112020012113 A2 BR 112020012113A2 BR 112020012113 A BR112020012113 A BR 112020012113A BR 112020012113 A2 BR112020012113 A2 BR 112020012113A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical product
determining
finished pharmaceutical
drug
nir
Prior art date
Application number
BR112020012113-4A
Other languages
English (en)
Inventor
Jörg Schwarz
David MAINKA
Original Assignee
Medios Manufaktur Gmbh
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 Medios Manufaktur Gmbh filed Critical Medios Manufaktur Gmbh
Publication of BR112020012113A2 publication Critical patent/BR112020012113A2/pt

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3155Measuring in two spectral ranges, e.g. UV and visible
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/063Illuminating optical parts
    • G01N2201/0636Reflectors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/065Integrating spheres

Landscapes

  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

A presente invenção refere-se a um processo para determinação de um produto farmacêutico acabado, apresentando: provisão de um produto farmacêutico acabado a ser determinado em uma embalagem primária fechada; medição de um espectro de medição NIR para o medicamento acabado a ser determinado através da embalagem primária fechada; comparação do espectro de medição NIR com um espectro de referência NIR, o qual está associado a um medicamento ou a uma substância ativa medicamentosa; e determinação de que o produto farmacêutico acabado a ser determinado contém o medicamento ou a substância ativa medicamentosa, quando o espectro de medição NIR e o espectro de referência NIR coincidem dentro de um limite. Está criado também um dispositivo para determinação de um produto farmacêutico acabado.
BR112020012113-4A 2017-12-14 2018-12-13 processo e dispositivo para determinaçao de um produto farmacêutico acabado BR112020012113A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17207496.5A EP3499219B1 (de) 2017-12-14 2017-12-14 Verfahren und vorrichtung zum bestimmen eines fertigarzneimittels
EP17207496.5 2017-12-14
PCT/EP2018/084818 WO2019115720A1 (de) 2017-12-14 2018-12-13 Verfahren und vorrichtung zum bestimmen eines fertigarzneimittels

Publications (1)

Publication Number Publication Date
BR112020012113A2 true BR112020012113A2 (pt) 2020-11-24

Family

ID=60856864

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112020012113-4A BR112020012113A2 (pt) 2017-12-14 2018-12-13 processo e dispositivo para determinaçao de um produto farmacêutico acabado

Country Status (9)

Country Link
US (1) US11092544B2 (pt)
EP (1) EP3499219B1 (pt)
KR (1) KR102613888B1 (pt)
BR (1) BR112020012113A2 (pt)
DK (1) DK3499219T3 (pt)
ES (1) ES2835782T3 (pt)
HU (1) HUE051191T2 (pt)
IL (1) IL275366A (pt)
WO (1) WO2019115720A1 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102020114823A1 (de) 2020-06-04 2021-12-09 Ayna Analytics Gmbh Verfahren zum Bestimmen eines flüssigen Fertigarzneimittels

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7218395B2 (en) * 2003-04-16 2007-05-15 Optopo Inc. Rapid pharmaceutical identification and verification system
DE10326152A1 (de) * 2003-06-06 2005-01-05 Aventis Pharma Deutschland Gmbh Verfahren und Vorrichtung zur quantitativen Analyse von Lösungen und Dispersionen mittels Nahinfrarot-Spektroskopie
TWI317715B (en) * 2007-07-25 2009-12-01 Quanta Comp Inc Paper housing structure
US7924424B2 (en) * 2007-10-11 2011-04-12 Ecolab Usa Inc. Optical product detection sensor
DE202009012784U1 (de) * 2009-09-23 2011-02-10 Steinweg, Detlef Vorrichtung zur Kontrolle des Inhalts Medikamente enthaltender Packungseinheiten
US8643274B2 (en) * 2010-01-26 2014-02-04 Scinopharm Taiwan, Ltd. Methods for Chemical Equivalence in characterizing of complex molecules

Also Published As

Publication number Publication date
EP3499219B1 (de) 2020-08-05
ES2835782T3 (es) 2021-06-23
WO2019115720A1 (de) 2019-06-20
EP3499219A1 (de) 2019-06-19
DK3499219T3 (da) 2020-10-26
US11092544B2 (en) 2021-08-17
KR20200103722A (ko) 2020-09-02
KR102613888B1 (ko) 2023-12-13
HUE051191T2 (hu) 2021-03-01
US20200386679A1 (en) 2020-12-10
IL275366A (en) 2020-07-30

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 3A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2658 DE 14-12-2021 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.