WO2025133221 - A METHOD FOR CCI TESTING

National phase entry is expected:
Publication Number WO/2025/133221
Publication Date 26.06.2025
International Application No. PCT/EP2024/088058
International Filing Date 20.12.2024
Title **
[English] A METHOD FOR CCI TESTING
[French] PROCÉDÉ D'ESSAI CCI
Applicants **
NOVO NORDISK A/S
Inventors
CABAÑEROS LÓPEZ, Pau
KUNOV-KRUSE, Andreas, Jonas
STAPPEN, Frederick
WANG, Jinyuhan
Priority Data
23219115.5   21.12.2023   EP
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting2032
EPO Filing, Examination, Granting8126
Japan Filing, Examination, Granting2155
South Korea Filing, Examination, Granting2071
USA Filing, Examination, Granting4740
MasterCard Visa
Total: 19,124

The term for entry into the National Phase has expired. This quotation is for informational purposes only

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Abstract[English] The present invention provides a method of testing container closure integrity which comprises (i) subjecting a container (10, 30) comprising a transparent wall portion (11, 31) and a drug chamber (17, 37) holding a liquid drug to a test environment (2) comprising a test gas with pH changing capabilities over a period of time sufficient to allow dissolution of any test gas from the test environment (2) in the liquid drug, (ii) combining at least a portion of the liquid drug with a pH indicator, and (iii) determining a presence or absence of dissolved test gas in the drug chamber (17, 37) from a protonation state of the pH indicator.[French] La présente invention concerne un procédé d'essai d'intégrité de fermeture de récipient qui comprend (i) la soumission d'un récipient (10, 30) comprenant une partie de paroi transparente (11, 31) et une chambre de médicament (17, 37) contenant un médicament liquide à un environnement d'essai (2) comprenant un gaz d'essai ayant des capacités de changement de pH sur une période de temps suffisante pour permettre la dissolution d'un gaz d'essai quelconque provenant de l'environnement d'essai (2) dans le médicament liquide, (ii) la combinaison d'au moins une partie du médicament liquide avec un indicateur de pH, et (iii) la détermination de la présence ou de l'absence de gaz d'essai dissous dans la chambre de médicament (17, 37) à partir d'un état de protonation de l'indicateur de pH.