Abstract: A sterile aqueous pharmaceutical composition contains methylene blue as active ingredient and water, wherein an Azure B impurity content of the composition ranges from 2.0 wt. % to 3.0 wt. %, a pH of the composition is below 4.0, and a total metal content of the pharmaceutical composition is above 20 ppm.
Type:
Application
Filed:
September 19, 2023
Publication date:
April 11, 2024
Applicant:
Galenicum Health S.L.U.
Inventors:
Luis Gómez Coello, Maria del Rocío Pérez Pérez
Abstract: The present invention relates to a method to prepare pharmaceutical compositions of sugammadex, to pharmaceutical compositions of sugammadex and uniform pharmaceutical batches of said compositions.
Type:
Grant
Filed:
July 2, 2020
Date of Patent:
May 10, 2022
Assignee:
Galenicum Health S.L.U.
Inventors:
Luis Gomez Coello, Javier Torrejón Nieto
Abstract: The present invention relates to a method to prepare pharmaceutical compositions of sugammadex, to pharmaceutical compositions of sugammadex and uniform pharmaceutical batches of said compositions.
Type:
Application
Filed:
July 2, 2020
Publication date:
January 7, 2021
Applicant:
Galenicum Health S.L.U.
Inventors:
Luis Gomez Coello, Javier Torrejón Nieto
Abstract: Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation.
Abstract: Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation.
Abstract: Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation.