| Autor: |
Stroppel L; Innovation Unit, PDB-TIP, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany.; Interfaculty Institute of Biochemistry, Eberhard Karls Universität Tübingen, Auf der Morgenstelle 34, 72076 Tübingen, Germany., Schultz-Fademrecht T; Innovation Unit, PDB-TIP, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany., Cebulla M; Innovation Unit, PDB-TIP, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany., Blech M; Innovation Unit, PDB-TIP, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany., Marhöfer RJ; Boehringer Ingelheim Animal Health, Binger Str. 173, 55216 Ingelheim am Rhein, Germany., Selzer PM; Interfaculty Institute of Biochemistry, Eberhard Karls Universität Tübingen, Auf der Morgenstelle 34, 72076 Tübingen, Germany.; Boehringer Ingelheim Animal Health, Binger Str. 173, 55216 Ingelheim am Rhein, Germany., Garidel P; Innovation Unit, PDB-TIP, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany. |
| Abstrakt: |
Biological drugs intended for multi-dose application require the presence of antimicrobial preservatives to avoid microbial growth. As the presence of certain preservatives has been reported to increase protein and peptide particle formation, it is essential to choose a preservative compatible with the active pharmaceutical ingredient in addition to its preservation function. Thus, this review describes the current status of the use of antimicrobial preservatives in biologic formulations considering (i) appropriate preservatives for protein and peptide formulations, (ii) their physico-chemical properties, (iii) their in-/compatibilities with other excipients or packaging material, and (iv) their interactions with the biological compound. Further, (v) we present an overview of licensed protein and peptide formulations. |
