Teicoplanin is an antibiotic made by fermentation in which a glycopeptide core is substituted by different fatty acids. The chemical structure and proportion of the various components are strictly dependent on the production process (Actinoplanes sp. strain, cell culture conditions and downstream process). Thus, a relevant variability can be introduced from different manufacturers. Interchangeability or substitution among the originator and the generic products of teicoplanin injections is under debate with respect to pharmaceutical similarity. In fact, depending on the manufacturer, the six major components of teicoplanin show different quantitative distributions compared to that of the originator. The European Pharmacopoeia fixed an undifferentiated upper limit for the component content. A statistical approach is required for comparing complex products. In this paper the use of principal component analysis (PCA) as a tool for identifying the pharmaceutical equivalence among teicoplanin products from different sources was explored. The results obtained show that PCA can distinguish the differing origin of this biological drug.

Complex product composition generates risks for generic substitution also with dosage forms for intravenous administration / Rossi, Alessandra; Buttini, Francesca; Colombo, Paolo; Mor, Marco; Pala, Daniele; F., Bortolotti; Colombo, Gaia. - In: INTERNATIONAL JOURNAL OF PHARMACEUTICS. - ISSN 0378-5173. - 451:1-2(2013), pp. 50-56. [10.1016/j.ijpharm.2013.04.064]

Complex product composition generates risks for generic substitution also with dosage forms for intravenous administration

ROSSI, Alessandra;BUTTINI, Francesca;COLOMBO, Paolo;MOR, Marco;PALA, Daniele;COLOMBO, GAIA
2013-01-01

Abstract

Teicoplanin is an antibiotic made by fermentation in which a glycopeptide core is substituted by different fatty acids. The chemical structure and proportion of the various components are strictly dependent on the production process (Actinoplanes sp. strain, cell culture conditions and downstream process). Thus, a relevant variability can be introduced from different manufacturers. Interchangeability or substitution among the originator and the generic products of teicoplanin injections is under debate with respect to pharmaceutical similarity. In fact, depending on the manufacturer, the six major components of teicoplanin show different quantitative distributions compared to that of the originator. The European Pharmacopoeia fixed an undifferentiated upper limit for the component content. A statistical approach is required for comparing complex products. In this paper the use of principal component analysis (PCA) as a tool for identifying the pharmaceutical equivalence among teicoplanin products from different sources was explored. The results obtained show that PCA can distinguish the differing origin of this biological drug.
2013
Complex product composition generates risks for generic substitution also with dosage forms for intravenous administration / Rossi, Alessandra; Buttini, Francesca; Colombo, Paolo; Mor, Marco; Pala, Daniele; F., Bortolotti; Colombo, Gaia. - In: INTERNATIONAL JOURNAL OF PHARMACEUTICS. - ISSN 0378-5173. - 451:1-2(2013), pp. 50-56. [10.1016/j.ijpharm.2013.04.064]
File in questo prodotto:
File Dimensione Formato  
Teicoplanin.pdf

non disponibili

Tipologia: Documento in Post-print
Licenza: Creative commons
Dimensione 876.61 kB
Formato Adobe PDF
876.61 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2602245
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 3
social impact