Journal of Clinical & Experimental Pharmacology

Extractable study for two plast syringes

Co-organized Event International Conference on Toxicology and Clinical Pharmacology & 2^nd International Conference on Generic Drugs and Biosimilars

December 14-16, 2017 Rome, Italy

Iben Larsson

Amgros, Denmark

Keynote: Clin Exp Pharmacol

Abstract:

The extractable profiles for single-use technologies represents an important aspect of pharmaceutical production to minimize any possible compromise in drug product quality or potential risk to patients by identifying substances that may potentially leach from such devices. Approach for the extractable assessment of prefilled syringes is described. Syringes from two different brands were analysed along with their corresponding plunger stoppers. The presented methodology represents a reference point for further studies focused on the characterisation of extractables and leachables from prefilled syringes.

Biography :

Iben Larsson, MSc in Polymer Chemistry and PhD in Powder Technology, is employed at Amgros I/S, the Danish Regions’ Pharmaceutical organization, in Denmark as Senior Research Scientist.  He/She is a Member of the Expert Group, European Paediatric Formulary, in European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Pharmacy Subcommittee under the Danish Pharmacopoeia Commission. He/She has broad experience within the field of stability of cytostatic and biologic drugs together with drug interaction with primary packaging as well as in depth knowledge of micronization of poorly soluble drugs by grinding techniques.