| Title: | Non-volatile extractable analysis of prefilled syringes for parenteral administration of drug products |
| Author(s): | Dorival-Garcia N; Larsson I; Bones J; |
| Address: | "Characterisation and Comparability Laboratory, NIBRT-The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, A94 X099, Ireland. Electronic address: Noemi.DorivalGarcia@nibrt.ie. Amgros I/S, Dampfaergevej 22, DK 2100, Copenhagen, Denmark. Electronic address: ila@amgros.dk. Characterisation and Comparability Laboratory, NIBRT-The National Institute for Bioprocessing Research and Training, Foster Avenue, Mount Merrion, Blackrock, Co. Dublin, A94 X099, Ireland; School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4, D04 V1W8, Ireland. Electronic address: jonathan.bones@nibrt.ie" |
| DOI: | 10.1016/j.jpba.2017.05.008 |
| ISSN/ISBN: | 1873-264X (Electronic) 0731-7085 (Linking) |
| Abstract: | "The determination of 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. An approach for the extractable assessment of prefilled syringes, a promising alternative for parenteral administration of pharmaceutical products, is described herein. Four extraction solvents were selected: a mixture 2-propanol:water (1:1), was intended to represent aggressive conditions to extract a broad spectrum of extractables, including organic additives and substances which are poorly water-soluble. Extractions with buffers at three different working pH values spanning a range standardly used in pharmaceutical formulations were also evaluated to identify substances that require specific conditions for their extraction due to their individual chemical properties. Syringes from two different brands were analysed along with their corresponding plunger stoppers. Syringes were extracted at 40 degrees C for 4days, the plunger stoppers were extracted with 2-propanol at 70 degrees C for 24h according to ISO 10993-12:2012. Extractables were identified by UHPLC-MS on a quadrupole time of flight instrument using a non-targeted discovery strategy. A total of 25 compounds were identified, mostly polymer additives and their degradation products. The presented methodology represents a reference point for further studies focused on the characterisation of extractables and leachables from prefilled syringes" |
| Keywords: | 2-Propanol Drug Packaging Pharmaceutical Preparations Solvents *Syringes Extractable Formulation Prefilled syringe Solvent extraction Stopper Uhplc-ms; |
| Notes: | "MedlineDorival-Garcia, Noemi Larsson, Iben Bones, Jonathan eng England 2017/05/26 J Pharm Biomed Anal. 2017 Aug 5; 142:337-342. doi: 10.1016/j.jpba.2017.05.008. Epub 2017 May 5" |
