TECHNIQUE Stevanato mise sur le marché que les coûts de développement. Afin d’évaluer ces pro- blèmes, Ompi a interviewé 30 experts de l’industrie pharmaceutique en 2014. Ceux-ci avaient des opi- nions différentes sur la récurrence des retards générés par les tests de stabilité échoués dans des seringues pré-remplies à cause de l’instabilité des médicaments. Cependant, ils ont tous reconnu que, si un problème survient à ce stade, ceci aura un impact significatif sur le proces- Figure 2 sus de développement de LES PARTICULES DES FLACONS ALBA SOUTIENNENT LA PERFORMANCE PAR médicaments. RAPPORT AUX FLACONS EN VRAC ET LA SERINGUE ALBA Le principal avantage de la ALBA VIALS PARTICLES RELEASE PERFORMANCE IN COMPARISON WITH BULKplateforme Alba est celui VIALS AND ALBA SYRINGE que tous les contenants ont relevant, the main added From conception to study being needed; in associated with new value of the Alba coating injection the worst-case scenario, packaging materials when is its barrier effect against the drug may have to be moving from Phase II aggressive drugs, preventing The Alba platform has reformulated, increasing to Phase III, de-risking 72 delamination from occurring. also been designed to both time-to-market and the whole development To demonstrate the support drug development development costs. process. performance of the Alba vial, ‘from conception to To assess these problems, The same concept and a comparison study with injection’, with the aim of Ompi interviewed 30 benefits can also be a bulk vial was performed de-risking any switch from pharmaceutical industry applied to marketed drugs, using a 2R ISO standard one container format to experts in 2014. They when the packaging is format. The vials were another, often from vials in had different views about changed or the drug is put filled with 3.6ml of distilled early phases to a syringe the recurrence of delays into a different container water, then subjected to or cartridge later. from failed stability tests format. In this case, an autoclave process (1h The final form of a drug in pre-filled syringes the Alba platform also at 130C°). The liquid was is usually selected during resulting from drug ensures that the switch analysed using an ICP- clinical Phase II. During instability. Nevertheless, can be made, drastically OES iCAP 7400 Thermo this transition, the drug all recognised that, if a reducing the need for new instrument. comes into contact with problem occurs at that drug characterisation and (Figure 2) new materials (i.e. silicone stage, it has a significant testing. Figure 2 shows the Alba oil and tungsten) which impact on the drug Because around 50% of vial’s excellent performance were not present in the development process. particles are normally in terms of inorganic relatively simple early The key benefit of the Alba generated by interaction extractable levels. The same phase container and which platform is that all the between the rubber test was also included in may become a source of containers show the same components and the drug, the accelerated ageing instability. If no problems contact surface (i.e. the Ompi collaborated closely study, showing comparable occur, this switch will still coating) to the drug. This with rubber manufacturers results at T0, T3 and T6. result in a new stability removes the uncertainties when developing Alba, so Avril / Mai / Juin - 2018Doses 71 /Le Magazine du Packaging des Produits de Santé