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Master Thesis

Molécules sensibles à l'oxygène : étude et optimisation des procédés d'inertage : applications aux seringues pré-remplies

Abstract : The present work is about formulation and manufacturing process of oxygen-sensitive drug solutions in pre-filled syringes. This issue mainly deals with the means to evaluate oxygen contents in solution and the process parameters to protect oxygen-sensitive drugs from oxidation. The first part presents the study of devices to measure the oxygen concentration in solution or in the headspace of the syringes. A final choice led to purchase two devices, Radiometer brand, ordinarily used for blood gas analyses and that measure oxygen partial pressure in solutions. In the second part, some studies conducted in a formulation laboratory underline the following points: the gas composition and the volume of the headspace are critical and highly impact the final dissolved oxygen concentration; inerted solutions get re-oxygenated in an important way during the time in corked glass syringes, and finally silicone tubing are permeable to oxygen in an important and fast way. The third part describes the way to optimize inerting on a pilot filling line. The important parameters are nitrogen flow rates at the filling and stoppering stations that have to be maximized. Some defects intrinsic to the filling machine would have to be fixed in order to avoid possible increase of the oxygen concentration in solution.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00592336
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Submitted on : Thursday, May 12, 2011 - 10:06:42 AM
Last modification on : Wednesday, July 15, 2020 - 8:56:03 AM
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  • HAL Id : dumas-00592336, version 1

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Chloé Pierson. Molécules sensibles à l'oxygène : étude et optimisation des procédés d'inertage : applications aux seringues pré-remplies. Sciences pharmaceutiques. 2009. ⟨dumas-00592336⟩

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