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Master Thesis

Implémentation et optimisation d'études de dégradation forcée en pré-développement pour l'amélioration du screening des formulations = Implementation and optimization of pre-development forced degradation studies for formulation screening improvement

Abstract : The thesis presented here mainly hinged on the implementation of the most predictive and rapid way to determine formulation factors influencing sensitivity of drugs when exposed to several stress conditions: pH variation, heat, light exposure, oxidation for example, in order to produce stable injectable solutions in syringes. The first part deals with the context in which this study was held and explains more precisely the mission. The more important advantage of pre-development forced degradation studies will be a time and cost benefit. Those tests will permit to determine earlier the optimal molecule stability conditions when put in solution and will help in the setting of final formulation parameters avoiding the wait for pre-stability results. The second part describes the bibliographic study held to find which kind of condition can influence molecules sensitivity, what kind of parameters can easily be tested and what the existing tests are. The research of stability information concerning the drug, named X, chosen to be developed by the team will also be developed. The third part develops studies performed in the formulation laboratory on the molecule X. Those studies were helpful to set the optimum formulation stability pH, to highlight the advantages of the inerting process to protect this molecule sensitive to oxidation, the possible interactions between formulation and syringes components and finally the formulation capability to undergo autoclaving cycles without excessive degradation. Repeatability of this method was evaluated and an extrapolation was calculated to estimate the formulation behavior at 25°C.
Document type :
Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00593124
Contributor : Jean-Hugues Morneau <>
Submitted on : Friday, May 13, 2011 - 1:45:04 PM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
Long-term archiving on: : Sunday, August 14, 2011 - 3:06:10 AM

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  • HAL Id : dumas-00593124, version 1

Citation

Florie Guillaumin. Implémentation et optimisation d'études de dégradation forcée en pré-développement pour l'amélioration du screening des formulations = Implementation and optimization of pre-development forced degradation studies for formulation screening improvement. Pharmaceutical sciences. 2010. ⟨dumas-00593124⟩

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