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History of organophosphorous neurotoxics antidotes made by the Pharmacie centrale des armées 1915 to nowadays – Organophosphorous neurotoxics were discovered after the First World War, engendering fear of their use. In spite of the Chemical weapons convention of Paris, toxics are still used today. The Pharmacie centrale des armées (PCA ) has developed antidotes to struggle organophosphorous neurotoxics intoxications. As part of the sanitary provisions centenary of Armed forces medical service, the aim of this memory is to show the evolution of organophosphorous neurotoxics intoxications antidotes produced by the PCA between 1915 and nowadays. PCA therapeutics range was developed due to pyridostigmine pre-treatment, atropine treatment and its different packaging and a self-injection device currently called Ineurope®. For more than a century, PCA has known how to develop and improve several organophosphorous neurotoxics intoxications antidotes to respond to operational requirement and to the nation need., Les neurotoxiques organophosphorés (NOP) furent découverts après la Première Guerre mondiale, entraînant la crainte de leur utilisation. Malgré la Convention d’interdiction des armes chimiques de Paris, les toxiques chimiques restent aujourd’hui encore utilisés. La Pharmacie centrale des armées (PCA ) développe des antidotes afin de lutter contre les intoxications par les NOP. Dans le cadre du centenaire du ravitaillement sanitaire du Service de santé des armées, nous nous sommes intéressés aux évolutions des antidotes contre les intoxications des NOP fabriqués par la PCA de 1915 à nos jours. La gamme thérapeutique de la PCA s’est développée avec le pré-traitement par pyridostigmine, les traitements par différents conditionnements de l’atropine et un auto-injecteur de prise en charge polyvalente, l’actuel Ineurope® . Depuis plus de cent ans, la PCA sait développer et perfectionner les différents antidotes des intoxications aux NOP afin de répondre au mieux au besoin opérationnel, mais aussi contribuer à la résilience de la Nation., Fontaine Tiphanie,Jarzuel Florence,Ormes Elodie,Caire-Maurisier François. Historique des antidotes des neurotoxiques organophosphorés fabriqués par la Pharmacie centrale des armées de 1915 à nos jours. In: Revue d'histoire de la pharmacie, 105e année, N. 397, 2018. pp. 13-22.

Container-content compatibility studies are required as part of the submission of a new product market authorization file or for a change relating to the primary product-contact packaging. Many regulatory publications and guidances are available in the USA, Europe, and Japan. However these publications and guidances are not sufficiently precise enough to allow for consistent interpretation and implementation of the technical requirements. A working group has been formed by the French Society of Pharmaceutical Science and Technology (SFSTP) in order to propose guidance for container-content interaction studies that meet both European and US requirements, and allows consistent and standardized information to be presented by the industry to the regulators. When a pharmaceutical drug product remains in prolonged contact with a material, the two critical points to consider are the drug product's quality and safety. A pharmaceutical evaluation of the container-content relationship should be done based on the knowledge of the contact material (e.g., type, physicochemical properties), its manufacturing processes (e.g., the type of sterilization that could potentially alter the interactions), and the formulation components involved in contact with this material (e.g., physicochemical properties, pharmaceutical presentation, route of administration). Quality is evaluated using the stability study performed on the product. Safety is partially evaluated with the stability study and is analyzed in conjunction with toxicity testing, specifically with cytotoxicity testing. The toxicity aspect is the key point of the container-content compatibility study and of patient safety. Migration tests are conducted when an interaction is suspected, or found based on previous results, to identify the component responsible for this interaction and to help select a new material if needed. Therefore, such tests are perhaps not the best ones to use for the purpose of safety evaluation. Consequently, a decision tree based mainly on the toxicity aspect is proposed in order to support the pharmaceutical companies' container-content interaction approach and filing.