Jonathan Marie, Bruno LE CORRE & Claire CANNETTE
APTAR PHARMA Route des Falaises 27100 Le Vaudreuil France
Summary
Thermo Plastic Elastomers (TPEs) are used for the manufacturing of inhalation devices in the pharmaceutical industry. Antioxidants are often added to the plastics to prevent the degradation of the polymers or to protect them during the molding process. Due to the influence of different factors such as oxidation (e.g. air, water), these antioxidants may be degraded to form oxidation degradation products, which could migrate into the drug formulation as leachables. It is thus very important to identify these potential degradation products to verify the absence of any toxicity risk for patients. The work herein details, through the sample preparation and analytical LCMSQTOF analysis process, how such degradation products have been identified. The comparison of several extraction techniques for sample preparation are presented. This case study uses a novel thermo-plastic elastomer, COC 920, a low extractable, low water vapor transmission and efficient static leakage barrier material used in Aptar Metered Dose Inhalers (MDIs).
Key Message
Potential extractables from a novel TPE gasket used in MDIs were isolated by various extraction techniques and identified.
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