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  6.  » AAPS 2019: IV Infusion In-Use Compatibility of the Regulatory Hormone Melatonin

AAPS 2019: IV Infusion In-Use Compatibility of the Regulatory Hormone Melatonin

Summary: The chemical stability challenges associated with many small molecule active pharmaceutical ingredients (API) necessitate the need for parenteral options for drug delivery.  Intravenous (IV) infusion remains a primary delivery method for numerous small molecule-based therapies used in the treatment of cancer, bacterial infection, and chronic pain. Due to the increasing potency of novel therapies driving dose concentrations ever lower, considerable attention must be given to the API/formulation/IV material interaction to ensure a successful NDA campaign. The a case study details the necessary methodology to evaluate IV in-use compatibility of the regulatory hormone melatonin. We present the evaluation of multiple melatonin formulations against standard clinical IV infusion setups identical to those used in the clinic. As part of the case study, we propose strategies to prevent formulation dependent leachable contamination and adsorptive loss to IV infusion materials. The results presented here highlight the importance of API/formulation/materials consideration to ensure the best possible outcome for patients.

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