Extemporaneous Formulations. Filling the Gap in the Pharmaceutical Industry with Personalized Medicines - Nunzio Denora;Antonio Lopalco

Pharmaceutical compounding remains a vital healthcare practice to address unmet clinical needs when authorised medicines are unavailable, unsuitable, or require individual dose adjustment. This Reprint brings together current contributions focused on extemporaneous and patient-centric formulations, with particular attention to paediatric, geriatric, and orphan drug settings where off-label use is frequently unavoidable. The collected papers discuss modern dosage forms and excipient selection, formulation design strategies, and the practical implementation of compounding technologies that enable flexible and reliable preparation of medicines at the point of care. A strong emphasis is placed on stability, compatibility, and degradation risk assessment, together with fit-for-purpose quality control approaches supporting reproducible compounding and safe use throughout the intended period of use. Regulatory and legislative perspectives are also covered, highlighting the evolving framework governing compounded preparations and the importance of harmonised standards, documentation, and risk-based decision making. Overall, this Reprint provides an up-to-date reference for researchers, pharmacists, and healthcare professionals seeking evidence-based guidance to enhance the quality, safety, and clinical impact of compounded medicines.