Patient-Centric Pharmaceutical Formulation Strategies For Paediatric And Geriatric Populations: Challenges, Regulatory Perspectives, And Emerging Technologies

Patient-centric pharmaceutical formulation has emerged as a critical paradigm in modern drug development, driven by the need to address the distinct physiological, functional, and behavioral characteristics of vulnerable populations such as paediatric and geriatric patients. Conventional, adult-centric dosage forms often fail to meet the safety, efficacy, and usability requirements of these age groups, leading to suboptimal therapeutic outcomes and poor adherence. Paediatric populations exhibit dynamic developmental changes in absorption, distribution, metabolism, and excretion, alongside heightened sensitivity to excipients and formulation attributes such as taste and dosing flexibility. In contrast, geriatric patients experience age-related organ function decline, polypharmacy, dysphagia, and cognitive impairment, all of which complicate medication administration and long-term adherence. This review critically examines patient-centric formulation strategies tailored to paediatric and geriatric populations, integrating physiological and biopharmaceutical considerations with practical formulation design challenges. Comparative evaluation of oral, parenteral, topical, and transdermal delivery systems is presented, highlighting how dosage form selection, excipient choice, and device design influence acceptability, safety, and therapeutic consistency across age groups. Regulatory perspectives from major agencies, including the US Food and Drug Administration and the European Medicines Agency, are analyzed to contextualize evolving expectations for age-appropriate formulations, excipient justification, and human factors engineering. Beyond established approaches, the review explores emerging technologies such as three-dimensional printing, nanocarrier-based systems, digital adherence tools, and smart drug delivery devices as enablers of personalized and adaptive therapy. By synthesizing current evidence, regulatory guidance, and technological advances, this article identifies key knowledge gaps and future research priorities essential for advancing truly patient-centric pharmaceutical design. Overall, the review underscores the necessity of integrating scientific rigor with real-world usability to optimize medication outcomes in paediatric and geriatric care.