How Dosage Form Decisions Shape Pediatric And Geriatric Drug Development

By Gus LaBella, MIKART

Age-appropriate drug development for pediatric and geriatric populations requires customized approaches that account for unique dosing, palatability, packaging, and real-world administration challenges. Unlike adults, these vulnerable patient groups often face difficulties like dysphagia, dexterity issues, or cognitive limitations, making standard tablets or capsules unsuitable.

Selecting the right dosage form involves balancing physical properties with user needs. Liquids offer flexible dosing for children, while oral solid doses like chewables, orally disintegrating tablets, or minitablets are often better suited for older adults. Palatability extends beyond basic flavor to include mouthfeel, viscosity, and age-specific taste preferences, frequently requiring specialized coatings or alternative sweeteners to mask bitterness.

Packaging design directly impacts adherence and safety. Features such as unit-dose cups, powdered sachets, or child-resistant closures balance portability, product integrity, and ease of use for patients and caregivers. Additionally, developers must navigate regulatory pathways and formulation constraints, such as moisture sensitivity or preservative concerns.

Partnering with an experienced Contract Development and Manufacturing Organization (CDMO) is vital for long-term success. A capable CDMO provides technical expertise across diverse dosage forms, ensures efficient scale-up from R&D to commercial manufacturing, and designs a comprehensive lifecycle strategy that prevents costly launch delays.