B2957 - Paediatric and Geriatric Medicinal Products

Learning outcomes

Upon completion of the course, the student: - possesses the specific knowledge and the ability to formulate, select raw materials and packaging solutions for medicinal products intended for the pediatric and geriatric populations; - possesses knowledge on the regulations specifically related to the medicinal products intended for the pediatric and geriatric populations; - possesses advanced knowledge on pharmaceutical technology and pharmaceutical compounding for medicinal products personalization; - possesses knowledge on the quality control, biopharmaceutics, production, and the stability issues of the medicinal products covered in the course.

Course contents

part 1: Introduction to Pediatric and Geriatric Drugs
Definition and classification of pediatric and geriatric drugs
Physiological and pharmacokinetic differences at different ages
Principles of pharmacodynamics and pharmacokinetics in children and the elderly

part 2: Formulation and Development of Pediatric Drugs
Need for specific formulations for the pediatric population, palatability and acceptability
Most used pharmaceutical forms in the pediatric sector
Safe excipients for pediatric use
Development of pediatric drugs: technological and regulatory aspects

part 3: Formulation and Development of Geriatric Drugs
Strategies for optimizing geriatric therapy
Polytherapy and drug interactions in the elderly
Development of specific formulations for the geriatric population
Adherence to therapy and tools for improving compliance

part 4: Legislation and Regulation
EMA and FDA regulations and guidelines on pediatric and geriatric drugs
Pediatric Investigation Plan

Readings/Bibliography

teachers slides

Teaching methods

frontal lessons

Assessment methods

oral interview with the student and in-depth analysis of topics of the student's choice

Teaching tools

microsoft powerpoint

Office hours

See the website of Leonardo Marchitto