Module 3 - Strategic case studies in practice

Exercise 1

Exercise 1 – Strategy for an old dossier

OBJECTIVE(s) The aim of this exercise is to make you think about how to manage construction of a Module 3 in support of a new application for a combination pack, based on two existing products that are supported by a Notice to Applicants dossier.

TEAM TASK This is a team task – please allocate one of the team to provide feedback.

TIMINGS Hopefully, you will have had some time to read this exercise before the course. You have 30 minutes to undertake the task and we will spend 15 minutes afterwards on feedback. In that time you need to allocate: • 5 minutes to review the questions and the information provided. • 15 minutes to review and decide on your answers • 5 minutes to agree your feedback. You have been asked to plan construction of a Module 3 for a COMBINATION PACK over the counter (OTC) product. The aim of the pack will be to provide “Day” and “Night” versions of a formulation indicated for the alleviation of cold and ‘flu’ symptoms. The “Day” formulation contains Paracetamol Ph Eur, Phenylephrine Hydrochloride Ph Eur and Caffeine Ph Eur. The “Night formulation contains Paracetamol Ph Eur, and Phenylephrine Hydrochloride Ph Eur. The presence of caffeine in the “Day” formulation alters the pharmacokinetic profile of paracetamol in vivo resulting in a faster time to peak concentration of paracetamol and a longer half-life. However, as a stimulant, caffeine needs to be avoided for the “Night” formulation. Each of the “Day” and “Night” formulations are conventional immediate-release gelatin capsules. The current approved dossiers for each of the “Day” and “Night” products have until recently, been based on the NTA format. A baseline dossier in eCTD format now exists. THE TASKS Background