Oct 26, 2009 ... Paediatric Formulations ... These PowerPoint slides are the intellectual property
of the individual presenter ... granule, orally dispersible tablet ?
Paediatric Formulations - Workshop outline
Julie Williams & Richard Kendall Co-Chairs
26/10/2009
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Paediatric Formulations 1. Age-appropriate dosage forms – what is expected vs. preferred?
2. Excipients – How do we judge acceptability?
3. Paediatric investigation plans – h how much h fformulation l ti d detail t il iis available il bl at time of PIP?
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1 A 1. Age-appropriate i t dosage d forms f Selection of dosage form for commercialisation g for oral - liquid, q tablet, mini-tablet, - e.g. granule, orally dispersible tablet ? - Size, volume, strength, container size? - What factors should govern the selection? p - Which are the most important? - Discuss framework for dosage form selection and evidence of suitability www.diahome.org
2 E 2. Excipients i i t – benefits b fit and d risks i k • Proposed discussion points: – Colours – when can they be justified? – Single versus multiple dose dose, preserved preparations– preparations what are the pros and cons? – Palatability – what are the considerations for sweeteners, flavours, mixing with foods
• There is an urgent need for a comprehensive and harmonized database documenting which excipients are preferred / acceptable and at what levels in children of different ages – How could this be expedited by industry / regulatory collaboration
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3. Paediatric Investigation Plan Quality Q y section – information • How much formulation detail should be provided in PIPs – – – –
What is the expectation from the PDCO? What is the reality? y Use of “enabling” clinical formulations Evolving formulation strategy
• What information is sufficient to support PIP approval? – How can we discuss any further developments? www.diahome.org
