Module 3 2019

Product Development Needs

Desirable Characteristics ➢ Simple DS synthesis from

Undesirable Characteristics ➢ Complex synthesis using expensive reagents and/or difficult reactions (= costly) ➢ Constrained manufacture reliant on sub-contractors or difficult to scale reactions (eg highly exothermic or explosive). GMP concerns? ➢ Cold Chain (or worse frozen) storage and distribution unless critical (vaccines etc)

readily available compounds and ‘easy’ reactions; simple DP formulation and packaging

➢ Scalable with ease (both DS and DP) to cope with market demand (no out of stock situations) ➢ Stable at ambient temperatures for oral dosage forms

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