phrmecy

Pharmaceutical packaging – an overview including some considerations for paediatrics
Training workshop:
Pharmaceutical development with focus on paediatric formulations Presenter: Dr Simon Mills
 Contact details: [e-mail]

Beijing, 21 to 25 June 2010
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Simon Mills | April 2008

Introduction
• Overview comments
– The Roles of Packaging
– Specific Paediatric Considerations

• Choosing the most Appropriate Primary Pack
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Terminology and Pack Diversity
Considerations for Pack Selection
Barrier Properties
Bottles and Closures
Blister Packs

• Regulatory Considerations
– China, US, EU, Pharmacopoeial
– Extractable & Leachables

• Packaging Development considerations through to Product Launch
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Simon Mills | April 2008

The Roles of Packaging (1)
• Protecting the product from the environment and vice versa
– Physical and chemical stability of the medicine (being an effective barrier to light, moisture, oxygen, bacteria, volatiles, etc. as appropriate)
– Mechanical trauma – protection from damage
– During transit, distribution and storage of the product, maintaining product integrity until:
• it’s in-use phase is completed or • the expiry date stated on the label has passed

• Providing all necessary information for...
– Identification of the medicine (including strength)
– Safe preparation of the medicine if required (e.g. reconstitution, dilution)
– Safe use of the medicine (e.g. clearly worded instructions, pictograms) including precautions
(food/drug compatibilities and side effects)
– Storage and shelf-life of in-use product
– Appropriate disposal of any unused medicine and the packaging itself
Labelling and Product Inserts/Patient Information Leaflets

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Simon Mills | April 2008

The Roles of Packaging (2)
• Enabling accurate dosing and compliance
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Spoons, cups or syringes for oral dose measurement and delivery
Dropper tubes for eye/ear/oral delivery