Bridging the Knowledge Gap in Formulation Processing ... · 17‐5‐2018 1 Page Version 7.9 1...
Transcript of Bridging the Knowledge Gap in Formulation Processing ... · 17‐5‐2018 1 Page Version 7.9 1...
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Bridging the Knowledge Gap in Formulation and Processing
Evonne Brennan
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Agenda
Agenda 2
Introduction
Knowledge
Important Advances
Formulation & Processing
What can we do?
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Introduction
Introduction 3
Importance of keeping up to date
Excipient functionality
Working with approved excipients
OE Lean Manufacture
Process Equipment
Scale-up and time pressures
Telling a story – if it is not clear, do we lose the audience –do we fail to learn?
Patience….
PageKnowledge 4
What is available?
• Continuous Learning – everyone plays a part
• “That was done before”
• Use of referencing
• Using Pharma materials in Academia IID, EP USP
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Header 5
A lot of information
Knowledge
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Focus on delivery
Knowledge 6
People driven Target Audience Connecting
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Responsibility in learning?
Knowledge 7
OwnershipAccessibility
Training
Work together
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How we learn?
Knowledge 8
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Repetition
Knowledge 9
Say it
Say
it A
gain
How to?When to?
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Learning
Knowledge 10
Known / Unknown
Understood / Not Understood
Practised / Not Practised
Documented / Not Documented
Science meets experience
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Science meets experience
Science meets experience 11
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Important Advances
Important Advances 12
• Excipient functionality
• Processing advances
• Academia Industry collaboration
• QbD
• Patient Centricity
• Fast track approvals
• PIP
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PageFormulation & Processing 13
Formulation Process
EquipmentExcipients
Examples of gaps
Cost
$$$
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Pharmaceutical Suspension
Formulation & Processing 14
…..suspension separation at end of production run
Anti-reflux suspension Developed in-house Scale-up and Production
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Anti-reflux raft formation
Formulation & Processing 15
Sodium Alginate Formulation Raft formation
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Carbopol in Anti-Reflux Suspension
Formulation & Processing 16
Processing impactExcipient Functionality
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Anti-Reflux Suspension
Anti-Reflux Suspension 17
Known Unknown
FailureSuccess
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Flow issue and content uniformity at scale-up
Formulation & Processing 18
Optimisation of Silica Granulated Lactose Blending
still had flow issue….
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Flow issue and content uniformity at scale-up
Formulation & Processing 19
Hopper Design
Changed Rotary Press
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Blending
20Blending
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Processing
Processing 21
Logo chipping Humidity controlReformulation
LOGO
Reviewed tooling design…
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Veterinary
Veterinary 22
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Back to basicsBack to basics
What can we do?
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Back to basics
What’s your niche?
DefineExplore by question
FocusDevelopDeliver
Know your gap .. fulfil
Experience + Knowledge = Success
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Not matrix driven
What can we do? 25
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We are close
What can we do?
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Take home:
Are you playing your role in bridging the
knowledge gap?
What can we do? 28
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Reporters,
Journalists,
Researchers
Play a major part
What can we do? 29
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Some gaps can
seem challenging,
use your
connections
What can we do? 30
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Beware of the gap, it
could delay your
experiment, or
launch
What can we do? 31
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Let us all play our part in
bridging the knowledge gap
What can we do? 32
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Our ambition is to exceed your expectations.
We deliver what we promise.
EVONNE Brennan
International Technical Marketing Manager
IMCD Ireland Ltd.
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