Bridging the Knowledge Gap in Formulation Processing ... · 17‐5‐2018 1 Page Version 7.9 1...
17
17‐5‐2018 1 Page Version 7.9 1 Bridging the Knowledge Gap in Formulation and Processing Evonne Brennan Page Agenda Agenda 2 Introduction Knowledge Important Advances Formulation & Processing What can we do?
Transcript of Bridging the Knowledge Gap in Formulation Processing ... · 17‐5‐2018 1 Page Version 7.9 1...
17‐5‐2018
1
Page
Ver
sion
7.9
1
Bridging the Knowledge Gap in Formulation and Processing
Evonne Brennan
Page
Agenda
Agenda 2
Introduction
Knowledge
Important Advances
Formulation & Processing
What can we do?
17‐5‐2018
2
Page
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
17‐5‐2018
3
Page
Header 5
A lot of information
Knowledge
Page
Focus on delivery
Knowledge 6
People driven Target Audience Connecting
17‐5‐2018
4
Page
Responsibility in learning?
Knowledge 7
OwnershipAccessibility
Training
Work together
Page
How we learn?
Knowledge 8
17‐5‐2018
5
Page
Repetition
Knowledge 9
Say it
Say
it A
gain
How to?When to?
Page
Learning
Knowledge 10
Known / Unknown
Understood / Not Understood
Practised / Not Practised
Documented / Not Documented
Science meets experience
17‐5‐2018
6
Page
Science meets experience
Science meets experience 11
Page
Important Advances
Important Advances 12
• Excipient functionality
• Processing advances
• Academia Industry collaboration
• QbD
• Patient Centricity
• Fast track approvals
• PIP
17‐5‐2018
7
PageFormulation & Processing 13
Formulation Process
EquipmentExcipients
Examples of gaps
Cost
$$$
Page
Pharmaceutical Suspension
Formulation & Processing 14
…..suspension separation at end of production run
Anti-reflux suspension Developed in-house Scale-up and Production
17‐5‐2018
8
Page
Anti-reflux raft formation
Formulation & Processing 15
Sodium Alginate Formulation Raft formation
Page
Carbopol in Anti-Reflux Suspension
Formulation & Processing 16
Processing impactExcipient Functionality
17‐5‐2018
9
Page
Anti-Reflux Suspension
Anti-Reflux Suspension 17
Known Unknown
FailureSuccess
Page
Flow issue and content uniformity at scale-up
Formulation & Processing 18
Optimisation of Silica Granulated Lactose Blending
still had flow issue….
17‐5‐2018
10
Page
Flow issue and content uniformity at scale-up
Formulation & Processing 19
Hopper Design
Changed Rotary Press
Page
Blending
20Blending
17‐5‐2018
11
Page
Processing
Processing 21
Logo chipping Humidity controlReformulation
LOGO
Reviewed tooling design…
Page
Veterinary
Veterinary 22
17‐5‐2018
12
PageWhat can we do? 23
Back to basicsBack to basics
What can we do?
PageWhat can we do? 24
Back to basics
What’s your niche?
DefineExplore by question
FocusDevelopDeliver
Know your gap .. fulfil
Experience + Knowledge = Success
17‐5‐2018
13
Page
Not matrix driven
What can we do? 25
Page 26
We are close
What can we do?
17‐5‐2018
14
PageWhat can we do? 27
Page
Take home:
Are you playing your role in bridging the
knowledge gap?
What can we do? 28
17‐5‐2018
15
Page
Reporters,
Journalists,
Researchers
Play a major part
What can we do? 29
Page
Some gaps can
seem challenging,
use your
connections
What can we do? 30
17‐5‐2018
16
Page
Beware of the gap, it
could delay your
experiment, or
launch
What can we do? 31
Page
Let us all play our part in
bridging the knowledge gap
What can we do? 32
17‐5‐2018
17
Page
Our ambition is to exceed your expectations.
We deliver what we promise.
EVONNE Brennan
International Technical Marketing Manager
IMCD Ireland Ltd.
33
