3m drug delivery systems 3m integrated dose-by-dose ......3mtm integrated dose-by-dose counter...
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3M Drug Delivery Systems
3M Confidential. 1 27 September 2013 . All Rights Reserved. © 3M
3M Drug Delivery Systems
3M™ Integrated Dose-By-Dose Counter September 2013
3M Drug Delivery Systems
3M Confidential. 2 27 September 2013 . All Rights Reserved. © 3M
FDA guidance (Mar 2003)
― Dose indicator or counter recommended for all new products for oral inhalation
― Should give clear indication of when label claim number of doses is approaching (or exceeded)
― Close to 100% accuracy
• But specifically designed to avoid undercounting (dose dispensed but no count registered)
― Lock-out is optional
― Dose-by-dose indication
Seretide™ launch in Europe and ProAir®,
Ventolin® and Dulera® launch in U.S.
― Dose-by-dose count and display
Symbicort® launch in U.S.
― Dose-by-dose indication
Why consider a dose counter?
Ventolin® is a registered trademarks of GlaxoSmithKline. Seretide™ is
a trademark GlaxoSmithKline. Symbicort® is a registered trademark of
AstraZeneca. Dulera ® is a registered trademark of Merck & Co., Inc.
ProAir® HFA is a registered trademark of Teva Respiratory, LLC.
3M Drug Delivery Systems
3M Confidential. 3 27 September 2013 . All Rights Reserved. © 3M
Counter
Individual count down
from 120 doses
Indicator
Increments with every shot fired
from 200 doses
3MTM
Integrated Dose-By-Dose Counter
3M Drug Delivery Systems
3M Confidential. 4 27 September 2013 . All Rights Reserved. © 3M
Listening to the patient …
Patient focus group research fielded
by an external agency experienced
in asthma market research
UK – 3 locations
USA – 3 locations
No significant differences in reactions
to the dose counter design across
markets
Sample included all FDA
named groups
Children interviewed in
pairs with parents present
Adults interviewed
in groups
Elderly interviewed in pairs
Mix of male and female
respondents
Ranging from moderate to
severe sufferers of asthma
Source: data on file, primary asthma patient market research, 2006-2007
96 interviews completed from Dec 2006 - Jan 2007
3M Drug Delivery Systems
3M Confidential. 5 27 September 2013 . All Rights Reserved. © 3M
Deliver what patients want
Patients want a simple, reliable, accurate dose counter that is integrated into their actuator…
…providing them with greater control and sense of security…which also allows parents and
caregivers a reliable method of monitoring medication Source: data on file, primary asthma patient market research, 2006-2007
3M Drug Delivery Systems
3M Confidential. 6 27 September 2013 . All Rights Reserved. © 3M
FDA approved and fully commercialized
3M technology
― In conjunction with an MDI product
Designed to be accurate and robust
Individual dose-by-dose display
Integrated into the actuator
Patient-approved – easy to see exactly
how many doses remain
3MTM
Integrated Dose-By-Dose Counter
3M Drug Delivery Systems
3M Confidential. 7 27 September 2013 . All Rights Reserved. © 3M
Make your product count Differentiate your metered dose inhaler
The first FDA approved* integrated dose counter
available to clients
Individual dose-by-dose counter
Integrated to maintain look and feel
of inhaler
Designed with the patient in mind
Highly accurate and robust
Ideal for:
― Lifecycle management to protect market share
― New metered dose inhaler developments
― Generic product to match innovator products
Seretide® vs. 3M Dose
Counter
Seretide® (fluticasone
propionate/salmeterol
xinafoate) is a marketed
product and trademark of
GlaxoSmithKline. * In conjunction with an MDI product
3M Drug Delivery Systems
3M Confidential. 8 27 September 2013 . All Rights Reserved. © 3M
Defining the industry standard with our commercialized dose-by-dose counter
Building on our experience by commercializing our dose-by-dose indicator in 2015
And now the industry feedback …
Source: based on VoC collected at core industry conferences, various years
3M Drug Delivery Systems
3M Confidential. 9 27 September 2013 . All Rights Reserved. © 3M
Suitable for products up to 120 doses
Designed to be accurate and robust
― Displacement-driven
― Designed to overcome tolerance
challenges of dose counting
Individual dose-by-dose display
― Increments and displays individual doses
― Counts down from label claim
3MTM
Integrated Dose-By-Dose Counter
Integrated into the 3M actuator
― Retains patient familiarity and
product identity
― Maintains inhaler size
(manufacturability and ergonomics)
Compatible with current marketed valves
3M Drug Delivery Systems
3M Confidential. 10 27 September 2013 . All Rights Reserved. © 3M
Dose indicator for 200 dose products
― Displays an analogue count
(200, 180, 160…)
― Increments with every shot fired
― Displays numbers with options for
colour coding at end of life
Utilises the same working principle as the
approved and commercialised dose counter
― Proven indicator design, currently
in commercialisation
― Displacement driven, accurate and robust
Integrated into 3M actuator
― Retains patient familiarity and
product identity
― Maintains inhaler size
(manufacturability and ergonomics)
Compatible with current marketed valves
3MTM
Integrated Dose-By-Dose Indicator
3M Drug Delivery Systems
3M Confidential. 11 27 September 2013 . All Rights Reserved. © 3M
Generation 1 dose counter in commercial production
since 2010
― Compatible with specific valve / canister
combination
Generation 2 production scale up ready for counter
and indicator customer delivery
― Samples available on request
― Expanded design capability to be compatible with
multiple valve and canister combinations
― Suitable for registration stability, clinical studies,
or commercial product
Manufacturing status
3M Drug Delivery Systems
3M Confidential. 12 27 September 2013 . All Rights Reserved. © 3M
Ready for program assessment? Required technical and market data
TECHNICAL
Valve Type and target Valve delivery volume
(e.g., 3M 63mcl, Vari, BK357, etc. )
Can type(s) (plain / coated / size) required
(e.g., 5ml, 10ml, 14ml, 19ml, 22ml)
Number of shots in product
(i.e., <= 120 for DC, 120 to 200 = DI
Check willingness to transition or stay with
Mk 6 type adaptor [square mouth]
Nozzle geometry, if known
(diameter, jet length)
Formulation information
(molecule, solution/suspension,
propellant system)
COMMERCIAL
Anticipated volumes Post-launch
(i.e., per annum)
Anticipated launch date
Markets in which product is to be sold
(e.g., Europe, USA, Global)
Customer expected response date
(Minimum evaluation time – 3 days)
3M Drug Delivery Systems
3M Confidential. 13 27 September 2013 . All Rights Reserved. © 3M
MDI specialists from start to finish
MDI pioneer, with over 50-year track record
Global team of experts passionate about
helping our customers succeed:
― First MDI
― First CFC-free MDI
― First single-cycle FDA review
― First FDA approved* integrated dose
counter available to clients
* In conjunction with an MDI product
3M Drug Delivery Systems
3M Confidential. 14 27 September 2013 . All Rights Reserved. © 3M
Delivering your dose counter solution
FDA, patients and product lifecycle
management are driving the need to
have the right dose counter
3M dose-by dose counter is becoming
the industry standard
― Accurate, robust, reliable, integrated
― Compatible with a wide range of
cans and valves
― Available as a counter or indicator
― FDA approved* and commercialized
* In conjunction with an MDI product
3M Drug Delivery Systems
3M Confidential. 15 27 September 2013 . All Rights Reserved. © 3M
Contact 3M Drug Delivery Systems
US: (1) 800 643 8086
UK: (44) 1509 613626
Japan: (81) 3 3709 9671
Singapore: (65) 6450 8888
China: (86) 21 22103008
Argentina: (54) 11 4469 8338
India: (91) 80 2233 1414
Thank You
www.3m.com/dds