how to deliver sterile eye drops with a safer alternative ...€¦ · how to deliver sterile eye...
TRANSCRIPT
How to deliver sterile eye drops
with a safer alternative to
preservatives?
CPhI 2017 – Faustine MUÑOZ
October 24th 2017
This document is the property of NEMERA and must not be copied, reproduced, duplicated nor disclosed totally or partially to any Third Party,
nor used in any manner whatsoever without the prior written consent of NEMERA © NEMERA 2014
Agenda
01
02
03 Case study on the PFMD eye dropper solution: Novelia®
Multidose eye droppers market & trend to PFMD
Patients’ needs and expectations
Multidose eye droppers market& trend to PFMD01
| 4
50% of Patients suffer from
preservatives side-effects
main players = 41%
MD eye dropper
market
(Novartis, Allergan, Santen)
RED EYES
Most common
preservative:
Benzalkonium
Chloride (BZK or BKC or BAC)
ALLERGIES ITCHINESS
All Key Opinion Leaders agree on
the danger of preservatives
“Communication on preservatives is
no longer needed; all necessary
studies have already been made
to prove the negative impact of
preservatives to the eye.”
Pr Florent Aptel, professor in
Ophthalmology at Grenoble CHRU,
Director of France Glaucoma
Association
| 5
Global MD eye dropper market driven up
by PFMD faster growth in all regions
MD eye dropper market size in 2020 (in units)
with 2.7% CAGR
PFMD: Preservative Free
Multidose
COMPLIANCEMULTIDOSE
EYE DROPPER
COMPLIANCE
MULTIDOSE
EYE DROPPERS
PRESERVATIVE
FREE
MULTIDOSE
EYE DROPPERS PFMD market CAGR until 2020
MD: Multidose
CAGR: Compound Annual Growth
Rate
PFMD sales in 2016
PFMD sales in 2020
IMPRESSIVE
GROWTH OF
PFMD
GLOBALLY
Patients’ needsand expectations02
| 7
Listening to Patients is key…
Listening to Patient feedback is key
to build and execute user assessments
(User interface, Patient adherence, Misuse cases…)
| 8
…and also Patient integration
in Device development
Co-create concepts
User needs andexpectations
Focus group
Product verificationand validation
Design selection
Product testing
| 9
Key findings
on Patients’ needs in Ophthalmics…
COMPLIANCECOMPLIANCENo side effects
(due to contamination)
COMPLIANCESAFETY
CONVENIENCE
No risk of contamination
• Hygiene of the bottle when dispensing
the drop
• Hermetic closing
(also during transportation)
• Flow control
• Drop dispensing until the last drop
• Eye targeting
• Easy to use with an intuitive handling
• Adapted to mobile use
…as first
foundations
to design
Novelia®
PFMD
eye dropper
Case study on the PFMD eye dropper solution: Novelia®03
| 11
The PFMD eye dropper solution: Novelia®
Novelia® avoids the need for preservatives in the drug and
prevent bacterial contamination over treatment duration
| 12
The PFMD eye dropper solution: Novelia®
PREVENT
…a continuous drug flow &
drop delivery
…with no bacterial
contamination
CONTROL
| 13
Novelia® functioning in 5 steps
5
Remaining drop
protection Silver ions embedded in
the Cap protect remaining
drop
(no contamination of any
liquid remaining on the tip)
| 14
Selecting design options
Solutions
Functions
Device PFMD Dropper
Drop Protection
Protection from
contamination
Hermetic closing system
Decontamination by contact, no
leaching in container
Drying
Simple but risk of contamination
(until drop is entirely dry + spore-forming strains when
dry)
Absorption
Good solution for sticky
formulations
Important to avoid contact between tip
and absorber
Air Intake
Filter
Impossible to guarantee
100% integrity in
mass production
PureFlow
100% controlled
No living organism can grow through or cross the
barrier
Novelia® Novelia®
Vented Cap
All Novelia®
| 15
Detailed functioning – valve reclosing
(step 3)
Valve recloses sealing the packaging system tight
• The one-way valve closes preventing liquid from being sucked back into the bulk,
thus preventing any retro-contamination by liquid backflow.
• The action of closing the one-way valve breaks the liquid column between the nozzle and
the bulk.
No liquid backflow
0% risk of contamination
| 16
Detailed functioning – Air compensation
(step 4)
PureFlow® technology :
an alternative solution to filters for a MAXIMUM SAFETY
By using the air permeation property of
the silicone PureFlow® technology
allows air to diffuse into the bottle and
prevent any germ/contamination to
enter the bottle. Solid, non porous material
Homogenous, no hole
Intermolecular distance
in nanometers 100% of the air entering the
bottle is PURE
0% risk of contamination
| 17
Filtration technology is NOT used
in Novelia®
• Filtration technology is NOT used in Novelia®
• Disadvantages of filter technology:
• Filter with pore size <0.22micron does not provide a continuous
barrier through product life. Bacteria can pass through 0.2micron
• Sterilizing filter cannot be verified by 100% on-line integrity testing
(Testing method introduces bacteria and liquid onto the surface of the filter.
This starts bacterial growth on the filter and therefore decreases the
subsequent shelf life of the dispenser. Therefore in-line testing of MD eye
droppers that rely on filter is not possible)
• Sterilizing filters fail if wetted
| 18
One drop at a time
into the Patient’s eye
• PureFlow® Technology is used for air filtration and also for flow control
Several flow controls for each type of viscosities
One drop at a time
into the patient’s eye
| 19
Detailed functioning – Remaining drop protection
Step 5
• Some residual liquid (20% of a nominal drop size) can remain on the outside of the tip
as the liquid is prevented from returning into the container by the one-way valve.
• The liquid remaining is protected from bacterial growth by the presence of silver ions in the
outer components (Top and Cap).
The remaining drop is further protected by the cap reclosing.
This does not influence the shelf life, as even without the cap reclosing, the remaining liquid
dries, minimising the likelihood of bacterial growth.
• Silver ions are only in contact with the remaining drop which is prevented from returning
to the bottle by the non-return valve, not with the drug. Silver ions act by contact.
With
the remaining drop
0% risk of
contamination
| 20
Easy to target the eye
and Novelia® intuitive handling
Blue tip for a better precision
when targeting the eye… …with an intuitive & user friendly
device as easy to use as any standard
eye dropper
Blue tip
| 21
Novelia®
a PFMD device designed to meet Patients’ needs
When drop
deliverance
No
side effects
No
contaminated
remaining
drop
Hermetic
closing
Easy targeting Adapted to
mobile use
Easy to use &
Intuitive
handling
SAFETY: NO RISK OF CONTAMINATION
CONVENIENCE
COMPLIANCE
Flow
control
| 22
Thank you for your attention !
• On our booth:
Hall 4.2 – Stand 42D40
• During the Innovation Tour:
Liquid formulation devices
on Thursday 26th October
You are most welcome to discover Novelia®!