The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five per cent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves (such as prefilled syringes, blow fill seal vials, powder applications and others) also have a direct impact on the packaging.
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Beyond the EU: DORA and NIS 2 Directive's Global Impact
Recent trends in pharmaceutical packaging
1. RECENT
TRENDS IN
PHARMACEUTIC
AL PACKAGING
By Mr.Prashant Patel
Department of pharmaceutical
technology
Indukaka Ipcowala college of pharmacy
2. Why Packaging development is
needed?
In India, pharma packaging today
stability and occupies a significant portion of
shelf life to the the overall drugs market.
drug
Earlier, the requirements of
convenience pharma packaging focused
and compliance exclusively on preserving the
of drug use. quality of enclosed medication.
to ensuring Now, they are extended to cover
product safety such criteria:
prevention of product tampering
and counterfeiting
Brand identity assurance of product dispensing
accuracy
promotion of patient compliance
with product dosage schedules.
3. stability and
shelf life to the
drug
Reckitt Benkiser launched the easily portable
'Handy Tube' version of its popular Strepsils
line of sore throat lozenges. The new
packaging is not only convenient to carry, but
at the same time provides adequate humidity
protection to the product during its shelf life.
4. convenience
and compliance
of drug use.
Moov - pain reliever by Paras
Pharmaceuticals now bought over by.
Reckitt Benckiser. It was earlier available in
tubes; but it is now also available as an
aerosol spray which is convenient, easy to
apply and ideal for people on the move.
5. Brand identity
“ The packaging contains coding by which
consumers can connect via smart phone to product
content in addition to what they can already see on a
drug's label, printed packaging and inserts. The
manufacturing and packaging contractor sees the
technology as a way to give clients' products a leg up
on crowded retail shelves” - Catalent Pharma
6. Major influences are:
Product trends influencing pack trends
Changes and trends in packaging materials
Changes in packaging processes
7. Current market scenario
Global pharma packaging industry studies show that by
2011 pharma packaging industry was expected to grow
by 5.9 percent per annum and was predicted to reach
$34 billion mark within 2011. While as per a McKinsey
report, Indian pharma packaging is expected to reach
$50 billion by 2015.
Nano technology, The global market for nano-enabled
packaging for blisters was $941 million in 2008 and is
expected to grow to $2.10 billion by 2014.
8. Different trends
Sustainability
Cost effective
Robots in primary packaging -
ESS Technology and FUNAC system
Radio-frequency identification(RFID)
Electronic-Enabled Packaging
Unit-dose packaging for greater dosage control
Packaging against counterfeiting
Child-resistant packaging
Eco-friendly pharma packaging
The Talking Packaging : “Self Talk”
Dispensing Caps
9. Sustainability
waste-
reduction
Recycling of
imperatives of
packing
the last
material
environmental
era
minimizing
greenhouse-gas
sourcing of
generation, wate
renewable
r use, and
materials
energy
consumption.
10. Cost effective
Chennai - based company Jumbo Bags who after
intensive R&D developed bags with corrugated linings
weights capacity-500 kgs to 2000 kgs.
it could be folded when not in use which was not possible
while using drums.
Price-drum costs Rs 120 to Rs 150. for 30 drums, the total
cost would be Rs 3600. The bag manufactured by Jumbo
Bags would cost only Rs 2500.
Robots (and robot-like devices) also increase flexibility of
packaging equipment, decrease time
consumption, increase output and reduce labor cost.
11. Robots in primary packaging -
ESS Technology and FUNAC system
the LR Mate - standard platform for the
TaskMate.
Motion control, high speed and
robotic dexterity makes it suitable for
product orientation, collation, and
repetitive tasks.
Capable of speeds above 40 picks
per minute.
the TaskMate can count, stack, load, or
unload medical devices, pouches, and
other related items.
12. Radio-frequency identification(RFID)
RFID tagging to simplify shipping, receiving, inventory
location, and control has been mandated by the
Department of Defense, several other retailers, and
various hospitals.
carry and collect the data needed to track and trace
product through the supply chain
prevent counterfeiting and diversion
coupled with sensors to monitor conditions during
shipping and storage and provide alerts if parameters are
exceeded.
to monitor patient compliance. Tagged blisters record
when doses are taken ("Med-ic" electrical compliance
monitor, Information Mediary
13. Dual-function tags - RFID with temperature
sensing, having cost less than traditional devices for
temperature monitoring e.g. integrates a
sensor, microchip, battery, and antenna on a paper-thin
label.13.56 MHz ("TempSens" smart label, KSW-
Microtec, Dresden, Germany.
This type of smart sensor label–equipped blister
package is being used by the National Institutes of
Health (Bethesda, MD), for a multiyear study of chronic
obstructive pulmonary disease that will involve nearly
half a million individual doses of medication.
14. Electronic-Enabled Packaging
In February 2011, Finnish
packaging company Stora Enso
unveiled the newest iteration of its
adherence control
packaging, Pharma DDSi
Wireless.
This technology is based on
conductive ink on a carton board-
based blister inlay, which is
Stora Enso's new Pharma
connected to a cellular module DDSi Wireless packaging
embedded in the package. leverages cellular networks
The removal of pills is tracked to track patient adherence
data, allowing reminders to
and the information can be sent be sent by text.
to an electronic database
automatically via GSM or GPRS
15. Catalent's Delpouch Starter Kit
packaging system, designed for
topical treatments.
Delpouch measures the right
amount of topical cream or
ointment to simplify the application
process.
Catalent's Media Enhanced
Packaging technology, which
allows patients to scan a digitally
embedded watermark in the
packaging with their smartphones
to access extra product
information, videos or even real-
16. Cypak's advanced medication Packaging can now connect with
monitoring and report card computers using sensor technology.
systems, can record the time and allowing patients to log their
date that a pill was taken based on feedback on side-effects and
when it is removed from its blister treatment efficacy and upload it.
17. Unit-dose packaging for greater
dosage control
Aim:-"With more of a focus on outpatient care and the
self-regulation of medicine, there's greater onus on
patients to take the right medications in the right
amount"
A January 2012 study by US-based market research
firm Freedonia suggests “unit-dose formats, including
vials, ampoules, prefillable syringes and premixed IV
solutions, are some of the biggest growth drivers of the
aseptic packaging market.”
In fact, prefillable syringes are predicted to represent the
fastest growing aseptic packaging type, with demand
expected to grow 11% each year to $1.1bn.
18. Bosch Packaging Technology
recently acquired the machinery
business of Eisai, a Japan-based
leader in filling single doses.
19. Packaging against counterfeiting
AS per FDA - counterfeit drugs account for 10% of all
medication in the US
EU believes between 1% and 3% of medicines
latest developments are fluorescent labels, packaging
with laser surface authentication, which can be
identified through a unique code, and near field
communication (NFC) tags.
In India for instance, drug companies have been
sending their medicines to overseas markets including
an obligatory sport barcode on their outermost
packaging, started in October 2011.
20. Child-resistant packaging
Keeping drugs secure from young children while ensuring
user-friendliness to seniors is one of the main objectives of
pharmaceutical packaging companies.
Child-resistant (CR) packaging was introduced in the late
1960s and early 1970s, and is most commonly known as a
safety cap on bottles that has to be pushed down before
being opened.
More advanced CR packaging, such as special blister
packs and cardboard packaging, has only been released
onto the market in the last decade, and looks set to
continue its growth in the future as its popularity increases.
21. Packaging company Amcor Flexibles followed suit a
few years later and introduced a CR blister pack, the
Guardlid, which is compliant to CR / senior friendly (SF)
regulations in Europe and the US.
22. UK packaging producer Burgopak's sliding CR blister pack
can only be opened by applying pressure at two separate
points on the packaging. The blister pack and information
leaflets are integrated with the outer box, which ensures the
product is never separated from its packaging.
Burgopak Healthcare & Technology - won the award for the
‘Most Innovative Child Resistant Packaging Design’ at the
Pharmapack Paris exhibition on 16th February 2012.
23. In 2006, Stora Enso and Bosch Packaging launched
Pharma small hands resistant (SHR), a re-closable and
tear-resistant carton ideal for highly toxic drugs, which
TestPak, lnc. started using and producing the same
year.
24. Eco-friendly pharma packaging
Environmental considerations must not lead to any
compromise on a package's safety or accessibility.
New pharmaceutical packaging concepts are beginning
to emerge that address environmental concerns without
sacrificing packaging advances made in the last decade.
25. In August 2011, Keystone Folding Box Company and
Legacy Pharmaceutical Packaging launched their
Ecoslide-RX sustainable compliance packaging.
The pack is made from 100% recycled material, using
unbleached paperboard and a clay-coated surface designed
to house blister packaging with a minimum of unsustainable
film and foil.
The slide package meets all the modern expectations for
child-resistance and accessibility for seniors, but doesn't
require heat sealing in the manufacturing process, reducing
26. Syreen prefilled syringe design
Environmental awareness is even
starting to extend to the syringe
market.
Syreen syringes replace glass with
cyclic olefin polymer (COP), this
material has allowed Cambridge
consultant to jettison secondary
packaging altogether as the COP
design forms its own outer shell.
The ability of packed syringes to clip
into place also eliminates the need
for packing materials like styrofoam
and cardboard.
Packaging weight reduction - 30%
and volume - 50%, compared to
27. Cyclo olefin polymer (COP)
Lightweight
breakage-resistant packaging for protein-based
peptide-based, floating particle, and high-viscosity
drugs suitable for use in prefilled syringes and vials
where transparency, sterilization, breakage-
resistance, and stability are important
mechanical properties of devices made from COP
have no significant change after steam-, ethylene
oxide-, and gamma-sterilization
Zeon Chemicals L.P., a wholly owned sub. of Zeon
Corp.
www.zeonex.com
28. The Talking Packaging : “Self Talk”
There are two developments in talking packaging at this
moment
The “TalkPack” from Wipak Walsrode GmbH in
Germany, a system, which can be invisibly integrated
into any printed image on any packaging material, but
needs a special scanning pen
a recent development by VTT Technical Research
Centre of Finland using tags with NFC (Near Field
Communication) based technology connected to
NFC-enabled mobile phones to download text, audio
or web page product information, which can be played
back on their handset.
29. Talk Pack-Wipac
A special pen-shaped reader is used
to retrieve the stored information and
to replay it as audio files and render
speech, music or sounds audible and
thus the consumer can obtain
information on the
manufacturer, brand, shelf-life or
other information.
Talk Pack does not require any RFID
or microchips.
the dot code is simply printed on top
of images and texts using a special
varnish. This technology can be used
with all printing technologies and
30. NFC tags - VTT Technical Research
Centre
NFC tags are added to any
packaging so a consumer could
touch the code on the packaging
with their NFC-enabled mobile
phone to download text, audio or
web page product
information, which can be played
back on his handset.
provided spoken dosage
instructions from pharmacy
staff, to aid a visually impaired or
blind person.
Currently, the number of mobile
phones with NFC technology is
31. Dispensing Caps
dispensing caps or functional caps - store dry or liquid
supplements separately from the water - released by the
consumer they form an energy or vitamin drink or sometimes
a medicinal drink.
everything from pharmaceuticals to nutraceuticals, from anti-
aging to anti-oxidants, from vitamins to functional
supplements, from male potency to stem cell
stimulants, from energy to relaxation and so on can be
packed and properly dosed by a dispensed cap.
it is generally claimed that pills and capsules have a very
short window of absorption
Liquid absorption is much higher: around 80-90%.
It would more preferred especially when it comes to children
32. One of the most basic
designs in a patent filed in
2002 by inventor Stephen
Carlson and assigned to The
Coca-Cola Company.
33. A typical dispenser cap includes a space which holds
the substance to be dispersed
(vitamin, flavour, medicine in powder form, liquid or
tablet), which is bounded and sealed on one side by a
membrane.
A membrane opening device is used, often activated by
depression of a flexible diaphragm, which causes the
membrane opening device to pierce the membrane, thus
enabling mixing of the contents of the dispenser with
those of the container to which it is attached.
34. Recent changes and development in
Inhalers (MID, pMID, DPI, nebulizers)
Hydrofluoroalkane (HFA) propellant replacing the
chlorofluorocarbon (CFC) due to concerns about the
latter’s damaging effect on the ozone layer.
The US Food and Drug Administration (FDA) has ruled
that no CFC MDIs will be sold in the US after 2008.
As a result of the requirement to use HFA
propellants, challenges arose with respect to re-
designing formulation, valves, and actuators and
conducting clinical trials.
The elastomeric components in existing metering valves
are generally incompatible with HFA propellants, and
some surfactan
35. DPI devices are categorized as
single-unit dose inhalers in which each dose is loaded
into the device before use (Aerolizer™, Novartis;
Handihaler™, Boehringer Ingelheim)
multidose reservoir inhalers in which a large supply of
drug is pre-loaded into the device (Turbuhaler™ or
Flexhaler™, Astra Zeneca; Twisthaler™, Schering-
Plough)
multiunit dose inhalers in which several single doses are
individually sealed and discharged each time the device
is actuated (Diskus™, GlaxoSmithKline).
36. The Aerolizer uses separate single-dose capsules while
the Flexhaler, Diskus, and Twisthaler all have dose
indicators.
In contrast, pMDIs do not have an independent means
by which to monitor the number of doses remaining in
the device.
In March 2003, the FDA issued guidelines that
recommended manufacturers integrate a dose-counting
device into new pMDIs (www.fda.gov/cder/guidance/
37. Aeroneb® Solo nebulizer
The Aeroneb® Solo nebulizer is designed
to operate in-line with standard ventilator
circuits and mechanical ventilators.
Operated without changing patient
ventilator parameters.
Refilled without interrupting ventilation.
Operated on its internal rechargeable
battery for up to 45 minutes when fully
charged.
Operates without compressed gas,
making it suitable for portable
applications
38. Aeroneb Pro
The Aeroneb Pro is a reusable, multi-patient use nebulizer
which is suitable for hospital environments where the
appropriate sanitization facilities are available.
Cost-Effective:
Negligible residual volume in medication cup, so
minimizes drug waste
Multiple patient use
Autoclavable at 132ºC - 135ºC (270ºF - 275ºF)
Flexible:
Operates in-line with standard ventilator circuits
off-vent with an aerosol mask or a mouth piece
Accessorized to treat for infant thorugh to adult
39. Aero Chamber plus Flow-Vu
-Monaghan Medical Corporation; marketed by Forest
Laboratories
40. Diskus Inhaler Technique
Device innovators and manufacturers were honored as
AANMA’s first innovative technology award at the 15th
annual Allergy & Asthma Day Capitol Hill
on Thurs., May 10, 2012.
A DISKUS® is a dry-powder inhaler that holds 60 doses.
It features a built-in counter, so that you always know how
many doses you have left in it.
First dry powder inhaler that simplifies asthma care by
combining an inhaled corticosteroid with a long-acting
bronchodilator in one device.- GlaxoSmithKline
41.
42. References
Chapter 17,packaging of pharmaceutical dosage forms, Gilbert S.
Banker, Christopher T. Rhodes,pg.
Dr. John Green, Dr. Erik Gommeren, PHARMACEUTICAL AEROSOLS –
ENHANCING THE METERED DOSE INHALER, DuPont Central Research
& Development.
Shyam Sunder B K, Pharmaceutical packaging - A growing
phenomenon, http://www.expresspharmaonline.com/20110131/packagings
pecial03.shtml
Dvaczek, Tracking Growth Trends, Pharmaceutical & Medical Packaging
News, March 2010, Volume 18, No. 3
http://www.pharmaceutical-technology.com
http://goarticles.com/article/Analysis-of-trends-in-recent-years-
pharmaceutical-packaging-carton-cartons-paper-packaging-whit
http://bestinpackaging.com/2012/03/18/developments-in-healthcare-
packaging