HOW PHARMACEUTICAL PACKAGING AND DRUG DELIVERY DEVICES HAVE CHANGED IN THE LAST 20 YEARS

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An overview of 20 years of Pharmapack awards

Dr Pascale Gauthier, Pharmacist PhD, UMR MEDIS 454, Faculty of Pharmacy, Auvergne University - 63000 Clermont-Ferrand – France.

Extract from presentation ‘Packaging as pharmaceutical partner: from dream to reality, now with digital integration.’ Session Innovation and compliance on Wednesday 1st February 2017, 20th Pharmapack edition - Porte de Versailles Paris.
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A good health is observed for the pharmaceuticals market which will reach $1,300 billion by 2018. An advance, thanks to the increase of generics and biotechnology products and proposal on therapeutic innovation drug that mainly target cancers, infections, metabolic diseases and, since 2011, orphan diseases with unfailing success [1]. As main definition offered by Public Health Code, the Pharmaceutical product remains a very specific one, ‘a substance prepared and administered to treat a disease’. The patient, final user of product is not the only one to enter in contact with drug form. It should not be forgotten that practitioner chooses and prescribe drug form; caregiver/nurses can dispense them [2] and the patient himself presents great diversities regarding ages and pathologies. From children (offer accuracy, avoid stigma) to elderly (drugs' top consumers with misuse due to polypharmacy), the pharmaceutical industry have the great challenge to adapt, simplify treatments for providing a better compliance both for acute and chronic diseases [figure 1]. A lot has been done thanks to packaging...For the near future packaging becomes smart with less, and offers a good adaptation to both patients and products thanks to a great design |3].

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Figure 1: Diversity of drug forms and users [2]

 

The first Pharmapack was held in 1997 in Paris, at the Cité des Sciences et de l'Industrie (the biggest science museum in Europe) with a nice view on snowy la Geode. In the beginning, it was a biannual event till 2007 then has became annual since 2008. With increasing size of the exhibitors and visitors, Pharmapack has been relocated in Paris Expo Porte de Versailles since 2014. Such a great success of a niche event dedicated to pharmaceutical packaging: from 1997 (40 exhibitors and 400 attendees) to 2017 (411 exhibitors and 5290 visitors) that established this fair as a must-attend event in the world of Pharmaceutical Packaging and drug delivery devices. [figure 2].

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Figure 2: 20 years of Pharmapack from Paris-La Villette to Paris-Porte de Versailles

 

Twenty years for fifteen Pharmapack Editions and 66 awards or mentions distributed. The injectable forms are the great winner with 24, that gave a shining proof that the rules do not hamper imagination, the other great part of the winners are devoted to solid oral forms with 15 awards, let's try to have a (non-exhaustive) overview of these prizes, that represent a travel in 20 years of packaging innovation.

Definitely, injectable forms remain the most regulated sectors, but also the fastest route for treatment administration with so much requirements regarding asepticity, non-pyrogenicity, and the absolute need of good product and dosage at once (no possibility for correction after administration) with the necessity of materials that avoid extractables and leachables [5].

Clever systems for injectable use have been sometimes combined and replicated in other routes of administration [6]. Allow a safe mixing and reconstitution of product is the aim of the first award in 1997, for securizing the reconstitution of lyophilized forms. Since then, numerous mix-sets appear and evolved by limiting the number of stages while keeping this initial idea: facilitate and increase the safety of product reconstitution. Digital can be integrated for providing a perfect reliability and accuracy, indispensable with the advent of biotech molecules (complex, unstable and expensive products with often a requirement of extemporaneous preparation).

Facilitating the patients' life and offering 'all-in-one' system are the purpose of the pre-filled syringes, both packaging and delivery system. Numerous safety-needle systems are included for heparin treatments and were distinguished at Pharmapack Awards such as:

  • Fraxiparine® by Sanofi, in 1997;
  • SmartDose®by Pro-Med AG in 2003;
  • Innohep®/multifunctional labels by LEO Pharma in 2001;
  • Safety Syringe System with needle retraction into the syringe by Credence MedSystems, in 2015.

They represent a great example of design adaptation to the contaminated blood problem emerging in the 80s. Safety needle can be combined with a mix-set system, such as:

  • Credence dual chamber reconstitution safety syringe® rewarded in 2016;
  • or with a pre-filled syringe safeguarded against reuse and drug tampering like Injecto® by INJECTO rewarded in 2016.

Prefilled-syringe can also be designed to offer the best and quick use in an emergency case as proposed with Epinephrine® by Aguettant, rewarded in 2010.

Injectable forms often targeted diabetes, a blockbuster pathology that has greatly contributed to the numerous succession of advanced injection pens, now currently used in various pathologies. Multiple generations of injection pens have picked up awards at Pharmapack such as:

  • Novo Echo™ by Novo Nordisk in 2013, proposing an adaptation for children (reliability of low doses/customization to improve adherence) or to the elderly (ergonomic pens with a simplified reading system and memory functions);
  • Safelia®by Nemera rewarded in 2017, for the high viscous formulation.

Limit or avoid the pain with finer needle, integrate a child-resistant design or a better recognition have also been rewarded:

  • Nanopass®34 by Terumo, rewarded in 2014, for finer needle;
  • K-pack Surshield™ by Terumo in 2012, improving safety with child-resistant features;
  • Levobupicaine Kabi by FRESENIUS KABI in 2016, providing safety of use and avoiding any confusion for caregivers with clear color on infusion set.

On the range of secondary packaging, all was done in term of colors, font size (or real size images of the pens) to provide a clear and safe recognition of product for the best security of users. Of course, for that last two years, digitalization for monitoring patient treatment adherence is represented on prize list, with rewarded products such as:

  • Rebismart® , an auto-injector/internet platform from Merck Serono in 2015;
  • Datapen®, an Internet-connected injector pen by Biocorp in 2015;
  • Easylog®, a smart sensor for insulin delivery devices by Biocorp, in 2016.

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Figure 3: examples for injectable route [2, 7,8,9,10, 11, 12,13,14]

Oral administration forms remain the second winner of Pharmapack with 17 awards received in 20 years. Helpful systems for monitoring treatments are the most often rewarded; as an anti-emetic to be used prior to chemotherapy (Emend® by Sanofi, rewarded in 2007), one of the first of this era of ‘wallet blisters’ subsequently rewarded for a variety of products:

  • Panadol® from GlaxoSmithKline in 2005;
  • Pocketpa ® by BurgoPack in 2008;
  • ‘Wallet Blister’ for OTC product by Pierre Fabre Medicament for CINFA LABORATORIES in 2015;
  • Compliance Pack by August Faller KG rewarded in 2017.
  • Actonel Combi® by P&G Pharmaceuticals rewarded in 2009, blister adapted to weekly/montly chronic treatments;
  • EasyBox® by Teva pharmaceuticals rewarded in 2015, with a clear visualization of the dosage form on the secondary packaging.

A wide diversity has been offered from an ergonomic pillbox: Efferalgan’s Easysnap® stopper by Somater, Airsec-Süd Chemie for BMS award in 2009, to a child-resistant blister BurgoPack’s child resistant slider award in 2012, and a tamper evident solutionTamper-Evident Folding award for IGB Bressan award in 2015.

Re-designing 'old products' for providing them a new youth is an example followed by FlackPulls, a fine twist on glass ampule (VitaBio Flor® by Nutrition & Santé in 2010).
More recently, a clever innovation for regulating the daily administration of opioïds with SmartBottle®by Etimimedix SAS rewarded in 2016 includes a self-blocking system (figure 4).

Few award on the target of pulmonary administration, except at the first Pharmapack Edition in 1997, with an award for the iconic Diskus® by Glaxo Welcome (now GSK) which embodied the basic characteristics (dose counters, easy use...); The Company retrieved another award in 2001 for the single-dose nasal spray Imigrane®.

Avoid the stigmatization and improving the use is a purpose rewarded several times:

  • Conveen® Optima by Coloplast in 2010;
  • Actreen®Lite Mini by B. Braun in 2011;
  • Talent BT™ by Primequal, in 2011,  an automatic, painless, single-button injection device  improving the application for dental care;
  • Ocular lens injector M-Jet® by Top Clean Packaging Group, in 2007.

Clever and innovative packaging are also rewarded in veterinary area and are designed to help treatments’ management, such as:

  • Flexibag® by Virbac in 2014, a spray resistant to corrosive products, integrated into a backpack;  
  • EasOtic®  by Virbac in 2009, an adapted spray for pet sector;
  • Twist’n’Use™ in 2015, a nice collaboration between Elanco and Neopac for Orsurnia.

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Figure 4: examples for various drug forms [2, 7,15,16,17,18,19,20]

 

Eco-design and recyclability have not been forgotten during these 20 years of Pharmapack awards, such as:

  • Kaletra® (lopinavir/Ritonavir) 200mg/50mg, film-coated tablets packaging from Abbott Laboratories, reduced the pack size by 40% with 70% less packaging, rewarded in 2011;
  • Pyclear Protection by a French start-up Pylote, rewarded in 2016, the breakthrough innovation integrate through ceramic beads the protection system directly on the packaging manufacturing process;
  •  ‘Compact box’ by Sanofi Pasteur and Campak, rewarded in 2017, reducing vaccine packaging by 50% and eliminates the use of blister with a clever cutting of the cardboard (figure 4).

As a conclusion, it can be seen that despite on their diversity all these packaging and drug delivery systems rewarded have common points for helping the usage, improving patient compliance, and ultimately bringing the shining proof that packaging is definitely established as an essential partner for the proper use of medicines.

 

References

1 - http://www.leem.org/chiffres-clés
2 - Gauthier P, ‘Packaging as a pharmaceutical partner: from dream to reality, now with digital integration.’ 2017, Pharmapack, Paris, feb 1st.
3- Gauthier P. ‘Much more than packs! Overview of innovative packaging that change life of drugs forms.’ Pharmapack Europe 2015, Paris, UBM Canon, Paris, 11-12th February 2015. ‘Ces emballages qui changent la vie et l’usage des médicaments’. Doses, N°60, 2015, 56-67.
4 - http://www.pharmapackeurope.com/fr/innovation/awards-winners-2017
5 - Gauthier  P. ‘Extractables and leachables an overview.’Aerosol Europe, 2015, vol 23, N°6, 7-13.
6- Gauthier P. ‘A complete world of design adaptation and product specificities for injectable drug delivery.’, Therapeutic Delivery, 2017, 8(11), 933–937.
7 - http://www.pharmapackeurope.com/fr/innovation/awards-winners-2017
8 - http://www.eveon.eu/en/solutions-and-services/intuity-mix-platform
9 - https://www.novologpro.com/prescribing/insulin-pens/novopen-echo.html 
10 - http://www.credencemed.com/dual-chamber/
11- https://www.schreiner-group.com/en/products/schreiner-medipharm-products/patient-safety/needle-trap/needle-trap/Product/show.html
12 - http://www.terumo-europe.com/en-emea/diabetes-management/pen-needles/nanopass%C2%AE-34g
13 - http://www.rebismart.com/en/index.html
14- https://biocorpsys.com/connected-medical-devices/datapen/
15 - http://www.igbressan.it/en/innovation/child-resistant-folding-box
16 - http://www.primequal.com/tech_description.php
17 - http://www.actreen-bbraun.fr/cps/rde/xchg/om-actreen-fr-fr/hs.xsl/7377.html
18 - https://www.virbac.fr/home/produits/main/produits/flexibag-et-farmpack.html
19 - http://www.ethimedix.com/key-features/
20- http://pylote.com/techno