Cases to counter non-compliance
You’d think that if you were unwell, there’d be nothing simpler or more expedient than being sure to follow whatever medication procedure had been recommended to chart the path to recovery. Apparently not.
According to figures produced by Datamonitor for 2004, while prescription drugs cost the NHS more than £8bn a year, four out of 10 patients failed to take their medication regularly enough to derive any benefit at all. It’s unlikely that either statistic will have improved, so not only is the UK the sick man of Europe, it’s becoming so by dint of its own negligence.
All the more galling is the fact that the UK pharmaceuticals industry spends an estimated £3.3bn a year on R&D to develop better drugs, and a further £850m on promoting them. The resultant waste of money is enough to make any self-respecting finance director reach for the headache pills – although there’s a 40% chance he’ll forget to swallow them.
The situation is exacerbated by two socio-economic factors: a readiness to seek a pharmacological remedy for aches and pains that 50 years ago might have been treated in a less chemical way; and the need to relieve the pressure on an over-stretched health service by encouraging self-medication.
Compliance and regulation
Within the context of an ageing population, it’s patently clear that, since the first of these is unlikely to alter, the second has to be made to work more effectively.
Fulfilling patient compliance is a key imperative for Big Pharma, and one that has served the packaging industry well in recent and increasingly regulated years. There are, however, safety margins to be maintained; not least in ensuring a correct balance between ease of accessibility and designated usage with specific regard to imposing child-resistance properties.
In this respect, the blister pack has proved to be the preferred dispensing mechanism for most pharmaceuticals manufacturers; increasingly incorporated within an integrated unit comprising comprehensive dosing information.
Bosch Packaging Technology introduced its SmartWallet concept last year, based on loading blisters and supporting information onto a pre-glued outer sleeve in a single run at 300 units a minute. ‘‘Its main USP is that it can be produced on an existing cartoning machine,” claims head of systems integration Andreas Graf. “We have a number of over-the-counter projects in the pipeline and there is one product now at trial stage. The problem at the moment is that every potential customer would like to have special modifications specific to his own application.”
More recently onto the market is the Stora Enso DDS (discreet dose slider) carton-based application, incorporating second-generation packaging technology developed by Swedish-based digital healthcare specialist Cypak.
The pack is accessed by simultaneously pressing an integrated button at one end while sliding out an inner-tray incorporating a fold-over blister, and has achieved the US-accredited F1 standard for child resistance as well as being approved for medication requiring high compliance.
Stora is looking to release an even more sophisticated version: the DDSi, incorporating electronic sensors. After each pill is dispensed an alarm sounds that requires the patient to press a button to deactivate it. The circuit then reverts to passive mode.
According to Cypak director Danevert Åsbrink, the slider pack is a new extension of a format first adopted by MeadWestvaco two years ago. “Stora are the first to have the new integrated circuit, which has streamlined about 30 standard components and so reduced the manufacturing cost dramatically.
“There’s always been a lot of interest in smarter packaging and digital health, but the sales process into the pharma business is traditionally quite long. However, we’re very confident that these types of medicine packs will be used quite widely in the future. Cypack co-operates with around 150 leading health service providers (including the NHS) via the international Continua Alliance, in part focused upon coming up with a system that really brings the cost down for treating patients.
“The big problem is that there aren’t enough sickbeds so one way of dealing with that is to treat patients at home. In every country this problem is being managed differently, but there are big healthcare providers that are willing to spend a couple of bucks to save more. In the UK it could be the NHS, for example, and they are currently evaluating Cypak technology,” he says.
Pharma at Interpack
Stora Enso will show the DDS system at Interpack, as well as other new applications aimed at the pharma market, confirms product development manager Marcus Dehlin. “The DDS can be universally produced on all kinds of existing equipment and utilises different combinations of materials, although its most likely commercialised end-use will be for blisters.
“We have a number of trial projects up and running with contract packers and manufacturers in the US and Europe, and are anticipating applications becoming available next year, including interest from a UK-based pharmaceuticals manufacturer.”
Also focusing on new applications at Interpack is the German pharma labelling specialist Faubel (represented in the UK by GP Solutions), with a new child-resistant, senior-friendly (CRSF) two-layer structure incorporating a permanent adhesive cover and a convenient opening flap that is reclosable to provide maximum security after each use. The opaque blister structure is covered by the first sheet, which also conceals the contents. The PET base layer fixed to the blister also increases the strength needed to access the pills, claims marketing manager Sascha Sonnenberg.
“The goal is always to combine child resistance and senior friendliness. We’re currently developing a way to introduce some logical thought process into the way in which the label is opened by turning the flaps in a specific direction, and with text instructions over-printed. This will meet F1 standards, and is on track to be launched at the show in April,” he says.
Direct dosing
An evolving trend could be for packaging and print technology to transmute into direct dosing solutions, as demonstrated by the development of a revolutionary new skin patch, substantially based upon HP’s thermal inkjet intellectual property and exclusively licensed to the Irish medical device developer Crospon.
Based on the same principles of thermally heated ink injection onto a substrate, the Crospon skin patch incorporates a series of minute individual ‘syringes’ arranged on a patch of about 2.5cm diameter and 3mm thick. Each syringe holds a precisely measured dose of a drug, which is pre-programmed to be directed via a micro-needle into the patient’s body, explains HP IP licensing director Charlie Chapman.
“HP’s laboratories developed an intermediate proprietary polymer, which has a very predictable rate of swelling when heated and is positioned between the heater element and the drug. The system can be programmed either in real time or by a pharmacist or a doctor to deliver drugs in the prescribed manner for a given patient.
“We see this as a very convenient life-style choice of application. The patch should have a life expectancy of three to five days in use, and when commercialised could be ideal for dispensing insulin, for example, or a range of hormone therapies that hitherto have required action on the part of the patient at inconvenient times,” he says.
FROM DVDS TO DRUGS
Burgopak is another packaging specialist to have extended applications of its intellectual property to meet the needs of a new end-user industry.
The London-based creative packaging design team first developed its sliding mechanism for use in the CD and DVD market, for which it has supplied more than 40 million units over the past five years.
But director Mark Whittaker says pharmaceuticals could become the firm’s principal revenue stream in less than half that time, following the recent automation of its PocketPak blister pack-based application production system, the first of which is being installed at Brecon Pharmaceuticals in April.
“Up until now, all our packs had to be hand-assembled. This automated system, developed for us by Bosch, produces and integrates single or double blisters, booklets and board all in one seamless transition – and at a rate of 20 million units per machine per year.
“Judging by the interest we’ve received, the pharma sector will become the major part of our business in terms of volume. This is entirely new revenue for us and we’re looking to double our current turnover during the next two years.”
PocketPak has full Medicines and Healthcare products Regulatory Agency accreditation and is already used for a number of over-the-counter drugs on sale at Boots, Alliance and Moss chemists.
Of particular appeal to co-packers will be Burgopak’s preferred strategy of installing the system on a royalty payment related to actual output basis, which allows a customer to take on a brand new pack design without having to invest upfront in machinery, says Whittaker.
“While our patent is for the sliding feature, it can of course be used for plenty of other blister sizes. Also, future customers could purchase the entire system outright if the volumes warrant it - 20 million units a year is based on a two-shift pattern at a running speed of 150 packs per minute.”
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