Medical Device Link.

FEATURE

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A decade of growth

During the past 10 years, the health care packaging market has grown at a compound annual growth rate (CAGR) of approximately 10 per cent each year, which resulted in a global market worth more than e14 billion in 2006.¹ Further increases are predicted at an annual rate of 5.9 per cent up to 2011.² The growth in packaging demands has mirrored the continued growth in consumer demand, which in turn has been driven mainly by the treatment needs of ageing populations in the developed world and the increasing availability of medications in developing regions. Changes in drug technologies such as biologics, which present their own packaging challenges, and new delivery platforms have also fostered growth in the health care packaging market.

In recent years there have been a number of significant technological advances that have enabled new packaging applications to be developed to meet changing market needs. Medical device and pharmaceutical packaging must not only ensure that packaged contents are protected from moisture, oxygen, light and heat, but it should now include anticounterfeit measures, traceability and contents monitoring. A variety of factors will continue to drive future innovative packaging solutions, as outlined below.

Legislation

From the drug delivery perspective, there is current and/or proposed United States (US) Food and Drug Administration (FDA) legislation and guidance on unit dose accuracy and consistency,³ dose counting on each activation of a metered dose inhaler (MDI),⁴ and the use of radio frequency identification (RFID) as an anticounterfeit measure.⁵ In addition, standards are being developed to secure the drug supply chain.

Counterfeit products

Counterfeiting of medical devices and pharmaceuticals is a serious and widespread problem.⁶ For example, the World Health Organisation (WHO) estimates that globally 1–10 per cent of drug sales for developed and developing countries are fake.⁷ The problem is so serious that WHO has set up an international collaborative body (IMPACT) to coordinate anticounterfeit activities for medical products on a global scale (www.who.int/impact/en). Counterfeit medical devices are particularly dangerous because they do not function as expected.

End user feedback

End user groups can provide powerful information and feedback to help optimise the designs of health care packaging and drive more innovative solutions to problems such as senior/elderly person friendliness, child security and patient compliance. Patient compliance requirements are being addressed across all areas of drug administration.

Materials

Many new materials have been developed that meet specific needs. There are applications that involve materials that react with or to their surroundings. Examples are adsorptive films and polymers that adsorb moisture or oxygen, light-sensitive materials that undergo a change when exposed to light, and materials that change under the influence of heat and/or pressure.

Drug delivery

To stay one step ahead in terms of intellectual property/patents, many companies are developing new drug delivery platforms, including, soluble thin films, microencapsulation, nanotechnologies, lipids and biodegradable polymers that do, or will, require special packaging.

Aesthetics

An area often neglected is the attractiveness of packaging and its ability to be used as a marketing tool. Packaging innovations and designs can be used to realise higher sales by being recognised by the purchaser as having a greater value in terms of attractiveness, thus providing differentiation for the manufacturer. For example, the market for medical devices to be designed with children and adolescents in mind is now receiving more attention.

Examples of where technologies have been developed or adapted to meet particular packaging demands and thus drive innovation are explored below.

Combating counterfeiting

Although not thought to be as big a problem as fake drugs, counterfeit medical devices can have devastating consequences for the users. For example, there have been instances of fake blood test strips in the US.⁸ FDA publishes guidance on purchasing items online, where many of these products are found (www.fda.gov/buyonline).

Electronic sensors and devices such as those based on RFID technology that collects and transmits data can be incorporated into packaging. Anticounterfeit measures can be used to help prevent the growing trend towards parallel sales where distributors buy branded products in a country with low drug prices and then sell them in countries where the prices are much higher. Anticounterfeiting works in three ways.

• Where the anticounterfeit measure is overt and can be easily seen and recognised by the untrained eye. Examples of overt measures are holograms such as those used on credit cards; optical inks, which can be viewed unaided; visible watermarks; and tear tapes.
• Covert measures are not easily recognised and special equipment is required to detect them. This involves the use of specialised detection equipment for observation and checking, examples include inks that are sensitive to ultraviolet or infrared radiation and show up under the detector.
• Traceability of products often involves RFID technology to collect and transmit data along the supply chain to ensure the integrity of products. It has been estimated that the total RFID market will increase in value to reach e1.5 billion by 2009 and the pharmaceutical packaging market is expected to make up an increasing proportion of this.⁹ In addition to information on supply chain history, RFID technology helps to improve efficiencies and lower costs through fully automated handling. Records can be made of the thermal history of devices or drugs that are sensitive to temp-erature. Data can be collected for products that need to be maintained at low temperatures to ensure they reach the patient in the correct condition. Temperature–time indicators (TTIs) are designed to show when a device or drug has been exposed to excessive temperature during its time in the supply chain or when in use by a patient. The indicator gives a visible signal of whether or not the medication or device is in a fit state to be taken or used. TTIs are commonly based on chemicals that react to the packaging environment. For example, TTIs may react with water, oxygen or bacteria to produce a colour change that provides the visible signal.

Patient noncompliance

The total cost of noncompliance in the US is estimated to be as much as US$100 billion.¹⁰ Blister packs have been introduced for clinical trials, which comprise a blister with individual tablet locations that incorporate a microprocessor and conductive ink. The microprocessor can record the time when the tablet is taken and relays this information to the researcher. The blister may also provide an audible reminder such as a beep. Other developments include electronics embedded in packaging of products for self-testing for diabetes, or to show when a syringe, vial or tablet has been removed from its packaging.

In addition, intelligent packaging contains embedded materials that can be scanned and thus indicate their identity. It has been estimated that the growth in intelligent or smart packaging will be at a CAGR of approximately 39 per cent between 2005 and 2010 to reach a market value of more than e15 million.¹¹

Figure 1: An electronic dose counter developed for the outer packaging of inhalers.

Other examples include an electronic dose counter that has been developed for MDIs that can be tailored to fit the outer packaging of most inhaler designs (Figure 1). The device includes embedded electronics that are capable of monitoring compliance and downloading the information ready for it to be transmitted to a health care professional.

Reactive materials

Active, or more accurately, reactive packaging materials, interact in some way with the surrounding environment to protect a medical device or a drug. A variety of multilayer films based on layers of thermoplastic polymers, iron compounds and barrier resins that react with oxygen can also be used as protective packaging. Active packaging materials help stop potential degradation of drugs, devices and other products such as test strips.

Nanotechnologies have been developed to help provide materials with significantly enhanced barrier properties. For example, nanoparticles can be incorporated into plastic films that can then be combined with layers that contain oxygen or moisture absorbing materials to provide greater performance. The nanoparticles present a physical barrier to the diffusion of oxygen and water molecules and hence greatly increase the barrier efficiency.

A smart industry

There are many technologies available for use in smart, active and intelligent packaging. Today, it is possible to see and sometimes hear packaging interacting with its surroundings to facilitate protection, patient compliance and traceability and to combat counterfeiting.

Dr Ian Buckley is Executive Director Innovation at Friedrich Sanner GmbH & Co. KG, Shillerstrasse 76, D-64625 Bensheim, Germany, tel. +49 6251 938 271, e-mail: i.buckley@sanner.de, www.sanner.de.