An open and shut case for pharma containers

The packaging of drugs continues to evolve to enhance both safety and shelf appeal. Manufacturing Chemist looks at the trends and some of the new products

The world pharmaceutical packaging market is estimated to increase 4% annually to US$18.2bn (€20.9bn) by 2005, with the eight largest drug-producing countries: US, Japan, Germany, France, China, UK, Italy and Switzerland accounting for more than 80% of demand (see table 1).

However, it is China that will generate the fastest growth opportunities as economic expansion and outside investment fuel the upgrading and globalisation of its national pharmaceutical industry, says a report from US market research company Freedonia Group.

Although blister packaging will provide the best growth prospects, with demand likely to increase by around 6% annually to $4bn (€4.5bn) in 2005, generally, non-glass containers will retain widespread usage in the packaging of solid oral ethical drugs and the vitamins and mineral supplements sector (VMS).

competitive and fast-growing

Cost advantages, coupled with adaptability to both standard and speciality applications, will push global demand for plastic pharmaceutical bottles up 3.9% annually to an estimated $3.6bn (€4.1bn) in 2005, the report says. One company tapping into this demand is Bibby Sterilin, based in Stone, UK, whose Azlon range of plastic bottles is suitable for liquids, powders or tablets.

The containers come in a range of sizes from 30ml to 2l, and a variety of designs, most of which can be manufactured in high density polyethylene (HDPE), low density polyethylene (LDPE) or polypropylene (PP). Child resistant and tamper-evident closure options are also available.

Another UK company, Rexam Closures & Containers, has invested £500,000 (€819,500) at its Portsmouth plant to expand manufacturing capacity to cope with the expected rise in business as a result of increasing demand for VMS.

The company has invested the money in a high-speed manufacturing cell for child-resistant closures, in recognition of the fact that the VMS market is moving towards child resistance, even for products that do not require it legally.

Also, and particularly important in the competitive and fast-growing VMS market, is the trend towards new eye-catching designs that stand out on retailers' shelves, to help sell the product.

It has been exploiting this market by working in partnership with Merck Selbstmedikation to develop a 180ml bottle for the company's Bion3 range of combined vitamins, minerals and probiotics.

The new container is manufactured from HDPE and has a twin-wall PP closure. It is an extension of Rexam's Co-Pharm range and complements the 60 and 120ml bottles already being produced in a bespoke deep blue.

Rexam has also expanded its range of Co-Pharm bottles for healthcare applications with new designs, which have a wider mouth for easier filling.

From a design viewpoint, the key requirements for packaging are:

Closures that combine child resistance with senior friendliness will provide the challenge in changing healthcare strategies. Alan Bearne, sales manager, healthcare, RPC Containers, said: 'Packaging will become increasingly senior friendly to meet the demands of an ageing population. Lloydspharmacy identified 60% of sales were to 55+.

'Yet increased otc packaging has required both healthcare companies and packaging manufacturers to become increasingly conscious of design and create original concepts to sell the product.'

While it is essential to prevent unwanted access to pharmaceutical products, particularly by children, this should not be at the expense of those for whom the products are intended. One solution from RPC Containers Halstead, the Group's specialist closure manufacturer, is the Easitop range of closures. The simple 'push down and turn' action has been combined with a long cap and large flute, requiring less strength or pressure for adults to open. The closure fulfils all current test protocols regarding safety for children and the elderly.

A further innovation is the availability of both fixable and portable cap keys to facilitate removing and resealing of the closure in one easy motion. The fixable key is attached to the underside of a shelf or cupboard. The cap is then inserted into the key and removed by turning the bottle. This can be achieved with one hand, leaving the other free to remove the contents before re-securing the closure.

The portable key has a wide, flat top to assist with opening the cap by placing it over the top. As well as being used in the home, it can also fit easily into a pocket or handbag.

Easitop is available in a range of sizes: 20, 22, 24, 28, 33 and 38mm with standard R3 threads, plus several ROPP versions. For additional product security, a tamper-evident feature can also be specified for the closure. The range has been developed so that the colour-coded inner section denotes thread size, but it can be specified in any colour combination for maximum on-shelf impact.

As part of its 'one-stop' healthcare packaging service, Easitop can be specified with RPC Market Rasen's Pharma Secure range of containers. Manufactured in HDPE in a variety of sizes, the containers offer good moisture vapour resistance and are suitable for tablets, powders and liquids. A wide neck allows fast, automatic filling and easy product dispense and there is a large decoration area for printing or labelling.

replacing ROPPs

Other options are RPC Market Rasen's Snap Secure tamper-evident and Tot Secure child-resistant containers. The Snap Secure range has a tear strip around the base of the closure, which allows consumers to verify that the contents have not been interfered with. The Tot Secure range also has these tamper evident features, but to make it child-resistant two tabs have to be lined up before the lid can be flipped open. A simple twist reseals and secures the container.

'RPC Healthcare packaging investment over its first six years has been in excess of 15% of sales per annum. This investment is planned to continue over the next few years to meet the customers' requirements,' Bearne commented.

United Closures and Plastics (UCP) is the largest European manufacturer of child-resistant closures (CRCs) and has dedicated supply to the pharmaceutical sector. Clic-Loc is widely used as a CRC for pharma liquids and solids. With its tamper-evident and user-friendly variants, the range provides security and customer convenience with sustained performance on automated filling lines. UCP is now supplying Clic-Loc Mk III closures and PP28 TE Clic-Loc.

The replacement of metal ROPPs with plastic closures is a continuing trend. Reckitt Benckiser, for example, has replaced the metal closures on its products with a cost effective two-piece 28TE closure from UCP.

The trend for induction heat-sealed (IHS) lined caps to replace pressure sensitive liners continues to grow for most pharmaceutical applications. This provides improved pack integrity/consumer security and tamper evidence.

Medication tubes are likely to generate weaker growth opportunities due to limited applications and increasing competition from plastic dispensing bottles, the Freedonia Group report suggests, but handling can also be a problem.

It is important that the creams, gels and pastes are dispensed safely, hygienically and in controlled, measured doses - something that is hard to achieve using a tube or a tub. Removing and applying product by hand from a tube or wide-mouthed container can affect its integrity - by leaving it exposed, the liability for contamination exists.

A pump dispenser is the obvious alternative, but because of the inability of the majority of creams, gels and pastes to self-level, conventional pumps tend to draw product from the centre of the container leaving large amounts of residue of what may be a very expensive product clinging to the container sides.

The Englass HVDS (High Viscosity Dispensing System) from Rieke Packaging Systems claims to solve this problem by means of an innovative 'follower-plate', which fits around the stem of the pump and rests on top of the product. As product is pumped out of the container, the follower-plate drops, ensuring that the product remains level at all times and thereby drastically reducing residue levels. Manufactured from pharmaceutical approved materials, the Englass HVDS is available in pack fill sizes of 450, 500 and 1000g and can be used in conjunction with a number of Englass dispensers to meet the precise application dosing requirements of individual products.

Another recent launch from RPC Halstead is a 40mm flip-top closure for tubes. Suitable for all types of collapsible plastic and laminate tubes, the cap incorporates RPC's specially developed FlexSpring hinge technology, which offers wide opening, improved aesthetics and long-term reliable performance. The new closure can be specified in any colour to complement existing pack designs, and will be available with a range of orifice sizes from 2-9mm inclusive.

change to PET

According to the Freedonia report, the world market for glass pharmaceutical bottles and jars is likely to decline, as applications are lost to blister packs and high barrier plastic bottles. 'There is a tendency to change from type III glass or PVC into PET for cosmetic (clarity) and practicality (breakage) purposes, where compatible,' confirmed Jon Wear, sales director at Johnson & Jorgensen, of Manchester, UK.

'There is also a growing trend towards putting stoppers into ready-for-sterilisation (RFS) Tyvek bags,' he said. Before such bags were used, pharmaceutical companies would resiliconise stoppers to ensure that they would go down the filling lines.

'By washing them on manufacturing site at Helvoet Pharma in Belgium and packing them in RFS bags, Johnson & Jorgensen can ensure silicone levels are accurately applied and monitored. Indeed different levels can be applied dependant on the customer's filling machinery,' Wear said. The stoppers then need only be autoclaved in their bags before use – not re-washing them saves time and money and gives better results, he claimed.

Another trend he noted was a move towards non-latex rubber stoppers. 'This is in response to US legislation, which requires that stoppers in RFS bags have no latex content,' he said.

The world market for pharmaceutical closures and accessories is estimated to increase 3% annually to $5.5bn (€6.3bn), or 30% of pharmaceutical packaging demand in 2005. About 1,400 companies produce pharmaceutical packaging products globally, says Freedonia, most of whom offer limited product lines and compete in relatively narrow geographical markets.

Based on revenues, the largest players include PCI Services (Cardinal Health – US), Alcoa (US), Schott Glas (Carl-Zeiss-Stiftung – Germany), Rexam (UK), West Pharmaceutical Services (US), Pechiney (France), Gerresheimer (Germany), Silgan Holdings (US), Owens-Illinois (US) and Westvaco (US). All of these companies operate internationally and together account for a quarter of total world demand for pharmaceutical closures.

Over the next five years, limited pricing flexibility and downward profit pressures will force an ongoing consolidation of the industry, a trend picked up by Rexam.

A spokesman said: 'Mergers have been the outstanding events within the healthcare industry in recent times, with the larger companies moving into global sourcing and applying global standards to their production. The implication for the container manufacturer is that global contracts represent massive business, and they must compete effectively in terms of cost and customer support.'

Style and practicality for new vitamin pack

RPC Containers Market Rasen has designed and produced a new rectangular shelf-space efficient VMS (vitamins and mineral supplements) pack for Lloyds-pharmacy. The brief was for a versatile design that could incorporate such features as a senior-friendly squeeze and turn" CRC closure conforming to European standards. An important consideration was to provide prominent wrap-around label space, to highlight and strengthen brand projection, together with colour-matched caps and labels to further strengthen on-shelf impact. The wrap-around labels also have a raised perforated strip either side that covers the cap to provide tamper evidence. To this end, RPC worked closely with packers TD Packaging during the concept stage to ensure a good alignment between the label and the pack for ease of filling. We wanted a design that projected convenience and safety," says Keith Randell, quality manager at Lloydspharmacy. The packs are injection moulded in HDPE in three sizes: 90, 130 and 170ml. In addition, RPC Market Rasen is also supplying its Snap Secure tamper-evident container in two sizes (265 and 330ml) for bulk packs of vitamins.

Message in a bottle

Snap Secure containers from RPC Containers Market Rasen are being used as part of a groundbreaking initiative devised by Bedfordshire Data Link Partnership to support the emergency services. The Emergency Information Scheme aims to help people who feel vulnerable living at home by providing essential health information should they suffer an accident or sudden illness. At the heart of the scheme is a printed RPC Snap Secure pack, which contains relevant data for each member of the household, including health record, details of any allergies and emergency contact name and numbers. The pack is stored in the refrigerator, with two matching labels displayed in the house, one on the outside of the fridge and the other on the inside of the front door. The Snap Secure containers were selected because they are lightweight, easy to handle and open, and fit neatly inside the fridge. A securely fitting lid ensures that the printed information is not affected by cold or moisture from the fridge. The bright green Data Link logo is printed on the containers by RPC Market Rasen, using its new high-speed printer. This is an unusual use for our Snap Secure range but the need for reliable and effective packaging is similar to any healthcare application," said Alan Bearne, sales manager healthcare, RPC Market Rasen.