Drug Packagers Step Up Use of Blister Packaging
New regulations, materials, and technologies have changed the way pharmaceutical companies package their products.
Erik Swain, Senior Editor
From the introduction of new materials and technology to the advent of new regulations, drug companies are changing the way they package and label their products. Now more than ever, balancing cost, quality, and regulatory issues is essential.
The U.S. pharmaceutical packaging market is expected to rise 3.8% annually to a total of $4.670 billion in 2004, according to a study by Cleveland-based market research firm The Freedonia Group Inc. (see Table I). The greatest advances in market share are projected to come from blister packages, which are predicted to grow 5.0% per year to reach $1.045 billion in 2004. Plastic bottles can expect a 3.8% annual growth to $845 million. Other forms of primary packaging should experience 3.7% growth to $1.325 billion in 2004, secondary packaging 2.8% growth to $670 million, and accessories 3.3% growth to $785 million (see Table II).
|% Annual Growth|
|Other Primary Containers||789||1105||1325||3.4||3.7|
|Source: The Freedonia Group Inc. (Cleveland)|
Table I. Pharmaceutical packaging demand ($ million).
|Pharmaceutical Shipments ($ bil)||42.7||67.9||102.1||148.6||210.0|
|Cost of Pkg/$1000 Shpts||58.6||46.2||38.0||31.4||26.4|
|Pharmaceutical Packaging Demand||2501||3138||3877||4670||5545|
|Other Primary Containers||789||914||1105||1325||1570|
|Source: The Freedonia Group Inc. (Cleveland)|
Table II. Pharmaceutical packaging demand by product group ($ million).
Interestingly, the cost of packaging per pharmaceutical shipment is dropping significantly, according to the Freedonia study. In 1989, drug companies spent $58.60 on packaging for every $1000 in pharmaceutical shipments. In 1999, that dropped to $38.00; it is expected to drop further to $31.40 in 2004 and $26.40 in 2009, indicating that drug companies are as serious as they say they are about keeping packaging costs down (see Table II).
Blister packaging will lead the growth because of its adaptability to unit-dose, compliance, clinical-trial, high-barrier, and high-visibility formats.
There have been major developments in blister materials, which might also spur growth. Ticona (Frankfurt, Germany) recently began commercial production of cycloolefin copolymer (COC), which aims to provide better barrier protection than lower-end materials at a lower cost than the higher-end materials. It is the first completely new polymer to be used for pharmaceutical blister packaging in years. There have been some advancements in the processing of cold-formed foil—which offers the highest barrier protection—to address its drawbacks of high cost and large cavity size requirement. And new grades of Honeywell's Aclar offer an expanded range of price and barrier protection.
Bottles, the Freedonia study says, will retain the advantage in volume, however, because of low cost and improving functional and protective qualities.
Pouches and strip packs should see above-average growth because of an increase in unit-dose applications and a cost advantage over blisters.
Among parenteral packages, prefillable syringes will see the best growth because of design advances and usage advantages.
The most growth potential among accessories lies with closures that make dispensing easier but still maintain child resistance. These are expected to have an advantage because of cost, regulatory issues, and ease-of-use benefits.
Among secondary containers, paperboard cartons and boxes will have the largest usage. Convertible-display shipping cartons, for instance, will show strong growth.
The outlook for packaging machinery is very strong, according to a purchasing plans study by the Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA). U.S. healthcare companies expect to increase spending for packaging machinery by 14 to 16% in the coming year, by far the highest percentage of the nine sectors surveyed and well above the 2–3% increase projected for all sectors combined. The highest demand is for labeling equipment; 68% of survey respondents in the healthcare sector say they plan to purchase labeling machinery in the coming year. Also, in strong demand are coding/printing and conveying/feeding equipment, all at 61%; and inspection/detection and cartoning equipment, both at 57% (see Table III).
The study attributes the growth to expanded production output to accommodate the growing healthcare product needs of the aging population. These new products, from drugs to nutritional supplements, require new packaging machinery. Also, with a sizable number of prescription drugs coming off patent, generic drug introductions are expected to grow, and that too creates packaging machinery demands. Increased work for contract packagers can bring demands for new machinery as well; 18.3% of the survey's respondents say they plan to use contract packagers more often in the coming year.
Whether these projections will hold will depend a lot on how pharmaceutical companies and their suppliers adapt to some significant recent developments.
One area undergoing a great transformation is postapproval changes. Before fall 1999, if you wanted to change virtually anything about the package of an existing drug, you had to get prior approval from FDA and often had to perform new and costly stability studies. An FDA guidance published last November, "Changes to an Approved NDA or ANDA," gave drug companies more leeway to make postapproval packaging changes that have moderate or minimal adverse potential. (For more details, see the Regulatory Focus column in the February 2000 issue of PMP News.)
Now that FDA has decreed when such changes can be made, what remains is how they should be made. Questions about what kinds of tests must be performed and how they should be analyzed will be addressed in PACPAC, the packaging version of FDA's SUPAC (Scale-Up and Postapproval Changes) guidance. Industry and FDA representatives met this spring to work on the document, which will likely not be ready for at least another year.
If successful, these developments will generate activity on several fronts. One, standards-setting bodies will have to devise procedures for how these tests should be performed. Two, suppliers could compete for business on the packaging of existing drugs as vigorously as they do for that of new drugs.
CHANGES IN LABELING
Another factor spurring new development is FDA's over-the-counter (OTC) labeling regulations scheduled to take effect for most packages in the spring of 2002. The new rules require larger type size and other measures designed to improve readability, and they call for the labeling to be structured in a very specific way. This means most every OTC drug is getting a label redesign, and some will be needing package redesigns.
Making the task even more difficult is that OTC drug packages had been increasing their reliance on appealing graphics in order to attain shelf presence. Now package designers will have to find solutions that appease both the regulators and the marketers.
OTC drug packagers still have a few things to learn about attracting consumers' attention, according to a report from Greenfield Knowledge on Demand (Westport, CT). Titled "Best Practices in Consumer Product Packaging: Differentiating Your Brand in the Mind of the Consumer," the report says that some products fail because their color and package design are created without considering whether they're in line with their categories. For example, Greenfield says, many headache remedies are packaged with bright colors—noticeable, but inconsistent with consumers' emotional response to the products.
Drugs and herbal remedies have a problem not shared by some other OTC products: consumers are especially concerned about safety and effectiveness when they are taking an OTC drug or supplement that is new to them. The Greenfield report says that "consumers will value a brand that can effectively reassure them prior to using the product." Drug and supplement companies can use packaging to build brand recognition and establish a reassuring reputation of expertise.
CREATING SAFE PACKAGES
Developing child-resistant, senior-friendly packages and closures has been a hot topic for several years and will continue to be. The Consumer Product Safety Commission has made it clear that it expects packages for all prescription drugs and some OTC drugs to be difficult to open for children and easy to open for seniors. The requirement is extending into specialized areas such as clinical trial packaging and physician samples.
John Bitner, manager of packaging design and development for drug maker Searle (Skokie, IL), a division of Pharmacia Corp., says that finding a child-resistant, senior-friendly design is one of the biggest challenges drug packagers face. "With more than 44 million Americans having hand debilitation, it becomes impossible for them to apply the necessary torque to twist and open bottles," he says, noting that this fact led his company and its packaging suppliers to develop a "friendly and safe" closure that is "the first in the industry to remove torque as a factor altogether."
A number of blister designs that eschew reliance on force have also been introduced recently.
Packaging is also expected to play a role in the drive to reduce medication errors. A report by the Institute of Medicine on the issue indicated that improved packaging can help, and that unit-dose packaging is particularly suited for the task.
Bar coding, especially when tied to a computer network in hospital pharmacies, is also being looked to as a solution. One hospital reported a 70% decrease in errors when its pharmacy switched to bar-coded unit-dose packages.
That is not the only electronic packaging innovation on the horizon. Pharmaceutical Research and Manufacturers of America (Washington, DC) hopes to convince FDA to allow electronic, paperless package inserts for pharmacists.
"If we get some new information about a drug, this would enable us to update it overnight and allow pharmacies to have the information instantaneously," says D. Bruce Cohen, director of packaging technology for Glaxo Wellcome Inc. (Research Triangle Park, NC), who has been one of the idea's chief proponents. "If a safety issue comes up and we get the wording approved by FDA, we could make the up-to-the-minute information available to everyone. It could be an Internet-based system or maybe a chip on the bottle itself." (For more details, see the Editorial column in the July 2000 issue of PMP News.)
Such a system could incorporate the physician and pharmacist labeling, and even some of the patient labeling, Cohen says, adding "to what extent would be the individual company's decision. I'm hopeful that in 2001 we will have enough data generated to present to FDA."
It's a brave new world in pharmaceutical packaging, where innovations and regulations move at a breakneck pace. Those ahead of the curve are poised for great success.