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Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.
Despite being one of the oldest methods of delivering medication, solid-dosage forms continue to experience innovation and gain volume. Solid-dosage forms rank as the largest and fastest growing segment of the healthcare packaging and labeling market, according to “Packaging and Labeling (Healthcare) Services Market–Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015–2023,” a report from Transparency Market Research, which forecasts a compound annual growth rate of 5.3% through 2023 for the healthcare packaging and labeling market overall (1). Current solid-dose packaging trends focus on enhanced product quality, equipment productivity, sustainability, and ease of use.
Quality concerns encompass shelf-life extension, assurance that the product is free from contaminants, and package integrity. For humidity-sensitive products, shelf life frequently depends on desiccants in cartridge or pouch form or integrated into the packaging material itself.
To automate insertion of desiccants, BellatRx has developed the Rx-Desiccant PLUS machine. Capable of dropping up to 140 desiccants per minute, it handles desiccant cartridges or pouches with a vibratory tray and funnel combination similar in concept to counters that dispense solid doses into bottles. Changeover between the pouch and cartridge formats requires a simple tool swap and can be completed in just a few minutes. One configuration, capable of inserting one or more pouches or cartridges into a glass bottle, indexes the container via a starwheel. Other features include a large capacity hopper, detectors for inverted or dropped bottles, and bottle reject (2).
To simplify use of its shelf-life-protecting desiccants, healthcare packagers now receive a certificate of analysis from Multisorb Technologies announcing, “USP <670> Compliant.” The statement reflects Multisorb’s successful completion of third-party testing and qualification of its silica gel and molecular sieve suppliers to ensure desiccant materials comply with testing requirements outlined in the United States Pharmacopeia (USP) <670> Auxiliary Packaging Components, which became effective May 1, 2016. “At Multisorb, our goal is to make compliance with this new standard as easy as possible,” said Adrian Possumato, vice-president of Multisorb’s Healthcare Packaging Group (3).
Another way to protect shelf life is via barrier packaging materials such as high-barrier Aclar laminates. The Pharmaceutical Packaging Innovation Business Unit of Bilcare Research recently installed a laminator at its facility in Wilmington, DE, to provide a US source for Aclar laminates for stability packaging, line trial samples, and commercial runs (4).
In addition, Bilcare has changed the layout of its Wilmington plant to segregate pharma-related converting operations and storage areas. “Packaging pharmaceutical products in an ideal fashion calls for a dedicated, siloed production environment throughout the supply chain, and we aim to set the bar high toward that goal,” stated Kevin Stevens, president and managing director of Bilcare Research, in a press release (5). Additional support for product quality includes installation of a thermoforming line (6) and its BilcareOptima service. The BilcareOptima service analyzes drug stability under various external influences, such as humidity, temperature, and light exposure, to optimize blister film barrier properties and define the best packaging solution (7).
To capture broken tablets before entry into the feeder, the eLIM tablet sorter from Prodieco relies on a vibratory system, two levels of product-specific sieve plates, and a flow-controlling gate mechanism. Level-one sieving removes small clumps of tablets or twins, while level two removes capped and broken tablets. As a result, tablet fragments, particles, and clumps can’t block the feeder and cause stoppages. Tests with various counter models show the eLIM tablet sorter can boost original equipment effectiveness up to 20% (8).
Package integrity can be checked in seconds on the VeriPac UBV universal blister tester from PTI-Packaging Technologies and Inspection. “With extremely oxygen-sensitive products, you need to be able to detect the smallest leaks,” explains Michelle Wolf, marketing communications manager at PTI. To check a blister package, it’s placed in any orientation in the input cavity. When the 10-second test using vacuum decay and volumetric imaging is completed, a pass/fail message is displayed along with an image of the package. The unit requires no changeover for different blister card formats and is compact enough to fit on the packaging line.
Ease of use
The importance of ease of use spans the supply chain. Easy-to-run machines are essential to productivity, and consumers appreciate any product or package feature that make it easier to take doses correctly.
Many patients, especially the youngest and oldest, find it hard to swallow pills, tablets, and capsules. In fact, “Over half of the patients have difficulty swallowing,” says Thomas Hillenbrand, CEO at DS Technology. The XStraw, developed by DS Technology and shown in the Harro Höfliger booth at INTERPHEX (see Figure 1), solves that problem. Instead of conventional pills, tablets, caplets, or capsules, which can be quite large, the XStraw relies on specially formulated, taste-masked pellets or granules in a straw-like primary package.
A custom machine from Harro Höfliger inserts pre-cut tubing into a transport system, inserts a filter at one end, crimps both ends, fills pellets or granules (even multiple fills are feasible), applies a cap with safety lock, and packages the straw in a secondary pouch at a rate of up to 300 straws per minute. An integrated cartoner loads pouches into cartons. Instructions call for cap removal prior to use. However, a vented design prevents choking should the cap be swallowed accidentally. The filter acts as a barrier and prevents contact between the medicine and liquid before use (so there’s no premature dissolution of the dose if the straw sits in the liquid for awhile before it’s sipped). As the patient sips, the filter moves up and stops at the top of the straw, ensuring all the medicine goes into the mouth and indicating the entire dose is taken. Because it uses water or another beverage as a vehicle, the design helps the elderly drink more fluids. The straw also introduces an element of fun, thereby encouraging kids to take their medicine. Hillenbrand reports, “The XStraw is patent-protected in the United States and beyond, offers a secure, new means of medicine delivery to patients, and increases compliance with dosage instructions. Applications are pending worldwide.”
Another option to overcome swallowing difficulties, microtablets and powders can be packaged on a stick-pack machine from Merz Verpackungsmaschinen. The one-lane, stick-pack machine with microtablet dosing unit offers numerous options including a segmented fill for a dual-chamber package, according to Jürgen Stein, sales manager at Merz.
Opening ease is the goal behind Safety-Pak Plus polyester/foil lidding for child-resistant blisters. Winpak Heat Seal supplies the paperless lidstock in two peelable versions, Safety-Pak Plus PL (full-panel peel) and Safety-Pak Plus PP (full-panel peel/push), plus a lock-tight version, Safety-Pak Plus LT, which requires a tool such as scissors for access or the addition of a tear notch. A broader sealing window means lower sealing temperatures and shorter dwell times (9).
Once a solid-dose container has been opened, and the leaflet removed and read, it’s difficult to refold it so that it can be returned to the container. As a result, the leaflet often becomes separated from the medication and misplaced. The Duma Combi container from Gerresheimer, shown in Figure 2, solves this problem with a separate compartment for the leaflet. “Duma Combi was designed to provide our customers with additional space on the outside surface for design elements and to offer the user additional convenience,” said Niels Düring, Gerresheimer’s global executive vice-president, Plastic Packaging, in a press release (10).
Equipment innovations include downtime-minimizing designs. For example, forming and sealing tools on the semiautomatic BlisterMate tabletop machine from PharmaWorks are easy to change, and the machine stores multiple recipes in memory. The unit, shown at INTERPHEX 2016 producing four blisters at a time, features dual shuttle mechanisms to expedite blister packaging of clinical trials, stability studies, and other low-volume batches. In action, the blister tray slides into the machine to form the blisters and out for loading. Meanwhile, the forming tool returns to home position on one side of the machine, and the sealing tool shuttles into place from the other side. Lidstock is set down, and the blister tray slides back into the machine for sealing at 170 oC.
For higher volume needs, the integrated, three-lane Blister Express Center 700 from Uhlmann Packaging Systems produces up to 700 blisters and 500 cartons/min. The blister line can operate with up to three lanes, and its cartoner module offers an output of 500 per minute for formats up to 80x90x155 mm or 300 per minute for cartons up to 105x105x155 mm. A modular design with three feeder options and continuous-motion rotary or intermittent-motion platen sealing permit a variety of configurations. A small number of format parts, 30-minute tool-free changeover, and a compact, easy-to-clean design minimize downtime (11).
Marchesini Group also offers a series of integrated blister packaging/cartoning systems. A new machine pitch controller and carton opening and loading system on the compact Integra 320 monobloc achieve speeds up to 320 blisters and more than 260 cartons a minute. A patented, three-axis Robocombi robotic head with suction-equipped gripper connects the blister and cartoning stations and simplifies size changeover. Modular design integrates change parts into systems that can be replaced with one single movement (12).
For less-sensitive pharmaceutical products, the Pharma Division of Constantia Flexibles has developed a downgauged lidstock with a renewable layer. Recognized by the European Aluminum Foil Association with an Alufoil Trophy for Resource Efficiency, the Constantia Blister Eco tissue paper/thin foil laminate weighs 23% less than standard lidding foil and cuts foil content roughly 50%. It also requires substantially less lacquer coating (13).
Another Alufoil Trophy winner for Resource Efficiency, the Formpack Ultra cold-form blister material from Amcor Flexibles, can be elongated more than standard cold-form materials due to improvements in raw material selection, manufacturing processes, and quality control. The ability to form deeper cavities and sharper wall angles means blister cards can be downsized or cavities can be added without expanding the size of the card. Commenting on the award in a press release, Andrea Della Torre, R&D director at Amcor Flexibles said, “Formpack Ultra supports a more responsible packaging use across the value chain and lowers the total cost of goods for pharmaceutical companies” (14).
Steve Meeker, president at Legacy Pharmaceutical Packaging, sees significant growth in solid-dosage forms, especially in the company’s bottling business. "We’re contract packaging a rapidly growing number of generic products. Pharmaceutical manufacturers are seeking value-added services such as serialization and demand planning. As a result, we help manage inventories for several of the products we package, and we are working with an expanding group of pharmaceutical manufacturers moving toward serialization,” says Meeker. “Serialization is becoming a differentiator. Its complexity serves as a barrier to entry, but we will be ready. We’ve had a serialization master plan in place for nearly two years and are on track with installation of hardware and software and a plan for data management.” In anticipation of industry need, Legacy will further increase its technical capacity by adding an additional Cremer/NJM high-speed bottling line. This line will arrive fully serialized.
The company has adopted lean concepts such as value stream mapping, six sigma, and waste elimination. Meeker says, “We take lean very seriously. It’s the bedrock, or platform, for everything else to grow on and allows us to provide even better service levels, value, and quality to customers.”
Legacy Pharmaceutical Packaging has made a commitment to standardizing its equipment. For example, it currently runs two Cremer electronic counters with a third to be installed and a fourth to be ordered. “Standardizing delivers synergies in maintenance and operator training, as well as vendor relationships,” explains Meeker.
Sustainability is also important to the company, which achieved source reduction by eliminating corrugated cases for shipments to a major retailer. In this case, Legacy ships double-stacked pallets of 12-count dispenser cartons of private-labeled compliance packages of product directly to the retailer’s distribution centers. The strength of the dispenser cartons, plus corner posts and stretch wrap tension maintain pallet integrity. “We’ve not only removed all corrugated from the value stream and significantly helped this retailer’s sustainability program, but also stripped out costs,” reports Meeker.
When referring to this article, please cite it as H. Forcinio, "Solid-Dosage Packaging Trends," Pharmaceutical Technology 40 (7) 2016.