OR WAIT null SECS
A review of some of the latest packaging and drug-delivery innovation presented at Pharmapack Europe.
This year marked the 14th edition of Pharmapack Europe. The event, which took place at Paris Expo Porte de Versailles on 11 and 12 Feb. 2015, is known for its focus on cutting edge innovation in pharmaceutical packaging and drug delivery solutions. “The industry is constantly innovating,” commented event director, Aurore Domange, and Pharmapack Europe serves as a platform for exhibitors to showcase their new products.
Aptar Stelmi unveiled a new range of coated stoppers, PremiumCoat (see Figure 1), designed for sensitive and high-value injectables, such as biotech drugs (1). Joel Cotten, business development director of Aptar Stelmi, pointed out that “biopharmaceuticals are very sensitive in nature and prone to interaction with the rubber of the stopper.” The challenge, therefore, is to maintain the integrity of the container closure while minimizing interaction between the formulation and the components of the elastomeric closure system. “To meet this demand, Aptar Stelmi developed the PremiumCoat range of elastomeric stoppers,” Cotten remarked. “The surface of the elastomer is coated with a barrier film (i.e., a thin fluoropolymer film) that effectively prevents extractables and leachables from contaminating the drug product.”
Catalent’s Advasept technology forms a glass-free container closure system, offering an alternative to glass vials for injectable drug products (2). According to Bill Hartzel, director strategic execution, Advanced Delivery Technologies, Catalent, the advanced aseptic processing of blow fill seal (BFS) mitigates the risk associated with aseptic manufacturing of injectables. “The process is fully automated, reducing the potential of foreign particulates and providing sterility assurance. The vial is constructed using medical grade polypropylene resin. Of course, with plastic, the risk of breakage is reduced. And because it is glass-free, you eliminate delamination issues.” Hartzel added. “It is a simple process in which the vials are formed, filled, stoppered, and sealed.” However, there are considerations that must be taken into account as BFS creates a container closure system, noted Hartzel. “Extractables and leachables will be different, and stability needs to be evaluated because plastic is not impervious.” Catalent has evaluated the stability profile of a monoclonal antibody formulation in its Advasept vial, and the results of six months storage were comparable to that in glass vials (2). Catalent’s Advasept technology could mean a shift away from traditional glass vial paradigm.
Celanese highlighted Hostaform MT SlideX POM, new tribologically modified polymers that enable the production of quiet, smooth-sliding medical devices. “During the past few decades, Celanese has analyzed the tribological behaviour of various thermoplastics and have found that engineering polymers are ideal candidates for use in medical applications,” said Andrew Brown, director, Celanese Global Medical Business. “Manufacturers use engineering polymers as an alternative to metal and ceramics in medical devices that require complex designs such as injection pens and inhalers. These plastics are different from metal because they are light weight, resistant to wear, have low coefficients of friction, and allow for dimensional accuracy through precision molding.” The advantages of inhalers and injection pens manufactured using Hostaform MT SlideX POM include a reduction in force required to activate the device and increased comfort during use because of the easy sliding properties.
Essentra showcased its portfolio of packaging solutions, which range from cartons, leaflets, and labels to printed primary packaging. ComboPack consists of a pre-assembled leaflet attached inside or outside the flat carton. “It removes the need for in-line insertion equipment, particularly for small to mid-size companies that do not have all the packaging equipment,” explained Tiffany Overstreet, director, category management, Essentra. The company’s Plurium leaflet, on the other hand, is a multipage folded booklet for the communication of high volume of information. “There is an increasing need to have multiple languages on product leaflets, and Plurium provides a realistic way to accommodate all the information required by regulators. You can have one language per page for example, which enables patients to easily find the information relevant to them” said Overstreet.
Gerresheimer introduced an application aid for eye drop bottles (3). The innovation, known as DropAid (see Figure 2), helps users to easily open their eye drop bottles. Its circular aperture fits onto the bottle top, enabling senior patients and children to open the bottle with little effort or pressure. When placed on the neck of an eye drop bottle, DropAid positions the dropper above the eye so that users can apply their eye drops without difficulty.
Gerresheimer’s Gx MultiShell vials combine an inner and outer layer of cyclic olefin polymer (COP) with a centre polyamide layer (4). This three-layer structure increases resistance to breakage. According to the company, COP minimizes the interaction between highly sensitive biopharmaceuticals and the packaging, which means considerably less adsorption. The special design of the outer layer provides barrier properties that are up to 40 times more effective than other polymers (4). The high level of oxygen impermeability of these vials make them suitable for packaging of reaction-sensitive parenterals.
Honeywell presented its Aclar films, designed to provide moisture barrier protection for hydroscopic formulations. The increasingly complex and sensitive nature of pharmaceutical products today create physical and chemical stability issues and the only blister packaging material available in the past was the cold formed foil. Aclar is a clear poly-chloro-tri-fluoro-ethylene film that is biochemically inert, chemical resistant, as well as plasticizer- and stabilizer-free. Honeywell’s latest innovation, the Aclar UltRx 6000 film, offers a theoretical 50% increase in moisture barrier protection according to the company (5).
MegaPlast’s airless dispenser for liquids, creams, and gels, features a child-resistant closure in addition to its ability to dispense the precise dose and maintain formulation integrity by protecting against oxidation (6). This innovation was developed to meet market demand for security measures in packaging solutions. MegaPlast’s airless dispenser consists of a protective band coupled with a press-and-rotate opening system. Opening does not require force, which is especially useful for seniors. This non-pressurized dispensing system combines a mechanically activated pump and container that, after filling and air-tight sealing, delivers the product with no air intake.
Schott has extended its delamination-controlled (DC) product range with the addition of 6-mL and 8-mL vial sizes (7). Schott Vials DC have been developed to minimize the risk of delamination, which is the detachment of glass flakes from the inner glass surface of a pharmaceutical vial as a result of interaction with its contents. The vials are produced using chemically highly resistant glass tubing (Fiolax) coupled with optimized manufacturing processes that ensure the glass surface is more homogenous and thus less susceptible to delamination (see Figure 3). “Production of the vials is routinely monitored for quality using our patented delamination quicktest,” explained Florence Buscke, global product manager, vials and coatings. “We check the sodium content because it correlates with delamination propensity. The aim is to ensure that Schott Vials DC do not exceed the set sodium limit.”
West Pharmaceutical Services launched a new sterile, ready-to-use drug vial seal, the Flip-Off Plus seal, designed to help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products (8). “Regulators are constantly pushing for higher standards,” noted Mike Schäfers, vice-president, Global Marketing, Pharmaceutical Packaging Systems, West. “Manufacturers of injectable drug products are required to use clean components for their filling operations.” Seals ensure that the injectable drug product remains sterile in its vial and is free from contamination. According to West, the company’s Flip-Off Plus seals consistently achieve reproducible and safe container integrity for drug products while keeping bioburden and particulates at low levels. “The seals are manufactured under clean environment using prewashed and sterilized components” continued Schäfers. “The production process ensures a clean, certified, and sterilized product that supports clean crimping.”
Article DetailsPharmaceutical Technology Europe
Vol. 27, No. 4
Citation: When referring to this article, please cite it as A. Siew, “Highlights at Pharmapack Europe 2015,” Pharmaceutical Technology Europe27 (4) 2015.