The barrier solutions presently available on the market all have their drawbacks, e.g. cost, water-sensitivity, opacity or perceived environmental bad-will. At the same time there is a trend to use more plastic-based packaging materials for different applications, e.g. as replacements for metal and glass containers. This situation has stimulated the industry to provide new, more efficient barrier solutions. The innovations go along five major lines: (a) thin, transparent vacuumdeposited coatings; (b) new barrier polymers as discrete layers; (c) blends of barrier polymers and standard polymers; (d) organic barrier coatings; and (e) nanocomposite materials. This paper provides a comprehensive review of the different approaches, outlining the principle behind each barrier technology, its performance, its potential and the companies developing and producing the materials.

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This article presents a late-stage formative usability study of an autoinjector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. Previous usability work on autoinjectors reported in the literature has been specific to single indications. This study was instead conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to evaluate whether users could use the devices safely and effectively, and could understand the instructions for use (IFU) as well as the accompanying training. Further objectives were to capture any usability issues and to obtain participants’ subjective ratings on the IFU and training as well as the confidence and comfort in using the device. A total of 43 participants in 5 groups received training and performed simulated injections either into an injection pad or a mannequin. All participants were able to successfully use the device. The device was well appreciated by all users, with a reported degree of confidence in using the device of 98%, of user comfort of 93%, and of comprehensibility of IFU and training of 98%. These values are higher than other comparable results reported in the literature. The presence of both audible and visible feedback during injection was seen to be a significant factor contributing to injection success. The observation that the device can be safely and efficiently used by all tested user groups provides confidence that the device and IFU in their current form will pass future summative testing in specific applications.

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This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.