Focus of the month

Engineering systems to deliver drug compounds is arguably just as important as developing the compound itself to ensure convenience for the patient, correct dosing and ultimately better outcomes. Novo Nordisk collaborates with patients to design and develop delivery systems for treatments in diabetes, obesity, haemophilia, and growth hormone disorders. A central part of these efforts is to contribute to the scientific literature, describing new developments within existing and future potential device technologies and platforms.

We invite you to explore the science and below introduce a collection of recent publications covering a range of interesting device-related topics.

Gastric autoinjectors to orally deliver drug compounds

Many prefer oral drug delivery over injections and recently some successes have been reported, including for oral semaglutide (a glucagon-like peptide 1 analogue). Nevertheless, oral administration of large molecules such as antibodies and proteins/peptides usually leads to very low bioavailability. To address this pitfall, Abrahamson and co-workers developed and tested the translational potential of a liquid auto-injector for oral dosing of both large and small molecules. In this study in pigs, the device carried and delivered drugs of different molecular sizes (proteins and smaller molecules).

Oral mRNA delivery using milli-injector devices

Using nucleic acids to address a range of health care challenges reached a high point with the advent of mRNA-based vaccination for COVID-19. However, as Abramson and colleagues describe, more progress might be in store: Orally delivered mRNA for use as vaccines or other purposes. To achieve this potentially ground-breaking development, the authors used ingestible milli-injector capsules, delivering mRNA-containing formulations directly into gastric tissue.

Smart insulin pens to improve diabetes care in children

Smartly designed delivery devices might help address the challenges that remain in ensuring optimal glycaemic control in people with type 1 diabetes – especially in the paediatric population. To that end, Adolfsson and co-workers in a real-world observational study found that children with type 1 diabetes using continuous glucose monitoring devices achieved better glycaemic control and less risk of hypoglycaemia when a smart insulin pen was introduced into their treatment regimen.

In another study, Adolfsson and colleagues found that also adults with type 1 diabetes may benefit from using smart pens to manage their insulin injections. Introducing smart pens to a cohort of 94 people with type 1 diabetes from Sweden was associated with significantly improved time-in-range (measure of glycaemic control) as well as fewer missed injections. Thus, this study suggested that better adherence and insulin dose data owing to the use of smart delivery devices might lead to improved diabetes care.

Patient-reported evaluation of pen devices

When trying to ensure optimal adherence to insulin treatment, the level of satisfaction with the delivery device reported by the end-users (i.e., patients with diabetes) has proven paramount. Until recently, however, no validated outcomes measure to assess this satisfaction had been available. The Diabetes Pen Experience Measure (DPEM) was developed to remedy this gap, based on input from clinical experts and patients. Thus, in their study, Brod and co-workers collected evidence that supports the use of DPEM in clinical trials evaluating how patients experience injection devices used in diabetes care.

One of the main issues for people using injectable pharmacotherapies is pain or discomfort at the site of injection. As an example of how to optimise delivery solutions for drug compounds to the benefit of the patient, Snitker and colleagues investigated different formulations of semaglutide (a GLP-1 receptor agonist). By omitting phenol (a preservative and an analgesic) and by replacing propylene glycol with sodium chloride as the tonicity regulator, the authors found that a single-dose injector device was just as good in terms of injection site pain as the previous benchmark device (a multi-dose injector). Consequently, the single-dose pen injector and the optimised semaglutide formulation is currently used for s.c. once-weekly semaglutide 2.4 mg in weight management.

In line with Novo Nordisk’ reinforced focus on patients in almost all development activities, Sparre and colleagues in this commentary outline how the needs of people requiring insulin for their diabetes should be the central focus when engineering new insulin delivery devices, including pens. This might be easier said than done, considering that such engineering efforts are characterised by being multidisciplinary. In the commentary, however, the authors describe previous successes, and provide thoughts on a framework that may help develop desirable, viable and feasible delivery solutions.

^{The ‘News’ section and The ‘Focus of the Month’ features are curated by Novo Nordisk. Newsworthy content is featured if the content relates to the therapy areas pertinent to Novo Nordisk and if it is deemed appropriately objective and scientifically relevant. Original texts developed by Novo Nordisk for the purpose of introducing external content have been reviewed by Novo Nordisk for medical and legal accuracy.}

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