Self-administration trend driving demand for subcutaneous drug delivery devices, says BD expert

Dosing complexity means programmable devices need to address several requirements around wearability and flexibility, CPHI Discover delegates are told

This was just one of the messages in the recent CPHI Discover webinar on Wednesday, Patient-Centric Drug Delivery Solutions for Self-Administration, sponsored by BD Medical – Pharmaceutical Systems.

“We see a trend that biotherapeutics are more considered for home safe administration,” Christian Sandmann, R&D Associate Director, BD Medical – Pharmaceutical Systems, told the CPHI audience. “Traditionally they were more delivered in the intravenous pathway which has certain impacts on the healthcare system because it has to be done in a clinical setting. Whenever you have intravenous delivery of drugs, from a patient perspective it is just more painful and certainly more inconvenient.”

He added that subcutaneous administration of biotherapeutics is regarded as safe and efficacious and therefore a powerful and strong alternative to intravenous administration.

“What this means is there is a need for devices to allow self-administration outside the clinical setting and this is obviously supporting the trend towards homecare,” Sandmann said.

Amid an increasing number of biologics being considered for combination therapy, Sandmann said dosing complexity has become much more complicated and certain aspects need to be addressed to deliver solutions for these new deliveries.

He listed flexible or variable dose schedules, variable dosing, individualised dosing—whereby some patients have very different requirements in concentrations – and cases where physicians may be ordering dosing adjustments during therapy as among the requirements.

He added that BD is currently developing BD Evolve, a programmable solution to enable these various drug delivery use cases, adding that such devices have their own set of requirements.

He said wearability was a key requirement; namely a device with smartphone factor, up to three days of on-skin wear, “and it needs to have audio and visual feedback and obviously a wireless option because you might want to share data to confirm that people are adhering to the drug therapy.”

The second requirement Sandmann mentioned was flexibility through the device’s programmable features: “Our device can deliver drugs either through bolus and/or continuous infusion, or multiple boluses over time and you achieve this by having an electromechanical device where you have a mechanical pump which is controlled by an electrical motor which in turn is controlled by software (a processor).”

Sandmann said BD Evolve has “very capable” audio feedback, a fill volume indicator, illuminated buttons with a range of colours to activate the device or request dosing events, and is geared for subcutaneous delivery.

He said there is a manually triggered catheter insertion device which when activated, pierces the skin with a steel needle, inserts a catheter into the subcutaneous space and then retracts the needle back into the device.

Sandmann said that the very first use case for BD Evolve which will be commercialised is for the delivery of pegfilgrastim.

“This is a very particular case where the device is activated and applied to the patient’s skin the day before the actual bolus delivery,” he said.

This webinar will be available on demand from 31 May. In the meantime, for details on how to register for this ongoing virtual event, head to the CPHI Discover website