Springboard’s Tom Oakley recently presented the latest developments of bolus (large volume) injectors at 2 major international conferences: the Management Forum in London and SMi America in New Jersey. Here is an update on the other hottest topics in injectable drug delivery… At the Management Forum, Amgen’s Mathias Romacker explained the trend to:
- Higher concentration formulations; and
- Larger doses with less frequent injections.
Interestingly, both of these trends point to an increased need for bolus injectors. 3P Innovation’s Tom Bailey and XstalBio’s Barry Moore showed the increased need for reconstitution devices, driven by the increased number of biologics being developed for subcutaneous delivery, especially therapeutic proteins. SHL’s Mats Persson described trends such as:
- Moving treatment from the hospital to the home for increased patient convenience and lower treatment cost;
- Using the injection device for drug product life-cycle management;
- Larger volume and higher viscosity injections required by new drug formulations;
- Increased emphasis by regulators on human factors studies;
- Interest in polymer, as opposed to glass, syringes;
- Autoinjectors for cartridges as opposed to syringes;
- Instructions for use on and in devices; and
- True end-of-dose indicators.
At the SMi America conference, Merck’s Scott Brown described the most common pitfalls of drug delivery device development, and Beroe’s Chanderkanth Gautam explained the opportunities and threats to electronic autoinjectors. In summary, developments in devices to inject drugs are being driven by:
- New biologics which may require larger injection volumes, higher viscosities, or reconstitution;
- Regulatory demands for human factors studies; and
- The need for increased adherence, which may be addressed by electronic functionality in devices.
If you work at a pharmaceutical company or medical device manufacturer and want to know more, please contact Tom Oakley.