The market for parenteral drug-device combination products has been evolving over the last 15–20 years, developing innovation both on formulation and device design fronts. The key priority in formulation development is to create a cost-effective drug with proven efficacy and safety that can be scaled up for manufacturing. Factors such as the ability to reduce administration frequency and provide less painful and quicker injections are also important considerations. Julie Cotterell at Owen Mumford Pharmaceutical Services discusses the new trends we are seeing in formulation science.
Extract:
‘Current Trends in Formulation Development and Implications for Drug Delivery Devices’
Design-Make-Test-Analyse cycle and productivity
The market for parenteral drug device combination products has been evolving over the last 15-20 years, developing innovation both on formulation and device design fronts. This change is driven by a series of factors including: the growth of biologics and biosimilars, predicted to increase at a compound annual growth rate (CAGR) of 23% from 2019 to 2027; evolving healthcare systems in need of affordable therapeutic options; the rise in self-administration and an increasing focus on patient and user experience.
The key priority in formulation development is to create a cost-effective drug with proven efficacy and safety that can be scaled up for manufacturing. However, more recently the focus has shifted towards patient experience and ease of use. This change is in part driven by the increase in self-treatment outside the acute care setting to treat a variety of chronic conditions via an increasing number of subcutaneous formulations. Here ease of administration becomes critical.
Factors such as the ability to reduce administration frequency and provide less painful and quicker injections are also important considerations. Drug delivery devices need to be intuitive to use and should require as few steps as possible for administration; auto-injectors for subcutaneous injection that are automatic, and pressure activated rather than requiring buttons, can help severely ill patients manage their own medication at home without assistance.
Speed to market is also an important commercial consideration in drug development which may affect choices around both administration route and delivery device, while managing risk is a critical challenge throughout development: working with novel excipients and custom devices, for example, adds complexity and additional stability and safety studies may be needed. This increase in requirements may delay time to market but is critical to provide assurance that the best drug candidate is taken forward and most appropriate delivery device is selected.
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