3D printed implantable drug delivery devices for women’s health: Formulation challenges and regulatory perspective

Modern pharmaceutical interventions are shifting from traditional “one-size-fits-all” approaches toward tailored therapies. Following the regulatory approval of Spritam®, the first marketed drug manufactured using three-dimensional printing (3DP) technologies, there is a precedence set for the use of 3DP in the manufacture of pharmaceutical products. The involvement of 3DP technologies in pharmaceutical research has demonstrated its capabilities in enabling the customisation of characteristics such as drug dosing, release characteristics and product designs on an individualised basis. Nonetheless, research into 3DP implantable drug delivery devices lags behind that for oral devices, cell-based therapies and tissue engineering applications.

Highlights

• Despite growing interest in formulating drug delivery devices using 3D printing, there is a clear gap in the research of drug delivery devices for women’s health applications.
• Key formulation challenges include the selection of materials that are suitable for the chosen printing technology as well as being medically safe and achieve the desired drug release profile.
• Standardised guidelines for the characterisation of drug delivery devices are needed to enable development of better systems and allow comparison between different printing technologies and formulation approaches.
• Regulatory challenges must be overcome to fully explore the potential of 3DP in the pharmaceutical manufacturing of customised and innovative implantable dosage forms. The UK has become the first to introduce a framework for manufacturing innovative medicines at the point of care.

The recent efforts and initiatives to address the disparity in women’s health is overdue but should provide a drive for more research into this area, especially using new and emerging technologies as 3DP. Therefore, the focus of this review has been placed on the unique opportunity of formulating personalised implantable drug delivery systems using 3DP for women’s health applications, particularly passive implants. An evaluation of the current landscape and key formulation challenges for achieving this is provided supplemented with critical insight into the current global regulatory status and its outlook.

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Karen Al-Litani, Tariq Ali, Pamela Robles Martinez, Asma Buanz, 3D printed implantable drug delivery devices for women’s health: Formulation challenges and regulatory perspective, Advanced Drug Delivery Reviews, 2023, 114859, ISSN 0169-409X,
https://doi.org/10.1016/j.addr.2023.114859.