From enhancing contraceptive methods to improving the treatment of reproductive health issues, drug delivery innovations are paving the way for a more personalised and effective approach to women's healthcare.
Various innovations, including nanotechnology- and biomaterials-based drug delivery technologies are addressing the unique challenges and requirements associated with women's wellbeing.
However, there are many practical challenges in developing drug delivery devices for women’s health. Patients have unique body types, microbiomes, and drug responses and the ‘one size fits all’ approach is not always in alignment with the growing trend towards personalised medicine.
Women have microenvironments such as the vagina and placenta which require specific design considerations for optimum drug delivery. There will also be instances where it is preferable to deliver more than one therapy with the same device platform; balancing biocompatible materials is a fine balance with safety and efficacy considerations for manufacturers.
It is worth noting that only 3.7% of all clinical trials from 2007 to 2020 focused on female gynaecology. A disparity still exists between the preclinical funding and ‘disease burden’ for women-specific disorders and men-specific disorders. This is one reason why research and development into drug delivery technologies specifically for women’s health has been limited. More investment and preclinical research is required to implement drug delivery technologies before these innovations can be fully optimised for the treatment of health conditions that are relevant to women.
Here are some of the latest drug delivery innovations in this space that could have an impact in the years to come.
- Contraceptive devices and beyond
The advent of long-acting reversible contraceptives (LARCs) has provided women with extended reversible protection for over 30 years. Intrauterine devices (IUDs), such as those containing levonorgestrel, a progestin hormone, now offer sustained release over an extended period, ranging from three to ten years.
Hormonal IUDs often use a silicone additive to release a controlled amount of progestin over time and similar devices can also treat symptoms associated with endometriosis and dysmenorrhea. The prospects for using silicone in this way are promising as it can be used for multi-platform drug delivery – not only for hormones, but potentially to deliver pharmaceuticals to treat sexually transmitted infections and other health conditions as well. Elkem Silicones is one of the leaders in this field, partnering with medical device manufacturers to create such drug delivery devices. A number of companies have also produced a silicone intravaginal ring (IVR) which has the potential to target patient-specific indications.
- Targeted therapies for reproductive health
Traditional treatments for endometriosis, polycystic ovary syndrome (PCOS), and other gynaecological conditions often involve systemic administration of medications, leading to potential side effects and reduced efficacy. However, recent innovations aim to deliver therapies directly to the affected areas, optimising treatment outcomes while minimising adverse effects.
Nanoparticles, with their small size and unique properties, can be engineered to transport drugs directly to the site of action. For example, researchers are exploring the use of nanocarriers to deliver anti-inflammatory drugs for the treatment of endometriosis. By precisely targeting the inflamed tissues, these nanocarriers enhance drug concentration at the site of action, potentially improving therapeutic outcomes and minimising side effects associated with systemic drug administration.
In November 2023, GlobalData analysts identified the leading innovators in drug delivery nanoparticles, and these industry players will be among the ones to watch in the women’s health sphere.
- Personalised hormone therapy
Hormone therapy plays a crucial role in managing various women's health conditions, including menopausal symptoms, hormonal imbalances, and fertility issues. However, achieving optimal therapeutic outcomes often requires a personalised approach, considering individual variations in hormone levels and responsiveness.
For years now, transdermal patches and gels, and intra-vaginal pessaries, have offered controlled and continuous hormone release and are a viable alternative to traditional oral medications, reducing the likelihood of fluctuations and systemic side effects. However, allergies to the sticky patches and the messiness of gels have always been downsides.
The more recent introduction of transdermal sprays is set to transform the market as these dry within seconds. The only brands of HRT spray available in the UK is Lenzetto, manufactured by Gedeon Richter, and Evamist produced by Padagis in the US. The sprays deliver estradiol oestrogen only and not progesterone which must be taken separately.
- Overcoming maternal-foetal barriers
Pregnancy presents a unique challenge in drug delivery, as certain medications may pose risks to the developing foetus while still needing to address maternal health issues. Emerging innovations in drug delivery are focused on overcoming the maternal-foetal barriers to ensure the safety and efficacy of treatments during pregnancy.
Researchers are exploring the use of nanoparticles to encapsulate drugs, protecting them from degradation and facilitating controlled release. This allows for the targeted delivery of therapeutic agents to specific tissues while minimising exposure to the developing foetus.
In cases where immediate intervention is required, implantable devices with on-demand drug release capabilities are being developed. These devices can be remotely activated to release medication as needed, providing a tailored and timely approach to maternal healthcare without compromising foetal wellbeing.
- 3D printing
Formulating drug delivery devices using 3D printing is a growing area of innovation, but research of drug delivery devices for women’s health applications has been slow to develop. A 2023 review by Karen Al-Litani et al explored the industry landscape.
In it, the authors explain that “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 are required for the characterisation of drug delivery devices. This will enable the development of better systems and allow comparison between different printing technologies and formulation approaches.
“Regulatory challenges also need to be overcome,” the review advises, “to fully explore the potential of 3D printing in the pharmaceutical manufacturing of customised and innovative implantable dosage forms.”
