John Burt, CEO of Medherant focuses on hormone therapy, specifically the challenges and opportunities in delivering testosterone for women’s health.
Medherant
The pharmaceutical industry invests heavily in discovering and developing active pharmaceutical ingredients (APIs), yet clinical and commercial success rarely depends on the molecule alone. How a drug is formulated and delivered often determines whether it achieves consistent efficacy, tolerability and real-world use, bridging the gap between pharmacological potential and actual patient benefit. Conversely, ineffective delivery can limit even the most promising API.
For manufacturers, formulation is therefore not a secondary technical step but a strategic capability. By combining material science, process expertise and an understanding of patient and clinical needs, advanced delivery approaches can translate innovation into meaningful therapeutic and commercial impact.
Optimising delivery technologies is particularly critical in therapies with narrow therapeutic windows, where small inconsistencies in dosing can have disproportionate clinical consequences.
Testosterone in menopause: a delivery-driven unmet need
Testosterone is often perceived solely as a male hormone, but it plays a vital role in women’s health as well. Levels of testosterone decline in women gradually with age and through menopause, with average levels dropping by around 50% between early adulthood (age 20) and age 60. This decline can be more abrupt following surgical menopause, such as oophorectomy, or iatrogenic menopause induced by medical or surgical treatment.
Testosterone is a key androgen hormone that contributes to the development and maintenance of female sexual anatomy, sexual psychology and modulation of sexual behaviour. Beyond sexuality, testosterone influences energy levels, mood, cognitive function and overall physical well-being, making it a critical yet often overlooked component of women’s health.
The most clearly defined clinical impact of testosterone decline is on sexual function, particularly Hypoactive Sexual Desire Disorder (HSDD). HSDD is characterised by a sustained loss of sexual desire that causes personal distress. It is estimated to affect more than 1 in 3 menopausal women and can significantly affect relationships, emotional wellbeing and overall quality of life. While HSDD is multifactorial - encompassing biological, psychological and sociocultural factors – biology remains a key, treatable component.
In the UK, the National Institute for Health and Care Excellence (NICE) recommends testosterone for postmenopausal women with HSDD when oestrogen-based HRT alone is insufficient. Despite this guidance, most available testosterone gels and creams are formulated to deliver higher doses suitable for men. This results in challenges around dosing accuracy, application issues and reduced adherence in women. Furthermore, no testosterone patch specifically designed for women currently exists on the market. This gap represents both a clinical need and a significant formulation and delivery oversight.
Why patches outperform creams and gels for certain therapies
Transdermal patches offer clear advantages over creams and gels, especially in hormone therapies. Compared to creams and gels, patches can provide more consistent and controlled dosing, as well as reduced mess. They often require application only once or twice a week, improving convenience and fitting better into patients’ daily lives.
Another key advantage is the reduced risk of accidental transfer of active pharmaceutical ingredients (APIs) to others. API transfer can occur when residues from creams or gels on a patient’s skin or hands are inadvertently passed on by touch, with children being particularly vulnerable to this risk. For therapies such as hormone treatments where dose control is critical, this is a significant safety consideration.
In transdermal systems, the adhesive itself can serve as a drug-containing matrix, meaning it both sticks to the skin and holds the drug, controlling release. Formulating the adhesive is a highly specialised challenge in material science, and flux can be optimised with approved permeation enhancers. This general principle, where the adhesive performs double duty as both a sticky surface and drug reservoir, makes the adhesive formulation a performance-critical component of transdermal delivery.
Next-generation transdermal delivery
Modern testosterone patches build on this with drug-in-adhesive matrix designs, where the drug is incorporated directly and uniformly within the adhesive rather than in a separate reservoir. This enables tighter control over flux, wear time and dosing consistency, which is crucial in hormone therapies requiring precise delivery.
For example, Medherant’s testosterone TEPI Patch for women utilises a proprietary pressure-sensitive adhesive that incorporates the drug directly within the adhesive matrix. This design enables controlled and reproducible transdermal delivery. The underlying adhesive chemistry is designed to remain stable on skin, avoiding cold flow (the unwanted spreading or running of the adhesive) due to its cross-linked polymer matrix structure.
The high payload capability supports smaller and more discrete patches while maintaining uniform drug distribution throughout the adhesive. Unlike many other patches, it doesn’t leave persistent dark rings or marks on the skin, which can be a common inconvenience for patients. The patch supports clean removal and maintains consistent skin contact throughout the wear period, enhancing patient comfort and adherence.
From a manufacturing perspective, next-generation patch systems such as this enable greater flexibility in drug and excipient loading, as well as solvent-free, scalable production processes. The lack of domestic patch manufacturing capability in key markets like the UK highlights an opportunity for European manufacturers with expertise in advanced formulation and delivery technologies to meet growing demand.
Delivery as a strategic capability
Drug delivery is frequently the decisive factor in translating clinical potential into real-world benefit. In women’s hormone therapy, and many other therapeutic areas, transdermal systems demonstrate how adhesive chemistry, dose control and wearability converge into a single, high-impact formulation platform.
For pharmaceutical manufacturers, delivery should be treated not as an afterthought but as a strategic capability that drives differentiation, optimises outcomes and creates long term value. Advances in drug formulation and delivery, such as next generation transdermal patches designed specifically for hormonal therapies like testosterone, offer improved dosing precision, patient convenience and adherence, which are critical to achieving effective treatment outcomes.