Compounding challenges in hormone therapy: A closer look at women’s and men’s health in Australia

Hormone compounding plays a vital role in delivering personalised treatment options for Australians experiencing hormonal imbalances. For both women and men, bioidentical hormone replacement therapy (BHRT) can offer relief from a range of symptoms for menopause, perimenopause, andropause, and testosterone deficiency. However, preparing customised hormone medications presents a series of technical, regulatory, and quality-related challenges that compounders across Australia must navigate daily.

The unique demands of hormone compounding

Hormone therapy compounds are typically delivered in topical creams, capsules, troches, gels, or suppositories. These formulations often involve low-dose, potent active ingredients such as: 

• Oestradiol, oestriol, and progesterone for women’s health

• Testosterone and DHEA for men’s health 

Given the potency of these substances, even minor inconsistencies in formulation can lead to suboptimal dosing, reduced efficacy, or increased risk of adverse effects. 

Common compounding challenges in hormonal preparations

1. Achieving Smooth, Homogeneous Creams

Creating hormone creams like bi-est or progesterone in a cream base can be particularly difficult. Many active ingredients have poor solubility or are prone to clumping, leading to gritty or uneven textures. For female patients using transdermal hormone creams, a non-uniform product may result in unreliable absorption and fluctuating symptom control.

Traditional approach:
Pharmacists often rely on mortars and pestles, unguators, or ointment mills to break down particles and distribute them evenly. This is an intensive and time-consuming process.

2. Preventing air incorporation and inconsistent dosing

High-shear mixing methods and manual compounding can inadvertently trap air within formulations. Air bubbles are not just a cosmetic issue. They can compromise dose accuracy and impact patient outcomes.

Clinical relevance:
Inconsistent dosing is particularly problematic in hormone therapy, where precision is critical for symptom management in both women and men. 

3. Handling Static-Prone and Micronised Powders

Hormone powders like micronised progesterone or testosterone base are often fine and prone to static, making accurate blending for capsules difficult. This can result in uneven API distribution and dosing variability across batches.

Typical workaround:
Manual techniques such as geometric dilution and sieving help but they increase compounding time and may not fully solve the problem (especially when working with small doses).

4. Supporting regulatory compliance and safety

In Australia, compounding pharmacies must adhere to USP 800-equivalent standards where applicable, especially when handling hazardous drugs like oestrogens and progesterone. Manual compounding methods often expose pharmacists to airborne particles or residues.

Work health and safety consideration:
Minimising direct exposure and product handling is key for staff safety and regulatory compliance in line with local guidelines.

5. Offering a range of personalised dosage forms

Australian patients are increasingly seeking more personalised care, including alternative delivery methods such as lozenges, troches, vaginal suppositories, and nasal sprays. Each of these requires different compounding techniques, increasing workload and risk of variability.

Pharmacy workflow impact:
Switching between tools and equipment for each dosage form leads to increased preparation time, material waste, and operational inefficiencies.

A smarter approach to hormone compounding

To meet the growing demand for accurate, personalised hormone therapy, pharmacies are looking for ways to improve efficiency while maintaining the highest quality standards. 

One such innovation is the MAZ® mixer, a closed-system mixing and milling device that addresses many of the common challenges in hormone compounding. By combining multiple steps such as mixing, melting, milling, and deaerating into a single process, the MAZ can produce smooth, uniform hormone creams, troches, or capsules in a fraction of the time. 

The system also helps reduce product loss, minimise staff exposure to hazardous APIs, and streamline production of a wide range of hormone delivery formats. For Australian compounders facing increasing demand and regulatory scrutiny, this type of technology offers a practical, scalable solution. 

Interested in seeing how advanced mixing solutions can enhance your hormone compounding process? 

 Explore how the MAZ® mixer is helping Australian pharmacies create consistent, compliant, and customised hormone therapies across women’s and men’s health. 

👉 Book a consultation to learn more about the MAZ ecosystem, formula library, and dosing adapters designed to support efficient, modern pharmacy practice.