Creating user-friendly fertility supplements for both sexes

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The industrialised world is gripped by an "infertility crisis" and there’s great opportunity for supplements to help but the market needs more consumer friendly dosage forms, according to Hermes Pharma.

Modern world impactors such as stress, delayed parenthood, unbalanced nutrition, environmental pollutants, unhealthy lifestyles and diet, and oxidative stress are all contributing to reducing chances of conception in both men and women, with sperm quality declining substantially in the last 40 years.

Given this trend, it’s no surprise that the fertility supplement market is growing rapidly. A recent report suggests the sector will expand by around $820 million between 2022 and 2026, fuelled by a 8% compound annual growth rate.

However, according to Dr. Bernice Wild, head of stability testing and senior QA manager GCP at to the developer and manufacturer of pharmaceuticals and supplements Hermes Pharma, many current fertility supplements fail to meet consumer needs.

“For one, common oral fertility supplements are fraught with uniformity issues," she asserts. "This is because some fertility-supporting nutrients are dosed in very small amounts, making product manufacture challenging. The result is that consumers get non-uniform products that deliver micronutrients in varying amounts from dose to dose.

“Moreover, most fertility supplement providers aren’t keeping up with consumers’ evolving preferences for purer, more natural products — namely, those with fewer excipients, and active ingredients derived from plants or other natural sources.

"For instance, fertility supplements often use vegetarian vitamin D3, but there is a rapidly growing (and unmet) demand for vegan alternatives - which are derived from lichens and are typically more expensive.”

User-friendly fertility supplements

However Dr Wild argues the biggest failure of today’s fertility supplements, is their reliance on conventional dosage forms, such as tablets and capsules, with around 50% of people saying they have difficulties swallowing these dosage forms, or simply don't like them.

“Where tablets and capsules aren’t the dosage form choice, manufacturers commonly turn to loose powders and granules in multi-dose containers. But here, consumers must measure out doses individually,” she says.

“Overall, the lack of convenient fertility formulations makes the regular, long-term dosing required for fertility supplementation success a pain. At worst, consumers may skip doses or give up on supplementation altogether.”

Dr Martin Koeberle, head of analytical development & stability testing at Hermes Pharma, argues the best replacement for tablets and capsules are easy-to-swallow orally disintegrating granules (ODGs) — fine granules or powders packaged into single-dose sachets (“stick packs”).

“Consumers can take them on the go, without water, making ODGs a smart choice for busy modern schedules,” he asserts.

There are several hurdles involved in the manufacturing of products such as this, namely ensuring content uniformity of several ultra-low dose micronutrients.

Dr Koeberle explains that to avoid de-mixing and segregation of raw materials during manufacture, ingredients need uniform particle size distribution. He adds that manufacturers must also ensure uniform particle size across ingredients to ensure they are appropriately dispersed.

What's more, analytical controls are needed throughout the manufacturing process to ensure consistency and rapidly detect deviation.

Fertility-supporting ingredients for males and females

The experts give their view on the key fertility supporting supplements for men and women as detailed in the tables below.

*EFSA health claims