A recent study published in the journal
Scientific Reports assessed the presence of soy- and gluten-derived excipients in medicinal products authorized in Portugal.
Food allergies are a major public health concern, and their prevalence has risen in recent decades. Gluten is a protein found in barley, rye, and wheat, and it can cause adverse reactions in individuals with gluten sensitivity. Gluten ingestion causes three clinical disorders: celiac disease (CD), wheat allergy, and non-celiac gluten sensitivity, which have distinct symptoms and characteristics.
Some excipients are used in various pharmaceutical forms, including sodium starch glycolate, starch, and pregelatinized starch, while others are derived from sources such as rye, barley, oats, and wheat. Potato starch and corn starch are also used, as they are gluten-free, making them safe for individuals with gluten-related disorders. As a common excipient, starch is a major source of gluten. However, when “starch” is listed without a specified botanical origin, it complicates allergen identification, as it may derive from wheat or gluten-free sources.
Furthermore, soy is among the top food allergens, frequently causing allergic reactions in children. Soy contains several distinct proteins with varying risks for severe reactions. Besides, soy allergies can manifest as urticaria, oral allergy syndrome, asthma, angioedema, and anaphylaxis. Currently, soy or gluten allergies lack a definitive cure, and the best treatment is to avoid these allergens altogether in diet and medicinal products. However, analyses on the presence of gluten or soy in medicinal products are scarce.
Even trace amounts of allergens in excipients like soy lecithin or starches derived from wheat may be clinically relevant in highly sensitive individuals despite their low protein content.
