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A groundbreaking study conducted by the Monash Milk Team has revealed that human milk significantly enhances the absorption of certain medicines in infants. The research, published in the European Journal of Pharmaceutics and Biopharmaceutics, found that the oral bioavailability of clofazimine, a drug used to treat leprosy and tuberculosis, increased by more than 2.5 times when administered with human milk.
The study, which utilized a neonatal piglet model, also demonstrated that both human and bovine (cow) milk improved clofazimine absorption, suggesting that milk-based formulations could serve as effective drug delivery vehicles. The findings have particular significance in treating infants suffering from cryptosporidiosis, a parasitic disease that causes severe diarrhea and is a major cause of morbidity and mortality in young children in low- and middle-income countries.
Clofazimine’s limited solubility in gastrointestinal fluids has been a challenge in pediatric treatments. However, human milk offers a natural solution by providing an environment that enhances the dissolution of the drug, eliminating the need for potentially toxic pharmaceutical additives.
Professor Ben Boyd, head of the Monash Milk Team at the Monash Institute of Pharmaceutical Sciences (MIPS), highlighted the significance of these findings, stating, “Through our research over the years, we’ve consistently demonstrated how certain medicines can ‘piggyback’ with milk, which the body digests as food. This process enhances drug absorption and therapeutic effectiveness.”
The study’s lead author, Ellie Ponsonby-Thomas, a Ph.D. candidate at MIPS, emphasized the potential of human milk in providing a safer and more effective method for drug administration in infants. “Poorly soluble medicines such as clofazimine struggle to dissolve in the stomach. Developing age-appropriate, safe, and effective formulations is challenging, but our findings suggest that milk-based vehicles could be a promising solution.”
The Monash Milk Team has been pioneering research on milk’s role in drug delivery for years. In 2020, they won a Eureka Prize for their innovative work, including studies showing that infant formulas can improve the solubilization of antimalarial medicines. Their research has also demonstrated that cow’s milk enhances the bioavailability of cannabidiol (CBD) for pediatric epilepsy patients and increases the solubility of praziquantel, a drug used for bacterial infections.
Despite the promising results, researchers acknowledge challenges in implementing milk-based drug delivery in developing countries. Issues such as refrigeration requirements and milk quality variations pose significant barriers. Professor Boyd noted that developing low-cost, milk-based formulations that meet strict regulatory standards could provide alternative solutions for treating diseases in resource-limited settings.
The human milk used in this study was generously donated to the Australian Red Cross Lifeblood by Australian mothers, highlighting the invaluable role of human milk in advancing medical research.
Disclaimer: This article summarizes scientific findings and does not constitute medical advice. Individuals should consult healthcare professionals before making any changes to medical treatments or infant feeding practices.
