Oily gels deliver essential medicine for kids who can't swallow pills
Oral medication has become an indispensable method of drug delivery, today accounting for around 90 percent of pharmaceuticals produced for human use. Despite their value in treating everything from headaches to COVID-19, children and adults can have difficulty swallowing pills, and a lack of clean water and refrigeration can complicate things in developing regions for those seeking alternatives. Scientists have devised an oil-based gel that addresses these issues, and can be loaded with essential medicines and dispensed like yogurt for easy swallowing.
The novel drug delivery method at the center of this research is around 10 years in the making, with scientists from MIT and Brigham and Women's Hospital setting out to make it easier for children to consume medication typically given in pill form. Some drugs can be suspended in water, but that assumes clean water is available and also requires refrigeration to keep the resulting mixture stable.
The scientists instead turned to oil-based gels, which hold promise as a medium that can dissolve drugs, keep them stable at extreme temperatures, be compatible with different pharmaceuticals and negate the need for clean water. These are known as oleogels and are used commonly in the food industry to change the texture of oily foods and increase the melting point of chocolate and ice cream.
By experimenting with different oils and edible gelling agents, including sesame, flaxseed, cottonseed, beeswax and rice bran wax, the scientists found they could form gels of different textures, ranging from substances resembling thickened beverages to ones much like yogurt. These also offered different flavor profiles, and after consulting with trained taste testers, the scientists found those with neutral or slightly nutty tones, such as from cottonseed or sesame oil, to be the most appealing.
The team then turned to the World Health Organization’s list of essential medicines for children and selected three drugs in praziquantel, lumefantrine, and azithromycin. These are used to treat parasitic infections, malaria and bacterial infections, respectively, and cannot be dissolved in water.
“Based on that list, infectious diseases really stood out in terms of what a country needs to protect its children,” said lead author Ameya Kirtane. “A lot of the work that we did in this study was focused on infectious disease medications, but from a formulation standpoint, it doesn’t matter what drug we put into these systems.”
The drugs were then mixed into the oil-based gels, with the team designing a dispenser system similar to a squeezable yogurt package. The drug delivery method was then tested on pigs, and the team found the oily gels could effectively deliver doses equal to or higher than what a subject can absorb from tablets. The gels also proved stable at temperatures of 40 °C (104 °F) for several weeks and at 60 °C (140 °F) for one week, boding well for the prospect of safe truck transportation without refrigeration.
Following these promising early results, the scientists have now gained FDA approval to conduct a phase I clinical trial, which they expect to kick off within a few months.
“This platform will change our capacity for what we can do for kids, and also for adults who have difficulty receiving medication," said study author Giovanni Traverso. "Given the simplicity of the system and its low cost, it could have a tremendous impact on making it easier for patients to take medications."
The research was published in the journal Science Advances.