Researchers develop an oil-based gel formula suitable for metered dosages of medication.
There are many reasons why someone might find it difficult to swallow solid medications like pills and tablets. This can be one of the challenges of administering medicine to children, alongside the need to alter a dose according to a child’s weight. Developing drugs that are easy for children to take is especially important in resource-limited countries with high infant and child mortality rates. Now, researchers from Brigham and Women’s Hospital (MA, USA) and the Massachusetts Institute of Technology (MIT; MA, USA) have developed a novel low-cost oil-based gel formulation called ‘oleogels’ to address this.
Oleogel takes its inspiration from the food industry and uses a vegetable-based oil (like sesame oil), a gelling agent to achieve the desired viscosity and heat stability (like beeswax or candelilla wax), and a solubilizer to ensure drugs can dissolve in the formulation. As these are already ingredients used in food manufacturing, this drug-delivery system has an established safety profile and could be easily and widely produced. Additionally, drugs can be administered as a fluid, a thickened beverage, or even something as stiff as a yogurt pudding.
The preclinical study found that oleogels successfully facilitated drug uptake at comparable, or better, levels than solid tablets. They could also be tailored to allow for metered dosages that would be suitable for children.
The study demonstrated that oleogel can deliver four anti-infective drugs with varied chemical properties and functions in pig models. These were azithromycin, praziquantel, lumefantrine and moxifloxacin. They showed that hydrophilic drugs like moxifloxacin could be delivered using an oleopaste, which is a slightly altered oleogel. Additionally, it was noted that oral versus rectal administration affected the uptake of medications, highlighting the importance of tailoring oleogels for specific drugs.
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“Most liquid or semi-solid systems are water-based and pose limitations for delivering drugs that cannot be dissolved in water,” said Ameya Kirtane, a researcher at MIT and the lead author of this study. “Our system is an oil-based system gel, which makes it compatible with most drugs. This enables the formulation of drugs that were not available in semi-solid or liquid dosage forms and allows patients, especially children, to more easily take their medicine.”
Some medications already have liquid or semi-solid alternatives. However, not all medications can be formulated as a liquid or semi-solid because, for example, some drugs become unstable in this state without a reliable cold supply chain. The oleogel system has been shown to withstand storage at 40°C (104°F) and does not need to be reconstituted with water, making it suitable for resource-limited environments.
The research team partnered with Sensory Spectrum, a consultancy firm, to organize a taste test to ensure an acceptable taste and designed packages that ensure metered doses are easy to administer.
Next, oleogels need to go through their first human trial with healthy adults to evaluate the efficacy when delivering azithromycin.
“We have a very simple but elegant solution to administering medications for those with swallowing difficulties,” said Giovanni Traverso (MIT), who is the corresponding author of the paper. “This was an enormous team effort, which included fundamental formulation science, sensory evaluation and dispensing system fabrication and testing, and it was inspired by methods that are recognized and used already within the food industry.”
Oleogels could be used beyond pediatric care in low-resource settings and benefit other patients including older adults, those with gastrointestinal disorders, and palliative care patients.
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