Giving medicines to children poses unique challenges, especially in resource-constrained countries with high infant and child mortality rates. Many medications are solid substances or tablets that children cannot easily swallow and which are difficult to dose depending on the child’s weight. While there are liquid and semi-solid alternatives to some drugs, many drugs lack this option or become unstable without a reliable cold supply chain. To address these concerns, researchers at Brigham and Women’s Hospital and the Massachusetts Institute of Technology have developed a new oil-based gel formulation. In a clinical study, researchers showed that cheap “oleogels”, obtained from materials already used in the food industry, can be formulated to be given as liquid, as a thickened beverage and as solid as yogurt pudding. In addition, preclinical studies have shown that oleogels can make it easier to take the drug at levels comparable to or better than solid tablets, while allowing measured doses suitable for children. The results were published in Science Advances.
“Most liquid or semi-solid systems are water-based and restrict the delivery of water-insoluble drugs,” said lead author Dr Ameia Kirtane of Brigham’s Department of Gastroenterology and MIT’s Department of Chemical Engineering. “Our system is an oil-based system gel, which makes it compatible with most drugs. This allows the formulation of drugs that were not available in semi-solid or liquid dosage forms and allows patients, especially children, to take the medication more easily.
The Oleogel system consists of simple ingredients: a plant-based oil (such as cottonseed oil, saffron or sesame oil), a gelling agent to optimize viscosity and thermal stability (such as beeswax, candela wax or carnauba wax) and a solubilizer that helps the drug to dissolve in the oleogel. Thus, the drug delivery system has an established safety profile and can be easily and widely manufactured. It does not have to be reconstituted with water and has been shown to withstand storage at 40 degrees Celsius (over 100 degrees Fahrenheit), making it ideal for environments with limited resources.
In an experiment with proof of concept in pigs, the researchers showed that their oleogel system can successfully deliver four anti-infective drugs (azithromycin, praziquantel, lumefantrine and moxifloxacin), whose chemical properties and functions are broad-spectrum. Researchers have found that a hydrophilic (water-soluble) drug like moxifloxacin can be delivered using a slightly modified oleogel, called oleopast. Significantly, the route of administration (oral versus rectal) influenced medication intake, emphasizing the importance of oleogel optimization for each drug of interest.
The research team has partnered with consulting firm Sensori Spectrum to put together taste panels to assess which combinations of oils and gelling agents would be most comfortable for patients. They also adjusted the packaging of the oleogel to adjust to the measured doses.
As a next step, the researchers will conduct the first study on people with healthy adults enrolled in Brigham to evaluate the effectiveness of oleogels in the delivery of azithromycin. Researchers emphasize that, in addition to being suitable for pediatric care in resource-constrained environments, the oleogel system could also be beneficial for older adults, people with gastrointestinal disorders, or palliative care patients.
“We have a very simple but very elegant solution for giving medicines to those who have difficulty swallowing,” said co-author Giovanni Traverso, MB, BChir, PhD, from Brigham’s Department of Gastroenterology and MIT’s Department of Mechanical Engineering. “This was a huge team effort, which included basic formulation science, sensory evaluation and the production and testing of dosing systems, and was inspired by methods that have been recognized and used in the food industry.
Reference: Kirtane AR, Karavasili C, Vahane A, et al. Development of oil-based gels as a variety of drug delivery systems for pediatric applications. Sci Adv. 2022; 8 (21): eabm8478. doi: 10.1126 / sciadv.abm8478
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