Invention could help kids and adults who have trouble swallowing pills

By Mark Waghorn via SWNS

Mary Poppins helped the medicine go down with a spoonful of sugar.

Now a tasty gel - used in the manufacture of chocolate and ice cream - has been created that may be just as effective.

It offers an alternative for kids - and grown-ups - who have trouble swallowing pills, say scientists

From simple white paracetamol to blue diamond-shaped Viagra, our tablets come in all shapes and sizes.

Many people have great difficulty taking them - meaning they don't adhere to prescriptions.

The US team's concoction is made out of sesame oil, beeswax and other plant-based secretions.

To store and deliver the drugs, a dispenser similar to a squeezable yogurt pack has been designed - with compartments that can be used to separate doses.

This could make it easier to deliver the right dosage for each child - depending on their weight.

Senior author Professor Giovanni Traverso, of MIT, said: "This platform will change our capacity for what we can do for kids, and also for adults who have difficulty receiving medication.

"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 average adult gullet is 2cm in diameter. Some medications can be longer than 1cm wide - which makes them a struggle to get down.

Some, such as contraceptive pills, are 'high potency' meaning a tiny amount is needed. They are often very small.

But others, like ibuprofen, are low potency and need a lot more to elicit the desired effects. They can get very large.

The gels can be prepared with a variety of textures - ranging from a thickened beverage to a yogurt-like substance.

They don't need refrigeration which means they could benefit children in developing nations - or anywhere else.

Older people or those who have suffered a stroke may also appreciate the new system of delivery.

Tests on mice showed it worked for several treatments of infectious disease - in the same doses as those from pills or tablets.

Results in Science Advances were so encouraging a clinical trial is expected to begin within few months.

The researchers combined sesame, cottonseed, and flaxseed oil with edible gelling agents such as bees and rice bran wax.

They achieved different consistencies depending on ingredients and concentrations.
Some ended up like a protein shake. Others were more akin to a pudding.

Working with consultants in consumer sensory experiences and panels of trained tasters, they found the most palatable were gels made from cottonseed or sesame oil.

The experiments included three water-insoluble drugs drawn from the World Health Organisation's list of essential medicines for children.

They were praziquantel used to treat parasitic infections, anti-malaria medication lumefantrine and antibiotic azithromycin.

Lead author Dr. Ameya Kirtane, now at Brigham and Women's Hospital, Boston, said: "Based on that list, infectious diseases really stood out in terms of what a country needs to protect its children.

"A lot of the work 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 researchers' technique is inexpensive, palatable, stable at extreme temperatures, and compatible with many different drugs.

The drugs don't need to be mixed with water beforehand and can be administered either orally or as a suppository.

Oil-based gels, also known as oleogels, are commonly used in the food industry to change the texture of oily foods - and raise the melting point of chocolate and ice cream.

Dr. Kirtane said: "That approach gave us the capacity to deliver very hydrophobic drugs that cannot be delivered through water-based systems. It also allowed us to make these formulations with a really wide range of textures."

For each drug, the 'oleogels' were able to deliver doses equal to or higher than the amounts that can be absorbed from tablets.

The researchers also showed a water-soluble antibiotic called moxifloxacin hydrochloride could be successfully delivered by the gel.

They were specially designed to be stable at 40 degrees Celsius (104 degrees Fahrenheit) for several weeks, and even up to 60 C (140 F) for one week.

Such high temperatures are uncommon but could be reached when drugs are being transported by trucks without refrigeration.

The researchers have obtained FDA (Food and Drug Administration) approval to run a phase I clinical trial of their olegel formulation of azithromycin.

They hope to start running it at the Brigham and Women's Hospital Centre for Clinical Investigation within the next few months.

The project is the culmination of ten years of work - when the team started investigating other kinds of ingestible drug-delivery systems.

There are existing strategies, but none is perfect. Some antibiotics and other drugs can be suspended in water, but that requires clean water and refrigeration after mixing.

Also, this strategy doesn't work for drugs that are not soluble in water. Dr. Kirtane and colleagues believe they have finally come up with a solution.