As every parent knows, kids aren’t just “little” people. This concept can be easily forgotten, especially with certain medical practices such as medication administration. Something that an adult is not intimidated about – “take this pill every 12 hours” – in little ones can make the difference between receiving, or not, a vital remedy. To facilitate the taking of certain medications in this age group, researchers from the Faculty of Pharmacy of the University of Buenos Aires, together with professionals from the Garrahan Hospital, are developing pediatric “mini-tablets”, which integrate different medicinal active ingredients in a medication format. that today is not manufactured in Argentina. These mini-pills are designed to be swallowed effectively and safely by young children or adults with certain disabilities or diseases that affect swallowing.
“Sometimes pediatricians have to prescribe low doses of a medication, in formulations that are not marketed, and end up asking the person in charge of supplying the medication to take the pill out of the blister pack and cut it “by eye” into three or four parts for later give them those “bits” at the indicated times”, said Fabián Buontenpo, professor of the subject “Pharmaceutical Technology” in the homonymous career at the UBA. Buontenpo, who also works in the internal pharmacy at Garrahan Hospital, added that “with this option the appropriate amount of the active ingredient ingested can vary greatly. And we cannot forget that there are medicines that need to be taken in the right dose so as not to end up causing excessive adverse effects or, on the contrary, they do not induce any positive change in health if they are taken in suboptimal quantities”.
To deal with this problem, several groups of scientists work at the Center for Pharmaceutical Research, Development and Control (Cidec) of the Faculty of Pharmacy of the UBA. “For more than a decade we have been designing special pediatric formulations. And in recent times we began to develop, with other colleagues in the country, novel solid oral formulations. Although for now it is on a small scale, we want to be able to supply the mini-tablets during, for example, a hospital stay,” explained Silvia Lucangioli, holder of the “Pharmaceutical Technology” chair and director of the Institute of Pharmaceutical Technology and Biopharmacy to PROFILE. The expert recalled that “there are many drugs that do not directly exist in a pediatric formulation or are not adapted to adequate doses for children. And although some medicines are available in liquid suspensions, it is also very useful to have them in the form of mini-tablets because it is a more stable format, which facilitates its conservation and does not require a refrigerator. Also, the pills are easier to handle and administer.”
Precisely to advance in these investigations, the research groups of the Faculty of Pharmacy received subsidies for some $30 million.
Dose. When manufacturing this pediatric medication, the dose is not the only key: as they are for children under six years of age, they also require other characteristics. For example, that they can dissolve completely in the mouth and thus facilitate swallowing and subsequent metabolic absorption. In this way they ensure that the intake does not generate dangerous “choking” or make it difficult to receive daily medication.
Research seeks to develop several “orodispersible mini-tablets”, three millimeters thick and up to 30 milligrams in weight (six times less than a conventional one).
Options. As good practices indicate that they should test pill by pill, they already have advanced work with a medication that until recently did not exist in a formulation for children. It is a therapy used in the treatment of a rare pathology, generated by the deficiency of coenzyme Q10.
Another study that they completed is the mini-tablets of another discontinued molecule in Argentina and that was only available through imports: trihexyphenidyl, a drug used to treat muscular dystonia. And, in recent months, they are moving forward with levothyroxine mini-tablets, used to treat hypothyroidism. “It is used in very low doses, of a few micrograms. And although pharmacies have pills, they are formulations designed for adults, not for pediatric patients,” Valeria Tripoli, a CONICET researcher and also a member of the “Medicine Quality” chair, explained to PROFILE.
In the immediate future, scientists are planning to advance in the development of pediatric formulations of drugs such as “ursodeoxycholic acid”, which is used in hepatobiliary pathologies and transplant patients. This option, for now, only exists in capsules for adults. And in the medium term they plan to test citrulline in a pediatric formulation, which is indicated for the treatment of hereditary metabolic pathologies related to urea cycle disorders.
Everything indicates that, more and more, in the near future, new pediatric mini-tablets “Made In Argentina” will be added to the shelves of pharmacies.
Two totally different metabolisms
“Kids are not little adults. But, many times, when they are thought of as patients, they are taken as such”, commented Dr. Valeria Tripoli, a CONICET researcher and one of the promoters of the mini-tablets. And Buontenpo detailed some differences: “little ones have other forms and times of metabolic absorption. When they are given a pill, it must be remembered that their stomach pH is different from that of adults and their enzyme concentrations are also different. In a neonate around 50% of the weight is water, while in the adult that value drops to 10 or 15%. All this means that the amount of active ingredient absorbed by the body can vary greatly between adults and children”. In addition, the pharmaceutical industry concentrates its research on the most attractive markets. And this is that of the adult, since the number of patients between 15 and 75 years of age who may need a dose of medication is exponentially greater than the number of younger patients who could take them. That is one of the reasons why biomedical research does not usually focus on pediatrics.
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