Preparation of pellets with controlled release of glucose as prevention of hypoglycaemia in paediatric patients.

Hypoglycaemic episodes represent serious and frequent complications of type 1 and 2 diabetes. Theoretically, the risk of hypoglycaemic states can be affected by a dosage form based on a food supplement containing a delayed release formulation of glucose. The release of glucose should compensate for balance the peak effect of an antidiabetic treatment. In clinical practice, a diet with fibre and grains is recommended and patients are broadly educated in the topic of low and high glycaemic indexes to achieve the same effect. However, a precisely-timed release of carbohydrates can favourably target expected hypoglycaemia and concurrently decrease carbohydrate content. To study the possibility of preparing the dosage form with controlled-release carbohydrates, a dosage form of pellets containing four osmotically active substances coated by a membrane created of ethylcellulose was prepared. These pellets can be administered in a mixture with liquid or semisolid food. The resulting dissolution profiles for selected compositions showed that delayed release can be achieved for 120, 240 and 360min in vitro, representing an ideal delay for clinical purposes.