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

Coated pellets with delayed-release glucose for prevention of hypoglycemic episodes

“…As observed previously, lag time is represented by the period when the coating is intact and the length of this period is usually based on the coating thickness. The glucose release starts with the formation of coating disruptions (punctures or ruptures) (6). These disruptions develop too early in lower coating concentrations, which is therefore insufficient for the purposes of this work.…”

“…This allows water diffusion and consequent activation of the core excipients, leading to core swelling and increase in osmotic pressure. Therefore, disruptions (ruptures or punctures) are formed in the pellet coating and glucose release starts after a specific lag time (6). Pellets were chosen as a dosage form due to their small size that enables easy administration even to pediatric patients.…”

“…Glucose release from coated pellets was determined by dissolution and analyzed by high-performance liquid chromatography. The developed compositions were originally extruded through a 1.0 mm mesh screen (6). Since the dietary supplement would be mainly intended for administration to pediatric patients, the current target was to prepare pellets with diameters reduced to 0.8 mm and to assess the characteristics and glucose release of such pellets.…”

Clinical assessment of the lag‐time and tmax of pellets with controlled release of glucose: in vitro/in vivo comparison using 13C–breath test

“…The dissolution conditions were determined in previous experiments. It was found that the lag time was unaffected by the rotation speed of the dissolution apparatus and the pH of the dissolution media (Franc et al, , ). Furthermore, it was verified that the type of dissolution apparatus (basket vs. paddle apparatus) did not influence the lag time either (unpublished results).…”

“…The characteristics of the above‐mentioned type 1 diabetes mellitus treatment and efforts to prevent excursions in glycaemia give reasons for the creation of a dosage form with a predictable glucose release. Since 2012, an effort has been made to prepare a carbohydrate formula that does not release its content right after administration, but with a specific time delay‐lag time (Franc, Muselík, Sabadková, & Neumann, ). Patients can easily imagine the effect of such a food supplement on their glycaemia, and professionals can simply educate patients by describing the effect as a snack of a well‐defined lag time eaten in advance (Christie et al, ).…”