ESPE Abstracts (2014) 82 P-D-2-3-340

Coated Pellets With Controlled Glucose Release in Treatment of Children with Diabetes

David Neumanna, Ales Francb & Jan Muselikb

aDepartment of Pediatrics, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic; bUniversity of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic

Background: Usually a diet plan includes meals with suitable glycaemic index together with sophisticated insulin delivery for balanced sacharides-insulin intake. Nevertheless, the need of controlled sugar release is urged in specific day-to-day life situations, especially for young children with diabetes. Nocturnal hypoglycaemia, parental fear of insufficient snack intake in nursery, sports with prolonged race periods and others are amongst these life situations.

Objective and hypotheses: To achieve a controlled glucose release formulation with a 4, 6, and 8 h lag time offering a chance to substitute snacks or other meals in advance. Aiming to decrease inconvenience in lifestyle and improve the therapy and adherence of children with diabetes and their parents.

Method: A dosage form with a controlled glucose release was successfully prepared, which included a lag time of 4, 6, and 8 h and a release period of 2–4 h. The variables of the dosage form included an optimal diameter of the pellet, resistance of the coat, volume, taste and acceptable form for swallow. These variables were refined via pharmaceutical methods for optimal efficiency in patient use.

Results: Two exchange units or more in the form of pellets are easily added to standard meals, e.g. yoghurt. Pellets (clinically powder) don’t cause abdominal discomfort. In CGM studies, formulation prevents nocturnal hypoglycaemia.

Conclusion: A successful formulation of dose was achieved with a controlled glucose release, it also expressed a specific easy-to-explain lag time. This can be an acceptable alternative means for diabetes treatment.

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