Lorazepam ODMT: an alternative pharmaceutical dosage form for pediatric therapy

ORCHOW C.; SCIOSCIA S.,; CECILIA, DOBRECKY; TORRICO E.; TRIPODI V.; LUCANGIOLI S.; FLOR S.

Rosario

Congreso; 7ma Reunión Internacional de Ciencias Farmacéuticas RiCIFA 2023; 2023

RICIFA

Lorazepam is a highly potent benzodiazepine used orally in children and infants for the treatment ofanxiety, sedation, and as an antiemetic. Of these three properties, the most important at the hospitalenvironment is sedation. The used dose is 0.05 mg/kg every 4-6-8 hours (maximum 2 mg). Currently,two alternatives are used for treatment and dose adjustment, the first is a extemporaneous solutionprepared from raw material that has a stability of only 15 days when stored in the refrigerator, whilethe second comprises split tablets of higher dose according to weight/required dose. The objectiveof this work was the development of orally disintegrating lorazepam mini-tablets (ODMT) at lowerdoses (0.100 mg) than those commercially available for use in pediatric patients. The ODMT combinethe traditional advantages of the solid pharmaceutical dosage form mainly related to greaterphysicochemical stability compared to aqueous solutions and, secondly, the rapid disintegration inthe oral cavity compared to traditional tablets, which indirectly improves the absorption rate of API.Three excipients (StarLac, Mannogem and Pharmaburst) were evaluated as diluents for directcompression. Magnesium stearate was used as a lubricant and croscarmellose sodium as asuperdisintegrant.