Development of a Method to Grind Hydrocortisone Tablets and Prepare an Oral Liquid Dosage Form for Administration to Patients in Neonatal Intensive Care Units

抄録

Summary: The aim of the present study was to develop hospital preparations of hydrocortisone (HC) tablets (Cortril^® tablets 10 mg, C-tab) for administration to patients in neonatal intensive care units. The following two methods were employed: the preparation of a powder from C-tab without drug loss and the establishment of a method to prepare an oral liquid dosage form (OLD) of HC from C-tab. When C-tab was ground using a mortar and pestle, 15.9% of HC in the tablet remained on the surfaces. The grinding of C-tab with 0.4 g of anhydrous dibasic calcium phosphate decreased this loss to 0.5%. The powder prepared showed content uniformity for HC with no drug loss. The solubility of HC in water at 4°C was 0.48 mg/mL. Therefore, 40 mL of purified water (water) was added to C-tab to prepare an OLD of HC at a concentration of 0.25 mg/mL. There was no adsorption of HC to insoluble additives in the OLD, which was homogeneous. In clinical settings, tap water may be used instead of water. OLDs were prepared using water and tap water and then subjected to measurements of general bacterial counts and stability tests. The results obtained in the measurement of general bacterial counts were all negative. In stability tests, HC in OLDs using water and tap water degraded at 40°C, but remained stable at 4°C for 2 weeks.