3PC-037 Stability study of hydrocortisone 1mg/ml oral suspension for neonatal use

<h3>Background and Importance</h3> The neonatal department uses therapies that require adjustments in dosage and formulations, including hydrocortisone (HCT) which prevent bronchopulmonary dysplasia in premature newborns. At present, HCT capsules are opened and diluted extemporaneously, highlighting the need for a ready-to-use oral suspension. <h3>Aim and Objectives</h3> The aim of the study was to produce an oral suspension of hydrocortisone free from excipients with known effects (EKE) framed by microbiological and physicochemical stability studies. <h3>Material and Methods</h3> Following the literature and the usual dosage regimens, the concentration of HCT oral suspension was set at 1mg/mL, using the EKE-free Syrspend SF PH4 Dry vehicle. Thirteen batches were produced. Six batches of 10 amber 20mL vials were designated to study stability before opening up to 84 days : batches 1 to 3 at room temperature (RT) and batches 4 to 6 at refrigerated temperature (4°C). Two batches of 200mL amber vials were designated to study post-opening stability up to 28 days : batch 7 at RT and batch 8 at 4°C. Batches 9 to 13 simulated temperature excursions after 7 and 14 days for 12h or 24h. An HPLC/UV assay was carried out at each control point, with measurement of pH, osmolality and visual inspection. Microbiological quality was checked, with specific testing for E.coli, in accordance with European Pharmacopoeia 11th edition. <h3>Results</h3> Results showed physicochemical stability at 4°C before and after opening, with HCT content between 98–101% of initial content (1.00±0.01mg/mL) pre-opening and 101–103% of initial content (0.99±0.03mg/mL) post-opening. pH was stable (4.24±0.08), as was osmolality (43±4mOsm/kg). At RT before opening, a 20.93% deviation in osmolality was observed at D56, while after opening a 10.64% deviation from the initial content was observed at D14. With the exception of two measurements at 4°C on D14, for which external contamination is suspected, microbiological quality was compliant. E.coli testing was negative. Physicochemical stability was not affected after 12 or 24-hour temperature excursions. <h3>Conclusion and Relevance</h3> This study enables us to store HCT oral suspension without EKE at 4°C for 3 months. Once opened, it should be stored at 4°C and used within 14 days. Drinkable suspension makes HCT administration safer and can now be deployed in neonatal department. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest