P26 Could the formulation and/or method of administration of oral nadolol have a clinically significant impact on the dose delivered to the patient

Conclusion
In this case, the patient was complex and unstable, and her clinical condition may well have contributed to the increase in ectopy experienced. However, the work done by regional QC identified the risk of inaccuracy and/or variation in the dose of nadolol delivered using different formulations and/or methods of administration.
The solubility limit of nadolol in water is estimated to be ~8mg/ml. Dispersed oral solutions must be thoroughly mixed prior to patient use especially if a proportional dose is required. Inconsistency of the dose of nadolol delivered should be considered when using this method.
Further, the change in formulation to the oral suspension could, unintentionally, have resulted in a difference in the dose delivered to the patient.
A consistent method for administration should be followed and, if a change in formulation is considered necessary, the patient monitored for any sign of reduction in efficacy and/or increase in adverse effects.

Reference
Regional QC. Investigation into the preparation of various nadolol oral formulations. LD2019017. Version C. 29th July 2021

Source: Archives of Disease in Childhood - April 20, 2022 Category: Pediatrics Authors: Aindow, A., Edrich, C., Corris, M., Milligan, K., Dwyer, P. Tags: Oral presentations Source Type: research