Paediatric oral formulations: comparison of two extemporaneously compounded suspensions from tacrolimus capsules

Abstract

Study objectives: The objective of this study was to determine the stability of tacrolimus in extemporaneously compounded liquid formulations. Methods: Two sets of liquid formulations were prepared using two different vehicles: one set in sterile water and in simple syrup (1:1) and one set using equal volumes of commercially available suspending agent (Ora-Plus) and simple syrup. The concentration of tacrolimus in each formulation was 0.5 mg/mL. The preparations containing Ora-Plus were stored at 25°C, the formulations that were prepared with sterile water and simple syrup were stored under refrigeration at 4°C. Results: Samples were collected at regular time intervals over a period of 56 days and tacrolimus concentration was determined using a stability-indicating, high performance liquid chromatography (HPLC) assay. The concentration of drug was found to be within the acceptable limit (± 10%) of the initial concentration in all tested samples. Conclusion: The HPLC results showed that simple syrup/sterile water formulations stored at 4°C are stable for at least eight weeks