Paediatric oral formulations: comparison of twoextemporaneously compounded suspensions fromtacrolimus capsules

Study objectives: The objective of this study was to determine the stability of tacrolimus in extemporaneously compounded liquidformulations.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 tacrolimusin each formulation was 0.5 mg/mL. The preparations containing Ora-Plus were stored at 25°C, the formulations that wereprepared 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 usinga stability-indicating, high performance liquid chromatography (HPLC) assay. The concentration of drug was found to be within theacceptable 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