Category: Professional Posters
Purpose: Oral liquid formulas of tacrolimus 1 mg/mL and hydroxyurea 100 mg/mL were compounded from whole unopened capsules in the liquid diluent, Ora-Blend®. The compounding was undertaken using a novel self-contained automated wet-milling technology. The technology compounds, stores and dispenses from a single-use specialized plastic container. The technology has been proven to eliminate aerosolization of powders during compounding. Thus unlike compounding undertaken with a mortar and pestle, the technology eliminates exposure of personnel to aerosolized powders during the process. Stability studies were employed to establish a BUD for the formulas.
Methods: Whole unopened capsules of tacrolimus and hydroxyurea were compounded into 1 and 100 mg/ml oral liquid preparations respectively. The requisite number of capsules and specified quantity of the liquid diluent, Ora Blend, were placed into the specialized plastic containers, the containers capped and processed employing an unattended specially developed cycle. The specifically textured surface of the container combined with a high RPM planetary motion from a milling machine results in the conversion of the contents into a fine uniform suspension. Stability studies employing HPLC were conducted on the compounded formulas.
Results: The compounded formulas were found to have a smooth texture and the required characteristics for proper dose withdrawal. A beyond use date (BUD) of 90 days at room temperature was assigned to both compounded products. The stability study results were within 10% of the label claim.
Conclusion: The data demonstrates that the automated wet milling technology safely compounds high quality oral liquid formulas of hazardous drugs using whole capsules. The lack of need to open capsules for compounding coupled with the self-containing features eliminates powder aerosolization and provides personnel with a safe procedure. The variability introduced by manual procedures is eliminated. The employment of a single-use disposable container for compounding, storage, and administration eliminates the need for cleaning and the risk of cross contamination. The collective features provide a benefit for patients. The technology provides an environmental benefit by eliminating hazardous waste streams emanating from cleaning procedures.