Category: Professional Posters
Purpose: Compounding of oral liquids from tablets and capsules is commonly conducted using a mortar and pestle. A novel automated wet-milling technology was developed to enable compounding to be performed within a single-use multipurpose specialized plastic container. The container allows for self-contained compounding, storage and administration of the compounded product. Oral liquid suspensions of clonidine hydrochloride 20 µg/mL were compounded from tablets, purified water and simple syrup. Stability studies were conducted to establish the dose uniformity and a BUD for the compounded preparation.
Methods: The requisite number of tablets and specified quantity of purified water for the desired volume to be compounded were placed into the specialized plastic containers, the containers capped and processed employing an unattended 10 minute wet-milling cycle. The specially textured surface of the container combined with a high RPM planetary motion from the milling machine results in the conversion of the contents into a fine uniform suspension. The required amount of simple syrup was then added to the suspension. Dose uniformity and stability of the compounded preparations were conducted using a validated HPLC method.
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 1 month at room temperature was assigned to the compounded product. The dose uniformity results were within 2% of the label claim. The stability study results were within 10% of the label claim.
Conclusion: The data demonstrate the effectiveness of the novel automated wet-milling compounding technology. The automated method allows for simultaneous compounding of up to four different products with consistent quality. The study demonstrates compounding of extremely low concentration suspensions can be achieved. The self-contained compounding system prevents transfer losses and eliminates variability introduced by manual procedures. 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 resultant formulas are especially beneficial for dosing neonatal patients and also make conversion to nationally accepted standard concentrations more feasible.