A Novel, Optimized Method to Accelerate the Preparation of Injectable Poly-L-Lactic Acid by Sonication

Current consensus for preparing injectable poly-L-lactic acid (PLLA) suggests adequate hydration 2-24 hours of reconstitution) of the lyophilized particles before injection, but the volume of reconstitution and the duration of hydration time varies. This study established a method to evaluate the distribution of PLLA particles after hydration and found that longer hydration time increased the effective portion (particles <60 pm) of PLLA products. Further investigation of the feasibility of reconstitution with sonication revealed that 2-hour hydration of PLLA powders with additional 5-minute-sonication could yield a comparable particle distribution with 48-hour-hydration of PLLA. Moreover, adding lidocaine into the diluent did not alter the distribution of PLLA particles. We proposed a new, feasible and efficient method of preparing PLLA injectable products: 2-hour hydration of the powders, sonication of the bottle or vial containing PLLA products for at least 5 minutes, and finalization with 1-2 mL of lidocaine immediately before injection.