Coring of Injectable Dosage Forms: Risk Minimization Strategies (Review)

INTRODUCTION. Contamination of injection and infusion preparations in the vials with fragments of a punctured stopper (coring) poses direct risks of microembolism, inflammatory reactions in patients, and dosing errors. No risk minimization strategy for coring of a punctured stopper currently exists in the Russian Federation.

AIM. This study aimed to determine the ways to minimize contamination risk of an injectable drug with particles of a vial stopper punctured by a needle.

DISCUSSION. Standardized puncturing technique for vial stoppers was found to be a fundamental preventative measure: puncturing at an angle of 45–60º, followed by a right angle, with the bevel facing upwards, significantly reduces the risk of a fragmented stopper. Using small-gauge needles (≥20G) and restricting the number of punctures (as few as possible and at least 0.75 mm apart) also minimized coring. Filter needles that trap the resulting particles were substantiated as a reliable technological solution, as well as choosing closed-loop transfer systems and prefilled single-use syringes that prevents any stopper manipulations. The important elements of the strategy include a thorough visual inspection of each dose against a dark background under intense light and training medical personnel to puncture the vials using simulation techniques.

CONCLUSIONS. Based on the references, the strategy offered to minimize the risks associated with the vial stopper fragmentation at injection and infusion integrates technological, methodological, and organizational solutions. For practical implementation, it is recommended to standardize the puncturing technique of the vial stopper; to train medical personnel in puncturing techniques that reduce the risk of forming stopper particles; to visually inspect each dose of the drug before administration; and to use specific medical devices that prevent manipulations with the vial stopper.

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