Abstract

PREFILLED SYRINGES: A REVIEW ON REGULATORY REQUIREMENTS

Aparna Peri*, Pravalika Methuku and V. Srivani

ABSTRACT

Prefilled syringes are pharmaceutical product which is used to deliver parenteral medications. A prefilled syringe is a single dose packet of parental drug to which a needle has been fixed by a manufacturer. Pre filled syringes are ready to use disposable syringes contains premeasured dosage, reduce dosing errors and increase patient compliance ,dosing accuracy, convenience, and safety; enhance patient quality of life; and reduce patient time in the clinic.A prefilled syringe helps to increase dosing accuracy, convenience, and safety; enhance patient quality of life; and reduce patient time in the clinic. It acts as primary container for the drug product like the ampoule. The advantages for drug developers using prefilled syringes are numerous; improved patient compliance and better cost efficiency, as well as mitigating the risks of drug wastage and product contamination. And mainly used for treatment of chronic conditions requiring patients to self-administer medication. The intent of this review article is to provide concise information about latest regulatory aspects of prefilled syringes, its manufacturing, advantages, disadvantages, challenges.

Keywords: prefilled syringes, disposable syringes, medication.