Guidelines for the development of prefilled syringe application formulations

Update:22 Feb 2020
Summary:

Pre-filled syringes have been widely recognized and app […]

Pre-filled syringes have been widely recognized and applied in Europe and the United States for their advantages of accurate drug delivery, high utilization of medicinal solution, and safe and convenient drug administration. In recent years, their development momentum in China has become more and more rapid. Attempts have been made to use pre-filled syringes as packaging materials.

First of all, compared to common injection packaging materials, pre-filled syringes have great advantages in terms of safety and ease of administration. Most of us have been injected. The doctor took the dangling needle of the syringe through the stopper of the vial (the tip of the needle may be barbed, which causes pain in the injection), sucking the medicine slowly, and then putting the medicine in the liquid A little bit of air is exhausted. Throughout the process, the risk of contamination of the medicinal solution is very high (if it is an ampoule, the scum of the ampoule will be more terrifying). The pre-filled syringe has been filled with a predetermined amount of liquid medicine in advance, which can avoid these problems well, and it is more convenient and quick for doctors to use. At the same time, pre-filled syringes also facilitate the self-use of chronically ill patients at home, like cartridges for insulin.

In addition, prefilled syringes have a great advantage. Use a syringe to extract the medicine solution in the vial. The medicine solution in the vial will definitely remain. According to the United States Pharmacopoeia, traditional medicine bottles require 20% -24% more filling doses. This means that if the liquid medicine is very expensive (such as biological preparations or vaccines), the pre-filled syringe can be filled with less liquid than the vial, and the advantages of the pre-filled syringe will be very obvious.

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