インスリン・プレフィルド製剤を用いたマイクロテーパー針 (TN-3305) の基礎的研究

抄録

A micro-tapered needle (TN-3305) with a 33 gauge (G) tip and 28G base has recently been developed. However, since there was a possibility of the reduction in needle diameter leading to reduced needle strength and an increase in injection resistance making the discharge time for insulin longer, we investigated the usefulness of this new type of needle in a basic study. A 33G injection needle (test product) and a commercially available pen-type special insulin syringe needle (pen-type syringe needle) for use in pre-filled insulin products were used as the controls. The study involved a strength test, a perforation resistance test using silicon rubber sheets and porcine skin, an injection resistance test and measurement of the insulin liquid lag time and size of the perforation scar. The results showed that the TN-3305 needle had almost the same strength as the 31G needle, and the injection resistance value and insulin liquid lag time were the same or less than those for the 30 G needle, and the perforation resistance value and size of the perforation scar were smaller than those for all of the commercially available pen-type syringe needles used. The tapered structure of the TN-3305 needle enabled it to overcome the problems associated with narrow needle diameters and to achieve the lowest perforation resistance in our basic study.