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Assessment of the Injection Performance of a Tapered Needle for Use in Prefilled Biopharmaceutical ProductsThe design of injection devices, including prefilled syringes (PFSs) and autoinjectors, requires an understanding of the optimization of injection conditions. The injection of highly concentrated biopharmaceuticals can lead to exceptionally high injection forces, due to their high viscosity. To overcome this challenge, a tapered needle has been recently developed by Terumo Corporation. In the present study, we measured the injection forces in PFSs equipped with 24G-29G tapered needle (29G TNN), 27G thin-wall needle (27G TW), and 29G TW using several model and pharmaceutical protein solutions. The injection forces measured in the 29G TNN PFSs were lower than those in 29G TW for all solutions, similar to those in 27G TW PFSs for Newtonian solutions, and were lower than those in the 27G TW PFSs for non-Newtonian solutions which demonstrated shear-thinning behavior. No significant changes in aggregates or micron-size particle concentrations were observed upon injection, regardless of the needle type. Mathematical modeling supported the experimental findings that under similar flow rate conditions injection pressure in a tapered needle is lower than that in a cylindrical needle. Our results indicate that there are advantages of using tapered needles for the injection of biopharmaceutical formulations particularly those showing shear-thinning behavior.
Introduction: Property and Language, or, the Ghost of the Fifth PanelIt is gratifying, hugely flattering, and at the same time somewhat embarrassing to have to open a conference and then a symposium issue on one's own academic work. No doubt understanding this embarrassment, my colleague and good friend Ian Ayres suggested a way out: since the conference was named "The Properties of Carol Rose," I should take the occasion to talk about the various residences I have owned. A great idea, and I did indeed think about it, because as Ian knows, I have had good luck in that dimension, with more than my share of weird and interesting addresses. But as intriguing as Ian's idea would have been, there was really another topic altogether that I thought I should address at the opening of the conference and now this symposium issue. That topic is the Missing Fifth Panel, or as I will sometimes call it in this Introduction, the Ghost Panel.
The Rose Theorem?Law resists theorems. We have hypotheses, typologies, heuristics, and conundrums. But, until now, only one plausible theorem - and that we borrowed from economics. Could there be a second, the Rose Theorem? Any theorem must generalize, be falsifiable, and have predictive power. Law's theorems, however, seem to require three additional qualities: they emerge from tales of ordinary stuff; are named for, not by, their creators; and have no single authoritative form. For example, Ronald Coase wrote of ranchers and farmers. He has always shied away from the Theorem project. When later scholars formalized his parable, they created multiple and inconsistent versions. Likewise, Carol Rose writes rich narratives of maypoles and foxes, rivers and roman roads. She offers a theory of human motivation and predictions about our behavior. And we may ask, though she might not, whether the rich alluvial mud of her scholarship crystallizes into a Rose Theorem.