title: Variability in syringe components and its impact on functionality of delivery systems.
abstract: Prefilled syringes and autoinjectors are becoming increasingly common for parenteral drug administration primarily due to the convenience they offer to the patients. Successful commercialization of such delivery systems requires thorough characterization of individual components. Complete understanding of various sources of variability and their ranking is essential for robust device design. In this work, we studied the impact of variability in various primary container and device components on the delivery forces associated with syringe injection. More specifically, the effects of barrel size, needle size, autoinjector spring force, and frictional forces have been evaluated. An analytical model based on underlying physics is developed that can be used to fully characterize the design space for a product delivery system.
  Use of prefilled syringes (syringes prefilled with active drug) is becoming increasingly common for injectable drugs. Compared to vials, prefilled syringes offer higher dose accuracy and ease of use due to fewer steps required for dosage. Convenience to end users can be further enhanced through the use of prefilled syringes in combination with delivery devices such as autoinjectors. These devices allow patients to self-administer the drug by following simple steps such as pressing a button. These autoinjectors are often spring-loaded and are designed to keep the needle tip shielded prior to injection. Because the needle is not visible to the user, such autoinjectors are perceived to be less invasive than syringes and help the patient overcome the hesitation associated with self-administration. In order to successfully develop and market such delivery devices, we need to perform an in-depth analysis of the components that come into play during the activation of the device and dose delivery. Typically, an autoinjector is activated by the press of a button that releases a compressed spring; the spring relaxes and provides the driving force to push the drug out of the syringe and into the site of administration. Complete understanding of the spring force, syringe barrel dimensions, needle size, and drug product properties is essential for robust device design. It is equally important to estimate the extent of variability that exists in these components and the resulting impact it could have on the performance of the device. In this work, we studied the impact of variability in syringe and device components on the delivery forces associated with syringe injection. More specifically, the effect of barrel size, needle size, autoinjector spring force, and frictional forces has been evaluated. An analytical model based on underlying physics is developed that can be used to predict the functionality of the autoinjector.
authors.affiliation: Drug Product and Device Development, Amgen, Thousand Oaks, CA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Rathore
authors.forename: Pratik
authors.initials: P
authors.lastname: Pranay
authors.forename: Bruce
authors.initials: B
authors.lastname: Eu
authors.forename: Wenchang
authors.initials: W
authors.lastname: Ji
authors.forename: Ed
authors.initials: E
authors.lastname: Walls
mesh_terms: D016503:Drug Delivery Systems / Q000295:instrumentation; D004867:Equipment Design; D006801:Humans; D007267:Injections / Q000295:instrumentation; D009339:Needles; D004364:Pharmaceutical Preparations; D012646:Self Administration; D013594:Syringes
chemical_list: D004364:Pharmaceutical Preparations