Functionality and Performance
Good patient outcomes depend upon performance of the drug product delivery system – both ease of use and reliability of delivery. Achieving these requires proper design and materials selection, and extensive testing – employing Quality by Design principles where possible. This section presents papers that consider these topics.
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Data shows component conformance regarding dimensional tolerances, piston/cartridge fit, fragmentation, resealability, and initiation and travel forces.
Examination of CZ syringes delivering various fill volumes and dispensing high viscosity solutions typical of high concentration biologic formulations.
Studies were performed to compare these flange strength and dimensional variability of CZ 1mL long syringes versus glass 1mL long syringes.
1-3 mL NovaPure® plungers can deliver a more consistent injection rate and help ensure patients receive accurate dosing of their treatment regimen.
This study examines the stability of pistons in CZ cartridges at pressures similar to those of extreme transportation scenarios.
<p>The design of a plunger has a significant influence on its performance as part of a glass syringe system in an auto-injector. Performance improvements can be examined by measuring the precision and accuracy of volume and times of injection; however, break-loose and extrusion curves, while providing critical information, can be difficult to quantify. Here, we compare two 1 mL Long plungers: legacy vs plunger developed with quality by design (QbD) principles. Performance of the two plungers were evaluated by testing in a spring-loaded model auto-injector system using three different viscosity solutions. Parameters compared were: volume; time of injection; break-loose/extrusion profiles; and Area under the Curve analysis (AUC, derived by using an EXCEL® macro written to derive energy of extrusion from BLE profiles).The QbD plunger displayed a lower break-loose force than the legacy plunger and required overall less extrusion energy at lower viscosities. It also produced more consistent values in both delivery time and volume; this effect was also most pronounced with high viscosity placebo solutions. This study illustrates the principle of how syringe system performance can be affected by component design, and how applying a new way of visualizing/quantifying traditional measurement methods can shed light on component improvements.</p>
NovaPure® 1 mL Long plungers were developed with the Quality-by-Design (QbD) method for use in pre-filled syringes – especially those coupled with autoinjectors. Present work is a 1-year study examining performance with placebos of different viscosities (1, 8, 15 cps) in a laboratory configuration that replicates an autoinjector. Parameters evaluated are: delivery time; delivery volume; initiation/sustaining force. Legacy comparison is FluroTec® 2340 1 mL Long plunger.
Study compares package integrity of glass and plastic PFS for piston movement and CCI under simulated transport conditions.
Compares performance of NovaPure to legacy plungers with varying lubricities, fluids, and rates to simulate different types of delivery systems.<br />
Presentation demonstrating how using Quality by Design can be applied using a systematic approach and how statistical data can drive product decisions.
This case study can help to understand options when selecting syringe platforms to mitigate quality risks from drug development through commercialization.
Providing superior quality products using technology investments by involving robust control strategies and the introduction of next generation elastomer components.
Details on what is meant by a Quality by Design approach and its benefits.
Creating a sound combination product testing strategy requires a scientific approach and thorough risk management consideration; it can also benefit from guidance from widely accepted standards. Having an early understanding of inherent product risks as well as industry testing trends, standard practices, and regulatory requirements will reduce time to market and product launch false starts. The end result is high quality, high reliability products that are low risk to clinicians and ultimately to the patient.
Discusses the differences between Coring and Fragmentation of Elastomeric Closures and contaminations that can occur as a result of these two phenomena. <p><em><em>By: Jia Min Boo</em></em></p>
This article discuss how interaction of drug product and drug product excipient with silicone oil in a pre-filled syringe can affect break loose and glide force performance.<br /> <br /> <em>G. Shi, et al. PDA J Pharm Sci Technol, 72(1), 50-61 (January/February 2018)</em>
Administration of drug products in pre-filled syringes is becoming ever more prevalent based on ease of use – either via self-administration or a clinician. This document specifies requirements for pre-filled syringes regarding quality, functional performance, safety, and relevant test methods.
Prefilled Syringe Small Molecule Market (Therapeutic Class - Neurology Drug, Cardiovascular Drugs, Analgesics, and Adjuvants) - U.S. and EU-5 Industry Analysis, Size, Share, Growth, Trends, and Forecast 2016 - 2024
This summary discusses projected growth (by indication) in pre-filled syringe use for small molecules in US and Europe through 2024. Combined annual growth rate (CAGR) is projected at 6 – 8%.
<p>This paper considers the effects of container and device components (i.e., barrel size, needle size, autoinjector spring force) on syringe performance in an automated delivery system. A model considering the basics physics is used to correlate the data.</p> <p> <em>N. Rathore, et al. PDA J Pharm Sci Technol, 65, 468-480 (September/October 2011) - (available to PDA members – nonmembers may download for a fee) </em></p>
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