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The recent growth of self-administration devices has provided the opportunity to truly change the landscape in drug delivery. These devices, such as auto-injectors, not only allow for more patient convenience, but also enable different dosing regimens and types of therapies that can now be injected via auto-injector. These advantages are why the auto-injector segment is the fastest growing delivery segment, and the majority of top selling drugs are delivered via PFS/auto-injector.
Given the growth and technical advantages of auto-injectors (safety, dose accuracy, convenience), it is important to optimize the delivery system using various inputs from the drug, container, device, and patient to ensure the target drug delivery system meets the needs of the patient, caregiver or healthcare provider. These various inputs are outlined below.
Drug Product Requirements: These inputs focus on drug product compatibility, sensitivity and complexity. These inputs tend to drive the selection of primary packaging components.
Container Requirements: The requirements for the container can refer to container type (cartridge or syringe), size (i.e. 1mL long, 2.25mL) or material (glass or polymer) and are largely determined by the drug product needs.
Delivery System: Impacting the delivery system are inputs such as volume, viscosity and injection time. Typical drug products delivered via auto-injector in a 1mL long PFS format target a delivery time of 10 seconds or less, and a drug product viscosity of no more than 20cp. Larger delivered volumes or viscosities tend to push the injection time beyond 10 seconds, and the delivery system would need to be modified accordingly or alternative delivery systems such as wearable injectors would need to be explored.
Patient/Caregiver Interface: Considerations for the target patient population or end user provide important insights to be included in delivery system development. Human Factors and other upfront user feedback can prevent missteps during development such as late stage modifications of the delivery system.
With the complexity of drug delivery systems continuing to expand beyond traditional injection systems, it is important to adopt an integrated approach for drug delivery that includes drug product, container, device and patient together to optimize the delivery system for success.
West offers a variety of PFS and containment solutions, including the SelfDose™ manual injector. Learn more about our PFS options here.
SelfDose™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
Extractables and leachables (E&L) pose a potential risk to patient safety. Both pharmaceutical companies and regulatory agencies have rising concerns regarding E&L, which has led the <em>Center for Drug Evaluation</em> under the China Federal Drug Administration (CFDA) to release a new standard for public comment (December 30, 2016): <em>Technical Guideline for Compatibility Study of Chemicals and Elastomer Closures.</em> The compatibility study discussed therein focused on E&L.
While medications can provide life-saving solutions to patients, they can also result in harm to medical personnel who might suffer unintended exposure to potent drugs. The seemingly simple act of placing a syringe needle into a septum-sealed vial can result in inadvertent needle-sticks, with potential drug exposure. Additionally, the transfer of potent chemotherapeutic drugs can result in fugitive droplets or volatilization of the drugs and therefore personnel exposure.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems. This addressed characterizing for biological reactivity, physicochemical testing and functionality testing and compliance was typically a supplier responsibility. The new chapter, USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, will become effective on December 1, 2025. This will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. Under the new chapter, it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system.
The current pharmaceutical market has faced a variety of challenges, including increasing expectations for quality from end-users and regulatory agencies driven by concern for patient safety. While pharmaceutical companies are working to assure that new quality and compliance paradigms are met, a balance must be achieved between the reality of managing costs to provide a product that meets payer’s requirements and facilitating profitability in order to continue adequate business reinvestment.
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