The rise of self-administration

Today, because of cost constraints and the introduction of maintenance-type drugs for treating chronic conditions such as arthritis, cancer, multiple sclerosis and other diseases that require frequent medication, health care revolves around the home. Many of the maintenance therapies are delivered by injection, driving a need for patient-friendly administrations systems. These systems have to ensure the potency of the drug, be tamper-evident, help deter counterfeiting, promote compliance with a dosing regimen, assure dosing accuracy, be safe and easy to use and as pain-free as possible.

An outgrowth of these changes is the move from the typical vial and disposable syringe to a prefillable syringe. With prefillables, dosing accuracy is assured. However, prefillables present some challenges for the industry. For the pharmaceutical company, the need is for a prefillable system that protects the integrity of the packaged drug product over time and will function as represented over the full shelf life of the drug. The response from component manufactures was the development of syringe plungers with barrier films that minimize the interaction between the packaged drug and the components. At the same time, they have developed elastomers for molded plungers that maintain functional properties such as seal integrity and breakloose and extrusion forces. Breakloose is the initial force it takes to move a plunger. Extrusion is the force it takes for the plunger to travel down the barrel of a syringe.

When self-administered drugs are in lyophilized or dry powder form, manufacturers must find methods or packaging systems that help to prevent accidental needle stick injuries, incomplete mixing, inaccurate dosing and drug spray-back. Manufacturers familiar with the drug administration process need to provide delivery systems that will simplify drug reconstitution, especially for non-professional care givers.