Bilcare says about the future of pharmaceutical packaging innovations

A changing pharmaceutical industry

Changes in pharmaceutical industry research and manufacturing technologies have driven significant developments in packaging and delivery systems. An increase in the number of large-molecule, bio pharmaceutical drugs in development pipelines has led to an increase in the need for injectable packaging and administration systems. The old glass and elastomer closure systems may not provide the effective barrier properties needed for high-value, life saving therapies. Component manufacturers have responded with new materials and technologies that ensure extended drug-product shelf-life. Many new biotechnology-derived drug therapies are unstable in liquid form and therefore are introduced as lyophilized or dry powder dosage forms. Lyophilized drugs need special stoppers for optimal performance in lyophilization chambers. The stoppers must solve the problem of the stopper sticking to the lyophilization shelf after the cycle is completed. In addition, lyophilized drugs typically are reconstituted at the point of care, thus requiring patient-friendly administration systems.

The increase in self-administered therapies

Decades ago, healthcare revolved around hospital care. Today, healthcare often revolves around the home - a situation that has largely resulted from 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. Many of these maintenance therapies are delivered by injection, spurring a need for patient-friendly administration systems. These systems must ensure the potency of the drug, be tamper-evident, help deter counterfeiting, promote compliance with a dosing regimen, ensure dosing accuracy, and be as safe, easy to use and painless as possible.

An outgrowth of these changes is the move from the typical vial and disposable syringe to the prefillable syringe. With prefillables, dosing accuracy is ensured but they present some challenges for the industry. A pharmaceutical company needs 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 product. The response from component manufactures was to develop syringe plungers with barrier films that minimize the interaction between the packaged drug and the components. At the same time, the industry has developed elastomers for molded plungers that maintain functional properties such as seal integrity, and break-loose and extrusion forces.

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