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Dale Herbranson Ph.D.

VP, Quality, CM

十月 21, 2013

Choosing Delivery Modes: An early decision with down-the-line thinking

At some point early in the development of a drug product, pharmaceutical manufacturers must make a very important choice.  How will the final product be delivered to the patient?  That choice leads to a variety of additional choices regarding drug formulations, stability, container closure systems and the various interactions of the drug with its packaging, and ultimately, patient compliance.

The primary purpose of drug product packaging is to contain and preserve the drug product  through the expiration date.  The packaging selected must do this without interacting with the drug formulation, and without transmitting anything through the packaging (extractables and leachables) or allowing leakage.  Proper packaging can help to maintain the original purity and potency of a drug, as well as aid in the delivery of the drug through physical and functional properties that interact with the delivery system.   Most importantly, the container closure system must do no harm to patients.

Many of the new biological drug products cannot be administered orally.  Choices for primary containment that are made during preclinical and Phase I studies can be extremely important when moving to pivotal clinical trials and commercial production.  Novel materials like cyclic olefin polymers may provide options for containment during the entire lifecycle of the drug product, since the moldable material can be used for bulk storage during development and allow for changes to the mode of delivery further down the line, without changing the container’s contact material.

When selecting packaging for an injectable drug product, manufacturers should consider the following:

Primary Packaging – does this product require glass, plastic or a specialty material?
Formulations – will the drug product formulation react with the packaging (i.e. elastomer formulation)? Will it remain stable throughout the course of its shelf-life?
Volume of Delivery – based on the concentration of the drug product, what size should the dose be? How will it be delivered?  How long will it take to inject?

West can help customers weigh the benefits and risks of material and packaging selection, as well as provide options for delivery that keep the end-user in mind while ensuring that the needs of the pharmaceutical manufacturer and the drug product itself are met.

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