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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.
When you think of injectable medication, a classic image may include a set of hands holding both a vial and a syringe to withdraw medication prior to injection. Advances in both drug products and self-injection options – including auto-injectors, pens and other self-injection devices – have helped to draw a new picture for injectable delivery.<br />
It can take more than 12 years and a major financial investment to bring a drug product to market.<sup>1</sup> A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of patient adherence. The importance of container closure and delivery systems as critical to success in the pharmaceutical industry is becoming more visible especially in respect to pharmaceutical and biotech organizations that desire to proactively minimize their risks.
The number of biologic drug products marketed with an injection device has approximately quadrupled over the last decade. The growth in these drug therapies has been driven by several factors including new, self-administered therapies for chronic conditions such as rheumatoid arthritis and autoimmune diseases. In addition, injectable therapy is now being considered as a treatment for more conditions, including asthma and cholesterol problems.
In a previous <a href="/blog/2012/may/lifecycle-planning"><span style="text-decoration: underline;">post</span></a>, my colleague Fran DeGrazio discussed lifecycle planning and the use of a single material for packaging components from development through commercialization. There has been a great deal of innovation around drug container materials. Although glass has been the traditional material of choice for drug containment, it has significant limitations including breakage, glass particulate, visual quality and functional performance.
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.
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