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Lyophilization (freeze drying) is the process of dehydrating a drug product at low temperature and reduced pressure. Absent water, degradation processes are greatly reduced; thus, it helps to enhance drug product stability. Moisture-sensitive drug products are often marketed in lyophilized form. For a primary package system, the selection of appropriate components is essential to prevent risks associated with alteration of the lyophilized drug product prior to reconstitution and use.
One of the critical success factors for a primary package system is protection against product degradation caused by moisture. Moisture can reach a lyophilized drug product in a variety of ways, including:
To help reduce these possibilities, the following aspects should be considered:
West’s AccelTRA® components employ a newly developed elastomer formulation, 4031/45G, which has a low MVTR. Stopper components have excellent container closure integrity (CCI) performance with glass vials that comply with the ISO standard. For more information on how AccelTRA components can help to protect lyophilized drug products, contact an Account Manager or Technical Customer Support (TCS) representative.
AccelTRA® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Parenteral drugs that are moisture sensitive are produced in a lyophilized state to protect against product degradation caused by moisture. As a result, when considering the stability and shelf life of lyophilized drugs, the residual drug moisture content is critical. It is also a crucial component in the dossier submitted for regulatory filing, which begs the question: How shall the moisture level in the lyophilized drug product cake be maintained during the drug product’s shelf life?
Some pharmaceutical substances, such as proteins, monoclonal antibodies, enzymes, and vaccines, are unstable in solution. They can degrade, for example by enzymatic or hydrolytic reactions. Lyophilization (also called freeze-drying) is the most common approach to address this.* Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. Absent water, the rates of degradative enzymatic/hydrolytic processes are reduced substantially, and thus drug product stability is improved.
<p><em>Dr. Heike Kofler, Amy Miller, Jennifer Riter<br /></em><em>West Pharmaceutical Services, Inc.</em></p><p>One of the critical success factors for packaging lyophilized drugs is protection against product degradation caused by moisture. Moisture can be introduced into a lyophilized drug product cake from the elastomeric stopper and from the atmospheric headspace; it can also permeate through the stopper, a process known as moisture transmission.</p>
Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (<em>freeze-drying</em>) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
Lyophilization is widely used for pharmaceuticals to help preserve parenteral drugs that are unstable in liquid formulation, particularly biologics. Lyophilized drugs have many advantages like prolonged shelf life, easy dissolution and good stability. However, a suitable container closure system is necessary to ensure the successful lyophilization of pharmaceutical products while maintaining product quality.
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