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Lyophilization removes water from a drug product through three phases: freezing, primary drying or sublimation, and secondary drying or desorption. To begin the process, the drug product is frozen and then placed under a vacuum, which allows the ice to change from solid to vapor without passing through a liquid phase.
The process typically includes the following phases:
According to the FDA, lyophilization has many advantages, including enhanced stability, extended shelf-life while maintaining potency, increased resistance to changes in temperature, and rapid and easy dissolution of the reconstituted drug product. However, the process requires increased handling and processing time, and can be complex and costly – particularly if the materials selected for the primary container are not consistent or interfere with the lyophilization process. The proper selection of a lyophilization stopper manufactured with Quality by Design (QbD) principles can help to ensure that the freeze-drying process moves smoothly while preventing and/or reducing potential contamination from the atmosphere or the container closure system.
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
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.
<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>
Lyophilization (freeze drying) is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products (> 400 FDA-approved); because absent water, the rates of degradative processes are reduced substantially. Essential to successful lyophilization, and subsequent rehydration, are use of proper containment and reconstitution systems. <br />
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.
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