We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
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.
To characterize the stability profile of a drug product, there is a focus on critical quality attributes (CQAs). For lyophilized drug products, one of the CQAs is “residual moisture content”. To maintain the optimal low moisture level over a lyophilized drug product’s shelf life, it is important to understand the properties and limitations of the primary containment system, i.e., the ability to restrict moisture ingress into the vial.
A first requirement for a primary containment system is proper fit of vial and elastomer stopper. This promotes container closure integrity, which is essential to preventing moisture ingress. A second requirement is suitable dryness of the stopper. Many stoppers are sterilized by autoclave/steam, which results in moisture absorption. Stoppers will not suitably dry during lyophilization. A separate, validated, drying step is needed, e.g., approximately 8 hours at 105oC. Note that over-drying is not acceptable, as degradation or alteration of the extractable and leachable profile may result. A third requirement is selection of the proper stopper, more specifically the proper elastomer formulation. Every formulation has a characteristic moisture vapor transmission rate (MVTR); one with a low value should be selected. For example, chlorobutyl rubber is 0.3 g/m2-day, as compared to natural rubber which is 9.0 g/m2-day.
For more on selecting vial containment systems for lyophilized drug products, contact an Account Manager or Technical Customer Support (TCS) representative.
*. Container and Reconstitution Systems for Lyophilized Drug Products. P. McAndrew, D. Hostetler, F. DeGrazio. Lyophilization of Pharmaceuticals and Biologicals (ISBN 978-1-4939-8927-0). K.R. Ward and P.Matejtschuk, Eds., Humana Press, 193-214 (2019)
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?
<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 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.
On July 3, 2013, Novartis issued a <span style="color: #0000ff;">voluntary recall</span> of its Menveo<sup>®</sup> vaccine. Menveo is a lyophilized meningococcal vaccine used against <em>Neisseria meningitidis</em>, a bacterium that causes meningitis, meningococcemia and septicemia, and rarely, carditis, septic arthritis or pneumonia.
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.
English
Chinese
