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West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics Pharmazeutische Packmittel (Elastomeric Pharmaceutical Packaging).
The chapter discusses the variable nature of medicinal products and their increased risk for potential interactions when coming into contact with materials used for drug product storage or targeted administration. The pharmaceutical industry has high expectations with respect to quality requirements, functional, physical and chemical properties as well as strict regulatory requirements. This has to be taken into account when manufacturing, processing and storing primary packaging that is in direct contact with the pharmaceutical product. The selection of suitable primary packaging according to design, toxicological, chemical and physical properties, and functional criteria is crucial to the successful development of a medicinal product.
<p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director</em><em>, Xavier University.</em></p><p>Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe. But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?</p>
As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it is important to understand the factors that affect the safety, purity and potency of the drug product as it relates to component selection.
West Pharmaceuticals will participate in two poster presentation sessions at the <a href="https://www.pda.org/"><span style="text-decoration: underline;">Parenteral Drug Association (PDA) Annual Meeting</span></a>, taking place March 16-18, 2015 in Las Vegas. During the meeting, West will also showcase innovations in integrated drug packaging and delivery systems that help ensure the quality, safety and efficacy of injectable drug products for pharmaceutical and biotechnology manufacturers worldwide at booth #405.
Want to learn more about quality planning for injectable delivery systems? Join West’s technical experts on April 24, 2012 at the Renaissance Raleigh North Hills Hotel for a free educational seminar.
Biologic drugs, rather than being synthesized from other compounds, are generally made using human or animal proteins. At the molecular level, they’re usually larger and much more complex than regular drugs. Routine oral administration of biologics has not been mastered as there is enzymatic and pH-dependent degradation of drugs in the stomach and intestines. Low permeability of epithelial cells that line the gastrointestinal tract means that proteins and peptides typically have extremely low bioavailability in the range of around 0-2% when taken by mouth.
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