Excipients

Pharmaceutical excipients, which can be functional or inactive ingredients, work to enhance the medically relevant properties of the API. When used to promote ingredient qualities, excipients can be an asset for formulators to increase stability, bulk up the formulation, or enhance the therapeutic effects of the API. Below you can explore helpful resources including editorial coverage and webinars related to pharmaceutical excipients.

  • Don’t Stop Thinking About Tomorrow

    My initial exposure to sterile product manufacturing was back in 1973 when I first observed the aseptic filling of small volume parenterals. The image is one the reader is likely quite familiar with: aseptically garbed operators wearing face masks, goggles and sterile gloves separated from a filling line covered by HEPA filters by flexible curtains... read more
  • Disinfect, Autoclave or Use Multiple-Bagged Disposables? Moving Materials into Controlled Areas Safely and Efficiently

    Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the greatest sources of contamination in the manufacture of sterile pharmaceuticals. To minimize the potential for adverse effects on patients, cGMP and EU GMP regulations have been tightened. Transfer procedures are complex, with materials typically having... read more
  • Process Capability to Ensure Product Quality

    Quality by Design (QbD) is a concept first developed by the quality pioneer Joseph M. Juran. Juran believed that quality should be designed into a product and that most quality crises and problems relate to how a product was designed in the first place. A high-quality drug product is a product free of contamination and reliably delivers the ... read more
  • Hydroxypropyl Cellulose for Orally Disintegrating Film Drug Application

    Hydroxypropyl cellulose (HPC) is a water-soluble polymer that has film formation properties with excellent plasticity. Its hydroxypropyl groups drive the solubilization of the cellulose thus hindering the hydrogen bonding of the hydroxyl groups. In this study, we evaluated the applicability and effectiveness of HPC in Orally ... read more
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