Lonza
Articles
Risk-Based Development Supporting Process Qualification for Spray-Dried Dispersion
November 13th 2024Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products.
Science of Scale for Spray-Dried Intermediates (July 2024)
July 24th 2024Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up-or scale-down-can play a key part in that process. Significant interest has been focused on the science of scale for spray drying, since this process is the leading technology for formulating drugs with slow dissolution rates or poor solubility, which results in low bioavailability. Lonza has over 20 years of experience in the scale-up and scale-down of spray drying processes. To learn more, read our executive summary.
Enteric delivery of my API: How to make it right?
November 15th 2023The enteric delivery of pharmaceuticals has long been a challenge for numerous reasons, including protecting the active pharmaceutical ingredients (APIs) from the harsh environment of the gastrointestinal tract and assuring consistent delivery and dosage in the small intestine. This paper reviews the challenges and the science that shows Lonza’s proposed hard capsule solution has been validated to provide acid protection, customization, and scalability.
From Powder to Particles - Inhalation Particle Engineering With Jet Milling
September 25th 2023Jet milling is a well-established particle engineering technique for producing micronized powders with controlled particle size distribution and increased surface area. This makes them suitable for inhalation drug delivery. However, successful implementation of jet milling requires a robust Quality by Design (QbD) approach that ensures the critical quality attributes of the micronized particles are maintained throughout the process development. This episode will cover the principles and intricacies of the jet milling process. It will also highlight some of the challenges when micronizing for inhalation delivery, and give some possible solutions. A case study will demonstrate a reliable process development strategy using a QbD approach for micronizing nilotinib, an API with potential for the treatment of severe chronic asthma. It will highlight the significance of implementing a QbD approach, and its benefits in process development. Overall, this presentation aims to provide valuable insights into the jet milling process and QbD approach for inhalation drug delivery and their potential applications in drug development.
