ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery

  Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

• Have You Selected The Right Stopper For Your Lyophilized Drug Product?

  Component selection is a complex process. Packaging considerations should occur concurrent with drug development to mitigate risk at every step of the drug development process.

• Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control

  In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.

• Masking Bitter Drug Taste In Pediatric Formulations With Microcaps

  The challenge was developing a taste masked, convenient dosage formulation of a very bitter API for patients two-years old and older undergoing treatment of HIV infection.

• Decoding the FDA Guidance on Essential Drug Delivery Outputs

  The FDA’s draft guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products discusses general concepts around essential drug delivery outputs (EDDOs). The guidance’s potential impact spans several device development topics, including design outputs, verification/validation, and control strategy.

• Spray Drying: Advantages And Disadvantages

  When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.

• Impact Of Post-Covid Literacy Decline On Medical Device Studies In Youth

  Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• When Glass Vials Fail At Low Temps, Consider A Cyclic Olefin Polymer System

  If the glass vial for a biologic drug experiences breakage, or does not maintain container closure integrity, a cyclic olefin polymer (i.e., Daikyo Crystal Zenith COP) system may be the solution.

• The Path To Commercialization For Wearable Drug Delivery Devices

  Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.