Oral Drug Delivery Videos

31. How High Drug Load Nanocrystalline Tablets Lower Pill Burden 3/12/2025

    We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.

32. Oral Peptide Delivery with Protagonist Therapeutics' Dinesh Patel 8/22/2024

    To stab or to swallow? For treating conditions in the I&I (immunology and inflammation) space – think psoriasis, as one common example – some see the holy grail of delivery as moving from injectable to oral administration. In this inaugural episode of Sit and Deliver, host Tom von Gunden invites Dinesh Patel, president and CEO at clinical stage biotech company Protagonist Therapeutics, to deliver the rationale for targeting I&I diseases and other therapeutic areas with oral peptides.

33. An EDDO Identification Tutorial For An On-Body Injector (OBI) 4/23/2025

    In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for an on-body injector (OBI) to demonstrate a template for identifying EDDOs.

34. What Happened to CAPA (Corrective and Preventive Actions) Requirements? 7/11/2024

    Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.

35. Risk Management and the New QMSR 7/11/2024

    What changes in approaches to risk management will the addition of ISO 14385 trigger? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses when and how organizations will now need to address risk management within the context of design development and controls.

36. Developing And Manufacturing Minitablets To Extend Drug Lifecycle 1/27/2025

    Pharmaceutical companies should leverage oral minitablets to extend drug lifecycles, optimize dosing, and improve patient-centric solutions while overcoming manufacturing challenges.

37. The Regulatory Intent Of A URRA For Combination Products 12/11/2024

    To what extent are approaches to conducting risk assessments specified in the FDA URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers context-setting perspective on what FDA is looking for when reviewing URRA compliance.

38. What Types Of Products Are Assessed With A URRA? 12/11/2024

    What types of products in development may need to be assessed in accordance with the FDA’s URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, describes several common scenarios that illustrate when a URRA approach may or may not be needed.

39. Partnering On Patient Needs With DSM-Firmenich's George Mihov And Lukasz Koroniak 10/23/2024

    Principal Scientist George Mihov and Global Biomaterials Director Lukasz Koroniak from DSM-Firmenich join Supplier Horizons host Tom von Gunden to discuss partnering with pharma on formulation development. Among the topics covered are translational research, materials development, and complex molecules required for biologic-based therapies.

40. Dramatic Reduction Of Solvent Usage In Pharmaceutical Spray Drying

    Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).