Oral Drug Delivery Articles

  1. Drug Delivery Innovation: If You Build It, Will Anyone Care? 7/1/2025

    In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace. 

  2. Sorriso's Path To Oral Biologics Dosing Is Through The Gut 6/30/2025

    Following positive results from a Phase 1b trial, company leaders describe scaling their yeast expression and spray-drying processes as they prepare for Phase 2.

  3. From Matrix To Medicine: New Frontiers In Treating Pulmonary Fibrosis And PH 6/25/2025

    Halo Biosciences is building a pipeline based on novel insights into how extracellular matrix dysregulation drives disease. We caught up with its leaders to discuss their approach to drug targeting and early development.

  4. Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet 6/19/2025

    This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.

  5. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

    Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

  6. 3 Lesser Known Keys To Effective Biopharma Supplier Engagement 6/4/2025

    In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

  7. Design Controls For Drug Delivery Devices, Part 2: A Practical Perspective 5/1/2025

    In this article, Fran DeGrazio provides recommendations for implementing Design Controls in the development of combination products and other drug delivery devices. In outlining tips for drug-device product developers, Fran focuses on key considerations including risk management, chemical and functional compatibility, and regulatory compliance.

  8. Oral Therapies Take Center Stage For PsO And PsA Treatment 4/1/2025

    The recent American Academy of Dermatology 2025 Annual Meeting in early March saw major updates for two key oral therapies in autoimmune diseases.

  9. Use-Related Risk Analysis: Considering The FDA Guidance On URRA 2/5/2025

    The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA. 

  10. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.