Oral Drug Delivery Articles

1. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

   The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

2. Understanding Annex 1 For Sterile Medicinal Products 8/4/2025

   In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training. 

3. New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development 7/3/2025

   The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase. 

4. 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. 

5. 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.

6. 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.

7. 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.

8. 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.

9. 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. 

10. 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.