Oral Drug Delivery Articles

1. Need A Drug Delivery Conversation Starter? Try Target Product Profile 5/18/2026

   In this article, Chief Editor Tom von Gunden explores the need for and existence of cross-functional communication during drug product development and delivery device selection. He consults industry veterans with experience in various formulation or delivery roles at GSK and Merck. They identify the Target Product Profile (TPP) as the core concept guiding collaboration. 

2. Treatment Adherence And Designing Therapeutics To Meet Patient Needs 5/6/2026

   Reformulation improves adherence by reducing pill burden and side effects, enhancing real-world usability and align therapies with diverse patient needs.

3. Gaining An Edge In GLP-1 Production 5/5/2026

   The shortage-driven production of GLP-1 drugs of the past few years is giving way to a long-term operation model characterized by digital enablement and supply chain resilience.

4. Patient-Centric Drug Delivery: Do Possible And Preferable Always Align? 4/22/2026

   In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.

5. Beyond Biologics: A Biophysical Approach To Crohn's Disease 4/2/2026

   Research into a nano-amorphous approach suggests a new breakthrough in Crohn’s management may come from a shift toward modulating the biophysical environment of the gut.

6. 3 Emerging Trends In Drug Delivery Device Pipelines 3/18/2026

   When analyzing the drug delivery product pipeline, three key technologies stand out. Check out the latest market research.

7. Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables 3/17/2026

   A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

8. GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products 3/2/2026

   In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions. 

9. Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions 3/2/2026

   In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods. 

10. Rethinking Product Development Through Lipid-Based Formulations 2/24/2026

    Optimization of lipid-based drug formulation, when developed with the correct technology, can lead to major product performance enhancements that benefits patients.