Oral Drug Delivery Articles

  1. The Key to Regulatory Innovation? Global Harmonization 6/4/2024

    Innovation in drug development and delivery is often thought of as purely a technical matter. In this article, Fran DeGrazio illustrates why innovation must also be applied to regulatory practices. 

  2. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

  3. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  4. The EU's Ban On TiO2 In Food May Impact Pharma. Here's What You Should Know. 4/18/2024

    Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.

  5. Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms 4/16/2024

    Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.

  6. Osmotic Controlled Release Oral Drug Delivery: A Closer Look 2/2/2024

    Osmotic controlled release drug delivery is not often spoken about, but it is a useful oral drug formulation technology. This article shares the mechanisms of the elements of oral dosage, including the semi-permeable membrane, pore-forming agents, and more, as well as advantages and applications of this type of drug delivery.

  7. Liposome Drug Delivery: Global Trends & Market Forecast 1/19/2024

    Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.

  8. 4 Strategies To Formulate Poorly Soluble APIs 12/18/2023

    One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies.

  9. Best Practices For Preformulation In Drug Development 12/14/2023

    Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

  10. Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges 11/7/2023

    Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.