Oral Drug Delivery Articles

  1. Emerging Market Trends For Drug Delivery Devices 10/5/2023

    The market for drug delivery devices is growing and it is estimated to reach a market size of $541.5 billion by 2035. This article shares new market research, including segmentation by product type (inhalers, smart pills, drug-eluting stents, and more), routes of administration, regional analysis, and more.

  2. 4 Tips To Leverage Your Ingredient Supplier For Faster Formulation 8/3/2023

    Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.

  3. 6 Emerging Trends In Pharmaceutical Tablet Coatings 6/26/2023

    Tablet coatings have evolved to play a pivotal role in improving the overall appearance, functionality, and stability of tablets. Here are six emerging trends and a look at the overall tablet coatings space.

  4. FDA's Digital Health Technologies Framework Addresses Important Challenges 5/16/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  5. A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms 5/16/2023

    The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.

  6. Addressing 3 Challenges Of Developing Or Using A New Excipient 5/8/2023

    As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.

  7. The Discriminative Power Of Dissolution Methods In The US & Europe 2/22/2023

    The discriminatory power is a factor that may be game changing for dissolution testing of immediate release tablets in quality control or R&D. Let's examine the American perspectives (FDA and USP) and the European perspective (EMA).

  8. EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products 1/18/2023

    The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.

  9. Prince Of Spray Drying Returns As Earl Of Dispersion 12/7/2022

    Tim Scott traces the arc of spray drying from its advent to today’s advanced amorphous dispersion technology. Now he's back at it again, pushing the technology to even higher levels of accessibility and productivity.

  10. FDA Releases Guidance On Drug Products Containing Nanomaterials 11/18/2022

    In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.