Oral Drug Delivery Articles

41. 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.

42. 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.

43. 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).

44. 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.

45. 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.

46. 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.

47. A Star Is Born To Deliver Drugs: Can It Be Outsourced? 8/15/2022

    A miniature manmade “star” – with round middle and triangular arms – collapses to fit into a capsule and provides patients an oral drug. The creators of this device-like drug are devoted to production through continuous manufacturing. Can the company also outsource some of what they've developed internally?