ARTICLES BY RAJENDRAN (RAJ) ARUNAGIRI

• 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.

• 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

  3/6/2024

  On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.

• 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.

• 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.

• 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 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities

  6/12/2023

  The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.

• 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.