Advancing non-destructive analysis of 3D printed medicines

2. May 2023

Pharmaceutical 3D printing (3DP) has attracted significant interest over the past decade for its ability to produce personalised medicines on...

FDA guidance: Continuous Manufacturing of Drug Substances and Drug Products

Continuous Manufacturing of Drug Substances and Drug Products – FDA announces guidance for Industry

13. March 2023

FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products in March 2023. The document...

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

1. February 2023

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to...

Excipients in pediatric dosage forms and related regulatory aspects with review to propylene glycol

18. January 2023

Pediatric formulations often contain excipients with lack of safety and toxicity data based on a unique and daily exposure, duration...

BASF Pharma Solutions excipient accepted into FDA Pilot Program for novel excipients – Press Release

7. December 2022

Florham Park, New Jersey, December 5, 2022 – BASF Pharma Solutions, a global business unit of BASF, announces today that...

Sex-Based Differences in the Biodistribution of Nanoparticles and Their Effect on Hormonal, Immune, and Metabolic Function

2. November 2022

Males and females respond differently to medications due to physiologic, metabolic, and genetic factors. At times, sex-related differences cannot be...

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

1. November 2022

WILMINGTON, Del., Oct. 31, 2022 -- Ashland Inc. (NYSE: ASH) today announced the United States Food and Drug Administration (FDA)...

Modified phase diagram with phase boundaries for fasted and fed state intestinal fluid.

Formulating Drug Products for Optimized Absorption: Elucidating Amorphous Solid Dispersions

8. September 2022

CDER scientists are seeking ways to improve the bioavailability of drugs that on their own do not dissolve well in...

Profiling the Process Development of Wurster Coating for Modified Release Capsule products in Approved Drug Product Applications

1. August 2022

In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to...

An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

19. June 2022

Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing...

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