Excipients

Stability in mRNA-LNP Formulations

April 15, 2023

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Quality Challenges Associated with Cryo/Lyoprotectants

April 03, 2023

Impurities and batch-to-batch variability present the biggest challenges.

Excipients Impact Stability in mRNA-LNP Formulations

March 03, 2023

Lipids aren’t the only important ingredients influencing stability and in vivo performance.

Drug Solutions Podcast: Progressing Excipients Through Review

February 21, 2023

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Excipients for Solubility Enhancement of Parenteral Formulations

November 03, 2022

High-concentration injectable formulations present unique challenges.

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

November 01, 2022

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

Roquette Launches Next-Generation Direct Compression Solutions

October 31, 2022

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

Emerging Applications of Vitamin E TPGS in Drug Delivery

October 15, 2022

The author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.

Roquette Acquires Indian Excipient Manufacturer

September 27, 2022

Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.

Mitigating the Risk from Excipient Variability

August 03, 2022

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.