Nitrosamines, Elemental Impurities, Extractables, and Leachables: The Pharma Industry’s New Normal
January 31st 2024Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.
Roller Compaction: New Trends, Challenges and Solutions
June 1st 2023When developing a tablet or capsule formulation, three widely used technologies are often considered to produce solid dosage forms: direct compression, wet granulation and dry granulation (including roller compaction). This article discusses why roller compaction is a robust option.
Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules
June 1st 2023The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this executive summary, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this executive summary includes an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.