Resources/Insights
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Stay informed with expert perspectives, technical articles, and practical tools to guide your pharmaceutical development journey.
At Pyrenees Pharmaceutical CMC Consulting, we believe that knowledge drives innovation. Our Resources and Insights section is designed to support pharmaceutical professionals with valuable guidance on CMC strategies, regulatory compliance, and process optimization.
Explore articles, technical briefs, and thought leadership pieces that reflect over 25 years of combined experience in drug development, manufacturing, and quality assurance. Whether you’re advancing early-stage formulations or preparing for regulatory submissions, our expert insights help you navigate the evolving pharmaceutical landscape with confidence.
Formulation Development – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
A practical look at assessing drug-excipient interactions early in development to ensure stability and formulation success.
Lipid-Based Delivery – Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox?
An overview of lipid-based systems, their role in improving bioavailability, and why they should be considered in modern formulation strategies.
How to Perform Antimicrobial Effectiveness Testing with Lipid-Based Formulations
The Challenge with Lipid-Based Formulations
Standard AET involves introducing an aqueous inoculum containing bacteria, yeast and mold into the formulation, then monitoring microbial counts over time. However, lipid-based formulations pose a unique challenge due to their immiscibility with water, which can result in:
- Poor dispersion of the inoculum, limiting microbial exposure to the preservative system.
- Non-homogeneous sampling, compromising the reliability of microbial recovery.
- False failures, where the formulation appears ineffective due to inadequate exposure rather than true preservative inefficacy.
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