Free E-Book
Most common quality issues in soft capsules
Quality issues in soft capsules can potentially impact the quality, safety and efficacy of your products. This free e-book gives a comprehensive overview of the most common defects, their typical root causes, and practical strategies for addressing them — essential reading for formulation and quality professionals.
What this free e-book covers:
Leakage and Crosslinking
Understand the four interconnected stages of softgel production, from shell and fill mass preparation through encapsulation to drying and finishing. Learn why each stage requires specialized equipment and precise control.
Crystaliization and content uniformity
Explore how water migration affects drug solubility and bioavailability, and why suspension homogeneity during encapsulation is critical for consistent dosing.
Shell Defects
Discover how excess or insufficient plasticization, improper drying, and storage conditions lead to shell-related defects — and what to do about them.
Root Cause Analysis and Troubleshooting
Learn a systematic approach to investigating multifactorial defects. Understand how formulation, process, and environmental factors interact across the entire softgel lifecycle.
From our e-book:
“Quality issues in soft capsules often have multifactorial root causes. Any investigations should be conducted thoroughly and considering the complexity of the dosage form.”
— Yanitsa Miteva, Founder and CEO of The Science of Softcaps
Why work with us
Despite a century of industrial production, softgel capsules remain poorly understood. Each formulation presents unique challenges, demanding expertise in excipients, processes, analysis, and regulations for success. Bringing together the best practices in soft gel development, we stand as independent experts with real solutions.
Mitigate softgel capsule quality control risks
Avoid common compatibility issues in soft capsules, such as crosslinking, migration, and drug crystallization, by adopting a systematic approach to shell formulation development that considers the complex interactions between the shell and the fill.
Become the expert for your soft gel product
We support you in conducting a comprehensive risk analysis, considering the drug substance and fill formulation characteristics, and performing formulation screening through encapsulation trials to evaluate compatibility and stability. Our expertise empowers you to develop a robust and compatible softgel product.
Prepare state-of-the-art CMC documentation
Leverage our specialist knowledge to ensure your softgel product meets regulatory expectations. We help you define the critical quality attributes of the capsule shell and drug product, and prepare the necessary CMC documentation for your regulatory filings.
Partner with top-tier quality control experts
Benefit from our deep understanding of raw materials, including gelatin types and plasticizers, and their impact on capsule shell properties, processability, and compatibility with the fill formulation. We help optimize your shell formulation to ensure product stability and performance.
Tell us about your project.
Our team of softgel capsule experts is standing by to help you on your journey.