Free E-Book
How softgel capsules are manufactured
Understanding the precision behind pharmaceutical softgel production is essential for pharmaceutical professionals. This free e-book reveals the intricate manufacturing process that combines chemistry, physics, and engineering principles, which directly impacts product stability and bioavailability.
What this free e-book covers:
Complete Manufacturing Process Overview
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.
Gelatin’s Thermoreversible Properties
Gain deep insight into the fundamental property that makes encapsulation possible. Learn how gelatin transitions between sol and gel states, and why precise temperature control is crucial throughout processing.
Shell Mass Manufacturing Essentials
Master the transformation of dry gelatin granules into processable mass. Discover the hot melt process, deaeration techniques, and critical quality controls that ensure consistent ribbon formation.
Fill Mass Manufacturing Strategies
Explore product-specific approaches for direct encapsulation, solution-type fills, and suspension formulations. Understand equipment requirements and critical controls for each formulation type.
From our e-book:
“The beauty and challenge of softgel manufacturing is this: the encapsulation process is standardized, but every fill formulation requires its own customized approach to processing.”
— 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.