by Softgel capsules, also known as soft capsules, are a type of capsules used for pharmaceutical and nutraceutical products that are filled with liquids, creams or other semisoft materials. Unlike traditional hard capsules which are usually made from either gelatin or hypromellose, softgels have a soft, elastic outer shell that allows the contents to be easily swallowed. The softgel capsule shell is typically made from glycerin and water along with other ingredients like animal or plant derived gelatin. These ingredients allow the softgel capsule to dissolve rapidly in the stomach for improved absorption of the active contents.
Advantages of Softgel Formulation
Some key advantages of the softgel formulation over traditional hard capsules include:
– Easy swallowing: The soft outer shell makes Softgel Capsule much easier to swallow compared to hard capsules. This improves patient compliance especially in pediatric or geriatric populations.
– Rapid gastric emptying: Softgels dissolve quickly in the stomach within 10-20 minutes, allowing faster delivery of the contents compared to enteric coated or sustained release hard capsules that may take over an hour to dissolve.
– Increased bioavailability: Because of the rapid dissolution, softgels are able to improve the absorption of lipophilic ingredients that would otherwise have low bioavailability if taken in tablet or hard capsule form. This allows use of lower doses to achieve the desired therapeutic effects.
– Compatibility with oils: Softgel shells are compatible with liquid or oil-based fill ingredients compared to hard shells that can leak or deteriorate when containing oils. This allows formulation of oil soluble vitamins and nutraceuticals.
– Moisture protection: The softgel outer shell acts as a moisture barrier and oxygen barrier, protecting sensitive contents from degradation due to external factors like humidity.
Softgel Manufacturing Process
The manufacturing process of softgels involves several steps to produce the gelatin based outer shell and fill it with the desired ingredients:
– Shell formulation: The gelatin shell ingredients like glycerin and purified water along with additional components are precisely weighed and mixed under heat to create a homogeneous mixture.
– Shell massing: The warm gelatin mixture is passed between two rollers to form thin gel sheets. The sheets are then cut into small cylindrical shapes called plaques using steel dies.
– Plaque drying: The cut plaques are dried in specialized drying tunnels to form sturdy but flexible softgel shells.
– Filling: In a separate process, the liquid, semi-solid or powder fill material is precisely weighed and transferred using automated machinery into the dried softgel shells.
– Sealing: The open ends of the filled softgel shells are hermetically sealed using compression to fuse the edges together and form an intact capsule.
– Curing: The sealed softgels undergo curing to allow the gelatin shell to develop optimal mechanical properties and brittleness for storage and handling.
– Inspection and packaging: Finished softgels are visually inspected, counted and packed into bottles or blister packs ready for commercial distribution and consumption.
Strict quality controls are implemented during each step to ensure product uniformity and integrity according to cGMP standards. Automated machinery also enhances production efficiency and precision.
Common Softgel Applications
Given their versatile formulation, softgel capsules are widely used in dietary supplements, nutraceuticals and pharmaceutical products:
– Fat-soluble vitamins: Vitamins A, D, E and K are commonly formulated in softgels due to their oil-soluble nature and poor absorption in otheroral dosage forms.
– Fish oil: Omega-3 fatty acids from fish oil are efficiently delivered via the softgel to provide cardiovascular and cognitive benefits.
– Probiotics: Certain probiotic strains require an immediately disintegrating format and are protected from stomach acid in softgels.
– Enzymes: Digestive enzyme supplements use the softgel to protect the enzymes from degradation in the stomach.
– Cannabidiol: CBD oil from hemp extract is effectively dosed using the softgel to improve bioavailability of this therapeutic compound.
– Coenzyme Q10: This vitamin-like compound with mitochondrial support activity is ideally formulated in a softgel to promote absorption.
The softgel capsule offers formulation scientists and supplement manufacturers a unique dosage form for optimized delivery of both hydrophilic and lipophilic active ingredients. Features like easy swallowability, rapid dissolution and compatibility even with oils make it an attractive choice. Modern softgel technology will continue to evolve in order to provide convenient, accurate and stable dosing of valuable nutrients to health-conscious consumers.
