Softgel capsules fast-track the delivery of medication to the bloodstream. Unlike solid pills, they do not need to be broken down by the body before the drugs can be absorbed. Moreover, they are optimal vehicles for oils and fat-soluble formulations that cannot be compressed into tablets.
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Primary ingredients to manufacture a softgel capsule
The essential ingredients of a softgel capsule are gelatin, water, and a plasticizer such as glycerin or sorbitol. The presence of water means that the API formula must not be hydrophilic because it would deteriorate the shell over time.
The capsule is typically transparent, so adding opacifiers protects your fill matrix from sunlight. Preservatives, meanwhile, ensure that your capsules remain free from bacteria. Finally, you may also incorporate colorants and flavorings to make the final product more palatable.
Preparing the gelatin base for softgels
The propensity of gelatin to melt in warm environments and form a gel while it is cooling down makes it an ideal substance for the administration of medication in a liquid or semisolid state.
Gelatin is an effective combining agent that holds the structure of the capsule together. Granulated gelatin is added to a blend of water and plasticizing substance, and the mixture is heated to around 60 °C until the particles are fully dissolved.
Inspect the capsules for air bubbles
Air pockets pose a risk to the production of softgel capsules. Bubbles weaken the structure of the shell and may lead to leakage of the drug.
This manufacturing defect typically occurs when your blending process is not conducted at the right temperature or for a suitable duration. The air inside the base components naturally rises to the surface and escapes the mixture, but inadequate heating leads to trapped bubbles.
Using vegan materials for softgels
You can substitute the gelatin to produce a vegetable-based softgel capsule. Derived from animal bone or connective tissue, gelatin makes traditional formulations incompatible with vegan requirements.
Hypromellose (HMPC) and Tapioca starch present viable alternatives made from vegetable cellulose. Besides using non-animal materials, vegan softgel capsules offer a higher bioavailability rate compared with gelatin options. Their low-moisture content also makes them less brittle in reduced humidity.