Soft Gelatin Capsules (Softgels)
Soft Gelatin Capsules (Softgels) They are drug delivery systems made of a liquid or a semisolid matrix inside a one-piece outer gelatin shell. Ingredients that are solid at room temperature can also be encapsulated into softgels, provided that they are at least semisolid at approximately 45oC. The drug itself may be either in solution or in suspension in the capsule-fill matrix. The fill matrix maybe hydrophilic (polyethylene glycols) or lipophilic (triglyceride vegetable oils).
Comparison between hard gelatin capsules and softgelsSoftgelsHard gelatin capsulesSingleTwoPiecesUsually semisolid and liquids, solids possible even a tablet can be encapsulated (Gel-Tab)Usually solids, semisolid and liquids possibleFill materialManyLimitedShapePlasticized and highly elasticNot-Plasticized, moisture makes it not brittlePlasticizationHermitically or inherently sealed (two halves of gelatin are fused during encapsulation by heat and pressureTraditional friction fit, interlocking, or liquid sealing ClosureShell manufacture and filling are performed in one processShell manufacture and filling are performed in completely two different processes Manufacturing1-3%2-5% with modern automatic machinesFill accuracy
Drug delivery systems Softgels can be formulated and manufactured to produce a number of different drug delivery systems: Orally administered softgels (easy to swallow, convenient dosage form). Chewable softgels (highly flavoured shell is chewed to release the drug liquid fill matrix). Suckable softgels (gelatin shell contains flavoured medicament to be sucked and a liquid matrix or just air inside the capsule). Twist-off softgels (designed with a tag to be twisted or snipped off allowing access to the fill material, it is very useful for unit dosing of topical medication, inhalations, or for oral dosing of pediatric product). Meltable softgels (patient friendly pessaries or suppositories).
Soft Gelatin Capsules (Softgels) Softgel Capsule Shell consists of: Gelatin Water (strongly bound to gelatin) Plasticizer Color and/or flavor Preservatives not usually needed because of the low water activity in the finished product.
Formulation of Gelatin Shell Gelatin A large number of different gelatin shell formulations are available, depending on the nature of the liquid fill matrix. Most commonly the gelatin is alkali-(or base-) processed (type B) and it normally constitutes 40% of the wet molten gel mass. Type A acid-processed gelatin can also be used. Bloom strength ~ 150g.
Formulation of Gelatin Shell Plasticizers Used to make the shell of the capsule elastic and pliable. Constitute 20-30% of the wet gel formulation.
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- Spring '17
- Dr. Bashar
- Gelatin, softgel