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Preparation
A soft gel capsule is a one piece, hermetically sealed soft gelatin shell containing a liquid, a suspension or a semisolid; referred
to as a fill. The soft gel shell is usually comprised of a film-forming material such as gelatin, and a water-dispersible or watersoluble plasticizer (to impart flexibility). The soft gel shell could also include minor additives such as coloring agents, flavors,
sweeteners, opacifying agent, medicaments, acid and preservatives. Soft gel capsules can also be enteric coated for certain
applications.
Coloring Agent. Colour used in shell has to be darker than color of encapsulating material. Color may be natural or
synthetic.
Opacifier. Usually used is titanium dioxide, may be added to produce an opaque shell, when the fill formulation is a
suspension or to prevent photo degradation of light sensitive fill ingredients. Concentration of oacifier may be up to 0.5%.
Chelating agents. Iron is always present in raw gelatin & should not contain iron more than 15 ppm. Additionally
chelating agent may be used for preventing the reaction of iron with materials or colors.
Gelatin
Soft Capsules Gelatin
Gelatin is derived mostly from collagen by thermal denaturing with the aid of diluted acid or alkali. Gelatin contains a mixture of
water-soluble proteins (84-90 percent), mineral salts (1-2 percent), and water (8-15 percent). These proteins contain a significant
amount of the amino acids: glycine, proline, hydroxyproline, glutamic acid, alanine, arginine, aspartic acid, lysine; in addition to
other amino acids in smaller amounts.
There are two types of gelatins:
1. type A : derived from pork skin by hydrolysis with an acid
2. type B : derived from bones and animal skin by hydrolysis with an alkaline solution.
Gelatin used in soft gels is a blend of both types, or used individually.
Gelatin is odorless, tasteless, colorless, and insoluble in most organic solvents, but soluble in glycerin, diluted acids and alkalis.
Gelatin swells and absorbs room-temperature water, up to five to 10 times its weight. It dissolves in hot water, and forms a gel
upon cooling.
The main source of gelatin is collagen, which is found in the skin and bones of animals such as deep-water fish. Most of the soft
gel capsules on the market are made from an animal source, bovine or porcine.
There are non-animal based forms of gelatin to meet the needs of those wishing alternatives to meat products for vegetarian,
ethical or religious reasons. A vegetarian gelatin made from Irish moss, which is derived from seaweed and grows off the coast of
Ireland, is available but is costlier than the animal-sourced gelatins. The brand name called Vegicap soft capsule.
Typical Formula of Soft Gelatin Capsule Shell for 1 batch = 120 L
Ingredients/Materials
Glycerin
Amount(kg)
52
Function
Plasticizer
Propylmethyl Paraben
0.512
Preservative
Methyl Parabe
0.128
Preservative
152
Basisofgelatin
0.3
Coloringagent
Sunset Yellow
0.3
Coloringagent
Titanium Dioxide
16
Opacifier
Water
Sorbitol Liquid
120L
16
Solvent
Plasticizer