Soft Gelatin Capsule Shell : Composition, Formula and 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 additi!es such as coloring agents, fla!ors, sweeteners, opacifying agent, medicaments, acid and preser!ati!es. "oft gel capsules can also be enteric coated for certain applications.
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Capsule shell composition: Water # $%& w'w. The ratio by weight of water to dry gelatin can !ary depending from .)-*.+ (water to *. (dry gelatin depending on the !iscosity of the gelatin being used. Plasticizer. sed to mae the soft gel shell elastic pliable. /ation used is between .+- *.0 for soft to hard shell on dry basis. 1lasticizer usually used # 2lycerin and sorbitol. Coloring Agent. 3olour used in shell has to be darer than color of encapsulating material. 3olor may be natural or
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synthetic. •
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Opacifier. sually used is titanium dioxide, may be added to produce an opaque shell, when the fill formulation is a suspension or to pre!ent photo degradation of light sensiti!e fil l ingredients. 3oncentration of oacifier may be up to .%&. Chelating agents. 4ron is always present in raw gelatin s hould not contain iron more than *% ppm. Additionally chelating agent may be used for pre!enting the reaction of i ron with materials or colors. Gelatin Soft Capsule’s Gelatin 2elatin is deri!ed mostly from collagen by thermal denaturing with the aid of diluted aci d or alali. 2elatin contains a mixture of water-soluble proteins (0$-5 percent, mineral salts (*-6 percent, percent, and water (0-*% percent. percent. These proteins contain 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# *. type A # deri!ed from por sin by hydrolysis with an acid 6. type 7 # deri!ed from bones and animal sin by hydrolysis with an alaline solution. 2elatin used in soft gels is a blend of both types, or used indi!idually. 2elatin is odorless, tasteless, colorless, and insoluble in most organic sol!ents, but soluble in glycerin, diluted acids and alalis. 2elatin swells and absorbs room-temperature water, up to fi!e to * times its weight. 4t dissol!es in hot water, and forms a gel upon cooling. The main source of gelatin is collagen, which is found in the s in and bones of animals such as deep-water fish. 8ost of the soft gel capsules on the maret are made from an animal source, bo!ine or porcine. There are non-animal based forms of gelatin to meet the needs of those wishing alternati!es to meat products for !egetarian, ethical or religious reasons. A !egetarian gelatin made from 4rish moss, which is deri!ed from seaweed and grows off the coast of 4reland, is a!ailable but is costlier than the animal-sourced gelatins. The brand name called 9egicap soft capsule.
Typical Typi cal Formula of Soft Gelatin Capsule Shell for !atch " #$ %
Ingredients/Materials Glycerin
Amount (kg)
52
Function
Plasticizer
Propylmethyl Paraben
0.512
Preservative
Methyl Parabe
0.128
Preservative
Gelatin 120 Bloom
152
Basis of gelatin
Briliant Blue Ponceau
0.3
Coloring agent
Sunset Yellow
0.3
Coloring agent
16
Opacifier
Titanium Dioxide ater
120 L
Sorbitol !i"uid
16
Solvent Plasticizer
Preparation of Soft Gelation Capsule Solution: The gel is prepared in a 100 liter stainless steel vessel: 1. Gelatin Powder is mixed with water and glycerin, then h eat and stir it.
2.
After the molten gelatin mass is formed, decanted into 200 g mo!ile vessels.
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#ix the molten gelatin mass $sing t$r!ine mixer then add color and flavors agent.
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&t ens$re consistency of gelatin mass
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This mass is ept at a constant temperat$re $ntil it is needed for the next stage of the process
