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Softgels - Coggle Diagram
Softgels
Manufacturing
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plate-press method
Two layers of wet gelatin sheets placed in moulds with depressions, active fill is then filled into the depression, then the two layers of gelatin sandwich the fill material in between.
Rotary Die Encapsulation: gel mass and fill material are processed simultaneously then encapsulated together
Wet Gel Mass
Manufacturing steps:
- Gelatin shell ingredient are mixed together and melted under vacuum to form a molten gel mass.
- At the encapsulation machine, the molten gel mass is passed though heated transfer tubes and casted onto chilled drums, to form two separate gel ribbons.
- Gel ribbons are aligned and their surfaces lubricated through rollers of the machine.
- Each gel ribbon constitutes one half of the softgel.
Encapsulation
- Lubricated gel ribbons are fed between a pair of counterrotating dies with surfaces containing matching pockets (appropriately sized and shaped) that serve as molds for the softgels.
- Die pockets are sealed on both sides to form a softgel.
- Formed softgel is then cut away from the residual gel ribbon.
- Softgels are then conveyed to a tumble dryer to initiate drying
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Fill material
Important parameters to consider before starting manufacturing process:
- viscosity of all fills
- particle size of suspended materials
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Applications
Advantages
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Enhanced drug stability (better protection against oxidation, photodegradation, and hydrolysis in lipophilic systems)
Improved patient compliance and consumer preference due to ease of swallowing, appealing product appearance, absence of offensive taste, convenience, pharmaceutical elegance
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Good product/brand differentiation (through selection of shapes, colours, and sizes)
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Excipients
Gelatin Shell
Plasticizers: used to make the softgel shell elastic and pliable.
- Ratio of plasticizer to gelatin and choice of plasticizer determine hardness of the shell and final product.
- Dissolution, disintegration, physical/chemical stability may be affected choice and amount of plasticizer.
- Must be compatible with fill formulation, processing time, and desired properties of final softgels (e.g. hardness, appearance, handling characteristics, stability, geographical location of sale)
- Examples: glycerin, sorbitol, propylene glycol, and/or sorbitol anhydrates mixed with sugar mixtures. Can be used alone or in combination with one another.
Water: ensures proper processing during gel preparation and softgel encapsulation.
- Excess water is removed (through controlled drying) from the softgels after encapsulation.
- Equilibrium water content is typically <10%.
Colourants/opacifiers: used to produce the desired colour, tint, or hue for product identification.
- Opacifiers mainly used to alter opacity of shell for suspension fills or light sensitive fills.
- Examples of colourants: FD&C water-soluble dyes, certified lakes, pigments, vegetable colours
- Example of opacifiers: titanium dioxide
Softgel Fill
Water-miscible liquids
polyethylene glycols and nonionic surfactants (e.g. polysorbates to promote wetting of ingredients and/or dispersion of the fill in vivo)
Water-immiscible liquids
vegetable and aromatic oils, aliphatic, aromatic and chlorinated hydrocarbons, ethers, esters, high MW organic acids, and some alcohols
Suspending agents
paraffin wax, beeswax, hyrogenated vegetable oil (for oily vehicles), glycol esters for non-oily vehicles (high MW PEG)