SOFT GELATIN CAPSULE
2nd Year, 4th Sem.
1. Write down the manufacturing steps of soft gelatin capsules (SGC). (5)
Answer:
SGC is one piece hermetically sealed soft gelatin shell containing a liquid, a suspension or
semisolid. The filling volume ranges from 0.1 ml to 20 ml. it is available in different shapes
like round, oval, oblong, tube shaped and many more.
They are most suitable for liquids and semisolids and are widely used, in spherical and
ovoid forms for vitamin preparations such as cod liver oil, vitamins A and D and multiple
vitamins. Content of a soft gel capsule is a liquid, or a combination of miscible liquids, a
solution of a solid(s) in a liquid(s) or a suspension of a solid(s) in a liquid(s).
Liquids are an essential part of the capsule content. Only those liquids that are both water
miscible and volatile cannot be included as major constituents of the capsule content since
they can migrate into the hydrophilic gelatin shell and volatilize from its surface.
COMPOSITION OF SOFT GELATIN CAPSULE SHELL
1. Gelatin
2. Water
3. Plasticizer: Glycerine, Sorbitol
4. Preservatives: Methyl paraben, Propyl paraben
5. Colorants: FD & C certified lakes
6. Opacifiers: Titanium Di Oxide
7. Flavouring agent:Ethyl vanillin
8. Anti tanning agent: Fumaric acid (Aid to solubility)
STEPS OF MANUFACTURING OF SOFT GELATIN CAPSULE SHELL
Medicament preparation & gelatin mass preparation → Encapsulation process → capsule
pre-shaping, washing and semi drying → capsule drying → capsule inspection → capsule
printing → quality assurance → packing → storage → process condition
Composition of the shell
The basic component of soft gelatin shell is gelatin; however, the shell has been
plasticize
The ratio of dry plasticizer to dry gelatin determines the “hardness” of the shell and
can vary from 0.3-1.0 for very hard shell to 1.0-1.8 for very soft shell
Up to 5% sugar may be included to give a “chewable” quality to the shell
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The residual shell moisture content of finished capsules will be in the range of 6-
10%.
Formulation for soft gelatin capsules involves liquid, rather than powder
technology.
The liquids are limited to those that do not have an adverse effect on gelatin walls.
The pH of the liquid can be between 2.5 and 7.5.
Gelatin shell formulation
Typical softgel shells are made up of gelatin, plasticizer, and materials that impart the
desired appearance (colourants and/or opacifiers), and sometimes flavours.
i) 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.
ii) Plasticizers
Plasticizers (20-30% of the wet gel formulation) are used to make the softgel shell
elastic and pliable.
The most common plasticizer used in softgels is glycerol, although sorbitol and
propylene glycol are also frequently used, often in combination with glycerol.
The amount and choice of the plasticizer contribute to the hardness of the final
product and may even affect its dissolution or disintegration characteristics, as well
as its physical and chemical stability.
Plasticizers are selected on the basis of their compatibility with the fill formulation,
ease of processing, and the desired properties of the final softgel, including hardness,
appearance, handling characteristics and physical stability.
iii) Water
The other essential component of the softgel shell is water.
Water usually accounts for 30-40% of the wet gel formulation and its presence is
important to ensure proper processing during gel preparation and softgel
encapsulation.
Following encapsulation, excess water is removed from the softgels through
controlled drying.
In dry softgels the equilibrium water content is typically in the range 5-8% w/w,
which represents the proportion of water that is bound to the gelatin in the softgel
shell.
This level of water is important for good physical stability, because in harsh storage
conditions softgels will become either too soft and fuse together, or too hard and
embrittled.
Capsule preshaping, Washing and Semidrying
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❖ Immediately after manufacture capsules are subjected to “naptha” wash to remove
mineral oil form the outer surface of the capsule.
❖ Centrifuge is used for capsule washing
❖ Products are pre-shaped, semi dried in tumbler washer drier units.
❖ Tumbler drier unit having temp. <350C which removes all the solvent used in
washing and 50 – 60% of water
Capsule drying
❖ CAPSULE DRYING TUNNEL SYSTEM is constructed from modular panels in stainless
steel AISI 304.
❖ The tunnels have a laminar flow air filtration unit, which allows a better and more
efficient drying of the capsule products.
Capsule inspection
❖ 100% inspection is performed on the external appearance (Improper Sealing, Color,
Soft spot & Seam continuity)
❖ Capsules are manually inspected for physical defects
Online Automatic Capsule Inspection Machine is used for inspection.
❖ Affordable
❖ 3 camera system
❖ 120,000 Capsules/hours
Capsule printing
❖ Capsules are over-printed for logos or trademarks, if required.
Packing
❖ Products are strip packed, blister packed, bottle pack and bulk packed as required.
2. Write in details about rotary dye process with a neat diagram. (5)
Answer:
Rotary die process
The rotary die process involves continuous formation of a heat seal between two
ribbons of gelatin simultaneous with dosing of the fill liquid into each capsule.
It is having two hoppers & two rotating dies.
Before the encapsulation process takes place, there are two sub-processes that are
often carried out simultaneously, yielding the two components of a softgel.
These are (a) the gel mass which will provide the softgel shell, and (b) the fill matrix
for the contents.
The gel mass is prepared by dissolving the gelatin in water at approximately 80°C and
under vacuum, followed by the addition of the plasticizer, for example glycerol.
The hot gel mass is then supplied to the encapsulation machine through heated
transfer pipes by a method that forms two separate gelatin ribbons, each
approximately 150 mm wide.
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During the casting process the gelatin passes through the sol-gel transition and the
thickness of each gel ribbon is controlled to ± 0.1 mm, in the range of about 0.5-1.5
mm.
The thickness is checked regularly during the manufacturing process.
The liquid fill matrix containing the active drug substance is manufactured separately
from preparation of the molten gel.
Manufacture of the active fill matrix involves dispersing or dissolving the drug
substance in the non-aqueous liquid vehicle using conventional mixer-homogenizers.
Once the gelatin is fully dissolved then other components, such as colours, opacifier,
flavours and preservatives, may be added.
Liquid mixture is placed in one hopper & the liquid medicament in other Hooper.
The two rotating dies rotate in opposite directions when the fluid gelatin mixture
enters the machine from the hopper it produces two continuous ribbons.
This half shell of the capsule is formed.
The two halves' of the capsules are sealed together by the heat & pressure of the
rotating dies.
As the die rolls rotate, the convergence of the matching dies pockets seals and cuts
out the filled capsules.
After manufacture the capsules are passed through a tumble drier and then, to
complete the drying process, spread on to trays and stacked in a tunnel drier that
supplies air at 20% relative humidity.
The tunnel drying process may take 2 or 3 days, or possibly as long as 2 weeks,
depending on the specific softgel formulation.
Finally, the softgels are inspected and packed into bulk containers in order to prevent
further drying and for storage.
Parameters to be controlled for active fill matrix preparation
A number of different parameters are controlled during preparation of the active fill
matrix, depending on the properties of drug substance.
Oxygen sensitive drugs are protected by mixing under vacuum and/or inert gas.
In some cases antioxidant component may be added to the formulation.
If the drug substance is present as suspension in the liquid fill matrix then it is
important to ensure that particle size of the drug does not exceed approximately 200
µm.
In the rotary die encapsulation process, the gel ribbon and the unit dose of liquid fill
matrix are combined to form the softgel.
Softgel Manufacturing
i) Inspection
Capsules should be submitted to a final inspection before packing for malformed,
damaged or improperly filled capsules.
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This can be done visually by hand on trays or tables or semi-automatically on a roller
inspection machine.
ii) Packaging
Packaging normally includes placing softgels into bulk containers, bottles or blister
packaging.
Blister packaging can be of PVC (polyvinyl chloride) or PVDC (poly vinylidene
chloride).
PVDC have higher level of water vapor barrier properties and are used for packaging
medicaments which require especially high moisture resistance.
Rotary Die Machine
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