HOW ITS MADE GEL CAPS

INTRODUCTION
A softgel or soft gelatin capsule is a solid capsule (outer shell) surrounding a liquid or
semi-solid center (inner fill). An active ingredient can be incorporated into the outer
shell, the inner fill, or both. They are oral dosage form for medicine similar to capsules.

PURPOSE
Soft gelatine capsules help protect, offer the possibility of achieving content uniformity
of fewer dosage drugs among others and enhance the scent retention. The outer shell of it
protects the active ingredients from oxidation by the ultraviolet rays. It also possesses a
unique outer shell that provides a safe, airtight enclosure for the inner fill materials.
Additionally, they have a neat appearance, completely masking the scent and can be
easily crushed to release essential oils.

INGREDIENT
The soft gel has got two distinct sections:
1. Outer shell
2. Fill matrix
Oval soft gel capsules: the sizes of the capsules vary accordingly in the range of 2.5 cm to
1cm even though the proportions may differ depending on the type of application.
OUTER SHELL OF SOFT GELATIN CAPSULES
It has the basic composition of Softgel capsule formulation.

Some of the components of the shell include:

1. Gelatin
2. Plasticizer
3. Solvent
4. Opacifiers
5. Preservatives
6. Other additives
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Gelatin isone of the significant components of the shell of the capsule. Moreover, it’s
very critical in determining some of the shell characteristics. Importantly, the approvals
also take into considerations the physiochemical specifications of each gelatin type.
Minimum specifications:

 The gel strength of 150 – 200 bloom.

 The viscosity of 2.8 – 4.5 mPas
 Optimum viscosity breakdown
 Uniform particle size for quick dissolution.
 A broad molecular weight distribution.
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Plasticizers are also other crucial components of the shell.

Always take care when selecting an appropriate one because for soft capsules, you only
need to use a non-volatile plasticizer together with the right amount of water to enhance
the stability of the capsule.

So generally the function of the plasticizer is to maintain the elasticity and flexibility of
the shell during the drying process and even after.

A few of the recommended plasticizers by pharmacopeias and regulatory bodies are

polyalcohols such as glycerol, aqueous sorbitol, and their respective combinations.

You also need to take into consideration the type and concentrations of the plasticizer you
use. These factors are consistent with the constituents of the fill matrix of the soft gel.

Moreover, the optimum weight ratio between the dry plasticizer to that of the dry gelatin
should vary in the range of 0.3 and 1.0.
You should, therefore, strive to maintain the ratio at that range since it determines the
strength of the outer shell.

In conclusion, a suitable plasticizer should be the one that appropriately interacts with the
gelatin molecules. Such kind of interactions contributes to the reduction of theglass
transition temperature of that of the gelatin shell.

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Water is the universal solvent in use here.

By far, water forms a very crucial component of the soft gel shell. As a show of its
importance, water occupies about 30 – 40 % of the overall wet gel formulation.

Water compliments the proper processing procedure, especially during the gel
formulation and encapsulation.

Besides, the ratio of water by weight to that of the dry gelatin should vary in the range of
0.7 to 1.0 though these values vary by the viscosity of the type of gelatin .

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The opacifiers have got only a single but essential function in the shell.

You only need to add these chemicals if you want to initiate the formation of a dark/
opaque shell. Note that, the use of such substances isn’t always at will but when dealing
with a suspension type of formulation.

Elsewhere, it’s preferred to prevent photodegradation of light-sensitive active ingredients.

The most common opacifier is titanium dioxide.

Titanium oxide on its own produces a whitish opaque shell. Opaque colored shell is
possible with the use of a mixture of several pigments.

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Preservatives are an additional component that strives to keep the product viable and safe
for predetermined long term storage.

FILL MATERIAL FOR SOFT GELATIN CAPSULES INGREDIENTS

Structure of soft gelatin capsules

Now the primary purpose for developing the soft gel was undoubtedly to dispense the
active medicinal values.
 Inside the shells, these active compounds formulations are either in a liquid solution,
semi-solid solution, suspension or emulsion.

The formulation of the fill is unique and takes into account some factors. Have a look at
the following minimum conditions that your formulation need to fulfill.

 To guarantee the chemical stability of the active ingredients.

 To enhance the bioavailability of the active component.
 To provide an efficient filling process
 To lead to the achievement of a physically sturdy capsule.
With that, let’s shift to the fill materials.

But before that, we have to classify the fill matrix.

We can generally categorize the fill materials into three groups, ie. Oily mixtures,
solutions fills, and suspension fills

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The oily mixtures are also occasionally referred to as neat substances since they purely
consist of oily liquids.

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The solution fills consists of active components of the drugs dissolved in a carrier
solution. Perfect examples are soybean oil and miglyol 812, polyethylene Glycols
specifically PEG 400 – 600.

Apart from that, this kind of fill matrix may include any other non-volatile solvent with
zero effect on the gelatin shell such as dimethyl isosorbide, diethylene glycol monoethyl
ether, surfactants, etc.
 The components don’t end there; you can as well incorporate some of the following
optional ingredients in the solution fill:

 Water and any other solvent such as alcohol with a concentration of 10% w/w essential
for added solubility.
 Glycerin in the range of 1 to 4 % w/w.
 Polyvinylpyrrolidone to a maximum of 10% w/w mixed with PEG. The whole
combination increases the solubility of the drug. Besides,it improves the stability of the
soft gel.
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The suspension fill comprises of the active ingredient uniformly dispersed in a carrier
formulation.

An added advantage of the suspension is because it comfortably accommodates upto 30

% solids without destabilizing the viscosity. In cases of viscosity problems during filling,
to lower it, then you may heat the suspensions upto a temperature of 35°C.

For the suspended solids, they need not exceed 80 mesh mill.

Ordinary suspension fills ingredients include:

 Oily mixtures: such as the soybean oil mixed with beeswax (4 – 10% w/w) and lecithin (2
-4% w/w). The lecithin in use is essential for improving the flow of the material in the
process, providing some degree of lubrication.
gelified oil.

 Polyethylene glycol: semi- solids fill should be PEG 800 – 1000, however for solid fills
PEG 10,000 – 100000. Or a blend of the both.
 Glycerides with long chain fatty acids
While other notable optional ingredients include:
 Surfactant: includes sorbitan products, i.e.,polysorbate 80/ lecithin.
Now up to this level, I am sure you already understand what it takes to come up with an
established outer shell and fill the matrix.

Now the pharmaceutical industry manufacturing process always takes into considerations
the post preparation treatments to almost all products, including the soft gels.

It’s a standard and necessary procedure in an equal magnitude.

EQUIPMENT

In order to make soft gel capsule, you need a soft gel encapsulation machine, which is
able to fill gelatin capsules with liquid or semi-liquid fillings using a process called
encapsulation. Soft gel encapsulation machines are able to produce precise dosages of the
filling, and produce completely airtight capsules, ensuring that no contaminants can enter
once the process is complete. Encapsulation machines have many parts, which may
include:

 Material tank or medicine hopper to hold the filling material.

 Material feeding pump.
 Injection wedge.
 Mixing tank to prepare the gelatin or other shell.
 Cooling drum to cool and solidify the gelatin web. The machine may also have a
refrigeration system to maintain the proper temperature.
 Lubrication rollers to protect the gelatin skin. Drying system.

METHOD
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