Softgels & filling process

This document is about softgels and filling process. Here i tried my level best to give the correct information.

1. Southeast University
‘Illustration softgels and filling process’
Prepared By: Md. Mehedi Hasan Shawon
Department of Pharmacy, Southeast University
Banani, Dhaka, Bangladesh
ID: 2018000300093
Batch: 31
st
(D)

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Index
Capsule....................................................................................................................................... 2
Softgel Capsule .......................................................................................................................... 2
Size of softgel......................................................................................................................... 3
Advantage of softgel .............................................................................................................. 3
Disadvantage of softgel.......................................................................................................... 3
Outer shell of softgel.............................................................................................................. 3
Gelatin:................................................................................................................................. 3
Plasticizer: ............................................................................................................................ 3
Solvent: ................................................................................................................................ 3
Potato starch matrix: .............................................................................................................. 4
Filling Process............................................................................................................................ 4
Filling Machine ...................................................................................................................... 6
Bench-scale filling.................................................................................................................. 7
Industrial-scale filling ............................................................................................................. 7
Pellet filling ........................................................................................................................... 8
Tablet filling .......................................................................................................................... 9
Semisolid and liquid filling...................................................................................................... 9
Filling process of soft gelatin capsule.................................................................................. 10
Bibliography............................................................................................................................. 10

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Capsule
Capsule is a solid dosage form in which the drug is enclosed in a hard or soft soluble
container, usually of a form of gelatin.
There are two types of capsule. They are:
1) Hard gelatin capsule: Hard capsules, which are more commonly seen, are made up
of a rigid shell in two pieces that fit together and is then filled with the drug. This
formulation is normally more suitable for drug powders and can only be used if the
drug will be easily dissolved in the stomach.
2) Soft gelatine capsule: Soft capsules are formed in a single piece and are more
suitable for oils e.g. Fish oils, or drugs that need to be dissolved in oils or other liquids
to aid the drug to be absorbed in the stomach. In soft capsules, the drug is combined
with an appropriate solvent in the centre of the capsule and the capsule shell melts
within minutes in the stomach. (anonymus, 2020)

Softgel Capsule
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. Softgel shells are a
combination of gelatin, water, opacifier and a plasticizer such as glycerin and/or sorbitol.

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Size of softgel
Softgel exists in various sizes depending on the volume of the medicine in the shell. Its
capsule fill weight is approximately 1000mg with a size of 20 minims. Some of the examples
include 3 oblong with minims of 2.3 to 3.0, 12 oblong with minims of 11.0 to 12. The shape
of soft gelatin capsule are round, oval, oblong, tube.

Advantage of softgel
1. Easy to swallow, no taste, unit dose delivery, tamper-proof.
2. Wide variety of colors, shapes, and sizes.
3. Accommodates a wide variety of compounds filled as a semi-solid, liquid, gel or
paste.
4. Immediate or delayed drug delivery.
5. Can be used to improve bioavailability by delivering drug in solution or other
absorption enhancing media.
Disadvantage of softgel
1. Requires special manufacturing equipment.
2. Stability concerns with highly water soluble compounds, and compounds susceptible
to hydrolysis.
3. Limited choices of excipients/carriers compatible with the gelatin.
Outer shell of softgel
The outer shell is composed of a gelatin or potato starch matrix. Gelatin matrix consists of
gelatin, plasticizer, solvent and optional ingredients such as flavors and colorants.
Gelatin: bovine, porcine, or piscine (fish) origin. Comes in a variety of bloom strengths, the
higher the bloom strength, the more resilient the gel.
Plasticizer: Glycerin and Sorbitol Special are the two most common plasticizers. Glycerin is
generally used with oil based fills. Sorbitol Special is used with PEG based fills. Sorbitol is
not soluble in PEG and therefore will not leach out of the shell into the PEG based fill like
Glycerin would.
Solvent: Water

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Potato starch matrix: This is a smooth, transparent substance resembling gelatin, which is
neutral in taste and color, easily digestible and of plant origin, and therefore, the concerns of
certain bovine related diseases are not an issue. (Raj, 2015)
Filling Process
The filling of hard gelatin capsules is an established technology, with equipment available
ranging from that for very small-scale manual filling (e.g., Feton capsule filling machine),
through intermediate-scale semi-automatic filling to large-scale fully automatic filling. Hard
gelatin capsules can also be hand-filled one at a time, as done in a compounding pharmacy.
The difference between the many methods available is the way in which the dose of material
is measured into the capsule body.
The basic steps in filling hard gelatin capsules include:

1) Rectification of capsules
2) Separation of caps from bodies.
3) Dosing of fill material
4) Replacement of caps/ closing capsule shells and
5) Ejection of filled capsules.
The substances to be avoided are:
1. those which are known to react with it, e.g. formaldehyde, which causes a
crosslinking reaction that makes the capsule insoluble,
2. Those that interfere with the integrity of the shell, e.g. substances containing free
water, which can be absorbed by the gelatin causing it to soften and distort.
(Anonymus, 2020)
There are two main methods by which powders are filled into hard gelatin capsules,
termed dependent and independent methods. The design and operation of these are
described below:
A) Dependent method (dosing system):
1. In this method, the lower half of the capsule is placed into slots that are
located within a revolving turntable.
2. The upper part of the capsule is also housed in a similar turntable.
3. The turntable containing the lower half of the capsule (which may be rotated
at a range of speeds) is rotated under a hopper that contains the powder
formulation and, as a result, the powder falls into the capsule.
4. The flow of the powder through the hopper and the homogeneity of the
powder mix are maintained by the circular movement of an auger.
5. At the end of the operation the two capsule halves are brought together to form
the finished dosage form.

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6. The mass of powder that is dispensed into each capsule is dependent on the
length of time that the hopper spends above the capsule (which is itself
dependent on the speed of rotation of the turntable).
7. At the end of the filling process, the filled capsules are removed from the
turntable.

B. Independent method (dosing system):
1. The independent method of capsule-filling involves the physical transfer of a plug
of powder from the mixed powder into the capsule.
2. In this method, a tube, which contains a spring-loaded piston, is depressed into a
powder bed enabling a volume (plug) of powder to enter the tube.
3. The settings of the spring-loaded piston control the volume of powder that enters
the tube.
4. If required, the bonding between the particles within the plug may be enhanced by
the application of a compression pressure.
5. The tube (containing the plug of powder) is then elevated out of the powder bed,
rotated and located above the lower half of the capsule and the plug of powder is
dispensed into the capsule by the depression of the piston.
Three methods is also used in filling of hard gelatin capsule:
1. Hand Operated methods.
2. Semi Automatic Capsules Devices.
3. Automatic filling machine.
Hand Operated methods: It is having following parts:
a) Bed having 200-300 holes.
b) Loading tray having 200-300 holes.
c) Powder tray.
d) Pin Plate having 200-300 pins.
e) Sealing plate having rubber top.

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f) Lever
g) Cam handel

JAANSUN CAPSULE FILLING MACHINE

SEMI AUTOMATIC MACHINE
Filling Machine
There are many filling machines are available. They are:
1. Bench-scale filling.
2. Industrial-scale filling.
3. Instrumented capsule-filling machines and simulators
4. Pellet filling.
5. Tablet filling.
6. Semisolid and liquid filling

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Bench-scale filling
1. These consist of sets of plastic plates which have predrilled holes to take from 30 to
100 capsules of a specific size.
2. Empty capsules are fed into the holes, either manually or with a simple loading
device.
3. The bodies are locked in their plate by means of a screw and the caps in their plate are
removed.
4. Powder is placed on to the surface of the body plate and is spread with a spatula so
that it is filled into the bodies.
5. The uniformity of fill weight is very dependent upon good flow properties of the
powder.
6. The cap plate is then repositioned over the body one and the capsules are rejoined
using manual pressure.

Industrial-scale filling
1. great variety of shapes and sizes,
2. varying from semi- to fully automatic
3. Ranging in output from 5000 to 15 000 per hour.
4. Automatic machines can be either.
5. Continuous in motion, like a rotary tablet press.

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Pellet filling
1. Preparations formulated to give modified-release patterns are often produced as
granules or coated pellets.
2. They are filled on an industrial scale using machines adapted from powder use.
3. All have a dosing system based on a chamber with a volume that can easily be
changed.
4. In calculating the weight of particles that can be filled into a capsule it is necessary to
make an allowance for their size.
5. Unlike powders, which have a much smaller size, they cannot fill all the available
space within the capsule because of packing restrictions.
6. The degree of this effect will be greater the smaller the capsule size and the larger the
particle diameter.

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Tablet filling
1. Tablets are placed in hoppers and allowed to fall down tubes, at the bottom of which
is a gate device that will allow a set number of tablets to pass.
2. These fall by gravity into the capsule bodies as they pass underneath the hopper.
3. Most machines have a mechanical probe that is inserted into the capsule to check that
the correct number of tablets has been transferred.
Tablets for capsule filling are:
i. normally film coated to prevent dust,
ii. Sized so that they can fall freely into the capsule body.



Semisolid and liquid filling
1. Liquids can easily be dosed into capsules using volumetric pumps.
2. The problem after filling is to stop leakage from the closed capsule.
This can be done in one of two ways, either
 by formulation
 by sealing of the capsule.
3. Both types of formulations are filled as liquids using volumetric pumps.
4. These formulation are similar to those that are filled into soft gelatin capsules, but
differ in one important respect:
5. They can have melting points higher than 35°C, which is the maximum for soft
gelatin capsules because this is the temperature used by the sealing rollers during their
manufacture.
6. Non-aqueous liquids, which are mobile at ambient temperatures, require the capsules
to be sealed after filling.

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7. The industrially accepted method for this is to seal the cap and body together by
applying a gelatin solution around the centre of the capsule after it has been filled.
(Anonymus, Hard gelatin capsule, 2020)


Filling process of soft gelatin capsule
A vacuum draws gelatin sheets into the die pockets. Die pockets are then filled with material
fill. Place a second gelatin sheet on the filled die pockets and sandwich using die press. It is at
this stage that the soft gelatin capsules are formed and cut. Two plasticized gelatin ribbons
(prepared in the rotary-die machine) are continuously and simultaneously fed with the liquid,
semiliquid or paste fill between the rollers of the rotary die mechanism.

Bibliography
Anonymus. (2020). Hard gelatin capsule. Retrieved from philadelphia:
http://www.philadelphia.edu.jo/academics/yalthaher/uploads/Advanced%20pharmace
utical%20technology/5_hard_gelatin_capsules.pdf
Anonymus. (2020, July 20). Hard Gelatin Capsules: Formulation and Manufacturing
Considerations. Retrieved from pharmaapproch:
https://www.pharmapproach.com/hard-gelatin-capsules-formulation-and-
manufacturing-
considerations/#:~:text=On%20a%20small%2Dscale%20manufacture,of%20the%20c
apsule%20shell%20used.

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anonymus. (2020). What is capsule. Retrieved from swallowingdifficulties:
https://swallowingdifficulties.com/healthcare-professionals/prescribing-different-
formulations/what-is-a-capsule/
Raj, A. (2015). Soft Gelatin Capsules (Softgels). PharmaTutor , 16-18.