Illustration of the manufacturing process of hard gelatin capsule shell form gelatin

In this document i tried to give information about manufacturing process and shell form of hard gelatin capsule. i hope it will help you a lot.

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Southeast University
‘Illustration of the manufacturing process of hard gelatin
capsule shell form gelatin’
Prepared By: Md. Mehedi Hasan Shawon
Department of Pharmacy, Southeast University
Banani, Dhaka, Bangladesh
ID: 2018000300093
Batch: 31st (D)

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Index
Content Page number
What is capsule 3
What is gelatin 3
Capsule shell 4
Capsule shell manufacture 4
Manufacturing process of hard gelatine
capsule
6
Machine use for Capsule shell 8
Bibliography 10

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What is Capsule?
Capsules are easier to swallow and are used by manufacturers when the drug cannot be
compacted into a solid tablet. They are also useful when the drug needs to be mixed with oil
or other liquid to aid absorption in the body. It is normally a shell or container made of
gelatin that contains the drug. (anonymus)
What is Gelatin?
Gelatin is a mixture of peptides and proteins produced by partial hydrolysis of collagen
extracted from the skin, bones, and connective tissues of animals such as domesticated cattle,
chicken, pigs, and fish. (Anonymus, 2020)
There are two types of gelatin, they are:
1) Type A gelatin: Type A gelatin is derived from acid-cured tissue.
2) Type B gelatin: Type B gelatin is derived from lime-cured tissue. (anonymus)
Those steps are involving in making empty gelatin capsules:
1) Dipping
2) Spinning
3) Drying
4) Stripping
5) Trimming and Joining
6) Polishing
Dipping: Pairs of the stainless steel pins are dipped into the dipping solution to
simultaneously form the caps and bodies. The dipping solution is maintained at a temperature
of about 500C in a heated, jacketed dipping pan. The pins are moved through a series of air
drying kilns to remove water.
Spinning: A series of bronze jaws strip the cap and body portions of the capsules from the
pins. The pins are rotated to distribute the gelatin over the pins uniformly and to avoid the
formation of a bead at the capsule ends.
Drying: The gelatin is dried by a blast of cool air to form hard shells. The pins are moved
through a series of air drying kilns to remove water.
Stripping: A series of bronze jaws strip the cap and body portions of the capsules from the
pins.
Trimming and Joining: The stripped cap and body portions are trimmed to the required
length by stationary knives. After trimming to the right length, the cap and body portion are
joined and ejected from the machine.
Polishing: Pan Polishing : Acela-cota pan is used to dust and polish.
Cloth Dusting : Capsule are rubbed with cloth.

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Brushing : Capsule are feed under soft rotating brush.
Capsule shell:
Capsules are solid dosage forms in which the drug is enclosed within either a hard
or soft soluble container or “shell.” The shells are usually formed from gelatin; however,
they also may be made from starch or other suitable substances. The gelatin cap-sule shell
may be soft or hard depending on their formulation. Capsules are intended to be swallowed
whole by the patient. In instances where patients (especially children) are unable to
swallow capsules, the contents of the capsule can be removed and added (e.g.,
sprinkled) on soft food immediately before ingestion. In the manufacture of
pharmaceuticals, encapsulation refers to a range of techniques used to enclose medicines in a
relatively stable shell known as a capsule, allowing them to, for example, be taken orally or
be used as suppositories. Hard-shelled capsules, which are normally used for dry, powdered
ingredients or miniature pellets, Both of these classes of capsules are made from
aqueoussolutions of gelling agents like:Animal protein mainly gelatine And Non-gelatin such
as Plant polysaccharides or their derivatives like carrageenans and modified forms of
starch and cellulose. Despite the great advantages, of gelatin capsules’, gelatin has several
drawbacks that limit its use for capsules. The animal source of gelatin can be a
problem for certain consumers such as vegetarians or vegans and religious or ethnic
groups, Since unmodifiedgelatin is prone to cross linking when in contact with aldehydes,
solubility problems might be expected with certain fill formulations. The non-gelatin capsule
shells are made up of such as Starch, HPMC, PVA, and Alginate. The gelatin capsule shell
may be soft or hard depending on their formulation. Capsules are intended to be
swallowed whole by the patient. In instances where patients (especially children) are
unable to swallow capsules, the contents of the capsule can be removed and added
(e.g., sprinkled) on soft food immediately before ingestion. In this case, capsules are
used as a vehicle to deliver premeasured medicinal powder.In the manufacture of
pharmaceuticals, encapsulationrefers to a range of techniques used to enclose medicines in a
relatively stable shell known as a capsule, allowing them to, for example, be taken orally or
be used as suppositories. The two main types of capsules are:
 Hard-shelled capsules, which are normally used for dry, powdered ingredients
or miniature pellets (also called beads that are made by the process of Extrusion and
Spheronization) -or mini tablets.
 Soft-shelled capsules, primarily used for oils and for active ingredients that are
dissolved or suspended in oil.Both of these classes of capsules are made from aqueous
solutions of gelling agentslike
Capsule Shell Manufacture:
Hard gelatin capsule shells are fabricated and supplied empty to the pharmaceutical industry
by shell suppliers and are then filled in a separate operation. During the capsule filling unit
operation, the body is filled with the drug substances and the shell is closed by bringing the
body and the cap together. (Anonymus, basicmedicalkey, 2017)

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Capsule Shell Design: Most manufactures have designed their own pins and all provide
for the same set of functions. The features required are as follows: to hold empty capsules
together to prevent separation on handling, to aid the entry of the body into the cap, to allow
air to escape during re-closure after filling, and to hold the cap and body together after filling.
Initially, there were two pre-lock features on capsules and it was observed that this tended to
make the cap less round. There are some components that use to make a capsule shell. They
are:
1) Gelatin: Gelatin is by far the most common and most well-known material used to
produce hard capsule shells. It is a generic term for a mixture of purified protein fractions
obtained from irreversible hydrolytic extraction of collagen obtained from the skin, white
connective tissue, and bones of animals. Gelatin is stable in air when dry but is subject to
microbial decomposition when it becomes moist.
2) Plasticizer: Plasticizers are added to gelatin to reduce the rigidity of the polymer and
make it more pliable. Common examples of plasticizers are glycerine and polyhydric
alcohol. Water is also a good plasticizer and is naturally present in the gelatin.
3) Colorants: Most frequently, hard gelatin capsules are coloured to enhance the
aesthetic properties and also to act as a means of identifying the product. Colorants used
must meet the regulatory requirements of those countries where the product will be sold.
4) Opacifying agents: Opacifiers may be included to make clear gelatin opaque.
Opaque capsules may be employed to provide protection against light or to conceal the
contents.
5) Preservatives: Preservatives were formerly added to hard capsules as an in-process
aid in order to prevent microbiological contamination during manufacture.
Manufacturers operating their plants to Good Manufacturing Practice (GMP) guidelines
no longer use them. In the finished capsules, the moisture levels, 12–16% w/ v, are such
that the water activity will not support bacterial growth because the moisture is too
strongly bound to the gelatin molecule. (Anonymus, pharmaapproch, 2020)

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Development of capsule shell by Gelatin:-Gelatin is the major component of the
capsules and has been the material from which they have traditionally been made.
Gelatin has been the raw material of choice because of the ability of a solution to
gel to form a solid at a temperature just above ambient temperate conditions, which
enables a homogeneous film to be formed rapidly on a mould pin. The reason for this is that
gelatin possesses the following basic properties:
-It is non-toxic, widely used in foodstuffs and acceptable for use worldwide.
-It is readily soluble in biological fluids at body temperature.
-It is good film-forming material, producing a strong flexible film
-The gelatin films are homogeneous in structure, which gives them strength.
Manufacturing process of hard gelatin capsule:
Hard gelatin capsules are solid dosage forms in which one or more drug substance and/or
inert materials are enclosed within a small shell. They are composed largely of gelatin and
consist of two parts: the body designed to contain the drug and the diluent, and the cap that is
approximately half as long as the body. Most capsule products manufactured today are of the
hard gelatin type. It is estimated that the utilization of hard gelatin capsules to prepare solid
dosage forms exceeds that of soft gelatin capsules by about 10-fold.

Components: Hard gelatin capsule shell is composed largely of gelatin. Other than gelatin,
it may contain materials such as plasticizer, colourants, opacifying agents, and preservatives
which either enable capsule formation or improve their performance. Hard gelatin capsules
also contain 12–16% water, but the water content can vary, depending on the storage
conditions.

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Sizes and shapes: The hard gelatin capsule is made in a range of eight sizes from size
000, the largest, to size 5, the smallest. The most popular sizes in practice are size 0 through
to 4.

Manufacture: Hard gelatin capsules are manufactured using a dip-coating method and the
various stages involved are as follows:
1) Preparation of the gelatin solution: A concentrated solution of gelatin is prepared
by dissolving the gelatin in demineralized water which has been heated to 60–70°C in
jacketed pressure vessels. This solution contains 30 – 40% w/w of gelatin and is
highly viscous, which causes bubbles as a result of air entrapment. The presence of
these bubbles in the final solution would yield capsules of inconsistent weight and
would also become problematic during capsule filling and upon storage. To remove
the air bubbles, a vacuum is applied to the solution; the duration of this process varies
with batch size.
2) Dip-coating the gelatin solution on to metal pins: Capsule shells are manufactured
under strict climatic conditions by dipping pairs (body and cap) of standardized steel
pins arranged in rows on metal bars into an aqueous gelatin solution (25 – 30% w/w)
maintained at about 50 ° C in a jacketed heating pan. Because the moulds are below
the gelling temperature, the gelatin begins to form a thin gelatin layer or film on the
moulds.
3) Rotation of the dip-coated pins: The bar containing the pins is removed and rotated
several times to evenly distribute the solution around the pins, correct gelatin
distribution being critical to uniform and precise capsule wall thickness and dome
strength.
4) Drying of the gelatin-coated pins: Once the gelatin is evenly distributed on the
mould, a blast of cool air is used to set the gelatin on the mould. At this point, the
gelatin is dried, and the pins are then passed through several drying stages to achieve
the target moisture content.
5) Stripping and trimming: After the gelatin is dried, the capsule is stripped off the
mould and trimmed to the proper length.

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6) Joining of the trimmed capsule shell: Once trimmed, the two halves (the cap and
body) are joined to the pre-closed position using a pre lock mechanism. At this point,
printing is done if needed before packing in cartons for shipping.
7) Printing: After formation, the capsule shells can be printed to improve identification.
Printing can be achieved using one or two colours, containing information such as
product name or code number, manufacturer’s name or logo and dosage details.
(Anonymus, pharmaapproch, 2020)

Machine use for Capsule shell:
Hard Capsule Shell Production Line:

Automatic Empty Capsule Production Line:

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shanghai Fish Gelatin Shell softgel capsules encapsulation machine:

Nut shell oil machine car oil filter making machine capsule filling oil machine:

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Bibliography
Anonymus. (2017, December 8). basicmedicalkey. Retrieved from Capsule shell
manufacturing: https://basicmedicalkey.com/capsule-shell-manufacture/
Anonymus. (2020, March 10). pharmaapproch. Retrieved from manufacture of hard gelatine
capsule: https://www.pharmapproach.com/manufacture-of-hard-gelatin-
capsules/#Manufacture_of_Hard_Gelatin_Capsules
Anonymus. (2020, July 10). Wikipidia. Retrieved from Gelatin:
https://en.wikipedia.org/wiki/Gelatin
anonymus. (n.d.). swallowing difficulties . Retrieved from What is capsule?:
https://swallowingdifficulties.com/healthcare-professionals/prescribing-different-
formulations/what-is-a-capsule/