Capsule

(pharmacy)

Hard-shelled antibiotic capsules

In the manufacture of
pharmaceuticals, encapsulation
refers to a range of dosage forms
techniques used to enclose
medicinesin 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

typically made using gelatin and
contain dry, powdered ingredients or
miniature pellets made by e.g.
processes of extrusion or
spheronisation. These are made in
two halves: a lower-diameter "body"
that is filled and then sealed using a
higher-diameter "cap".
 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 agents, such as animal protein
(mainly gelatin) or plant
polysaccharides or their derivatives
(such as carrageenans and modified
forms of starch and cellulose). Other
ingredients can be added to the
gelling agent solution including
plasticizers such as glycerin or
sorbitol to decrease the capsule's
hardness, coloring agents,
preservatives, disintegrants,
lubricants and surface treatment.

Since their inception, capsules have

been viewed by consumers as the
most efficient method of taking
medication. For this reason,
producers of drugs such as OTC
analgesics wanting to emphasize the
strength of their product developed
the "caplet" or "capsule-shaped tablet"
in order to tie this positive association
to more efficiently-produced tablet
pills. After the 1982 Tylenol tampering
murders, capsules experienced a
minor fall in popularity as tablets were
seen as more resistant to
tampering.[1]

Single-piece gel
encapsulation ("soft
capsules")

Cod liver oil soft gel capsules.

In 1834, Mothes and Dublanc were

granted a patent for a method to
produce a single-piece gelatin capsule
that was sealed with a drop of gelatin
solution. They used individual iron
moulds for their process, filling the
capsules individually with a medicine
dropper. Later on, methods were
developed that used sets of plates
with pockets to form the capsules.
Although some companies still use
this method, the equipment is not
produced commercially any more. All
modern soft-gel encapsulation uses
variations of a process developed by
R. P. Scherer in 1933. His innovation
was to use a rotary die to produce the
capsules, with the filling taking place
by blow molding. This method
reduced wastage, and was the first
process to yield capsules with highly
repeatable dosage.

The current owner of Schrerers

technology is Catalent Pharma
Solutions, the world's largest
manufacturer of prescription
pharmaceutical softgels.

Softgels can be an effective delivery

system for oral drugs, especially
poorly soluble drugs. This is because
the fill can contain liquid ingredients
that help increase solubility or
permeability of the drug across the
membranes in the body. Liquid
ingredients are difficult to include in
any other solid dosage form such as a
tablet. Softgels are also highly suited
to potent drugs (for example, where
the dose is <100 g), where the highly
reproducible filling process helps
ensure each softgel has the same
drug content, and because the
operators are not exposed to any drug
dust during the manufacturing
process.

In 1949, the Lederle Laboratories

division of the American Cyanamid
Company developed the "Accogel"
process, allowing powders to be
accurately filled into soft gelatin
capsules.

Two-piece gel
encapsulation ("hard
capsules")

Two-piece, hard starch capsules

Reconstruction from CT-data of a hard starch
capsule containing Diclofenac. Resolution 18,6
m/pixel.

0:00

Flight through the image stack of the above

Flight through the image stack of the above
scan.

James Murdock of London patented

the two-piece telescoping gelatin
capsule in 1847.[2] The capsules are
made in two parts by dipping metal
pins in the gelling agent solution. The
capsules are supplied as closed units
to the pharmaceutical manufacturer.
Before use, the two halves are
separated, the capsule is filled with
powder or more normally pellets
made by the process of Extrusion &
Spheronization (either by placing a
compressed slug of powder into one
half of the capsule, or by filling one
half of the capsule with loose powder)
and the other half of the capsule is
pressed on. With the compressed
slug method, weight varies less
between capsules. However, the
machinery required to manufacture
them is more complex.[3]

The powder or spheroids inside the

capsule contains the active
ingredient(s) and any excipients, such
as binders, disintegrants, fillers,
glidant, and preservatives.

Manufacturing materials
Gelatin capsules, informally called gel
caps or gelcaps, are composed of
gelatin manufactured from the
collagen of animal skin or bone.

Vegetable capsules are composed of

hypromellose, a polymer formulated
from cellulose.

Manufacturing equipment
The process of encapsulation of hard
gelatin capsules can be done on
manual, semi-automatic and
automatic machines. Softgels are
filled at the same time as they are
produced and sealed on the rotary die
of a fully automatic machine.Capsule
fill weight is a critical attribute in
encapsulation and various real time
fill weight monitoring techniques such
as NIR and vibrational spectroscopy
are used, as well as in line weight
checks, to ensure product quality.[4]

Standard sizes of two-

piece capsules
Size Volume (mL)[A] Locked length (mm)[A] External diameter (mm)[A]

5 0.13 11.1 4.91

4 0.20 14.3 5.31

3 0.27 15.9 5.82

2 0.37 18 6.35

1 0.48 19.4 6.91

0 0.67 21.7 7.65

0E 0.7 23.1 7.65

00 0.95 23.3 8.53

000 1.36 26.14 9.91

13 3.2 30 15.3

12 5 40.5 15.3

12el 7.5 57 15.5

11 10 47.5 20.9

10 18 64 23.4

7 24 78 23.4

Su07 28 88.5 23.4

A Approximate

See also
Capsule endoscopy
OROS
 Pharmacy Automation - The Tablet
Counter
Pharmaceutical formulation
Pill splitting

References
1. Sims, Calvin (1986-02-15). "Despite
"mystique" of capsules, many drugs
work in other forms" . New York
Times.
2. "History of dosage forms and basic
preparations". Encyclopedia of
Pharmaceutical Technology. 7.
Informa Health Care. 1998. pp. 304
306. ISBN 0-8247-2806-8.
3. Bill Bennett; Graham Cole (2003).
Pharmaceutical Production, an
Engineering Guide. IChemE. pp. 126
129. ISBN 0-85295-440-9.
4. "Pharmaceutical Encapsulation" .
PharmaCMC. Retrieved 27 September
2016.
L. Lachman; H.A. Lieberman; J.L.
Kanig (1986). The Theory and Practice
of Industrial Pharmacy (Third ed.). Lea
& Febiger, Philadelphia. ISBN 0-8121-
0977-5.

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