Capsule (pharmacy)

Transparent capsules

In the manufacture of pharmaceuticals,

encapsulation refers to a range of dosage
forms—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 contain

dry, powdered ingredients or miniature
pellets made by e.g. processes of
extrusion or spheronization. These are
made in two halves: a smaller-diameter
“body” that is filled and then sealed
using a larger-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”, a portmanteau of “capsule-
shaped tablet”[1], in order to tie this
positive association to more efficiently-
produced tablet pills, as well as being an
easier-to-swallow shape than the usual
disk-shaped tablet.

Single-piece gel
encapsulation ("soft
capsules")

Soft gel capsules.

Advil liqui-gels
In 1833, 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 molds 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 no longer produced
commercially. All modern soft-gel
encapsulation uses variations of a process
developed by R. P. Scherer in 1933. His
innovation used a rotary die to produce the
capsules. They were then filled by blow
molding. This method was high-yield,
consistent, and reduced waste.

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 µg), 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 µCT-data of a hard starch
capsule containing Diclofenac. Resolution 18,6
µm/pixel.
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. or Pullulan, polysaccharide
polymer produced from tapioca starch.

Manufacturing equipment
The process of encapsulation of hard
gelatin capsules can be done on manual,
semi-automatic and automatic capsule
filling 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 near-infrared
spectroscopy (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
Tablet
Oblaat

References
1. Safire, William (1986-03-09). "On
Language; The Caplet Solution" . The
New York Times. Retrieved
2017-12-06.
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. Archived from the
original on 6 October 2016. 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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