CAPSULES

Capsules are solid dosage forms in which one or more

medicinal or inert substances (as powder, compact, beads, or
granulation) are enclosed within a small gelatin shell.

● Gelatin capsules may be hard or soft .

● Most capsules are intended to be swallowed whole, but
occasionally, the contents are removed from the gelatin
shell and used as a premeasured dose.
ADVANTAGES
➢ Capsules are tasteless, odorless and can easily be administered.
➢ Combination of powders
➢ Physician can change the dose and combination of drug according to patient
requirement.
➢ There are attractive in appearance.
➢ The drugs having unpleasant odor and taste are enclosed in a tasteless shell.
➢ They can be filled quickly and conveniently.
➢ They are economical.
➢ They are easy to handle and carry.
➢ The ready solubility of gelatin at gastric pH provides rapid release of medication
in the stomach.
➢ Packaged and shipped by manufacturers at lower cost less breakage than liquid
forms.
LIMITATIONS
➢ Capsules are not suitable for liquids that dissolve gelatin, such as
aqueous or hydro alcoholic solutions.
➢ Highly soluble salt (e.g. Iodides, Bromides, and Chlorides) generally
should not be dispersed in HGC.
➢ Not useful for efflorescent or deliquescent materials.
➢ Difficult to swallow in case of children and older people.
HARD GELATIN CAPSULES
Hard gelatin capsules
● The powder blend is simpler and less compacted than the blend in a
compressed tablet.
● After ingestion, the gelatin softens, swells, and begins to dissolve in
the gastrointestinal tract.
● Encapsulated drugs are released rapidly and dispersed easily, and
bioavailability is good.
● Hard gelatin capsules are the preferred dosage form for early clinical
trials of new drugs.
A. Preparation of filled hard capsules includes preparing the formulation,
selecting the appropriate capsule, filling the capsule shells, and cleaning and
polishing the filled capsules.

○ Empty hard capsule shells are manufactured from a mixture of

gelatin, colorants, and sometimes an opacifying agent (e.g., titanium
dioxide). The USP also permits the addition of 0.15% sulfur dioxide
to prevent decomposition of gelatin during manufacture.

○ Gelatin USP is obtained by partial hydrolysis of collagen obtained

from the skin, white connective tissue, and bones of animals. Types
A and B are obtained by acid and alkali processing, respectively.
○ Capsule shells are cast by dipping cold metallic molds or pins
into gelatin solutions that are maintained at a uniform
temperature and an exact degree of fluidity.
■ Variation in the viscosity of the gelatin solution increases
or decreases the thickness of the capsule wall.
■ After the pins are withdrawn from the gelatin solution,
they are rotated while being dried in kilns. A strong blast of
filtered air with controlled humidity is forced through the
kilns. Each capsule is then mechanically stripped, trimmed,
and joined.
B. Storage

Hard capsules should be stored in tightly closed glass containers and protected
from dust and extremes of humidity and temperature.

1) These capsules contain 12% to 16% water, varying with storage conditions.
When humidity is low, the capsules become brittle. When humidity is high,
the capsules become flaccid and shapeless.

2) Storage at high temperatures also affects the quality of hard gelatin

capsules.
C. Sizes
3) Selecting capsules. Capsule size should be chosen carefully.
A properly filled capsule should have its body filled with the
drug mixture and its cap fully extended down the body.
D. Filling capsules
Whether on a large- or a small-production scale, the cap
is first separated from the body of the capsule before
filling the capsule body with the formulation and then
reattaching the cap.

(1) the spoon or bowl method. This method works best

with a shallow, concave small bowl or spoon. The less
powder you have, the smaller the container should be, so
that you can press the capsule to the bottom. If the powder
is too deep, you don’t get the resistant needed to pack the
powder.

(2) Manual Capsule Filling Machine - The manual

capsule filler is able to fill and close hard gelatin
capsules containing powders and granules.
(3) Automatic encapsulator is a capsule filling machine that is
developed and designed to automatically fill empty hard gelatin
capsule with powders and granules. They are used in the large scale
production of capsule.

After they are filled, capsules must be cleaned and polished.

(a) On a small scale, capsules are cleaned individually or in

small numbers by rubbing them on a clean gauze or cloth.

(b) On a large scale, many capsule-filling machines have a

cleaning vacuum that removes any extraneous material as
the capsules leave the machine
SOFT GELATIN CAPSULES
Soft gelatin capsules
● nonaqueous solution, powder, or a drug suspension.
● The vehicle may be water miscible.
● The cardiac glycoside digoxin, dispersed in a water-miscible vehicle
(Lanoxicaps), has better bioavailability than a compressed tablet formulation
(Lanoxin).
● However, a soft gelatin capsule that contains the drug dissolved in a
hydrophobic vehicle
A. Preparation
(1) Soft gelatin capsules are prepared from gelatin shells. Glycerin or a
polyhydric alcohol (e.g., sorbitol).

(2) These shells contain preservatives to prevent the growth of fungi.

B. Uses
They are used to contain liquids, suspensions, pastes, dry powders, or pellets.
(1) Drugs that are commercially prepared in soft capsules include demeclocycline
hydrochloride, chloral hydrate, digoxin,vitamin A, and vitamin E.
(2) Soft gelatin capsules are usually prepared by the plate process or by the rotary
or reciprocating die process.
DIFFERENCES OF HARD AND SOFT CAPSULES

HARD SOFT

● Titanium oxide ● Plasticizers

● Less flexible ● More flexible
● Machine filling
● Possible hand filling process
UNIFORMITY and DISINTEGRATION
a. The uniformity of dosage forms can be demonstrated by either weight
variation or content uniformity methods.

b. Disintegration tests are not usually required for capsules unless they have
been treated to resist solution in gastric fluid (enteric coated). In this case,
they must meet the requirements for disintegration of enteric-coated tablets.
FORMULATION
Hard Gelatin Capsule Formulation

1. Active ingredients
2. Fillers (diluents)
3. Glidents
4. Lubricants
5. Disintegrants
6. Surfactants
7. Hydrophilic agents
 Soft Gelatin Capsule Formulation

● Formulation for soft gelatin capsules involve liquid.

● Materials generally formulated to produce the smallest possible capsule
consistent with maximum stability, therapeutic effectiveness and
manufacture efficiency.
● The liquids are limited to those do not have adverse effect on gelatin walls
● Emulsion can not be filled because water will be released that will affect
the shell
● The pH the liquid can be between 2.5 and 7.5
Capsule shell (soft gelatin capsule)
● Gelatin
● Plasticizer
● Preservatives
● Colorants
● Opacifier
● Flavoring agents
● Sugar