Small amounts of powder may adhere to

the outside of capsules after filling. The

powder maybe bitter or otherwise
unpalatable and should be removed
before packaging or dispensing.
Small Scale may be cleaned
individually or in small numbers by
rubbing them with a clean gauze or
cloth.
Large Scale capsule-filling machines
are affixed with a cleaning vacuum that
removes any extraneous material from
the capsules as they exit the equipment.
Accela-Cota
Apparatus
- equipment
use in cleaning
and polishing of
filled hard
capsules.
Made of gelatin, glycerin or a polyhydric
alcohol such as sorbitol
Contain more moisture than hard
capsules
May have a preservative, such as
methylparaben and/or propylparaben,
to retard microbial growth
May be oblong, oval, or round.
Single colored or two toned
May be imprinted with identifying
markings
As with hard gelatin capsules, they
maybe prepared with opaquants to
reduce transparency and render
characteristic features to the capsule
shell
Used to encapsulate and hermetically
seal liquids, suspensions, pasty materials,
dry powders and even performed
tablets
Pharmaceutically elegant
Easily swallowed
Plate Process using set of molds to form
the capsules.
- A warm sheet of plain or colored gelatin is
placed on the bottom plate of the mold
- Medication liquid is evenly poured
- Second sheet of gelatin is carefully placed
on top and the top plate is put into place
- Pressure is then applied to the mold to form,
fill and seal the capsules
Rotary Die Process or Reciprocating Die
Process capsules are filled and sealed in a
continuous operation
Rotary Die Process most soft gelatin
capsules are prepared by this process
- Liquid gelatin flowing from an overhead
tank into continuous ribbons
- Metered fill material is injected between
the ribbons
- The dies form pockets of the gelatin ribbons
- These pockets of fill containing gelatin are
sealed by pressure and heat and then
severed from ribbons


Reciprocating Die Process similar to
rotary die process but it differs in actual
encapsulating process
- The gelatin ribbons are fed between a set
of vertical dies that continually open and
close to form rows of pockets in the
gelatin ribbons
- Pockets filled with medication
- Sealed, shaped and cut out of the film
- The capsules are cut from the ribbons

Water-immiscible volatile and non-volatile
liquids (vegetable and aromatic oils,
aromatic and aliphatic hydro carbons,
etc.)
Water-miscible non volatile liquids
(polyethylene glycols, and nonionic surface
active agents, such as polysorbate 80
Water miscible and relatively non volatile
compounds (propylene glycol and
isopropyl alcohol)
Liquids that can easily migrate through
shell are not suitable for soft gelatin
capsule (water above 5% and low-
molecular-weight-water-soluble and
volatile organic compounds
Solids may be encapsulated into soft
gelatin capsules as solutions in a liquid
solvents, suspensions, dry powder,
granules, pellets or small tablets
ADDED SUBSTANCES
-Substances added to official preparations
including capsules may be use only if they
1. Are harmless in the quantities used
2. Do not exceed the minimum amounts
required to provide their intended effect
3. Do not impair the products bioavailability,
therapeutic efficacy, or safety
4. Do not interfere with requisite compendial
assays and tests
CONTAINERS FOR DISPENSING CAPSULES
- Depending on the item, the container may
be required to be tight, well-closed, light-
resistant, and/or all of these
DISINTEGRATION TEST FOR CAPSULES
- Capsules are placed in the basket rack
assembly which is immersed 30 times per
minute into thermostatically controlled fluid
at 37C
- To satisfy the test, the capsules disintegrate
completely into a soft mass having no
palpably firm core and only some
fragments of the gelatin shell
DISSOLUTION TEST FOR CAPSULES
- The empty capsule shells dissolved in the
dissolution medium before proceeding
with the sampling and chemical analysis
WEIGHT VARIATION
- The uniformity of dosage units may be
demonstrated by determining weight
variation and/or content uniformity
HARD CAPSULES
- Individually weighed ad contents
removed. Net weight of the contents is
calculated by subtraction
SOFT CAPSULES
- gross weight is determined individually.
Each capsule is cut open and the
contents are removed by washing with a
suitable solvent

CONTENT UNIFORMITY
- The amount of active ingredient ,
determined by assay, is within the range
of 85% to 115% of the label claim for 9
days of 10 dosage units assayed, with no
unit outside the range of 70% to 125% of
the label claim
CONTENT LABELING REQUIREMENT
- All official capsules must be labeled to
express the quantity of each active
ingredient in each dosage unit
STABILITY TESTING
- Help determine the appropriate
conditions for storage and the products
anticipated shell life
MOISTURE PERMEATION TEST
- To ensure the suitability of single-unit and
unit-dose containers for packaging
capsules

Approximately 200 officially recognized
medications in capsule form are listed in
the USP.
However, many times this number of
capsule products are available from
various manufactures for various drugs
and in various dosage strengths.