CAPSULES
Capsules are not useful for extremely soluble materials such as KCl, KBr
sudden release may cause irritation.
Capsules not useful for efflorescent or deliquescent materials .
Efflorescent cause Capsules to soften
Deliquescent may dry capsule shell to brittleness
Preparation Of Gelatin
HARD GELATIN CAPSULE
the shell of HGC basically consist of
• 1) Gelatin
• 2) Plasticizer
• 3) Water
Gelatin
• Gelatin is the most important constituent of the dipping solution
• Gelatin is prepared by the hydrolysis of collagen obtained from animal tissues.
Popularly these are two grade of gelatin (two basic types)
• Pharmagel A (type A) which is produced by an acid hydrolysis is manufactured
mainly from the pork skin.
• Pharmagel B (type B) which is produced by alkaline hydrolysis is manufactured
mainly from the animal bones.
They differ only in their isoelectric point i.e.
Pharmagel-A pH 4.8-5.2
Pharmagel-B pH 6.5-9.2 and by their viscosity building & film forming
characteristics.
Either type of gelatin may be used, but combination of pork skin &
bone gelatin is often used to optimize shell characteristics.
Bone gelatin- contributes firmness where as Pork skin- contributes
plasticity & clarity.
PLASTICIZERS
the plasticizers used are glycerin, sorbitol etc.
If preservative are intended generally a mixture of methyl
& propyl paraben (4:1) up to 0.2 %
If flavors are used should not exceed up to 2% generally
ethyl vanillas or essential oils. If sugar up to 5%.
The physiochemical properties of gelatin that are of
interest to the shell manufactures are-
• 1) Bloom strength
• 2) Viscosity
Bloom strength-
If an empirical gel strength measure, that gives an
indication of the firmness of the gel. It is a measure of
the cohesive strength of cross linking that occurs
between gelatin molecules and is propotional to
molecular weight of gelatin.
It is measure in a bloom gelometer which determine
the weight in grams required to move a plastic plunger
that is 0.5 inches in diameter, 4mm into a 62/3 % w/w
gelatin gel held at 10°C for 17 hrs.
Bloom strength in the range of 150-250g is
considered suitable for capsule.
Viscosity-
The viscosity of the gelatin is vital to control the
thickness of the cast film.
Viscosity is measured on a standard 6-2/3%w/w
solution at 600 C in a capillary pipette & generally in the
range of 30-60 mille poise.
COLOURANTS-
Commonly, various soluble synthetic dyes (coal tar
dyes) & insoluble pigment are iron oxide.
Colorant plays an important role in improving
patient compliance.
Thus the color of drug product may be selected in
consideration of the disease state for which it is intended.
e.g. White – analgesics.
Orange/Yellow – stimulants & anti depressants.
OPACIFIERS –
Titanium dioxide may be included to render the shell
opaque.
OPAQUE CAPSULES –
May be employed to provide protection against light or to
conceal the contents.
PRESERVATIVES –
When employed, to provide parabens are often selected.
WATER –
Hot, demineralised water is used in the preparation of the
dipping solution.
Initially a 30-40% w/w of solution of gelatin is prepared in large
stainless still tank.
Vacuum may be applied to assist in the removal of entrapped air
from this vacuum pumps.
Portion of this stock solution are removed & mixed with only other
ingredient as required to prepare the dipping solution, at this point the
viscosity of the dipping solution is measured & adjusted.
The viscosity of solution is critical to control the thickness of the
capsule shell.
SHELL MANUFACTURE
• Empty hard gelatin capsules are manufactured on Colton machines
which was invented about 50 years ago.
• HGC are manufacture by a process in which stainless steel mould pins
are dipped into warm gelatin solution & the shells are formed by the
gelatin on the pin surfaces.
MANUFACTURE OF EMPTY GELATIN CAPSULES
Steps involved in making empty gelatin
capsules…
• Dipping
• Spinning
• Drying
• Stripping
• Trimming and Joining
• Polishing.
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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.
Spinning :
The pins are rotated to distribute the gelatin over the pins uniformly
and to avoid the formation of a bead at the capsule ends.
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Drying :
The gelatin is dried by a blast of cool air to form a 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.
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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.
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SORTING
The moisture content of the capsule as they are
ejected from the machine will be in the range of15-18%
w/w, additional adjustment of moisture content towards
the final desired specification will occur during the sorting
step.
During the sorting, the capsule passing on a lighted
moving conveyer are examined visually by inspector, any
defective capsule spotted are thus manually removed.
Defects are generally classified according to their
nature & potential to cause problems in use.
The most serious of these are that could cause
stoppage of a filling machine, such as imperfect cuts,
dented capsule or those with holes.
Other defects may cause problems on use, such as
capsule with splits, long bodies or cracks inside.
PRINTING
In general, capsules are printed before filling.
Empty capsule can be handled faster than
filled capsule & should there be any loss or
damage to the capsules during printing, no active
ingredient would be involved.
Generally, printing is done on offset rotary
process having through put capacities as high as
there-generator machine capsule per hour.
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