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HARD GELATIN CAPSULES
Introduction;
Shell Formulation and
Shell Manufacturing
Mr. A.V. SURENDRA
M.Pharm, (PhD)
Assistant Professor
K L College of Pharmacy
K L University
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Capsules
Unit solid dosage forms in which drug substance(s)
is/are enclosed in either a hard or soft soluble shell
of a suitable form of gelatin or some polymer.
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Gelatin Capsule Shells
Hard Soft
Depending on their composition
advantages
Number of production steps, analytical tests,
validation parameters are < tablet production.
Allow incorporation of various formulations like
granules, powders, liquids & semisolids.
Suitable for controlled release formulations.
Reduction in number of excipients required.
Easily identified in view of unique color & shape.
Suitable to mask organoleptic properties.
Provide smooth, slippery, easily swallowable.
Patient compliance is more.
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Highly elegant.
More suitable for clinical studies.
Allow dispensing of incompatible ingredients.
Improve stability of sensitive drugs.
Improves bioavailability of poorly soluble drug.
disadvantages:
Rate of production of capsules < tablet production
rate.
Cost of capsule dosage form higher.
Not suitable for highly water soluble salts like KCl,
KBr, NH4Cl (sudden release of compounds in
stomach irritating concentrations).
Chances of oesophageal adhesion.
Not suitable for bulky materials.
Susceptibility to moisture absorption.
Some ingredients may react with capsule shell.
Problems in filling. 8
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Not used for highly efflorescent or deliquescent
materials.
Efflorescent materials capsules to soften.
Deliquescent powders dry capsule shell to
excessive brittleness.
HGC a base or body & a shorter cap, which fits
firmly over base of capsule.
Human use 8 sizes of capsules.
Capacity of each size varies according to
combination of drugs & their apparent densities.
HGC locking cap, which makes it more difficult
to reopen capsule.
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formulation
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Composition of emptY HgC sHell:
Empty gelatin capsule shell composition may vary
from supplier- supplier.
Gelatin (80-85%).
Water (12-16%).
Plasticizer (0.1%).
Preservative.
Lubricant.
Coloring Agent.
Suitable Edible Printing Ink.
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gelatin:
Heterogeneous product derived by irreversible
hydrolytic extraction of treated animal collagen.
Sources of collagen animal bones, hide portions,
& frozen pork skin.
Chemical & physical properties, depending upon
source of collagen & extraction.
tYpes of gelatin
Type A – Produced by acid hydrolysis from pork
skin (7 – 9).
Type B – Produced by alkaline hydrolysis from 16
animal bones (4.8 – 5).
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Differentiated isoelectric points, viscosity & film
forming characteristics.
Combination based on availability & cost.
Bone gelatin contributes firmness.
Pork skin contributes plasticity & clarity.
Blends of bone & pork skin gelatins of high gel
strength used for HGC production.
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Physico chemical properties of gelatin are
influenced by
Parent collagen
Method of extraction
pH
Thermal degradation
Electrolyte content
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properties of gelatin
Bloom strength: HGC– 200 to 250 gm, SGC – 150
gm
Viscosity: 6 2/3 % w/w at 60o C gives 30 – 60 mill
poise.
Iron Content : < 15 ppm
Free from transmitting animal spongiform
encephalopathy agents.
Gelatin alternatives
MC, HPMC, Starch.
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Process of manufacturing gelatin used in capsules
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Shell manufacture
Dipping Rotation Drying
Stripping Trimming Joining
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Shell manufacture :
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industrial Capsule sHell manufaCturing
proCess
Once raw materials have been received & released
by QC, gelatin & hot demineralized water are mixed
under vacuum in R&J Engineering's Stainless Steel
Gelatin Melting System.
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After aging in stainless steel receiving tanks, gelatin
solution is transferred to stainless steel feed tanks.
Dyes, opacifiers & water are added to gelatin in feed tanks
to complete gelatin preparation procedure.
Feed tanks are then used to gravity-feed gelatin into R&J
Capsule Machine
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i. dipping :
Pairs of stainless steel pins are dipped into dipping
solution to simultaneously form caps & bodies.
Pins are at ambient temperature; whereas dipping
solution is maintained at a temperature of about
500C in a heated, jacketed dipping pan.
Length of time to cast film has been reported to be
about 12 sec.
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ii. rotation :
After dipping, pins are elevated & rotated 2-1/2
times until they are facing upward.
This rotation helps to distribute gelatin over pins
uniformly & to avoid formation of a bead at
capsule ends.
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iii. drYing :
Racks of gelatin coated pins then pass into a series
of four drying oven.
Drying done by dehumidification.
Temperature elevation of only a less degrees is
permissible to prevent film melting.
Under drying will leave films too sticky for
subsequent operation.
Here gently moving air which is precisely
controlled for volume, temperature & humidity,
removes exact amount of moisture from capsule
halves.
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Precision controls constantly monitor humidity,
temperature & gelatin viscosity throughout
production process.
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Once drying is complete,
Pin Bars enter Table
section which positions
capsule halves for
stripping from Pins in
Automatic section
In Automatic section,
capsule halves are
individually stripped
from Pins.
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iv. stripping :
A series of bronze jaws strip cap & body portions
of capsules from pins.
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v.trimming :
Stripped cap & body portions are delivered to
collects in which they are firmly held.
As collects rotate, knives are brought against shells
to trim them to required length.
Cap & body lengths are precisely trimmed to a
±0.15 mm tolerance.
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vi. Joining :
Cap & body portions are aligned concentrically in
channels & 2 portions are slowly pushed together.
Capsule bodies & caps are joined automatically in
joiner blocks.
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Finished capsules are pushed onto a conveyer belt
which carries them out to a container
Capsule quality is monitored throughout production
process including size, moisture content, single wall
thickness, & colour.
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3) sorting :
Moisture content of capsules as they are from
machine will be in range of 15 – 18% w/w.
During sorting, capsules passing on a lighted
moving conveyor are examined visually by
inspectors.
Defects classified according to their nature &
potential to cause problems in use.
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4) printing :
Capsules printed before filling.
Printing offset rotary presses having through
output capabilities as high as three-quarter million
capsules per hour.
Perfect capsules are imprinted with client logo on
high-speed capsule printing machines.
Capsules are now ready to be sterilized & packaged.
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5) sizes & sHapes :
Human use, empty gelatin capsules are manufactured
in 8 sizes, ranging from 000 to 5.
Capsule capacities in table:
Size Volume Fill weight(g) at 0.8
g/cm3 powder density
000 1.37 1.096
00 0.95 0.760
0 0.68 0.544
1 0.50 0.400
2 0.37 0.296
3 0.30 0.240
4 0.21 0.168
08 June 2009 SRTM University, NandedDept. of
5 0.15
Pharmaceutics
0.104
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Veterinary capsules are available in sizes designated
as No.10, No.11, & No.12, with relative capacities
of 1 oz., 6 oz. & 8 oz.
Colored capsules are available in almost any desired
form & combination: solid colors (base & cap are
same) or mixed (bases & caps are different colors).
Almost any color can be prepared as a special order.
If coloured capsules are not available, pharmacist
can add an approved dye to powdered material &
place powder inside a clear capsule.
Capacity of capsule is dependent upon density &
characteristics.
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6) sealing :
Capsules are sealed & somewhat reshaped in
Etaseal process.
This thermal welding process forms an indented
ring around waist of capsule where cap overlaps
body.
7) storage :
Finished capsules EMC of 13-16%.
To maintain a relative humidity of 40-60% when
handling & storing capsules.
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Ratio dry
Hardness glycerin / Usage
dry gelatin
Hard 0.4/1 Oral, oil-based, or shell-softening
products & those destined primarily
for hot, humid areas.
Medium 0.6/1 Oral, tube, vaginal oil-based, water-
miscible-based, or shell-hardening
products & those destined,
primarily for temperate areas.
Soft 0.8/1 Tube, vaginal, water-miscible-based
or shell-hardening products & those
destined primarily for cold, dry
areas.
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