26-08-2021

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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