Hard gelatin capsules are two-piece capsules consisting of a cap and body. They are manufactured through a dipping, spinning, drying, stripping, trimming and polishing process. The shell contains gelatin, dyes, opacifiers, plasticizers and preservatives. Capsules are filled using machines that separate the caps from bodies, fill the bodies with powders or granules, replace the caps and seal the capsule. Quality control tests include size, shape, content uniformity and dissolution. Capsules provide advantages like easy swallowing, taste masking and compatibility of multiple active ingredients.

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INDEXINDEX
1. Introduction.
2. Hard Gelatin Capsule.
3. Hard Gelatin Capsule Machine.
4. Chemical Requirements.
5. Gelatin.
6. Preparation of empty gelatin capsule.
7. Hard gelatin capsule machine.
8. Hard gelatin capsule.
9. Hard Gelatin Capsule Filling.
10. Quality control of capsules.
11. Advantages and Disadvanages.

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 CAPSULES:
Capsules are solid dosage forms in which the drug
substance is enclosed within either a hard or soft soluble
shell, usually formed from gelatin. The term capsule is
derived from the Latin word capsula, meaning a small
container.
 The first capsule prepared from gelatin was a one-piece
capsule patented in France by Mothes and Du Blanc in
1834.
 Today capsules may be classified as either hard or soft,
depending on the nature of the shell. Most capsules of
both types are intended to be swallowed whole; however,
some soft gelatine capsules are intended for rectal or
vaginal insertion as suppositories.

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 Hard Gelatin Capsule:Hard Gelatin Capsule:
 The hard gelatin capsule consists of two pieces in
the form of cylinders closed at one end. The shorter
piece is called the cap. This cap fits over the open
end of longer piece called body.
 Hard gelatin capsules are also known as dry-filled
capsules or two piece capsules. Hard gelatin capsules
consists of two parts known as capsule body (longer
part) and the capsule cap(the shorter part) The drug
substance placed in the body and the caps are slided
over it, hence enclosing the drug substance.

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• Cap
• Body

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Capsule sizeCapsule size Body fill volumesBody fill volumes
Capsule size Body volume(ml)
1
2
3
4
0.50
0.37
0.28
0.20

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 FORMULATION OF HARD GELATIN SHELL :FORMULATION OF HARD GELATIN SHELL :
 Gelatin: It is prepared by the hydrolysis of collagen
obtained from animal connective tissue, bone and pork
skin.
There are two types of gelatin
Type A (Acid hydrolysis of pork skin)
TypeB (Alkaline hydrolysis of bones)
The two types of gelatin can be distinguished by iso
electric point as:
Type A iso electric point near to PH 9

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 Certified Dyes :
Colour approved by D & C act.
 Opacifiers:
Tio2
 Plasticizers:
Sorbitol, Glycerin.
 Preservatives:
Propyl and Methyl Parabens
 Sugar
Water - 12 to 16 % but may vary depending on the
storage condition
Sulfur dioxide (15%) - prevent decomposition
during manufacture

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 Types of excipients used:Types of excipients used:
Powder-filled capsule
Diluents
Lubricants and Glidants
Wetting agents
Disintegrants

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 MANUFACTURING OF CAPSULE SHELL :MANUFACTURING OF CAPSULE SHELL :
Steps involved in making empty gelatin capsules -
1) Dipping
2) Spinning
3) Drying
4) Stripping
5) Trimming and Joining
6) polishing

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 FILLING OF HARD GELATINFILLING OF HARD GELATIN
CAPSULES :CAPSULES :
Various Filling Machines Available…
• Eli-lily and Co
• Farmatic
• Hofliger and Karg
• Zanasi
• Parke-Davis.
• Macofar
• capsuegel

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ZANASI AUTOMATIC
CAPSULE FILLING MACHINE
HOFLIGER KARG AUTOMATIC
CAPSULE FILLING MACHINE

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POWDERS GRANULES
BEADS TABLETS

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 FILLING HARD CAPSULE SHELLS:FILLING HARD CAPSULE SHELLS:
A hand operated gelatin capsule filling machine
consist of following parts:
• A bed with 200-300 holes.
• A capsule loading tray.
• A powder filling tray.
• A pin plate having 200 or 300 pins corresponding to
the number of holes in the bed and cap holding tray.
• A lever handle.
• A cam handle.
• A plate fitted with rubber top.

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 THE PROCESS OF WORKING:THE PROCESS OF WORKING:
 Rectification.
 Separating the caps from empty capsules.
 Filling the bodies.
 Scraping the excess powder.
 Replacing the caps.
 Sealing the capsules.
 Cleaning the outside of the filled capsules.

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 RECTIFICATION :RECTIFICATION :
• The empty capsules are oriented so that all point
the same direction i.e, body end downwards.
• In general capsule pass one at a time through a
channel just wide enough to provide grip at cap end.
• The capsule will always be aligned body end
downwards regardless of which end entered the
channel first with the help of specially designated
blades.

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 SEPARATION OF CAPS FROM BODY :SEPARATION OF CAPS FROM BODY :
• The rectified capsules are delivered body end first
into the upper portion of split bushings or split
filling rings.
• A vaccume applied from below pull the body
down into the lower portion of the split bushing.
• The diameter of the bush is too large to allow
them to follow body.
• The split bushing are separated to expose the
bodies for filling.

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 FILLING :FILLING :
• Auger fill principle : because the auger mounted in the
hopper rotates at a constant rate, the rate of the delivery
of the powder to the capsules tend to be constant.
Flat blade auger – Screw auger E.g. capsule type8 filling
machine.
 Scraping the excess powder.
 Replacing the caps.
 Sealing the capsules.
 Cleaning the outside of the filled capsules.

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 LIQUID-FILL BASED FORMULATION ADVANCESLIQUID-FILL BASED FORMULATION ADVANCES
AND CHALLENGES:AND CHALLENGES:
• This technology offers an inherently safer process
than powder filled capsules and tablets for highly
potent or cytotoxic drugs, as dust generation does not
occur with liquid-fill formulations.
• The process involves the addition and mixing of the
active substance in a liquid or molten vehicle (which
could be a single excipient or a multi-component mix).
The drug formulation is then filled into capsules,
which can be sealed if necessary to prevent leakage.

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 DUO CAP TECHNOLOGY :DUO CAP TECHNOLOGY :
• Single oral capsule dosage units comprising capsule-
in-a capsule technology such as Duocap offer a broad
range of therapeutic applications.
• The inner and outer capsules may contain the same
active drug, providing multiple release profiles from
the dosage unit – for example, an immediate release
formulation from the outer capsule and a controlled
release formulation from the inner capsule.
• Alternatively, the inner and outer capsules may
contain different actives for use with combination
therapies or actives that are incompatible.

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A
b
C

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CFS 1000 semi industrial machine for filling
liquid and semi solid formulation into two
piece capsule and sealing.

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 MICRO ENCAPSULATION :MICRO ENCAPSULATION :
• It is a process by which very tiny droplets / particles of liquid / solid
materials are surrounded or coated with a continious film of polymeric
material.
• The primary reason m.e is found to either sustained/prolonged drug release.
•Used for masking taste & odour of many drugs to improve patient compliance.
• Drugs which are sensitive to oxygen, moisture, light, can be stabilized by
M.E & Incomptability among drugs can be prevented
• Many drugs have been en capsulated to reduce toxicity, GI irritation
Ex. of coating material used for encapsulation
water soluble resins : gelatin, pvp
water insoluble resins : poly ethylene, cellulose nitrates.
Waxes : Paraffin, Bees wax
Enteric resins : shellac, cellulose acetate pthallate.

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 FILLING POSSIBILITIES :FILLING POSSIBILITIES :
• By using hard gelatine capsule a variety of
materials can be filled like powders, granules, pellets,
liquids, semisolids, tablets etc
• It is probably by using capsugels conisnap capsules
are worlds most popular brands of two piece gelatine
capsules.

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1) Powders or granules
2) pellet mixture
3) paste
4) capsule
5) Tablet

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 TYPICAL SHELL HARDNESS AND THEIR USES

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 Quality control ofQuality control of
capsules:capsules:
1. Close length test.
2. Shape, size & Color.
3. Thickness of capsule shell
4. Content of API.
5. Weight variation test .
6. Uniformity of content.
7. Disintegration test.
8. Dissolution test.

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 AdvantagesAdvantages
Easy to swallow.
Masking capacity .
Protection of medicament .
Therapeutically inert & easy to digest .
Easy to handle and carry .
Different sizes are available.
Product Identification.
Provide enteric & sustained release effects.
Moisture content .
No need of complicated machinery
Filling of incompatible substance in the same

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 DIS -ADVANTAGES :DIS -ADVANTAGES :
1. Highly soluble salts (e.g., iodides, bromides, and
chlorides) generally should not be dispensed in hard
gelatin capsules. Their rapid release may cause gastric
irritation.
2. Filling equipment is slower than tableting.

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 CONCLUSION :CONCLUSION :
• Capsules are more advantageous than the other
dosage forms. Capsules contain drug in a liquid form
having more advantages in the pharmaceutical field.
• The novel advances such as micro filling,enteric
coating of hard gelatin capsules, Duo cap technology
and material and machinery advances have been a
significant improvement in the current days Hence
capsules are the most preferred dosage forms than
other conventional dosage forms.

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 REFERENCE BOOKS :REFERENCE BOOKS :
• Leon lachman and HerbertA. Liberman The theory and practice
of industrial pharmacy
special Indian edition 2009 pg no 374 – 398
• Tapash K. Ghosh Bhaskara R jasti Theory and Practice of
CONTEMPORARY
PHARMACEUTICS EDITED BY pg no 314-323
• Edited by james swarbick Encyclopedia of pharmaceutical
technology vol 1 3rd
edition pg no 406-430
• Ansels pharmaceutical dosage forms and drug delivery system 8th
edition
pg no 204-226
• LA Augsburger (1995) “Hard and soft gelatin capsules” in
Modern Pharmaceutics
GS Banker & CT Rhodes, Eds., Marcel Dekker, Inc.: New York,
NY, pp 395–440.

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