Capsules
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CAPSULES
presented by S.Nandhini
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DEFINITION
• Capsules are a solid dosage form in which the drug
substance is enclosed in a water soluble shell or an
envelope.
• A capsule shell is made up of gelatin
• Primarily intended for oral delivery.
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ADVANTAGES
• The drug having unpleasant odour and taste can be
administered by enclosing them in a tasteless shell.
• They are smooth, become very slippery when moist and
can be easily swallowed.
• The ready solubility of gelatin at gastric pH provides
rapid release of medicament in the stomach.
• They are attractive in appearance
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DISADVANTAGES
• The hygroscopic drugs cannot be filled in capsules.
• The concentrated preparations which need previous
dilution are unsuitable for capsules because it may
lead to irritation in stomach if administers as such.
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TYPES OF CAPSULES
• Capsules are available in two types:
1.Hard gelatin capsules 2.Soft gelatin capsules.
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GELATIN
• Gelatin is heterogeneous product derived by hydrolytic extraction
of animal's collagen.
• The sources of gelatin including animal bones, and frozen pork
skin.
Types
• Type A: gelatin is mainly derived from pork skin by acid
treatment
• Type B : gelatin is derived from bones and animal skin by
alkaline process.
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Hard gelatin capsules
• These are used for administration of solid
medicaments.
• It consists of two parts i.e. body and cap.
• Example : omeprazole
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Filling of Capsules
POWDERS w/ capsules GRANULES
BEADS TABLETS
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CAPSULE NUMBER AND I TS APPROXI MATE CAPACITY
Capsule number Approximate capacity in mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100
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MANUFACTURING OF HARD
GELATIN CAPSULE.
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MANUFACTURE OF EMPTY HARD GELATIN CAPSULES
Steps involved in making empty gelatincapsules…
• Dipping• Spinning• Drying• Stripping• Trimming and Joining
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METHODS OF FILLING THE HARD GELATIN CAPSULES
• Capsule filling machine ( hand operated)
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• It consists of:1.A bed having 200-300 holes2.A loading tray having 200-300 holes3.A powder tray4.A pin plate having a 5.A lever6. A cam handle.
rubber top
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The empty capsules are filled in the loading tray . ↓
and it is placed over the bed↓
The cam handle is operated to separate the capsule caps from their bodies.
↓ The powder tray is placed in a proper position and filled with an
accurate quantity of powder with scraper.↓
The excess of powder is collected on the plat for of the powder tray↓
The pin plate is lowered and the filled powder is pressed by moving the pin downwards
↓
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After pressing ,the pin plate is raised and the remaining powder is filled into the bodies of the capsules
↓The powdered tray is removed after its complete filling
↓The cap holding tray is again placed in position
↓The plate with the rubber top is lowered and the lever is operated
to lock the caps and bodies ↓
The loading tray is then removed and the filled capsules are collected
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Heat-welding process
Fuse the cap & body through double wall thickness at their
juncture
distinctive ring around the capsule
where heat welded
SEALING OF CAPSULES
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CLEANING OF CAPSULES
• Accela-cota tablet coating pan may be used to clean
and polish capsules.
• A polyurethane or cloth liner is placed in the pan,the
liner is used to trap the removed dust as well as to
import a gloss the capsule
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ACCELA- COTA COATING PAN
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SOFT GELATIN
CAPSULES
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SOFT GELATIN CAPSULES
• These are used for administration of liquid
medicaments.
• Soft gelatin are used to enclose liquid medicaments-
oils,suspension,semi solid,ophthalmic products.
• Example - Cyclosporine capsules .
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SHAPE OF CAPSULE
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MANUFACTURING OF SOFT GELATIN CAPSULES.
Soft gelatin capsules may be prepared by
•Plate process
•Die process
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PLATE PROCESS
• A warm sheet of gelatin is placed on the bottom plate of the mold.
• The liquid medication is poured on it
• Then the second sheet of the prepared gelatin is carefully laid in
place on top of the medication,and the top plate of the mold is put
in place
• The entire mold is then subjected to a press where pressure is
applied to form fill and seal the capsules simultaneously.
• Then the capsule is removed.
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DIE PROCESS• Rotary machine
• In rotary die machine ,the soft gelatin capsules are
prepared and then filled immediately with the liquid
medicaments.
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• The warm liquid gelatin flows over the two chilled drums which are
located at both sides of the machine through a spreader box that sits
over each drum and this transforms the liquid gelatin into two solid
ribbons of gel.
• The left and the right ribbons pass over rollers which feed them
through two die rolls.
• These die rolls determine the shape and size of soft gels and cut the
soft gel shell from the ribbon as they turned around
• Simultaneously, displacement pump delivers the fill materials into the
heated wedge which sits between the rotary dies.
• The wedge injects the fill material into die cavities between ribbons
just right before the die rolls cut the ribbons and seal the two halves
together.
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DRYING:• After the soft gels are formed through the die rolls,they contain around
20 % of water
• This process is divided into two stages:
STAGE 1:
• Performed by tumble dryer .
• This equipment tumbles the soft gelatin around 30-40 minutes .
• It removes approximately 25 % of water content in the soft gelatin
capsules.
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STAGE 2:
• Soft gelatin capsules are spread on stackable trays
and transferred to the drying room or tunnel where
high air flows exists and they stay around 24-48
hours or until the soft gels become hard enough.
• This process is called natural manual drying..
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INSPECTION :• Any damaged and/or not fully filled capsules are removed
manually in small batch size production.
• Fully automatic soft gel sorting machine equipped with electronic
sensors can be used to sort and remove the damaged gelatin
capsules
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POLISHING
• The final step before packing is to clean and polish the
soft gel capsule to remove any mineral oil or
glycerine that the capsules may have on their outer
skin.
• STORAGE
• Finished soft gelatin capsule product should be stored
in the temperature around 20-24 c .⁰
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THANK YOU