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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

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