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Hard Gelatin

Hard Gelatin

Capsule Filling

Capsule Filling

Machines

Machines

DR. MOHAMMAD SHARIARE

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Industrial Scale

Industrial Scale

Techniques

Techniques

 The machines can be semi to fully automatic ranging in output from 5000 to 50000 capsules per hour.

 Automatic machines can be continuous in motion or intermittent, where the machine stops to perform a function and then moves to the next position to repeat the operation.

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Capsule fill Dosing Systems

Capsule fill Dosing Systems

Dependent Dosing system:

 Dosing systems that use the capsule body directly to measure

the powder.

 Uniformity of fill weight can only be achieved if the capsule is

filled completely

 eg. Auger filling.

Independent Dosing system:

 Dosing systems where the powder is measured independently of

the body in a special measuring device.

 Weight uniformity is not dependent on filling the body completely.  With this system the capsules can be part filled.

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Auger Filler

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Types Of Capsule Filling

Pellet Filling:

 Preparations are

formulated to give

modified release pattern.

 Often produced as

granules or coated pellets.  They cannot fill all the

available space within the

capsule because of

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Types Of Capsule Filling

Tablet filling:

 Tablets are placed in hoppers and allowed to fall

down tubes.

 They fall by gravity into capsule bodies as they pass

underneath the hopper.

 Machines contain mechanical probes to check that

correct number of tablets are transferred.

 Tablets for capsule filling are normally film coated to

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Types Of Capsule Filling

 Semi-solid and Liquid Filling:

 Liquids can be dosed into capsules using volumetric pumps.

 The problem after filling is to stop leakage

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Capsule Shell Filling

Capsule Shell Filling

Machines

Machines

 Hand operated hard gelatin capsule filling machines –

Hand operated and electrically operated machines are in practice for filling the capsules but for small and quick dispensing hand operated machines are quite economical. A hand operated gelatin capsule filling machine consists of the following parts:

1. A bed with 200-300 holes. 2. A capsule loading tray

3. A powder tray

4. A pin plate having 200 or 300 pins corresponding to the number of holes in the bed and capsule loading tray.

5. A lever 6. A handle

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http://www.youtube.com/watch?v=fUInW7wSy0g

Capsule Shell Filling

Capsule Shell Filling

Machines

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 All parts of the machine are made up of stainless steel. The machines are generally supplied with additional loading trays, beds, and pin plates with various diameters of holes so as to fill the desired size of the capsules.

 These machines are very simple to operate, can be easily dismantled and reassembled

Capsule Shell Filling

Capsule Shell Filling

Machines

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Capsule Filling Machines

Capsule Filling Machines

HOFLIGER KARG AUTOMATIC CAPSULE FILLING MACHINE ZANASI AUTOMATIC

CAPSULE FILLING MACHINE

OSAKA MODEL R-180 SEMI AUTOMATIC CAPSULE

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Preparation of filled hard gelatin

Preparation of filled hard gelatin

capsules

capsules

The process of working:  Rectification

 Separating the caps from empty capsules  Filling the bodies

 Scraping the excess powder  Replacing the caps

 Sealing the capsules

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Cleaning and polishing

Cleaning and polishing

capsules

capsules

Small amount of powder may adhere to the outside of capsules after filling.

1) Pan Polishing: coating pan is used to dust and polish capsules. A poly urethane cloth liner is used to trap the removed dust as well as to impart gloss to the capsules.

2) Cloth Dusting: bulk filled capsules are rubbed with cloth that may or may not be impregnated with inert oil.

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Cleaning and polishing

Cleaning and polishing

capsules

capsules

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Difficulties in filling capsules

Difficulties in filling capsules

 1. Deliquescent or Hygroscopic powders – a

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Capsule polishing Machine

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Difficulties in filling capsules

Difficulties in filling capsules

Eutectic mixtures – certain substances when mixed

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Capsule Printing Machine

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Difficulties in filling capsules

Difficulties in filling capsules

3. Addition of inert powders – when the quantity of the drug to be filled in capsules is very small and it is not possible to fill this much small amount in capsules then inert substance or a diluent is added so as to increase the bulk of the powder, which can be filled easily in capsules.

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Difficulties in filling capsules

Difficulties in filling capsules

5. Filling of granular powder – some powders which lack adhesiveness and most granular powders are difficult to fill in the capsules by

punch method because they are not

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Quality control of capsules

Quality control of capsules

 Whether capsules are produced on a small scale or large scale all of them are required to

pass not only the disintegration test, weight variation test and percentage of medicament test but a visual inspection must be made as they roll off the capsule machine onto a conveyor belt regarding uniformity in shape, size, color and filling. As the capsules moves in front of the inspectors the visibly defective or suspected of being less than the perfect are picked out.

The hard and soft gelatin capsules should be subjected to following tests for their standardization -

 1. Shape and size

 2. Color

 3. Thickness of capsule shell

 4. Leaking test for semi-solid and liquid ingredients from soft capsules

 5. Disintegration tests

 6. Weight variation test 20

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Disintegration test

 Disintegration test: For performing disintegration test

on capsules the tablet disintegration test apparatus is used but the guiding disc may not be used except that the capsules float on top of the water.

 One capsule is placed in each tube which are then

suspended in the beakers to move up and down for 30 minutes, unless otherwise stated in the monograph.

 The capsules pass the test if no residue of drug or

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Disintegration Tester

Shaft Disc

basket

Mesh

Beaker with G.I fluid/ water

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Weight variation test

 20 capsules are taken at random and weighed. Their average weight is calculated,

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Content uniformity test

References

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