Hard Gelatin Capsule1

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DEFINITION

ADVANTAGES

DISADVANTAGES

TYPES

HARD GELATIN

SOFT GELATIN

EXTRACTION OF GELATIN

SHELL MANUFACTURING

CAPSULE SIZES

HARD GELATIN CAPSULES

MANUFACTURING FILLING

SOFTGELATIN CAPSULES

MANUFACTURING

FILLING


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DEFINITION:

Capsules are solid dosage forms in which one or more

medicinal and or inert substances are enclosed within

a small shell or container generally prepared from a

suitable form of gelatin.


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Easy to handle

Economical

Masking of odour & taste

Attractive in appearance


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Hygroscopic drugs cannot be filled in

capsules


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Hard Soft

Depending on their composition


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Gelatin

WaterOpacifying agents

Plasticizer

Preservatives


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Bone

Degreasing

Grading

Demineralisation

washing

Liming

Deliming/

acIdificati

on

Extraction

Filtration

clarificationDeionisation

concentration

Filtration

Sterilistion

Chilling&drying

Grinding

seiving

Blending


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Dipping

Rotation

Drying

Stripping

Trimming

Trimming

Joining

Joining

Sortingsorting

Printing


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For human use, empty capsules ranging in size

from 000 (the largest) to 5 (the smallest) are

commercially available


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Manufacturing of hard gelatin capsules


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1)Once raw materialshave been received andreleased by QualityControl, the gelatin and

hot demineralized waterare mixed under vacuumin Stainless Steel GelatinMelting System.


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2) After aging in

stainless steelreceiving tanks, thegelatin solution istransferred to

stainless steel feedtanks.


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3 Dyes, opacifants, and

any needed water areadded to the gelatin in thefeed tanks to complete thegelatin preparationprocedure. The feed tanksare then used to gravity-feed gelatin into theCapsule Machine


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4. From the feed tank, the

gelatin is gravity fed toDipper section. Here, thecapsules are molded ontostainless steel Pin Bars which

are dipped into the gelatinsolution


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5. Once dipped, thePin Bars rise to theupper deck allowingthe cap and body to

set on the Pins.


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6. The Pin Bars passthrough the upper and

lower kilns of CapsuleMachine Drying System.Here gently moving airwhich is preciselycontrolled for volume,

temperature, andhumidity, removes theexact amount ofmoisture from thecapsule halves


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7. Once drying iscomplete, the PinBars enter the Tablesection which

positions the capsulehalves for strippingfrom the Pins in theAutomatic section.


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8. In the Automaticsection, capsulehalves areindividually stripped

from the Pins.


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9. The cap andbody lengths arepreciselytrimmed to a0.15 mmtolerance.


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10. The capsule bodies and caps are joinedautomatically in the joiner blocks.


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11. Finished capsules are pushedonto a conveyer belt which carriesthem out to a container.


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12. Capsule quality is monitoredthroughout the productionprocess including size, moisturecontent, single wall thickness,and color


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13. Capsules are sorted andvisually inspected on

specially designed R&JInspection Stations


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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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Punch Method

powder is placed on a sheet of a cleanpaper or porcelain plate

using spatula - formed into a cake havinga depth of approximately one-fourth toone-third the length of the capsule body

then empty capsule body is held betweenthe thumb and forefinger and punchedvertically into the powder cakerepeatedly until filled


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2. Feton capsule filling

@ with empty capsule in the loader tray, the

tray placed on top of the filler unit

@ the loader inserts the capsules into thefilling unit and is removed, and the top

plate is lifted to separate the caps from

the bodies

@ the powder is placed on the unit and thecapsule bodies filled

@ the top plate is returned to the unit and the

caps placed on filled capsule bodies


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ProFill 100 - The ProFill 100 Capsule

Filling Machine utilizes an advanced

design for fool-proof manual filling of

two-piece capsules. With the ProFill100 machine, there is no need for

expensive capsule filling equipment

and electrical/vacuum connections.


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Manually Operated Bench-top Equipment


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Capsule caps and bodies arerejoined and the capsules are

closed.


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Powder or granules are contained in mass

flow hoppers with rotating augers

Powder is fed continuously out of the hopper

outlet due to the rotation of the auger.Amount of powder fed into the body

depends on the time capsule body spends

underneath the hopper outlet and auger speed

- slower rotation increases the fill

weight


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Auger-Filling equipment


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Plate process

Globex Method

Rotary Die Method


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The plate process1

A warm sheet of plain or colored gelatin is placedon the bottom plate of the mold and the liquid-

containing medication is evenly poured on it.

A second sheet of gelatin is carefully placed on topof the medication and the top plate of the mold is put

into place.


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Pressure is then applied to the mold to

form, fill, and seal the capsules

simultaneously.

The capsules are removed and washed witha solvent harmless to the capsules.


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The rotary or reciprocating die2

Liquid gelatin flowing from an overhead

tank is formed into two continuous

ribbons by the rotary die machine andbrought together between twin rotating dies.

At the same time, metered fill material is

injected between the ribbons precisely atthe moment that the dies form pockets of the

gelatin ribbons.


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These pockets of fill-containing gelatin are

sealed by pressure and heat and then

severed from the ribbon.

Use of ribbons of two different colors results in

bicolored capsules


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The rotary or reciprocating die2


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Advantages:- capsules can have allkinds of shapes andsizes

- different colors forboth sides

- wide variety of fills

Disadvantages:

- high amount of shellwaste material

- longer drying timecompared to Globex

Method

Rotary Die Method


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Filling is pumped through the inner capillary of aconcentric double capillary

Shell forming solution is pumped through theouter capillary of the concentric double capillary

The soft capsules are then immersed in a coolingbath of about 4oc (usually liquid paraffin).

Cooling bath ensures immediate sol-geltransformation, hence formation of flexible yetfirm robust outer film.


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Globex Method

Soft capsules are collected,

washed with organic solvent

to remove residues of

cooling liquid, and gentlydried at a relative humidity

of 20% in infrared tunnels.

Advantage: production ofseamless capsules which are

tamper-evident and free of

contamination or entrapped

air.


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Use of soft Gelatin Capsules

Soft gelatin capsules are prepared to

contain a variety of liquid, paste, and dry

fills.


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POWDERS w/ capseal

GRANULES


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BEADS

TABLETS


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PASTES

LIQUIDS w/

capseal


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Documents

Hard Gelatin Capsule1