Transcript
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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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