BY SAMEERA M-PHARMACY PHARMACEUTICSPULLA REDDY INSTITUTE OF PHARMACY
DEFINITION• ADVANTAGES• DISADVANTAGESTYPES• HARD GELATIN• SOFT GELATINEXTRACTION OF GELATINSHELL MANUFACTURINGCAPSULE SIZESHARD GELATIN CAPSULES• MANUFACTURING• FILLINGSOFTGELATIN CAPSULES• MANUFACTURING• FILLING
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.
Easy to handle Economical Masking of odour & taste Attractive in appearance
Hygroscopic drugs cannot be filled in capsules
3 Dyes, opacifants, andany 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
4. From the feed tank, thegelatin is gravity fed toDipper section. Here, thecapsules are molded ontostainless steel Pin Bars whichare dipped into the gelatinsolution
5. Once dipped, thePin Bars rise to theupper deck allowingthe cap and body toset on the Pins.
6. The Pin Bars pass through the upper and lower kilns of Capsule Machine Drying System. Here gently moving air which is precisely controlled for volume, temperature, and humidity, removes the exact amount of moisture from the capsule halves
7. Once drying iscomplete, the PinBars enter the Tablesection whichpositions the capsulehalves for strippingfrom the Pins in theAutomatic section.
8. In the Automaticsection, capsulehalves areindividually strippedfrom the Pins.
9. The cap andbody lengths arepreciselytrimmed to a±0.15 mmtolerance.
10. The capsule bodies and caps are joined automatically in the joiner blocks.
11. Finished capsules are pushedonto a conveyer belt which carriesthem out to a container.
12. Capsule quality is monitoredthroughout the productionprocess including size, moisturecontent, single wallthickness, and color
13. Capsules are sorted andvisually inspected onspecially designed R&JInspection Stations
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
Punch Method powder is placed on a sheet of a clean paper or porcelain plate using spatula - formed into a cake having a depth of approximately one-fourth to one-third the length of the capsule body then empty capsule body is held between the thumb and forefinger and punched vertically into the powder cake repeatedly until filled
2. Feton capsule filling@ with empty capsule in the loader tray, thetray placed on top of the filler unit@ the loader inserts the capsules into thefilling unit and is removed, and the topplate is lifted to separate the caps fromthe bodies@ the powder is placed on the unit and thecapsule bodies filled@ the top plate is returned to the unit and thecaps placed on filled capsule bodies
ProFill 100 - The ProFill 100 CapsuleFilling Machine utilizes an advanceddesign for fool-proof manual filling oftwo-piece capsules. With the ProFill100 machine, there is no need forexpensive capsule filling equipmentand electrical/vacuum connections.
Capsule caps and bodies arerejoined and the capsules areclosed.
Powder or granules are contained in massflow hoppers with rotating augersPowder is fed continuously out of the hopperoutlet due to the rotation of the auger.Amount of powder fed into the bodydepends on the time capsule body spendsunderneath the hopper outlet and auger speed - slower rotation increases the fillweight
1 The plate processA 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 putinto place.
Pressure is then applied to the mold toform, fill, and seal the capsulessimultaneously.The capsules are removed and washed witha solvent harmless to the capsules.
The rotary or reciprocating die2Liquid gelatin flowing from an overheadtank is formed into two continuousribbons by the rotary die machine andbrought together between twin rotating dies.At the same time, metered fill material isinjected between the ribbons precisely atthe moment that the dies form pockets of thegelatin ribbons.
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 inbicolored capsules
Rotary Die Method Advantages: - capsules can have all kinds of shapes and sizes - different colors for both sides - wide variety of fills Disadvantages: - high amount of shell waste material - longer drying time compared to Globex Method
Filling is pumped through the inner capillary of a concentric double capillary Shell forming solution is pumped through the outer capillary of the concentric double capillary The soft capsules are then immersed in a cooling bath of about 4oc (usually liquid paraffin). Cooling bath ensures immediate sol-gel transformation, hence formation of flexible yet firm robust outer film.
Globex MethodSoft capsules are collected,washed with organic solventto remove residues ofcooling liquid, and gentlydried at a relative humidityof 20% in infrared tunnels.Advantage: production ofseamless capsules which aretamper-evident and free ofcontamination or entrappedair.
Use of soft Gelatin Capsules Soft gelatin capsules are prepared to contain a variety of liquid, paste, and dry fills.