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SEMINAR ON
CAPSULES MANUFACTURING&
FILLING
BYSAMEERA
M-PHARMACYPHARMACEUTICS
PULLA REDDY INSTITUTE OF PHARMACY
CAPSULESDEFINITION• ADVANTAGES• DISADVANTAGES
TYPES• HARD GELATIN• SOFT GELATIN
EXTRACTION OF GELATINSHELL MANUFACTURINGCAPSULE SIZES
HARD GELATIN CAPSULES• MANUFACTURING• FILLING
SOFTGELATIN CAPSULES• MANUFACTURING• FILLING
CAPSULES 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.
EXTRACTION & PURIFICATION OF GELATIN
BoneDegreasing
Grading
Demineralisa
tion
washingLiming
Deliming/
acIdification
Extraction
Filtrationclarificati
onDeionisat
ionconcentr
ation
Filtration
Sterilistion
Chilling&drying
Grinding
seiving
Blending
SHELL MANUFACTURING•Dipping
•Rotation
•Drying
•Stripping
Trimming •Trimming
Joining •Joining
•Sorting
sorting •Printing
CAPSULE SIZES For human use, empty capsules
ranging in size from 000 (the largest) to 5 (the smallest) are commercially available
1)Once raw materials have been received and released by Quality Control, the gelatin and hot demineralized water are mixed under vacuum in Stainless Steel Gelatin Melting System.
2) After aging in stainless steel receiving tanks, the gelatin solution is transferred to stainless steel feed tanks.
3 Dyes, opacifants, and any needed water are added to the gelatin in the feed tanks to complete the gelatin preparation procedure. The feed tanks are then used to gravity-feed gelatin into the Capsule Machine
4. From the feed tank, the gelatin is gravity fed to Dipper section. Here, the capsules are molded onto stainless steel Pin Bars which are dipped into the gelatin solution
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 is complete, the Pin Bars enter the Table section which positions the capsule halves for stripping from the Pins in the Automatic section.
12. Capsule quality is monitored throughout the production process including size, moisture content, single wall thickness, and color
FILLING OF HARD CAPSULE SHELLS
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
FILLING EQUIPMENTS
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
FILLING EQUIPMENTS- CONTINUED
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 the filling 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 the capsule bodies filled
@ the top plate is returned to the unit and the caps placed on filled capsule bodies
ProFill 100 - The ProFill 100 Capsule Filling Machine utilizes an advanced design for fool-proof manual filling of two-piece capsules. With the ProFill 100 machine, there is no need for expensive capsule filling equipment and electrical/vacuum connections.
AUGER-FILLING PRINCIPLE
Powder or granules are contained in mass flow hoppers with rotating augersPowder 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
The plate process 1
A warm sheet of plain or colored gelatin is placed on 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 top of the medication and the top plate of the mold is put into place.
Pressure is then applied to the mold to form, fill, and seal the capsules simultaneously.
The capsules are removed and washed with a solvent harmless to the capsules.
The rotary or reciprocating die 2
Liquid gelatin flowing from an overhead tank is formed into two continuous ribbons by the rotary die machine and brought together between twin rotating dies.
At the same time, metered fill material is injected between the ribbons precisely at the moment that the dies form pockets of the gelatin 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 in bicolored capsules
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
Rotary Die Method
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 Method
Soft capsules are collected, washed with organic solvent to remove residues of cooling liquid, and gently dried at a relative humidity of 20% in infrared tunnels.
Advantage: production of seamless capsules which are tamper-evident and free of contamination or entrapped air.
Use of soft Gelatin Capsules
Soft gelatin capsules are prepared to contain a variety of liquid, paste, and dry fills.