BY SAMEERA M-PHARMACY PHARMACEUTICS PULLA REDDY INSTITUTE OF PHARMACY

DEFINITION
ADVANTAGES DISADVANTAGES

TYPES
HARD GELATIN SOFT GELATIN

EXTRACTION OF GELATIN
SHELL MANUFACTURING CAPSULE SIZES

HARD GELATIN CAPSULES

SOFTGELATIN 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

Hard

Soft

Depending on their composition

Gelatin
Water Opacifying agents Plasticizer Preservatives

Bone

Filtration clarification Deionisation concentration

Filtration
Sterilistion
Chilling&dryin g

Degreasin g

Extraction Grinding Liming Deliming/ acIdificati on washing

Grading

seiving

Demineral isation

Blending

Trimming

Dipping Rotation Drying Stripping Trimming Joining Sorting Printing

Joining sorting

 For

human use, empty capsules ranging in size from 000 (the largest) to 5 (the smallest) are commercially available

Manufacturing of hard gelatin capsules

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 gravityfeed 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

5. Once dipped, the Pin Bars rise to the upper deck allowing the cap and body to set 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 is complete, the Pin Bars enter the Table section which positions the capsule halves for stripping from the Pins in the Automatic section.

8. In the Automatic section, capsule halves are individually stripped from the Pins.

9. The cap and body lengths are precisely trimmed to a 0.15 mm tolerance.

10. The capsule bodies and caps are joined

11. Finished capsules are pushed onto a conveyer belt which carries them out to a container.

12. Capsule

quality is monitored throughout the production process including size, moisture content, single wall thickness, and color

13. Capsules are sorted and visually inspected on specially designed R&J Inspection 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, 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.

Manually Operated Bench-top Equipment

Capsule caps and bodies are rejoined and the capsules are closed.

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

Auger-Filling equipment

Plate process Globex Method Rotary Die Method

The plate process

A warm sheet of plain or colored gelatin is placed on the bottom plate of the mold and the liquidcontaining 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

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

The rotary or reciprocating die

Rotary Die Method

- 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 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

POWDERS w/ capseal

GRANULES

BEADS
TABLETS

PASTES

LIQUIDS w/ capseal