USEFUL FOR ALL PHARMACY STUDENTS ESPECIALLY FOR M-PHARMACY (PHARMACEUTICS). .

2. BY
SAMEERA
M-PHARMACY
PHARMACEUTICS
PULLA REDDY INSTITUTE OF
PHARMACY

3. DEFINITION
• ADVANTAGES
• DISADVANTAGES
TYPES
• HARD GELATIN
• SOFT GELATIN
EXTRACTION OF GELATIN
SHELL MANUFACTURING
CAPSULE SIZES
HARD GELATIN CAPSULES
• MANUFACTURING
• FILLING
SOFTGELATIN CAPSULES
• MANUFACTURING
• FILLING

4.  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.

5.  Easy to handle
 Economical
 Masking of odour & taste
 Attractive in appearance

6.  Hygroscopic drugs cannot be filled in
capsules

7. Hard Soft
Depending on their composition

8. Gelatin
Water
Opacifying agents
Plasticizer
Preservatives

9. Filtration Filtration
clarification
Deionisation Sterilistion
Bone concentration Chilling&dryin
g
Extraction
Degreasin
Grinding
g
Liming
Deliming/
Grading acIdificati seiving
on
Demineral
washing Blending
isation

10. • Dipping
• Rotation
• Drying
• Stripping
• Trimming
Trimming
• Joining
Joining
• Sorting
sorting
• Printing

11.  Forhuman use, empty capsules ranging in size
from 000 (the largest) to 5 (the smallest) are
commercially available

13. Manufacturing of hard gelatin capsules

14. 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.

15. 2) After aging in
stainless steel
receiving tanks, the
gelatin solution is
transferred to
stainless steel feed
tanks.

16. 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

17. 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

18. 5. Once dipped, the
Pin Bars rise to the
upper deck allowing
the cap and body to
set on the Pins.

19. 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

20. 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.

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

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

23. 10. The capsule bodies and caps are joined
automatically in the joiner blocks.

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

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

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

29.  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

30. 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

31. 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

32. 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.

33. Manually Operated Bench-top Equipment

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

35. 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

36. Auger-Filling equipment

38. Plate process
Globex Method
Rotary Die Method

39. 1 The plate process
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.

40. 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.

41. 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.

42. 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

43. The rotary or reciprocating die
2

44. 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

45.  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.

46. 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.

50. Use of soft Gelatin Capsules
Soft gelatin capsules are prepared to
contain a variety of liquid, paste, and dry
fills.

51. POWDERS w/ capseal
GRANULES

52. BEADS
TABLETS

53. PASTES
LIQUIDS w/
capseal