Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.

1. CAPSULES
presented by
S.Nandhini
1

2. DEFINITION
• Capsules are a solid dosage form in which the drug
substance is enclosed in a water soluble shell or an
envelope.
• A capsule shell is made up of gelatin
• Primarily intended for oral delivery.
2

3. ADVANTAGES
• The drug having unpleasant odour and taste can be
administered by enclosing them in a tasteless shell.
• They are smooth, become very slippery when moist and
can be easily swallowed.
• The ready solubility of gelatin at gastric pH provides
rapid release of medicament in the stomach.
• They are attractive in appearance
3

4. DISADVANTAGES
• The hygroscopic drugs cannot be filled in capsules.
• The concentrated preparations which need previous
dilution are unsuitable for capsules because it may
lead to irritation in stomach if administers as such.
4

5. TYPES OF CAPSULES
• Capsules are available in two types:
1.Hard gelatin capsules
2.Soft gelatin capsules.
5

6. GELATIN
• Gelatin is heterogeneous product derived by hydrolytic
extraction of animal's collagen.
• The sources of gelatin including animal bones, and frozen
pork skin.
Types
• Type A: gelatin is mainly derived from pork skin by acid
treatment
• Type B : gelatin is derived from bones and animal skin by
alkaline process. 6

7. Hard gelatin capsules
• These are used for administration of solid
medicaments.
• It consists of two parts i.e. body and cap.
• Example : omeprazole
7

8. Filling of Capsules
POWDERS w/ capsules GRANULES
BEADS TABLETS

9. CAPSULE NUMBER AND ITS APPROXIMATE
CAPACITY
Capsule number Approximate capacity in
mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100 9

10. MANUFACTURING OF HARD
GELATIN CAPSULE.
10

11. 11
MANUFACTURE OF EMPTY HARD GELATIN
CAPSULES
Steps involved in making empty gelatin
capsules…
• Dipping
• Spinning
• Drying
• Stripping
• Trimming and Joining

12. 12

13. METHODS OF FILLING THE HARD
GELATIN CAPSULES
• Capsule filling machine ( hand operated)
13

14. • It consists of:
1.A bed having 200-300 holes
2.A loading tray having 200-300 holes
3.A powder tray
4.A pin plate having a
5.A lever
6. A cam handle.
14
rubber top

15. The empty capsules are filled in the loading tray .
↓
and it is placed over the bed
↓
The cam handle is operated to separate the capsule caps from their
bodies.
↓
The powder tray is placed in a proper position and filled with an
accurate quantity of powder with scraper.
↓
The excess of powder is collected on the plat for of the powder tray
↓
The pin plate is lowered and the filled powder is pressed by moving
the pin downwards
↓
15

16. After pressing ,the pin plate is raised and the remaining powder is
filled into the bodies of the capsules
↓
The powdered tray is removed after its complete filling
↓
The cap holding tray is again placed in position
↓
The plate with the rubber top is lowered and the lever is operated
to lock the caps and bodies
↓
The loading tray is then removed
and the filled capsules are collected
16

17. Heat-welding process
Fuse the cap & body
through double wall
thickness at their juncture
distinctive ring around the
capsule where heat welded
SEALING OF CAPSULES
17

18. CLEANING OF CAPSULES
• Accela-cota tablet coating pan may be used to clean
and polish capsules.
• A polyurethane or cloth liner is placed in the pan,the
liner is used to trap the removed dust as well as to
import a gloss the capsule
18

19. ACCELA- COTA COATING PAN
19

20. SOFT GELATIN
CAPSULES
20

21. SOFT GELATIN CAPSULES
• These are used for administration of liquid
medicaments.
• Soft gelatin are used to enclose liquid medicaments-
oils,suspension,semi solid,ophthalmic products.
• Example - Cyclosporine capsules .
21

22. SHAPE OF CAPSULE
22

23. MANUFACTURING OF SOFT GELATIN
CAPSULES.
Soft gelatin capsules may be prepared by
•Plate process
•Die process
23

24. PLATE PROCESS
• A warm sheet of gelatin is placed on the bottom plate of the
mold.
• The liquid medication is poured on it
• Then the second sheet of the prepared gelatin is carefully laid in
place on top of the medication,and the top plate of the mold is
put in place
• The entire mold is then subjected to a press where pressure is
applied to form fill and seal the capsules simultaneously.
• Then the capsule is removed.
24

25. DIE PROCESS
• Rotary machine
• In rotary die machine ,the soft gelatin capsules are
prepared and then filled immediately with the liquid
medicaments.
25

26. 26

27. • The warm liquid gelatin flows over the two chilled drums which are
located at both sides of the machine through a spreader box that sits
over each drum and this transforms the liquid gelatin into two solid
ribbons of gel.
• The left and the right ribbons pass over rollers which feed them
through two die rolls.
• These die rolls determine the shape and size of soft gels and cut the
soft gel shell from the ribbon as they turned around
• Simultaneously, displacement pump delivers the fill materials into the
heated wedge which sits between the rotary dies.
• The wedge injects the fill material into die cavities between ribbons
just right before the die rolls cut the ribbons and seal the two halves
together. 27

28. DRYING:
• After the soft gels are formed through the die rolls,they contain
around 20 % of water
• This process is divided into two stages:
STAGE 1:
• Performed by tumble dryer .
• This equipment tumbles the soft gelatin around 30-40 minutes .
• It removes approximately 25 % of water content in the soft
gelatin capsules.
28

29. 29

30. STAGE 2:
• Soft gelatin capsules are spread on stackable trays
and transferred to the drying room or tunnel where
high air flows exists and they stay around 24-48
hours or until the soft gels become hard enough.
• This process is called natural manual drying.
.
30

31. INSPECTION :
• Any damaged and/or not fully filled capsules are removed
manually in small batch size production.
• Fully automatic soft gel sorting machine equipped with electronic
sensors can be used to sort and remove the damaged gelatin
capsules
31

32. POLISHING
• The final step before packing is to clean and polish the
soft gel capsule to remove any mineral oil or
glycerine that the capsules may have on their outer
skin.
• STORAGE
• Finished soft gelatin capsule product should be stored
in the temperature around 20-24 ⁰c .
32

33. 33
THANK YOU