2. Definition
2
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 from gelatin. The capsules are available both as hard
capsule and soft capsule.
The first capsule prepared from gelatin was a one-piece
capsule patented in France by Mothes and Du Blanc in 1834
3. Advantages of capsules
3
1. The drugs having unpleasant odour and taste can be
administered by enclosing them in a tasteless shell.
2. They are smooth, become very slippery when moist and can be
easily swallowed.
3. They are economical.
4. They are easy to handle and carry.
4. Advantages of capsules
4
5. The capsules release the medicament as and when desired in
gastro-intestinal tract.
6. Capsules are made from gelatin and hence they are
therapeutically inert.
7. They are attractive in appearance
5. Disadvantages of capsules
5
1. The hygroscopic drugs cannot be filled in capsules. They
absorb water present in the capsule shell and hence make it
very brittle, which ultimately breaks into pieces.
2. The concentrated preparations which need previous dilution
are unsuitable for capsules because it may lead to irritation in
stomach if administered as such
6. Types of Capsule
Capsules are available in two types:
1. Hard gelatin capsules
2. Soft gelatin capsules
7. HARD GELATIN CAPSULES
7
A hard gelatin capsule shell consists of two prefabricated,
cylindrical sections (a cap and a body) each of which has one
rounded, closed-end and one open end. The body has a slightly
lower diameter than the cap and fits inside the cap.
9. FORMULATION OF HARD GELATIN SHELL
9
1. Gelatin
Why GELATIN ?
Non toxic widely used in foodstuff
Soluble in biological fluids at body Temp.
Film forming capacity.
Solution at conc. Are mobile at 50° C.
Good Plastisizer
10. FORMULATION OF HARD GELATIN SHELL
10
1. Gelatin
It is prepared by the hydrolysis of collagen obtained from animal
connective tissue, bone and pork skin.
There are two types of gelatin
Type A (Acid hydrolysis of Bovine bone & pork skin)
Type B (Alkaline hydrolysis of calf skin)
The two types of gelatin can be distinguished by isoelectric point as:
Type A isoelectric point near to PH 9
Type B isoelectric point near to PH 4.7
12. Bloom
strength
The strength in gm require to push 0.5
inch standard plunger up to 4mm in
gelatin which is store at 10° C temp.
for 17 hrs..
12
SGC —150 gm
HGC –- 200-250 gm
13. FORMULATION OF HARD GELATIN SHELL
13
2. Plasticizers
Are used to make capsules shell elastic and pliable
Glycerol, Sorbitol, PPG
3. Water
SGC– 30- 40 %
HGC – 5-8 %
4. colourants
15. 15
Steps involved in making empty gelatin capsules…
1.Dipping
2.Spinning
3.Drying
4.Stripping
5.Trimming and Joining
6.Polishing
16. 16
1.DIPPING:
Pairs of the stainless steel pins are dipped into the dipping solution
to simultaneously form the caps and bodies.
The dipping solution is maintained at a temperature of about 50°C
in a heated, jacketed dipping pan.
17. 17
2.SPINNING:
The pins are rotated to distribute the gelatin over the pins
uniformly and to avoid the formation of a bead at the capsule ends.
18. 18
3.DRYING :
The gelatin is dried by a blast of cool air to form a hard shells.
The pins are moved through a series of air drying to remove water
19. 19
4.STRIPPING :
A series of bronze jaws strip the cap and body portions of the
capsules from the pins.
20. 20
5.TRIMMING AND JOINING:
The stripped cap and body portions are trimmed to the required
length by stationary knives.
The cap and body lengths are precisely trimmed to a ±0.15 mm
tolerance.
After trimming to the right length, the cap and body portion are
joined.
Finished capsules are pushed onto a conveyer belt which carries
them out to a container. Capsule quality is monitored throughout
the production process including size, moisture content, single wall
thickness, and color.
Capsules are sorted and visually inspected on specially designed
Inspection Stations.
Perfect capsules are imprinted with the client logo on high-speed.
21. 21
6.POLISHING :
a)Pan Polishing : Acela-cota pan is used to dust and polish.
b)Cloth Dusting : Capsule are rubbed with cloth.
c)Brushing : Capsule are feed under soft rotating brush.
24. Powder filling
24
1. Laboratory Method
a. Feton
b. Labocaps
2. Industrial Method
A. Dependent Dosing
a. Auger Filling
B. Independent Dosing
a. Dosators
b. Tamping finger &
loading Disc Method
26. Bioavalability of HGC
26
2. Diluents
Diluents are inert material added to dosage form to increases
its bulk to easy handling
1960’s Australia Diphenylhydantoin case
Calcium Sulphate to lactose
27. Bioavalability of HGC
27
3. Lubricants & Glidants
Are added to formulation to improve their filling properties.
Simmons et al 1972..
Mag. Stearate + Chlordiazepoxide (0%, 1 % & 5%)
Nakagawa et al 1980...
Mag. Stearate + Rifampicin (180 – 355 μm, less than 75μm)
30. Soft Gelatin Capsule
30
A softgel or soft gelatin capsule is a solid capsule (outer shell)
surrounding a liquid or semi-solid center (inner fill). An active
ingredient can be incorporated into the outer shell, the inner fill,
or both. They are oral dosage form for medicine similar to capsules.
Softgel shells are a combination of gelatin, water, opacifier and
a plasticizer such as glycerin and/or sorbitol(s).
31. Advantages of softgels
· Easy to swallow, no taste, unit dose delivery, tamper-proof.
· Wide variety of colors, shapes, and sizes.
· Accommodates a wide variety of compounds filled as a semi-solid, liquid,
gel or paste.
· Immediate or delayed drug delivery.
· Can be used to improve bioavailability by delivering drug in solution or
other absorption enhancing media.
31
32. Disadvantages of softgels
· Requires special manufacturing equipment.
· Stability concerns with highly water soluble compounds, and compounds
susceptible to hydrolysis.
· Limited choices of excipients/carriers compatible with the gelatin.
32
34. Soft Gelatin Encapsulation Processes
In 1933 invention of rotary die encapsulation machine by Robert Pauli
Scherer.
Before encapsulation Method
a) The Gel Mass
b) The fill matrix
34
35. gel Mass
35
Gel mass prepared by dissolving the gelatin in water at 80°C
followed by plasticizer, colours, opacifier, flavours &
preservatives.
Two ribbons of gelatin are fed continuously into a rotating die
assembly and are simultaneously formed into the two halves
of a capsule.
Width-150 mm Thickness- (± 0.1) 0.5-1.5 mm
