This document discusses the history, definition, manufacturing process, advantages, and quality control testing of gelatin capsules. It begins by outlining the 1834 patent for gelatin capsules and patient preferences for capsules versus tablets. Key points include: - Gelatin capsules consist of a soluble shell enclosing a drug substance and are commonly made from type A or B gelatin. - Hard gelatin capsules have separate body and cap pieces while soft gelatin capsules form a single shell during manufacturing. - Quality is ensured through testing weight variation between capsules and uniformity of drug content.

1. BY – Virendra Vaishnav
B. Pharmacy 3rd Year
Apollo College of Pharmacy, Durg

2. ❖ In 1834 first patent was granted to Josef Gerard
Auguste Dublance, a pharmacist and Francois Achille
Barnabe Mothes, a pharmacy student for gelatin
capsule.
❖ In European countries about 66% of patients prefer
capsules for swallowing, 18% of patients like coated
tablets and only 4% of patients prefer uncoated tablets.
❖ According to the USP, capsule is defined as a solid
dosage form in which drug is enclosed within either a
hard or soft soluble container or shell.
❖ The shells are commonly prepared from gelatin.

3. ✓ Appearance is neat and elegant.
✓ Non-toxic and biocompatible.
✓ The shell is readily soluble in biological fluids.
✓ Suitable for enclosing drugs having unpleasant odor
and bitter taste.
✓ Easy to swallow.
✓ Can release medication rapidly as the shell material is
soluble in water at body temperature.
✓ Required less processing time.
✓ Economic.

4. ❑ Needs controlled environment for storage and
processing.
❑ Not suitable for highly efflorescent and deliquescent
materials.
❑ Susceptible to microbial contamination, if not properly
stored.
❑ Shape can be easily deformed.

5. ❖ Gelatin is a translucent solid substance, colorless or slightly
yellowish, almost tasteless and odorless.
❖ It is chemically a protein substance.
❖ It is obtained by partial hydrolysis of collagen extracted from
pork skin, cartilage, ligaments, bones etc.

6. ▪ TYPE A
Type A is obtained from acid-treated precursor and
shows isoelectric point at about pH 9.
▪ TYPE B
Type B is obtained from alkali-treated precursor and
shows isoelectric point at about pH 4.7.

8. ❖ Hard Gelatin capsules consist of two pieces- Body and
Cap, it is also called as two piece capsule.
❖ This type of capsule is normally used for filling dry
powders, granules, beads (microspheres) and other
solid particles.

9. ➢ In 1931 Arthur Colton designed successfully a machine
that could manufacture both bodies and caps
simultaneously, and fitted these together to form hard
gelatin capsule.
General steps:
1. Preparation of gelatin solution
2. Dipping
3. Spinning
4. Drying
5. Stripping
6. Trimming and joint of body and cap

10. 1. Preparation of gelatin solution
Gelatin is dissolved in hot water, additives such as
wetting agent ( sodium lauryl sulphate), plasticizer
(glycerin,sorbitol etc), colorants or opacifier (TiO2),
preservative (methyl paraben and propyl paraben) are
added and mixed.
The temperature is maintained at about 50⁰C.

11. 2. Dipping
The paired stainless steel pins are dipped into the
gelatin solution maintained at 50⁰C for
predetermined period. The gelatin adheres onto
the pin surface and forms film around the film.
3. Spinning
When dipped, the pins are rotated at a certain speed to
ensure uniformity in thickness of the film and to avoid
deposition of extra gelatin (bead) at the tip of the pins
(top of the capsule)

12. 4. Drying
The film formed over the pins are dried by blast of air,
followed by series of air drying kilns to remove water.
5. Stripping
The caps and bodies of the capsules are stripped out of
the pins by a series of bronze jaws.
6. Trimming and Joining of body and cap
The stripped cap and body portions are trimmed to
required length by stationary knives. After trimming the
caps and bodies are joined, and then the capsules are
ejected from the machine.

13. CAPSULE NUMBER APPROXIMATE CAPACITY IN mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100

14. Fig: Capsule Filling Machine (Hand Operated)

15. ▪ 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 powder is collected on the platform of the
powder tray.
▪ The pin plate is lowered and the filled powder is
pressed by moving the pin downward.

16. ▪ After pressing, the pin plate is raised and the remaining
powder is filled into the bodies of the capsules.
▪ The powder 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.

18. ❑ Eli Lilly
❑ Farmatic
❑ Hofliger and Karg
❑ Macofar
❑ Osaka
❑ Parke-Davis
❑ Zanasi Nigris

19. ▪ These are used for administration of liquid
medicaments.
▪ The thickness of soft gelatin capsule is somewhat more
than that of hard gelatin capsule.
▪ In general the moisture content of soft gelatin capsule
varies from 6 to 13%.

20. ▪ Soft gelatin capsules are generally filled mechanically.
▪ The manufacturing of capsule shell and the filling of
the medicament take place simultaneously.
▪ Nowadays, a rotary machine is used for this purpose.

22. ❖ In a rotary die machine, the soft gelatin capsules are
prepared and then filled immediately with the liquid
medicaments.
▪ The machine is consist of two hoppers.
▪ Liquid gelatin mixture is placed in one hopper and the
liquid medicament in the other hopper.
▪ There are two rotating dies which rotate in opposite
directions.
▪ When fluid gelatin mixture enters into the machine
from the hopper, it produce two continuous ribbons.

23. ▪ These ribbons come over the rotating dies from
opposite directions and enter in between the dies.
▪ Thus, half shell of the capsule is formed.
▪ At this stage measured quantity of the medicament is
filled into it with the stroke of a pump.
▪ With the subsequent movement of the dies, the other
half of the capsule is formed.
▪ The two half of the capsules are sealed together by the
heat and pressure of the rotating dies.
▪ The rotary machines are capable of producing between
25000 to 30000 capsules in an hour.

24. Hard Gelatin Capsules Soft Gelatin Capsules
The hard gelatin capsule shell consist
of two parts:
(A) Body (B) Cap
The soft gelatin capsule shell becomes
a single unit after the sealing of two
halves of the capsule.
They are cylindrical in shape. They are available in round, oval and
tube like shapes.
The content of a hard gelatin capsule
usually consist of the medicament or
mixture of medicaments in the form of
powder, beads or granules.
The content of a soft gelatin capsule
usually consist of liquids, suspensions
or emulsions.
Capsules are sealed after they are
filled to ensure that the medicaments
may not come out of the capsule due
to rough handling.
Filling and sealing of soft gelatin
capsules are done in a combined
operation on machines.

25. ▪ Both soft gelatin and hard gelatin capsules are packed
in the same way.
▪ Depending on the frequency and duration of use,
stability of the product, either blister packing or bulk
packing is commonly done.
▪ The temp of the room should be with in 23-25⁰C.
▪ Relative humidity should be maintained within 33-
37%.

26. 1. Weight variation
❖ 20 intact capsules are individually weighed and the
average weight is determined.
❑ The test requirements are met if:
None of the individual weights are less than 90%, or
more than 110%, of the average.

27. 2. Content unoformity
▪ 30 capsules are selected.
▪ 10 of which are assayed by the specified procedure.
❑ The requirements are met if:
9 of the 10 are within the specified potency range of 85
to 115%, and the tenth is not outside 75 to 125%.
❖ If more than 1, but less than 3, of the first 10 capsules
fall outside the 85 to 115% limits, the remaining 20 are
assayed.
❑ The requirement are met if:
All 30 capsules are within 75 to 125% of the specified
potency range, and not less than 27 of the 30 are within
the 85 to 115% range.