Introduction,advantages, disadvantages,capsule manufacturing and evaluation

1. CAPSULES
Presenter:
Amruta Balekundri
M.Pharm 2nd semester,
Department of Pharmaceutical
Quality Assurance,
KLE College of Pharmacy, Belagavi.

2. CONTENT
• Introduction
• Advantages
• Disadvantages
• Manufacturing process
 Hard gelatin capsules
 Soft gelatin capsules
• Evaluation of capsules

3. INTRODUCTION
Capsules are solid dosage forms in which drug
substance is enclosed within hard or soft soluble
shell. The shells are generally formed from
gelatin.
Capsules are of two types:
 1. Hard gelatin capsules
 2. Soft gelatin capsules

4. CAPSULE SIZE
• For human use, empty capsules ranging in size
from 000 the largest to 5 the smallest.
• Generally, hard gelatin capsule are used to
encapsulate between 65 mg to 1 gram.

5. ADVANTAGES
• Capsules are tasteless, odorless and can easily
be administered.
• Combination of powders can be used.
• They are attractive in appearance.
• The drugs having un-pleasant odour and taste
can be enclosed in a tasteless shell.
• They can be filled quickly and conveniently.
• They are economical.
• They are easy to handle and carry.

6. DISADVANTAGES
• Hygroscopic drugs are not suitable for filling
into capsules, because they absorb water
present in capsule shell makes shell very
brittle and ultimately lead it to crumble into
pieces.
• The concentrated solutions which require
previous dilution are unsuitable for capsules
because if administered as such lead to
irritation into stomach.

7. Plasticizer and Gelatin ratio
• In soft gelatin capsule the amount of
plasticizers used is more.
• In soft gelatin capsule the plasticizer and
gelatin ratio is 0.8 : 1
• In hard gelatin capsule the plasticizer and
gelatin ratio is 0.4 : 1

8. HARD GELATIN CAPSULES

9. • Hard gelatin capsules, are made of two parts,
the body and the cap. This form of capsule
holds dry ingredients in powder form.
• The body is first filled with the mix of active
ingredients and any excipients used, and then
closed with the cap using either a manual or
automatic press machine.
• Once ingested, the hard capsules disintegrate
within three minutes and quickly release the
drug inside.

10. CAPSULE SHELL
• These capsules are made up of gelatin blends,
small amount of certified dyes, opaquants,
plasticizers and preservatives.
• Certified Dyes: Colour approved by D & C act.
• Opacifiers: Titanium dioxide.
• Plasticizers: Sorbitol, Glycerin.
• Preservatives: Propyl and Methyl Parabens

11. GELATIN
• Gelatin is heterogeneous product derived by
hydrolytic extraction of animal's collagen.
• The sources of gelatin include animal bones,
hide portions and frozen pork skin.
• TYPES OF GELATIN
 Type A
 Type B

12. PRODUCTION OF GELATIN
• On a commercial scale, gelatin is made from by-
products of the meat and leather industry, mainly
pork skins, pork and cattle bones, or split cattle
hides.
• Contrary to popular belief, horns and hooves are
not commonly used.
• The raw materials are prepared by different
curing, acid, and alkali processes which are
employed to extract the dried collagen
hydrolysate.
• The entire process takes several weeks.

13. MANUFACTURING OF HARD
GELATIN CAPSULES
1. Dipping
2. Spinning
3. Drying
4. Stripping
5. Trimming and Joining
6. Polishing

14. • 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 500°C
in a heated, jacketed dipping pan.
• 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.

15. • 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 kilns to remove
water.
• Stripping :
A series of bronze jaws strip the cap and body
portions of the capsules from the pins.

16. Trimming and joining
• The stripped cap and body portions are
trimmed to the required length by stationary
knives.
• After trimming to the right length, the cap and
body portion are joined and ejected from the
machine.

17. Polishing
• Pan Polishing : Acela-cota pan is used to dust
and polish.
• Cloth Dusting : Capsule are rubbed with cloth.
• Brushing : Capsule are feed under soft rotating
brush.

19. Preparation of filled hard gelatin
capsules:
• In large scale or small scale, preparations of
filled hard gelatin capsules are divided into the
following general steps:
1. Developing and preparing formulation.
2. Filling the capsule shell
3. Capsule sealing
4. Cleaning and polishing the filled capsules.

20. FILLING OF HARD GELATIN
CAPSULES
• Hand Operated methods.
ex: feton capsule filling machine
• Semi Automatic Capsules Devices.
• Automatic filling machine.
ex: osaka capsule filling machine ,macofar capsule
filling machine

21. • A hand operated gelatin capsule filling
machine consists of the following parts:
1. A bed with 200-300 holes.
2. A capsule loading tray
3. A powder tray
4. A pin plate having 200 or 300 pins corresponding
to the number of holes in the bed and capsule
loading tray.
5. A lever
6. A handle
7. A plate fitted with rubber top.

22. • Working:
 The empty capsules are filled into the loading
tray which is then placed over the bed.
 By opening the handle, the bodies of the
capsules are locked and caps separated in the
loading tray itself which is then removed by
operating the liver.
 The weighed amount of the drug to be filled in
the capsules is placed in powder tray already
kept in position over the bed.
 Spread the powder with the help of a powder
spreader so as to fill the bodies of the capsules
uniformly.

23.  Collect excess of the powder on the platform of
the powder tray. Lower the pin plate and move it
downward so as to press the powder in the
bodies.
 Remove the powder tray and place the caps
holding tray in position. Press the caps with the
help of plate with rubber top and operate the
lever to unlock the cap and body of the capsules.
 Remove the loading tray and collect the filled
capsules in a tray. With 200 hole machine about
5000 capsules can be filled per hour and with
300 hole machine 7500 capsules can be filled
per hour.

24. CAPSULE SEALING
1. Tamper evident capsules are made by sealing
the joint between the 2 capsule parts.
2. Distinctive looking capsules by sealing them with
colored band of gelatin (Kapseals). If removed,
the band cannot be restored without expert
sealing with gelatin .
3. Through a heat welding process that fuses the
capsule cap to the ring around the capsule
where heat welded.
Example: Weld’s gelatin seal

25. 4. Capsule may also be sealed through a heat
welding process that fuse capsule cap to the
body.
5. Lightly coating the inner surface of the cap
with a warm gelatin solution immediately
prior to placement on the filled capsule body.

26. Storage:
• Finished capsules normally contain an
equilibrium moisture content of 13-16%.
• To maintain a relative humidity of 40-60%
when handling and storing capsules.

27. SOFT GELATIN CAPSULES

28. • Soft Gelatin capsules are one piece,
hermetically sealed, soft gelatin shells
containing a liquid, a suspension, or a
semisolid.
• Soft gelatin is mainly composed of gelatin,
plasticizers, preservative, colouring and
opacifying agents, flavoring agents and sugars.

29. SHAPE OF CAPSULE
• The shape of soft
gelatin capsule are
round, oval, oblong,
tube.

30. MANUFACTURING OF SOFT
GELATIN CAPSULES
• 1.Composition of the shell :
 The basic component of soft gelatin shell is
gelatin; however, the shell has been plasticize.
 The ratio of dry plasticizer to dry gelatin
determines the “hardness” of the shell and can
vary from 0.3-1.0.
 Up to 5% sugar may be included to give a
“chewable” quality to the shell.
 The residual shell moisture content of finished
capsules will be in the range of 6-10%.

31. • Formulation :
 Formulation for soft gelatin capsules involves
liquid, rather than powder technology.
 Materials are generally formulated to produce the
smallest possible capsule consistent with
maximum stability, therapeutic effectiveness and
manufacture efficiency.
 The liquids are limited to those that do not have
an adverse effect on gelatin walls.
 Emulsion can not be filled because water will be
released that will affect the shell.
 The pH of the liquid can be between 2.5 and 7.5.

32. MANUFACTURE OF SOFT
GELATIN CAPSULES
• Manufactured by four methods:
1)Plate process
2)Rotary die process
3)Reciprocating die
4)Accogel machine

33. PLATE PROCESS
• Place the gelatin sheet over a die plate
containing numerous die pockets.
• Application of vacuum to draw the sheet in to
the die pockets.
• Fill the pockets with liquid or paste.
• Place another gelatin sheet over the filled
pockets, and sandwich under a die press
where the capsules are formed and cut out.

34. ROTARY DIE PROCESS
• In this machine the soft gelatin capsules are
prepared & then filled immediately with liquid
medicaments it is having two hoppers & two
rotating dies
• Liquid mixture is placed in one hopper & the
liquid medicament in other Hopper.
• The two rotating dies rotate in opposite
directions when the fluid gelatin mixture enters
the machine from the hopper it produces two
continuous ribbons . With these half shell of the
capsule is formed.

35. • At this stage the measured quantity of the
medicament is filled in to it with the stroke of
a pump with the subsequent movement of
the dies the other half capsule is formed.
• The two halves' of the capsules are sealed
together by the heat & pressure of the
rotating dies.
• As the die rolls rotate, the convergence of the
matching die pockets seals and cuts out the
filled capsules

37. ACCOGEL MACHINE
• Accogel Capsule Machine Or Stern machine,
uses a system of rotary dies but is unique in
that it is the only machine that can
successfully fill dry powder into a soft gelatin
capsule.

38. EVALUTION OF CAPSULES
1. STABILITY TESTS.
a) Shell integrity test
b) Determination of shelf life
2.INVARIABILITY TESTS.
a ) Weight variation
b) Content uniformity
3. DISINTEGRATION TEST.
4. DISSOLUTION TEST.
5. MOISTURE PERMEATION TEST

39. 1.STABILITY TESTS
• Stability tests for capsules are performed to
know the integrity of gelatin capsule shell (but
not to know the stability of therapeutically
active agent ) and for determining the shelf
life of capsules.
• The tests helps in improving the quality of
contents of capsule shell and for choosing the
appropriate retail package.

40. a) SHELL INTEGRITY TEST :
This test is performed to find out the
integrity of capsule shell. The standard
capsule shells kept at the room temperature
40 ⁰c and 80% RH becomes more soft ,sticky
and swollen .
b) DETERMINATION OF SHELF LIFE :
Shelf life or the expiry date of packed
capsules is determined under normal storage
conditions.

41. 2. INVARIABILITY TESTS
The invariabilty in the medicaments packed in
the capsule shells can be determined by
performing the following tests :
a) Weight variation test
b) Content uniformity test

42. a) Weight variation test:
In which 20 capsules are individually weighed
and standard deviation from mean weight was
measured that should not be <90% or >110% .
b) Content uniformity:
The amount of active ingredient should be within
the range of 85% to 115% of the label amount for
9 of 10 capsules, with no unit outside the range
of 70% to 125% of label amount.

43. 3. DISINTEGRATION TEST
Disintegration test is a method to evaluate the
rate of disintegration of solid dosage forms .
disintegration is defined as the breakdown of
solid dosage form into small particles after it is
ingested .

44. 4. DISSOLUTION TEST
• Dissolution test is an official method to
determine the dissolution rate of a solid
dosage form .
• Dissolution rate is defined as the rate at
which the drug is released into the systemic
circulation from the dosage from .

45. 5. MOISTURE PERMEATION TEST
To assure the suitability of containers for
packaging capsules . The moisture permeating
feature of capsules packaged in:
 single unit containers – blister pack or strip pack
 unit dose containers – glass or plastic bottles
Are to be determined .

46. REFERENCE
• The science and practice of pharmacy by
Remington
• The theory and practice of industrial
pharmacy by Leon Lachman ,Herbert
A.Lieberman
• Pharmaceutics the design and manufacture of
medicines by E. Aulton
• Practical pharmaceutics by Dr.G.D. Gupta ,
R.S .Gaud