5. Advantages of capsules
• Variety of dosage strengths
• Individualized dose
• Manufactured efficiently and productively
• Packaged and shipped at low cost with less
breakage
• Source of medicinal agent when no otherwise
available
• Modified drug release
• Patients compliance
6. Disadvantages of capsules
• Difficult to swallow in case of children and
older people
• May be bitter
• Less or no flexibility of dose
7. Types of capsules
• There are two types of capsule;
• (a) Hard gelatin capsule
• (b) Soft gelatin capsule
8. Hard gelatin capsule
• Water portion or moisture content is 13 -16%
• For example;
• Amoxicillin
• Fefol
9. Soft gelatin capsule
• Moisture content is greater than 16%
• Also known as soft gels
• For example;
• Evion (vit. E)
13. Parts of capsule
• There are two parts of capsule which are as
follows;
• Cap –smaller in size
• Body – slightly larger in size
• When cap and body come in contact with each
other , they join , overlap by snugly i.e.;
mechanical locking.
14.
15. Gelatin
“Gelatin is obtained by partial hydrolysis of
collagen obtained from the skin , white
connective tissue , and bones of animals”.
Available in form of powder , flakes or sheets
and sometimes in form of granules.
16. Types of gelatin
• Acidified by nature
• Obtained from pork skin
• Type A • Type B
• Alkalinized in nature
• Obtained from
animal bones
17. Stability of gelatin
• Gelatin is stable in air when dry but is subject
to microbial decomposition when it becomes
moist.
Moisture content and humidity must be
controlled during the production of gelatin
shells.
18. • As ;
• Hard gelatin capsule – more humidity –
distorted and lose their rigidity
• Dryness – loss of moisture – brittle and
crumble
19. Manufacturing of gelatin shell
• Hard capsule shell;
• Caps and body are made separately.
• Temperature and humidity are controlled
during the manufacturing process.
• Plates containing pegs are dipped in the
mixture of gelatin , stay for some time , then
taken out and followed by trimming.
• Caps and bodies are joined together by means
of mechanical locking.
20.
21. Preparation of filled hard gelatin
capsule
• The large scale or small scale preparation of
filled hard gelatin capsules is divided into the
following general steps;
I. Developing and preparing the formulation
and selecting the capsule size.
II. Filling the capsule shells.
III. Capsule sealing (optional).
IV. Cleaning and polishing the filled capsules
22.
23. Developing and preparing the
formulation
• It includes
• Accurate dosage
• Good bioavailability
• Ease of filling
• Production stability
• Elegance
26. Punch method
• In this method precise number and size of
capsule are selected which are to be filled.
• Capsules bodies and caps are separated.
• Powder to be encapsulated is taken and
placed on a piece of clean paper or glass sheet
or porcelain sheet, then cake formation of this
powder is done and the height of this cake is
¾ of the size of the capsule shell.
27. Now , the filling is done by holding the body of
capsule in between your thumb and forefinger.
28. Automatic filling method
• 200 – 2000 capsules /hour
• Operation of machine
• Machine automatically separate the capsule’s
body and cap.
• The body will be filled with the medicoment
• Then , there will be scrapping of excessive
material from the body because it will cause the
swallowing problem
• Rejoin the cap and body
• And then, sealing is also done automatically.
29.
30. Capsule sealing
• Tamper evident capsules by sealing the joint
between the 2 capsule parts.
• Distinctive looking capsule by sealing them
with colored band of gelatin. If removed the
band can not be restored without expert
sealing with gelatin.
• Through the heat welding process that fuses
the capsule cap to the body.
31. Another method, uses a liquid wetting agent
that lowers the melting point in the contact
areas of capsule’s cap and body and then
thermally bonds the two parts using low
temperature.
32.
33. Cleaning and polishing capsules
• Small amounts of powder may adhere to the
outer side of capsules after filling.
• Powder should be removed before dispensing
as follows ;
• Small scale ---by rubbing with a clean piece of
paper
• Large scale---automatically by cleaning
vacuum that remove extraneous material
from the capsule.
34.
35. Soft gelatin capsules
• Soft gelatin capsules are made of gelatin to
which glycerin or a polyhydric alcohol such as
sorbitol has been added.
• Soft gelatin contain more moisture than hard
capsule therefore we use preservatives such
as methylparaben and propylparaben to
retard the microbial growth.
36. Shapes of soft gelatin capsule
• They may be;
• Oblong
• Oval
• Round
37. Methods of preparation
• It is manufactured by following methods;
• Plate process
• Rotary die process
• Reciprocating die process
38. Plate process
• In this process a warm sheet of plain or
colored gelatin is placed on the bottom plate
of the mold and the medication containing
liquid is evenly poured on it.
• Then, a second sheet of gelatin is carefully
placed on top of the medication and the top
plate of the mold is put into the place.
39. • Pressure is then applied to the mold to form ,
fill and seal the capsule simultaneously.
• The capsules are removed and washed with a
solvent harmless to the capsule.
40. Rotary die process
• By this method liquid gelatin flowing from an
overhead tank is formed into two continuous
ribbons by 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 ribbon.
41.
42. Reciprocating die process
• This method is similar to the rotary process ,
in that ribbons of gelatin are formed and used
to encapsulate the fill , but it differs in actual
encapsulating process.
• The gelatin ribbons are fed between a set of
vertical dies that continually open and close to
form rows of pockets in the gelatin ribbon.
43. • These pockets are filled with medication and
are sealed , shaped , and cut out of the film a
they progress through the machinery.
• As the capsule are cut from the ribbons , they
fall into refrigerated tanks that prevent the
capsule from adhering to one another.
44. Uses of soft gelatin capsules
• Soft gelatin capsule are prepared to contain a
variety of liquids , paste , and dry fills.
• Liquids that may be encapsulated into soft
gelatin capsules include the following;
• Water immiscible volatile and nonvolatile
liquid such as vegetable and aromatic oils ,
ethers, alcohols, esters and organic acid.
45. Compendial requirements
• Weight variation test
• Disintegration test
• Content uniformity test
• Bloom strength test
• Dissolution test
46. Inspecting , counting , and packaging
• Inspect ;
• Uniform appearance
• Counting ;
• Automatically by especially designed trays
• Manually
• packaging ;
• Wide mouth container---jar screw cap
• Blister packing---strip packing by using aluminium foil
