Solid Dosage
Forms
CAPSULES
Content 2
• Definition
• Advantages and disadvantages
• Types of capsules
• Methods of filling the hard gelatin capsules
• Method of filling of soft gelatin capsules
• Different between hard gelatin and soft gelatin capsules
• Evaluation of capules
• Special Applications of Capsules
• Packing and Storage of Capsules
Definition 3
• 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.
Advantages of capsules 4
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.
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.
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.
2014/05/31
Types of Capsules
• Capsules are available in two types:
1. Hard gelatin capsules
2. Soft gelatin capsules
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1 Hard Gelatin Capsules
• These are used for administration of solid
medicaments.
• The capsule shell is prepared from gelatin, color and
titanium dioxide to make it opaque.
• It consists of two parts i.e. body and cap.
• The powdered material is filled into the cylindrical
body of the capsule and then the cap is placed over it.
• The empty capsules are available in various sizes.
• They are numbered according to the capacity of the
capsules.
• The number starts from 000 and goes up to 5.
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1 Hard Gelatin Capsules 8
Capsule number Approximate capacity
in mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100
2. Soft Gelatin Capsules 9
• These are used for administration of liquid medicaments.
• Soft gelatin capsules are available in round, oval and tube
like shapes.
• They are made from gelatin.
• The gelatin is plasticized by the addition of glycerin and
sorbitol etc.
• The soft gelatin shell may contain a preservative to
prevent the growth of fungi.
• They are used to enclose liquid medicaments-oils,
suspensions, food concentrates and ophthalmic products.
Excipients used in the
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filling of capsules
• While filling solid medicaments in a powder form
into the body of hard gelatin capsule, the following
additives, too are included in the formulation:
1. Diluents
2. Absorbents
3. Glidants
4. Antidusting compounds
Methods of filling the hard
gelatin capsules
• The capsules can be filled either by hand or by a semi-
automatic device or by an automatic filling machine.
• Capsule filling machine (Hand operated) 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 200-300 pins
5. A sealing plate having a rubber top
6. A lever
7. A cam handle
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Capsule Filling Machine
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(Hand operated)
Method of filling of soft
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gelatin capsules
• Soft gelatin capsules are generally filled mechanically.
• The manufacturing of the capsule shell and the filling of the
medicament take place simultaneously.
• Nowadays, a rotary machine is used for this purpose.
• In a rotary die machine, the soft gelatin capsules are prepared
and then filled immediately with the liquid medicaments.
• The machine consists 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.
Rotary machine 14
Gelatin and Soft Gelatin Capsules
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Sl. No. Hard gelatin capsules Soft gelatin capsules
01 The hard gelatin capsule shell consists The soft gelatin capsule shell becomes a single
of two parts: (a) Body; (b) Cap. unit after sealing the two halves of the capsules.
02 They are cylindrical in shape. They are available in round, oval and tube like
shapes.
03 The contents of a hard gelatin capsule The contents of soft gelatin capsules usually
usually consists of the medicaments or consists of liquids or solids dissolved or dispersed
mixture of medicaments in the form of in suitable excipients to give a paste-like
powder, beads or granules. consistency.
04 These are prepared from gelatin, These are prepared from gelatin, plasticizer
titanium dioxide, coloring agent and (Glycerin or Sorbitol) and a preservative.
plasticizer.
05 Capsules are sealed after they are filled Filling and sealing of soft gelatin capsules are
to ensure that the medicaments may done in a combined operation on machines.
not come out of the capsule due to
rough handling.
Evaluation of Capsules 16
• The following tests should be carried out for
evaluation of the capsules:
1. Uniformity of weight
2. Content of the active ingredients in the capsules
3. Disintegration test
4. Dissolution test
Special Applications of Capsules
1. Enteric-coated capsules
2. Sustained release capsules
3. Rectal capsules
4. Capsules containing ophthalmic ointments
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Packing and Storage of Capsules
• Capsules should be packed in well-closed glass or
plastic containers and stored at a temperature not
exceeding 30 0C.
• They should comply with such additional storage
requirements as are specified in the individual
monographs given in the pharmacopoeia of India.
• Capsules can be individually protected by enclosing
them in a strip or blister packs.
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Packing and Storage of Capsules
• In strip packing, the capsule is hermetically sealed
within the strips of an aluminium foil and/or plastic
film.
• The contents are removed from the strip packs by
tearing or cutting to separate the capsules.
• In case of blister packs, a press on the blister forces
the capsule through the backing strip.
• Generally, capsules have a longer shelf life in
unopened glass bottles than in strip-packs but this is
reversed, once a bottle has been opened.
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Microcapsules
Techniques are now available for enclosing very fine
particles in individual capsules.
They are prepared using two techniques
▪ Coacervation
▪ Fluidised Bed Coating
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Applications of Microcapsules
a) Protection
i. oxygen sensitive drugs may be more stable e.g.
Vit A
ii. Volatilization of volatile subs. is decreased
b) Separation
i. When separately encapsulated, incompatible
drugs can be dispensed together
ii. Unpleasant tastes and odours can be masked
c) Controlling release
Microencapsulation can used to apply sustained 6
Microcapsules
Size range from 5µm to 5mm.
Depending upon size of nucleus and the method and
conditions of preparations.
They are used in several types of pharmaceutical
products, including sustained release preparations and
oral suspensions.