Solid dosage forms (capsules)

Solid dosage forms (capsules

1. Solid Dosage Forms
(Capsules)
Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
Faculty of Pharmacy
Omer Al-Mukhtar University
Tobruk, Libya.
E-Mail: [email protected]
2014/05/31 1
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

2. Content
•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
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

3. Definition
•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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

4. Advantages of capsules
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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

5. Disadvantages of capsules
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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

6. Types of Capsules
•Capsules are available in two types:
1.Hard gelatin capsules
2.Soft gelatin capsules
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Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.

7. 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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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

8. 1. Hard Gelatin Capsules
Capsule number Approximate capacity in mg
000 950
00 650
0 450
1 300
2 250
3 200
4 150
5 100
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

9. 2. Soft Gelatin Capsules
•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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

10. Excipients used in the
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
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

11. 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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Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.

12. Capsule filling machine
(Hand operated)
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

13. Method of filling of soft
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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

14. Rotary machine
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

15. Difference between Hard Gelatin
and Soft Gelatin Capsules
Sl. No.Hard gelatin capsules Soft gelatin capsules
01 The hard gelatin capsule shell consists
of two parts: (a) Body; (b) Cap.
The soft gelatin capsule shell becomes a single
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
usually consists of the medicaments or
mixture of medicaments in the form of
powder, beads or granules.
The contents of soft gelatin capsules usually
consists of liquids or solids dissolved or dispersed
in suitable excipients to give a paste-like
consistency.
04 These are prepared from gelatin,
titanium dioxide, coloring agent and
plasticizer.
These are prepared from gelatin, plasticizer
(Glycerin or Sorbitol) and a preservative.
05 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.
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

16. Evaluation of Capsules
•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
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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

17. Special Applications of
Capsules
1.Enteric-coated capsules
2.Sustained release capsules
3.Rectal capsules
4.Capsules containing ophthalmic ointments
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Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.

18. Packing and Storage of
Capsules
•Capsules should be packed in well-closed glass or
plastic containers and stored at a temperature not
exceeding 30
0
C.
•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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Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

19. •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.
2014/05/31
Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.
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Packing and Storage of
Capsules

20. THANK YOU
e-mail [email protected]
2014/05/31
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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