CAPSULES

Mr. Jadhav R. S.
Capsules:
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

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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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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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Types of Capsules
Capsules are available in two types:

1. Hard gelatin capsules

2. Soft gelatin capsules

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GELATIN
Gelatin is heterogeneous product derived by hydrolytic extraction of
animal's
collagen.
The sources of gelatins including animal bones, hide portions and frozen
pork skin.

TYPES OF GELATIN

Type A

Type B
There are two basic types of
gelatin
TYPE A
Derived from acid treated precursor that exhibits an iso electric point at pH-
9. It is manufactured mainly from pork skin.

TYPE B
Derived from alkali treated precursor that exhibits an iso electric point at pH-
4.7. It is manufactured mainly from animal bones
Preparation Of Gelatin
Manufacturing of hard gelatin capsules
Steps involved in making empty gelatin capsules…

1.Dipping

2.Spinning

3.Drying

4.Stripping

5.Trimming and Joining

6. Polishing
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 50 0C 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.

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.
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.

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.

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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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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 Methods of filling the hard gelatin capsules
• The capsules can be filled either by hand
or by a
semiautomatic 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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https://youtu.be/QBN2JdNQank
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 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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The shape of soft gelatin capsule are round, oval, oblong, tube.

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Is manufactured by four methods

1)Plate process
2)Rotary die process
3)Reciprocating die
4)Accogel machine

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•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.

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1) In this machine the soft gelatin capsules are prepared & then filled
immediately with liquid medicaments it is having two hoppers & two rotating
dies

2)Liquid mixture is placed in one hopper & the liquid medicament in

other Hooper.

3)The two rotating dies rotate in oppositedirections when the fluid gelatin
mixture enters the machine from the hopper it produces two continuous ribbons .

4) These half shell of the capsule is formed.

5) 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.

6) The two halves' of the capsules are sealed together by the heat &
pressure of the rotating dies.

7) As the die rolls rotate, the convergence of the matching die pockets seals
and cuts out the filled capsules
Accogel Capsule 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.
 vehicles used in soft gelatin capsules:
Two main groups :
1.Water immiscible, volatile or more likely more volatile liquids such as vegetable
oils, mineral oils, medium-chain triglycerides and acetylated glycerin.
2.Water miscible, nonvolatile liquids such as low molecular weight PEG have come
in to use more recently because of their ability to mix with water readily and
accelerate dissolution of dissolved or suspended drugs.
● All liquids used for filling must flow by gravity at a temperature of 350C or less.
● The sealing temperature of gelatin films is 37-400C
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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Difference between Hard Gelatin and Soft Gelatin Capsules
Hard gelatin capsules
The hard gelatin capsule shell consists of
two parts: (a) Body; (b) Cap.
They are cylindrical in shape.
The contents of a hard gelatin capsule
usually consists of the medicaments or
mixture of medicaments in the form of
powder, beads or granules.
Soft gelatin capsules
The soft gelatin capsule shell becomes a
single unit after sealing the two halves of
the capsules.
They are available in round, oval and tube
like shapes.
The contents of soft gelatin capsules
usually consists of liquids or solids
dissolved or dispersed in suitable
excipients to give a paste-like consistency.

These are prepared from gelatin, These are prepared from gelatin,
titanium dioxide, coloring agent and plasticizer (Glycerin or Sorbitol) and a
plasticizer. preservative.
Capsules are sealed after they are filled Filling and sealing of soft gelatin capsules
to ensure that the medicaments may not are done in a combined operation on
come out of the capsule due to rough machines.
handling.
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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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Special Applications of Capsules
1. Enteric-coated capsules

2. Sustained release capsules

3. Rectal capsules

4. Capsules containing ophthalmic ointments

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