Capsule, Capsule as dosage from, presentation on capsule, complete capsule, capsule for pharma students, capsule as solid unit dosage form

1. CAPSULE

2. Capsules are solid dosage forms in which
medicinal agents and/or inert substances are
enclosed in a small shell of gelatin.
Gelatin capsule shells may be hard or soft,
depending on their composition.
Gelatin is obtained by partial hydrolysis of
collagen obtained from the skin, white
connective tissue, and bones of animals.
Gelatin is available in form of powder ,
flakes or sheets and sometimes in form or
granules.

3. Types of capsules
a) HARD GELATIN CAPSULES
b) SOFT GELATIN CAPSULES

4. Sr.No. Hard Gelatin Capsule Soft gelatin capsule
1. Hard Gelatin Capsule shell
consists of two parts 1. Body
2. Cap
Soft gelatin capsule shell become a
single unit after sealing the two halves
of the capsules
2. They are cylindrical inshape They are available in round , oval &
tube like shapes
3. The contents of a hardgelatin
capsules usually consist of
the medicaments is 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
.
4. These are prepared fromgelatin
,Titanium dioxide, coloring
agents and Plasticizer
These are prepared from gelatinplasticizer
(Glycerin or Sorbitol ) and apreservative
5. Capsules are sealed after they
are filled to ensure that the
medicaments may not come out
of the capsule due to rough
handling
Filing and sealing of soft gelatin
capsules are done in a combined
operation on machines

5. Advantages :
 The drug having unpleasant odour & taste can be
administered by enclosing them in a tasteless shell.
 Smooth become very slippery when moist & can be
easily swallowed.
 They are economical.
 Easy to handle &carry.
 Release the medicament as and when desired in GIT.
 They are made up from gelatin hence they are
therapeutically inert.
 Theyare attractive in appearance.
 Available in various sizes.
 Microencapsulation provides the sustainedrelease
dosage form.

6. Disadvantages:
Difficult to swallow in case of children and older
people
May be bitter
Less or no flexibility of dose
The hygroscopic drugs cannot be filled in capsules.
They absorb water present in the capsule shell & make it
very brittle, which ultimately breaks into pieces.
The concentrated preparation which needprevious
dilution are unsuitable for capsules because it may lead
to irritation in stomach if administered

7. SIZE OF CAPSULES Capacity in mg VOLUME
(cm3
)
000 950 1.37
00 650 0.95
0 450 0.68
1 300 0.50
2 250 0.37
3 200 0.30
4 150 0.21
5 100 0.13
The biggest size of capsule is 000 with the capacity of 950mg and
The smallest size of capsule is 5 with the capacity of 100mg.

8. MANUFACTURE OF EMPTYGELATIN CAPSULES
Steps involved in making empty gelatin capsules:-
 Dipping
 Spinning
 Drying
 Stripping
 Trimming
 Joining
 Polishing

9. • Once raw materials have been received and released by
Quality Control, the gelatin and hot demineralized water are
mixed under vacuum in Stainless Steel Gelatin Melting
System.
• From receiving tanks, the gelatin solution is transferred to
stainless steel feed tanks.
• Dyes, Opacifying agent, and any needed water are added to
the gelatin in the feed tanks to complete the gelatin preparation
procedure.

10. 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
it is rotated 2½ times by moving upward.
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, Here
gently moving air which is precisely controlled for volume,
temperature, and humidity, removes the exact amount of moisture
from the capsule halves.
Dipping: Pairs of the stainless steel pins are dipped into the dipping
solution to simultaneously form the caps and bodies for 12sec. The
dipping solution is maintained at a temperature of about 50º C in a
heated, jacketed dipping pan & pins are at 22ºc.

11. Stripping : A series of bronze jaws strip the cap and body portionsof the
capsules from the pins.
Trimming and joining: The stripped cap and body portions are
trimmed to the required length by stationary knives. The cap and
body lengths are precisely trimmed to a ±0.15 mm tolerance.
 Finished capsules are pushed onto a conveyer belt which carries
them out to a container.
After trimming to the right length, the cap and body portion are joined.
 Capsule quality is monitored throughout the production process
including size, moisture content, single wall thickness, and color.
 Capsules are sorted and visually inspected on specially designed
Inspection Stations.
 Perfect capsules are imprinted with the client logo on high-speed.

12. Excipients used in the filling of capsules:
Diluents: e.g. Lactose, Mannitol, Sorbitol,Starch
Absorbents: e.g. Magnesium oxides,Magnesium
carbonates, Calcium oxides, Calcium carbonates, Kaolin
 Glidants: Talc, Magnesium stearate, Calcium stearate
Ant dusting agents: Inert edible oil.

13. EVALUTION OF CAPSULES
 Content uniformity
 Disintegration test
 Uniformity of weight
 Dissolution test

14. Content Uniformity
As per I.P. this test is applicable to capsule that
contain less than 10mg or less than 10% w/w active
ingredient.
This test is not applicable to capsules containing
multivitamins & trace elements.
The test pass if not more than one individual content
is outside the limit of 85-115% of the average
content.

15. Place 1 capsule in each of the 6tubes of the
basket & suspend the assembly in water at
37℃ ± 2ºC,which is repeatedly immersed
30 times per minute.
For h.g.c time is 30 minutes.
For s.g.c time is 60 minutes.
Disintegration Test For Capsules
The capsules pass the test if no residue of
drug or other than fragments of shell
remains on No. 10 mesh screen of the tubes.

16. Dissolution Test For Capsules
 Place 1000ml of water having a temp. of 36.5º to 37.5º
into the vessel. Place specified number of capsules in
basket 7 adjust the speed to 100 rpm.
Withdraw req. volume for every 10min time interval.
Filter and determine the amount of active ingredient.
The sample passes the test if the amount of active
ingredients in the solution is not less than 70% of the
stated amount.

17. Uniformity Of Weight
Test perform with 20 capsules
Average weight
of capsule
content
% of deviation
acceptable
Less than 300 mg 10%
300mg or more 7.5%

18. Angle Of Repose
The frictional forces in the case of loose powder are measured by the angle of
repose. The maximum angle which is formed between the surface of a pile of
powder and horizontal surface is called the “angle of repose”.
Angle of repose depends on the shape of the particles. Lubricants decrease
the angle of repose to a certain extent but the excess quantity of lubricant
increases the angle of repose.
The angle of repose depends upon the cohesive of the particles.
The powder flows smoothly, if the angle of repose is 250 if there angle is
more than 500 than powder does not flow properly.
h
D
An angle of repose is defined by the equation:-
tan𝜃=
2ℎ
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