Capsules

1
07/20/2023 Department of Pharmaceutics

INTRODUCTION:
CAPSULES:
The term capsule is derived from the Latin word
capsula, meaning a small container.
Capsules are defined as solid unit dosage forms
enclosing accurately measured quantity of medicaments in
a water soluble shell made up of gelatin.
Depending on the composition of gelatin, capsules
are available in two types-hard gelatin capsules which are
intended for the capsulation of particulate solids ( such as
powders, granules, and pellets) and soft gelatin capsules
which encloses the medicaments in the form of powders,
pastes, or non-aqueous liquids.
2
ADVANTAGES OF CAPSULES:
 Capsules are easy to swallow because of their
slippery texture.
 They efficiently mask the unpleasant taste of certain
drugs which cannot be achieved in case of tablets or
liquid oral formulations.
 There are attractive in appearance.
 They can be filled quickly and conveniently.
 They are economical.
 They are easy to handle and carry.
3
.
The ready solubility of gelatin at gastric pH provides
rapid release of medication in the stomach.
 Packaged and shipped by manufacturers at

lower cost less breakage than liquid forms
4
DISADVANTAGES OF CAPSULES:
Capsules are not suitable for liquids that dissolve gelatin,
such as aqueous or hydro alcoholic solutions.
The concentrated solutions which require previous dilution
are unsuitable for capsules because if administered as such
lead to irritation into stomach.
Capsules are not suitable for enclosing highly acidic or
alkaline drugs because acidic drugs cause hydrolysis of
gelatin, whereas alkaline drugs cause tanning effect which
reduces
07/20/2023 the solubility gelatin
of the of
Department shell
Pharmaceutics 5
Hygroscopic ingredients cannot be capsulated as they absorb
water from the shell and make it brittle.
Efflorescent substances cannot be capsulated as they make the
shell moist by releasing moisture.
6
SHAPES OF CAPSULE:
*The largest size of the capsule is No: 000.

*The smallest size is No: 5.
*The standard shape of capsules is traditional,
symmetrical bullet shape.
75
Formulation of hard gelatin capsule shell:
Gelatin,
water,
colorants,
opacifying agents,
Preservatives:
Flavours,
Sugars
Solvents
Thickening agents
8
GELATIN:
Gelatin is a heterogeneous protein obtained by irreversible
hydrolysis of animal collagen processed from bones, white
connective tissue, skin trimmings and frozen pork skin.
Gelatin is a regarded as the best suitable ingredient for the
manufacture of capsule shell owning to its unique physical,
chemical and physiological properties.
9
These properties depend on the collagen source, methods of
extraction, ph value, thermal degradation and electrolyte
content. commercially it is available as fine or coarse
powder, flakes and sheets. It has unique solubility
characteristics, being soluble in hot water and in warm
gastric fluids but insoluble in cold water. However it softens
upon absorbing 10 times its weight of water, a property
which facilitates the disintegration of capsules in the
stomach upon ingestion.
10
TYPES OF GELATIN:
There are two basic types of gelatin
1. Type - A
2. Type - B
3. TYPE - A
It is obtained by acid hydrolysis of pork skin and
exhibits an iso electric point at pH-9. type A gelatin
contributes plasticity and clarity to the gelatin blend
therefore reduces the cloudiness in the finished capsules.
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2. TYPE - B
This grade of gelatin is obtained by acid and alkaline
treatment of animal bones and hide portions. exhibits an iso
electric point at pH-4.7.
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PROPERTIES OF GELATIN:
1 Bloom strength:
 physical stability and strength of the capsule shell is
directly proportional to the bloom strength . Bloom
strength is defined as the measure of cohesive strength
of cross linking b/w the gelatin molecules.
Bloom strength is determined by measuring the weight
in grams required to penetrate a plastic plunger of 0.5
inches in diameter 4 mm deep into 6.66% w/w gelatin
gel maintained at 10 degree centigrade.
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13
Bloom strength
Bloom strength ranges from 150-250 gms.
15
3. Viscosity;
In general the higher the bloom, the greater the
viscosity.
Viscosity is determined by measuring the flow time of a
6.67% solution of gelatin through a U-tube viscometer
at 60 °C. Viscosity measurement is given in millipoise
units and varies between 25 and 40mps.
14
16
4. Foamability;
 In general pigskin grades tend to have better
foaming properties.
 Gelatin lowers the surface tension,

allowing for the incorporation of
air, and stabilizes the foam
once aerated.
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Color and odor;
 The gelatin should be as clear as possible in solution.
 Clarity is measured using a turbidimeter .
 The gelatin should be without odor.
15
18
Plasticizers: these are added to the gelatin mass
to confer softness, hardness, elasticity and
thickness to the capsule shell. The amount of
plasticizer to be added depends upon the type of
capsule (hard or soft) and storage conditions.
Eg: glycerin, sorbitol, propylene glycol
19
Water : Water is essential component in
preparation in gelatin mass. Similar to the
plasticizer , the amount of water to be added
depends on the type of capsule and storage
conditions. Soft gelatin capsule shells contain
more water and plasticizer than hard gelatin
capsule.
20
Colorants:
Capsule shells may be clear and colourless, but to
improve their elegance and to make them
distinctive and consumer appealing, certain FD&C
and D&C approved dyes, pigments are added to
the gelatin mass.
21
Opacifying agents:
These are used to minimize the transparency
and to make the capsule shell opaque.
Opacified capsule shells prevent the
degradation of photosensitive fill materials.
Eg: titanium dioxide
22
Presevatives:
Since gelatin contains water, preservatives are
added to retard the growth of microbes and to
maintain the stability of the shells for a long period
Eg: methyl paraben, propyl paraben.
Flavours: these are added to impart good flavour
to the capsule shell.
Sugars: these are used in chewable gelatin
capsules to impart sweet taste and to mask
objectionable taste.
23
Solvents:
These are added to impart elegance and
palatability to the capsule shells.
Eg: oils
Thickening agents:
Since viscosity of the gelatin is an important
aspect of the its quality therefore certain
thickening agents are added to adjust the desired
viscosity.
Eg: methyl cellulose.
24
FORMULATION OF HARD GELATIN
CAPSULE
FILL MATERIAL
A. SLECTION OF INGREDIENTS:
IN ADDITION TO THE ACTIVE INGREDIENTS, CAPSULE
FORMULATION REQUIRE THE USE OF ADDITIONAL NON-ACTIVE
INGREDIENTS CALLED EXCEPIENTS TO PRODUCE A CAPSULATED
BLEND.
IDEAL PROPERTIES OF ADDITIVES:
THEY SHOULD NOT ALTER THE THERAPEUTIC ACTIVITY OF THE
DRUG.
THEY SHOULD NOT REACT WITH OTHER ADDITIVES OF THE
PREPARATION.
THEY SHOULD BE STABLE THROUGHT OUT THE SHELF LIFE OF THE
PRODUCT.
THEY SHOULD BE OF GOOD QUALITY AND SHOULD NOT IMPART
ANY IMPURITIES TO THE DOSGEFORM.
25
FORMULATION OF CAPSULE
FILL MATERIAL
DILUENTS: THESE ARE ALSO CALLED AS FILLERS.

WHEN THE DOSE OF PARTICULAR DRUG SUBSTANCE IS
TOO SMALL TO COMPLETELY FILL THE SMALLEST
CAPSULE SHELL, DILUENTS ARE ADDED TO PRODUCE
THE PROPER CAPSULE FILL VOLUME.
EG: LACTOSE, MANNITOL, MCC, STARCH
DISINTEGRANTS:THEY PROMOTE THE BREAKUP AND

DISTRIBUTION OF THE CAPSULE CONTENTS IN THE
STOMACH. HENCE HELP IN EVOKING FASTER
THERAPEUTIC EFFECT.
26
FORMULATION OF CAPSULE
FILL MATERIAL
GLIDANTS/ LUBRICANTS: THEY ENHANCE THE FLOW

PROPERTIES OF THE CAPSULE FILL BY ALLOWING
STEADY PASSAGE FROM THE HOPPER THROUGH THE
AUTOMATED EUIPMENT INTO THE CAPSULE SHELLS.
EG: CALCIUM STEARATE, MG.STEARATE, AND TALC ETC
SURFACTANTS: THESE AGENTS FACILLITATES THE
WETTING OF DRY PARTICLES BY THE GI FLUIDS BY
MINIMIZING THE WATER PROOFING PROPERTIES OF
CERTAIN WATER INSOLUBLE AGENTS FILLED IN THE
CAPSULE.
EG: SLS,
27
ANTIDUSTING AGENTS:
DUST IS CONSIDERED TO BE THE MAJOR PROBLEM IN LARGE SCALE
CAPSULE FILLING OPERATIONS. DUST FROM POWDER MIX CONTAING
POTENT DRUGS IF INHALED BY THE OPERATORS MAY LEAD TO
SEVERE HEALTH COMPLICATIONS. TO PREVNT THIS SOME
ANTIDUSTING AGENTS ARE MIXED.
28
B. PRPEARATION OF FORMULATION:
THERAPEUTICALLY ACTIVE CONSTITUENTS ARE THOROUGHLY
MIXED WITH SUITABLE ADDITIVES. THE UNIFORM MIXTURE SO
OBTAINED IS FILLED INTO THE CAPSULE SHELLS. DRUGS IN LOW
DOSES ARE TO BE STRICTLY MONITORED WHILE BLENDING FOR
UNIFORMITY, THE LACK OF WHICH MAY ALTER THE DRUG
DISTRIBUTION THUS AFFECTING THE DESIRED THERAPEUTIC
EFFICACY.
FOR FILLING OF POWDERED DRUD IN THE CAPSULE SHELL THE

DENSITY AND PARTICLE SIZE OF BOTH THE DRUG AND ADDITIVES
SHOULD BE ALIKE FOR UNIFORM MIXING.
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PELLETS:
DRUGS SUBTSNCES WHICH ARE DESIGNED FOR
MODIFIED RELEASE ARE MADE INTO PELLETS AND
COATED WITH SUITABLE COATING AGENTS. THESE
COATED PELLETS ARE THEN FILLED IN THE EMPTY
CAPSULE SHELL.
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TYPES OF CAPSULES:
 Capsules are available in two

types: 1.Hard gelatin capsules
2.Soft gelatin capsules.
1.Hard gelatin capsule 2.Soft gelatin capsule

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1. HARD GELATIN CAPSULES:
The hard gelatin capsule consists of two pieces in the
form of cylinders closed at one end. The shorter piece
is called the cap. This cap fits over the open end of
longer piece called body.
Hard gelatin capsules are also known as dry-filled
capsules or two piece capsules.
The drug substance placed in the body and the caps
are slided over it, hence enclosing the drug substance.
32
PRODUCTION OF EMPTY CAPSULE SHELLS
capsule shells are manufactured by fully automatic machines

holding about 500 pins or pegs. made up of stainless steel to
produce shells of desired shape and size. both caps and bodies
are prepared simultaneously. such machines have mechanisms
for dipping, spinning, drying, trimming, stripping and joining of
caps and bodies.
33
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
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1.DIPPING:
Pairs of the stainless steel pins
are dipped into the dipping
solution(Gelatin solution) to
simultaneously form the caps and
bodies.
The dipping solution is
maintained at a temperature of
about 500C in a heated, jacketed
dipping pan.
2. SPINNING:
The pins arerotated
distribute to gelatin over
the uniformly.
pins the
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3.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
4. STRIPPING :
A series of bronze jaws strip the cap and
body portions of the capsules from the pins.
20
36
5.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.
After trimming to the right length, the cap and body
portion are joined.
Finished capsules are pushed onto a conveyer belt
which carries them out to a container.
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37
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.
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6. POLISHING :
a)Pan Polishing : Acela-cota pan is used to dust
and polish.
b) Cloth Dusting : Capsule are rubbed with
cloth.
.
c)Brushing : Capsule are feed under soft
rotating brush
Fig : Capsule polishing machine

23
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Capsule size selection:
for human use empty gelatin capsule shells are
available in eight different sizes varying in their
length, diameter, and capacities. The size ranges
from 000(largest) to 5(smallest) and are used to
capsulate 65 mg to 1g of powdered material.
Depending upon the nature of powdered drug,
65mg may be placed in capsule size 5 and 1g in
000. for veterinary purpose larger sizes of
capsule sizes of numbers 10, 11, and 12 are also
available which approximately contain 7.5, 15,
and 30 g of the drug substance.
41
FILLING OF HARD GELATIN CAPSULES :
Hand Operated methods or Semi Automatic
Capsules Devices.
 Punch Method or Manual Filling.
 Automatic filling machine.
ex: osaka capsule filling machine ,macofar
capsule filling machine
 HAND OPE
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• It consists of:
1.A bed having 200-300 holes
2.A loading tray having 200-30 0
holes
3.A powder tray
4.A pin plate having a rubber t op
5.A lever
6. A cam handle.
43
The empty capsules are filled in the loading tray .
↓
and it is placed over the bed
↓
The cam handle is operated to separate the capsule caps from
their
bodies.
↓
The powder tray is placed in a proper position and filled with
an
accurate quantity of powder with scraper.
↓
The excess of powder is collected on the plat for of the powder
tray
↓
The pin plate is lowered
07/20/2023 and
Department the filled powder is pressed44
of Pharmaceutics
After pressing ,the pin plate is raised and the remaining
powder is
filled into the bodies of the capsules
↓
The powdered tray is removed after its complete filling
↓
The cap holding tray is again placed in position
↓
The plate with the rubber top is lowered and the lever is
operated
to lock the caps a nd bodies
↓
The loading tray is then remo ved
and the filled capsules are llected
co 45
07/20/2023 Department of Pharmaceutics 28
 PUNCH METHOD:
 Powder is placed on a sheet of a clean paper

or porcelain plate using spatula which is formed into
a cake having a depth of approximately one-fourth
to one-third the length of the capsule body. Then
empty capsule body is held between the thumb and
forefinger and punched vertically into the powder
cake repeatedly until filled.
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46
FILLING OF HARD CAPSULE SHELL
The process of working:

 Rectification
 Separating the caps from empty
capsules
 Filling the bodies
 Replacing the caps
 Sealing the capsules
 Cleaning the outside of the filled ca
 160,000 capsules per 8hour shift
47
Rectification ; The empty hard gelatin capsules are
fed from the storage hopper into the rectifying unit
which aligns the capsules with their caps turned up
and bodies down.
4831
Separation of caps from body ;
•From the rectifying unit the capsules are fed

into the rotating ring . The ring consists of two parts
the upper ring and lower ring with cavities for holding
the capsules shells. Vaccum is applied from the
underside of the lower ring which causes the capsule
bodies to sit into the lower ring leaving the cap in the
upper ring.
32
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50
51
Principles of capsule Filling:
Auger Fill principle:
empty capsules – rectifying unit
Rectifier descends the capsules such that caps are
turned up and bodies down. From rectifying unit these
are placed one by one in filling ring kept on rotating
mode. The lower ring is rotated with a suitable speed
and the hopper containing powdered drug is held over
this ring. The auger drives the drug into bodies.
33
52
Vibratory Fill Principle:
The feed is placed in the feed hopper and
the capsule bodies are passed under it. A
perforated resin plate is placed in the feed
hopper. Due the vibrations of the resin
plate, the powder flows freely through the
pores into bodies.
53
Piston – Tamp principle:
These piston tamps alter the shape of powder by
compressing the powder to form slugs. These plugs are
transferred into the empty capsule bodies with the
application of slight pressure. Finally the bodies are ejected
from the machine. Compression force 50-200N
a)Dosator machine b) Dosing Disc
54
Vacuum Fill principle:
It consists of an open ended cylinder. The upper end of this is
fitted with a piston. The open end is placed in bulk powder.
Vacuum is applied & the piston is moved upward by sucking
the predetermined amount of powder which results in filling
55
ZANASI AUTOMATIC
HOFLIGER KARG AUTOMATIC
CAPSULE FILLING MACHINE
CAPSULE FILLING MACHINE
35
Various Filling Machine Available…
 Eli-lily
 Farmatic
 Hofliger and Karg
 Zanasi Nigris
 Parke-Davis
 Osaka
 Macofar SAS
(These machine differ in there design
and output ) 36
SEALING, POLISHING,
SORTING, AND CAPSULE
IMPRINTING
The capsules filled by manual or hand filling
machines are sealed in order to prevent the
detachment of caps from the bodies during
packaging, handling or storage.
Different manufacturers adopt different sealing
techniques.
1.Banding: in this method capsules are sealed by
Placing gelatin colorbands at the meeting
point of caps and the bodies.
58
Locking and Sealing of Capsules :
Moistening – in this method , inner surface of caps is

moistened with warm gelatin solution and these are then
quickly slipped over the filled bodies.
Spot Welding – capsules are sealed by welding process.

which causes the cap and body to fuse. the joints which
leaves a ring like appearance at the point of sealing
37
59
Thermal welding – In this method, Applying
wetting sol. At the meeting points of cap and
body which causes lowering of M.P at
applied area. Finally they are sealed at a
temp. 40-45ºc.
60
Polishing:
 Polishing: before final packaging the filled and sealed

capsules are subjected to dusting and polishing to remove
any adhering particles and to make them glossy.
 Cloth dusting: it is a manual method in this small number
of capsules are rubbed with a cloth.
 Pan polishing: accela- cota tablet coating pans may be
used for polishing the filled capsules. These pans are
lined with cheese cloth or polyurethane which captures
the dust and other powders adhering to the capsules.
38
61
Sorting: this operation is used to remove the imperfect
and damaged capsules. On a small scale this can be done
visually however on large scale this is done by automated
electronic sorting devices.
Imprinting: usually capsules are printed with company
name and logo or product identification. They are printed
before filling.
39
62
SOFT GELATIN CAPSULE:
Definition:-
Soft Gelatin capsules are also known as soft elastic
capsules or soft gels. The composition of soft gelatin
capsules is similar to the hard gelatin capsules shells,
the only diff, being the high conc. Of water and
plasticizer. soft gelatin shells containing a liquid, a
suspension, or a semisolid.
Soft gelatin is mainly composed of gelatin,
plasticizers, preservative, colouring and opacifying
agents, flavoring agents and sugars.
63
ADVANTAGES OF SOFT GELATIN CAPSULES:
 Easy to administer.
 Easy to manufacture.
 Liquids can be encapsulated
 Small to large sizes possible.
 Elegance.
 Bioavailability of drugs is improved since they are
present in liquid form.
 Odour and taste masking.
 Can be used for ophthalmic preparations.
e.g. aplicaps, vaginal/ rectal suppositories.
64
SHAPE OF
CAPSULE:
The shape
of soft gelatin
capsule are round,
oval, oblong,
tube. 65
soft gelatin capsules composition:
•A typical gel mass formula for making soft
gelatin capsules would be:
• Gelatin 35-45%
• Plasticizer 15-25% (glycerin or sorbitol)
• Water ~40%
• Dye / Pigment as needed
• Opacifier as needed
• Other (flavour, sugar,) as needed
43
66
Formulation :
Formulation for soft gelatin capsules involves
liquid, rather than powder technology.
Materials are generally formulated to
produce the smallest possible capsule
consistentwith maximum stability, therapeutic
effectiveness and manufacture efficiency.
The liquids are limited to those that do not have an
adverse effect on gelatin walls
. 44
67
Vehicles used in soft gelatin capsules:
Two main groups :
likely more
1.Water immiscible, volatile or more
volatile liquids such as vegetable oils, mineral oils,
medium-chain triglycerides and acetylated glycerin.
2.Water miscible, nonvolatile liquidssuch 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 forDepartment
07/20/2023 filling must flow by gravity at a
of Pharmaceutics 45
68
Manufacturing of soft gelatin
capsules:
1. Plate process
2. Rotary die process
3. Reciprocating die process
46
Plate process
The molten glycogelatin preparation is placed on a

plate containing hollow elliptical or hemispherical
dies. Over this a measured amount of anhydrous
liquid containing medicaments is evenly poured
which is then carefully covered with a second sheet
of gelatin. The sandwich is then compressed b/w
the two plates by applying mechanical pressure.
The pressure forces glycogelatin sheet and fill
material into the dies resulting in simultaneous
formation,
07/20/2023
filling and sealing of capsules.
Department of Pharmaceutics 70
2.ROTARY DIE PROCESS:
This process developed by Robert P.Scherer in

1933, is the most widely used method for the
prepration of soft gelatin capsules. The rotary die
machine consisting of one pair of contra rotating
cylinders with dies set in them. Previously molted
gelatin flowing under gravity from a tank is fed to a
metering device which controls the flow of gelatin
onto the cylinder and forms two continuous ribbons
. The ribbons are fed through a mineral oil
lubricating bath over guide rolls and then down b/w
the wedges and rotating cylinders. At the moment71
When the opposite dies converge and form pockets
of gelatin ribbon, a metered fill of drug flowing
under gravity through the leads and wedge is
injected b/w the die rolls by a metered fill pump.
The capsule at this moment is half sealed when the
pressure of the pumped materials forces the gelatin
into the die pockets. Simultaneously, these pockets
of gelatin containing the fill material are sealed by
the mechanical pressure on the die rolls and heat
by the wedge. The capsules are shaped and cut
from the ribbon. Department of Pharmaceutics
07/20/2023 72
Figure 3.8 Schematic drawing of a
rotary-die soft gelatin capsule filler (R.P.
Scherer: Detroit, MI). 49
73
3.Reciprocating die process
This process is similar to rotary die process, the

only diff” being that the gelatin ribbons are fed b/w
a pair of vertical dies that continuously open and
close to form rows of pockets in the gelatin
ribbons. These pockets are filled with the fill
material are sealed, shaped and cut off from the
ribbon as they move through the machine.
74
Packing and storage
Capsules may be packaged in suitably designed
unit dose containers made up of glass or plastic or
as single unit dose in blister packs or aluminum
strip packs.
Storage: hard gelatin capsules have moisture
content b/w 12-15%. When stored at high humidity,
they absorb moisture and soften resulting in the
loss of shape. Under low humidity conditions, they
lose water from the shell and become brittle.
So, ambient temp.. And humidity levels are
required
75
Minimum- 35% RH, 15C
Best possible- 50%RH, 20C
Maximum- 65% RH, 25C
Soft gelatin capsules should be stored in air

conditioned area wherein the humidity does not
exceed 45% RH at 21-24C.
76
EVALUATION OF CAPSULES:
 Content uniformity test

Moisture permeation test
 Weight variation test
 Dissolution test
 Disintegration test
56
77
Content uniformity test
30 Capsules are selected and 10 of these are
assayed individually by the specified procedure to
determine the percentage purity of the active
ingredient.
At least 9 of these contain 85-115% of drug and
none contain below 75-125% of drug. If 1 to 3 of
them fall outside of 85 -115% limits , the
remaining 20 capsules are individually assayed
and the net result of the 30 capsules assayed
should prove that not less than 27 of the 30
capsules are within the 85-115% and no capsule
is beyond the stated potency range of 75-125%.
78
Moisture penetration test
USP demands the determination of degree and

rate of moisture penetration by single unit and unit-
dose containers to assure their suitability for
packaging capsules. Accordingly moisture
penetration test is carried out by packaging the
capsule together with a colour revealing desiccant
pellet and exposing to known RH for a specific time
period. Any change in colour of pellet reveals
absorption of moisture. The weight of test dosage
form is then compared with its weight before test.
79
Weight variation test:
20 capsules are taken at random and weighed. Their
average weight is calculated, then each capsule is weighed
individually and their weight is noted. The capsule passes
the test if the weight of individual capsule falls with in 90-
110% of the average weight.(percentage deviation is
±10%).If the variation exceeds ±10%, then determine the
actual weight of the medicament separately and compare it
with the average weight.
80
 Dissolution Test:
Place 1000 ml of water free from dissolved
air having temperature of 36.5ºC to 37.5ºC
 Place specified number of capsules in each basket.
 Start motor and adjust speed 100 rpm as
per monograph. Withdraw the required
volume of solution after 45 minutes or
as specified in the monograph. Filter and weigh the
amount f active ingredients by the method specified in
the monograph. The test is said to
pass if the amountof active
ingredient is not less than 70% of
the statedgivenamount
in the monograph.
59
81
 Disintegration Test:
 Place one capsule in each basket.
 Set the temperature of water to 37 +/- 2
 Use disc if HGC floats whereas for soft gelatin use
the disc.
 Operate the apparatus for 30 mins for HGC and
60 minutes for SGC.
 The test is said to pass if no residue is left on the
screen of the apparatus.
 Repeat the test for 12 capsules if more than 1 or 2
capsules fails to disintegrate
 The test passes if 16 out of 18 capsules
disintegrate or else fail.
60
Diff”b/w hard and soft gelatin
capsules
Hard gelatin capsule Soft gelatin capsule
Consisting of two detachable parts, body It turns into a single unit after sealing
and cap
Shape of the capsule is cylindrical Shape of the capsule may be oval, round,
or tube like
Mainly used for capsulating solid Liquid medicaments, may be oils,
medicaments suspensions, ophthalmic products
The size of capsule varies from 000 to 5 The capacity of capsule varies from 0.1 ml
to 30 ml
Bioavailability is relatively less as the solid Bioavailability is relatively more
medicaments have to undergo
disintegration and dissolution before their
absorption.
83
84

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07/20/2023 Department of Pharmaceutics

 Packaged and shipped by manufacturers at

*The largest size of the capsule is No: 000.

 Gelatin lowers the surface tension,

DILUENTS: THESE ARE ALSO CALLED AS FILLERS.

DISINTEGRANTS:THEY PROMOTE THE BREAKUP AND

GLIDANTS/ LUBRICANTS: THEY ENHANCE THE FLOW

FOR FILLING OF POWDERED DRUD IN THE CAPSULE SHELL THE

 Capsules are available in two

1.Hard gelatin capsule 2.Soft gelatin capsule

capsule shells are manufactured by fully automatic machines

Fig : Capsule polishing machine

 Powder is placed on a sheet of a clean paper

The process of working:

•From the rectifying unit the capsules are fed

Moistening – in this method , inner surface of caps is

Spot Welding – capsules are sealed by welding process.

 Polishing: before final packaging the filled and sealed

2.Water miscible, nonvolatile liquidssuch as low

The molten glycogelatin preparation is placed on a

This process developed by Robert P.Scherer in

This process is similar to rotary die process, the

Soft gelatin capsules should be stored in air

 Content uniformity test

USP demands the determination of degree and

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