UNIT-III

CAPSULES
 CAPSULES
"Capsules are solid dosage forms in which one
or more medicaments are enclosed in a water
soluble bio degradable shell made up of
gelatin"
 TYPES OF CAPSULES

They are of two types:

i. Hard gelatin capsules
ii. Soft gelatin capsules
 HARD SHELLED CAPSULES

“Hard-shelled capsules, which are typically made using gelatin

and contain dry, powdered ingredients”

These are made in two halves:


Lower-diameter "body" that is filled

Then sealed using a higher- diameter "cap".
 SOFT SHELLED CAPSULES

Soft-shelled capsules, primarily used for oils and for

active ingredients that are dissolved or suspended in oil.
Capsules Are Made From Aqueous Solutions Of Gelling Agents
Like:

 Animal protein, mainly gelatin

Plant polysaccharides or their derivatives like carrageenans and
modified forms of starch and cellulose.
 Other ingredients can be added to the gelling agent
solution like:
plasticizers such as glycerin or sorbitol to decrease the
capsule's hardness,
 coloring agents,
 preservatives,
 disintegrants,
 Lubricant
 surface treatment
 COMPONENTS OF CAPSULES
1. Gelatin
2. Certified dyes
3. Sugar
[Link] - 12 to 16 % but may vary depending on the storage
condition
[Link] dioxide (0.15%) - prevent decomposition during
manufacture
6 Opaquants /Opacifying agent - titanium dioxide
 GELATIN
 Gelatin or gelatine (from Latin: gelatus meaning "stiff", "frozen") is a translucent,
colourless, brittle (when dry), flavourless foodstuff, derived from collagen obtained from
various animal by-products.
 It is commonly used as a gelling agent in food, pharmaceuticals, photography, and
cosmetic manufacturing.
 Gelatin is an irreversibly hydrolyzed form of collagen

TYPES OF GELATIN
TYPE A
Derived from acid treated precursor that exhibits an iso electric point at pH-9. It is
manufactured mainly from animal bones
TYPE B
Derived from alkali treated precursor that exhibits an iso electric point at pH-4.7. It is
manufactured mainly from pork skin
 HARD GELATIN CAPSULES
•Also referred to as “DFC” Dry Filled Capsule.

CAPSULE SIZES:
•For human use, empty capsules ranging in size from 000 (the
largest) to 5
•(the smallest) are commercially available.
•Generally encapsulates between 65mg to 1g of powdered
material.
•For veterinary use: No's 10, 11and 12 having capacities of 30, 15
and 7.5 g, respectively
 SIZE OF CAPSULES
Size Volume in ml Size in mm
000 1.37 26.3
00 0.95 23.7
0 0.68 21.8
1 0.50 19.2
2 0.37 18.3
3 0.30 15.3
4 0.21 14.7
5 0.15 11.9

11
 SHAPES OF CAPLUSE
*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.
 ADVANTAGES OF CAPSULES
 Ease of use due to the fact that it is smooth, slippery and
easy to swallow.
 Suitable for substances having bitter taste and unpleasant
odor.
 As produced in large quantities it is economic, attractive and
available in wide range of colors.
 Minimum excipients required.
 Little pressure required to compact the material.
 Unit dosage form.
 Easy to store and transport.
 DISADVANTAGES OF CAPSULES

 Not suitable for highly soluble substances like

potassium chloride, potassium bromide, ammonium
chloride, etc
 Not suitable for highly efflorescent or
deliquescent materials.
 Special conditions are required for storage.
 ADVANTAGES OF CAPSULES FOR ORAL
ADMINISTRATION
1. Easy to swallow due to their smooth and slippery nature
2. Easy to handle and carry.
3. Can mask the unpleasant taste, colour and odour of drug using
tasteless shell.
4. Better bioavailability than tablets and faster onset of action
than tablets.
5. The shells are physiologically inert and easily and quickly
digested in the gastrointestinal tract.
6. The shells can be opacified (with titanium dioxide) or
coloured, to give protection from light.
 MANUFACTURE OF EMPTY GELATIN CAPSULES

Steps involved in making empty gelatin capsules…

Dipping
Spinning
Drying
Stripping
Trimming and Joining
Polishing

6
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 500C 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.

8
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.

10
 HARD CAPSULE
FILLING
1) Bench scale filling (for small scale filling)
- Manual filling machine
eg: feton capsule filling machine
2) Industrial scale-filling
Comes in varying shapes and sizes
- semi automatic machine
- fully automatic machine
• At present about 9 manufacturing companies supplies the capsule filling
machines with different models. The following famous companies which
provides capsule filling machines are
 Eli Lilly and company indianapolis IN
 Farmatic SNC, Bologna, Italy
 Macofar SAS, Bologna, Italy
 Hofliger and Karg, Waiblingen, Germany
 mG2 S.P.A., Bologna, Italy
 Osaka, Osaka, Japan
 Parke-Davis and company, Detroit, MI
 Perry Industries, Green BayWI
 Zanasi Nigris, S.P.A., Bologna, Italy

The largest number of total machines are supplied by Lilly and Parke-Davis.
The method of operation and the description of the machines are similar in
these two companies.
The nine famous companies which provides capsule filling machines of
different models and types are as follows:

 Lilly capsule filling machine, Lilly ROTOFIL capsule filling machine.

 Farmatic Model 2000/15, 2000/30 and 2000/60 capsule filling machine.
 Hofliger and Karg model GKF-303, GKF-602, GKF-1500 and GKF-2500
capsule filling machine.
 Macofar:MT-12, MT-13/1 and MT-13/2 capsule filling machine.
 mG2:Model G36/4, G36/2, G36, G37N and G38 capsule filling machine.
 Osaka Model 180 capsule filling machine.
 Perry: Perry Model CF ACCOFIL capsule filling machine.
 Zanasi:Zanasi Model LZ-64 and AZ-20 capsule filling machine
What is the common working principle of all capsule
filling machines?
 BENCH SCALE FILLING
Sealing plate with rubber top Pin plate with 200-300 holes

Bed – 200-300 holes

Cam handle

Powder tray

lever
loading tray
with 200-300 scraper
holes
 HAND OPERATED CAPSULE FILLING MACHINE
 It consist of a bed having 200-300 hole, a loading tray having 200-300 holes, a powder tray,
a pin plate having 200-300 pins, a sealing plate having a rubber top, a lever, a cam handle.

 The empty capsules are filled in the loading tray and it is palced 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 the powder is collected on the platform of the powder tray. The
pin plate is lowered and the filled powder is pressed by moving the pin downwards.

 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 and bodies. The loading tray is then removed and filled capsules are collected.

 With a 200 hole machine, about 5000 capsules can be filled in one hour, whereas in a
machine having 300 holes, about 7500 capsules can be filled in one hour.
• JAANSUN CAPSULE FILLING MACHINE
 SEMI-AUTOMATIC FILLED MACHINE

There are 3 stations in this semi-automatic capsule filling

machine
 orientation of capsule
 powder filling
 capsule closing.
FIRST STATION: ORIENTATION OF CAPSULES

The functions of first station include :

1. capsule feeding
2. Aligning
3. Insertion into bores of holding ring
4. Vacuum is used for separating capsule cap and body in first
station.
5. After orientation of capsule, capsule cap can stay in upper
holding ring and capsule body can stay in lower holding ring.
 THE SECOND STATION: POWDER FILLING
Separate the holding ring,put the lower (body) holding ring on the rotary table,
pull the powder hopper over the lower (body) holding ring, then auger inside
powder hopper starts to run and fill powder into the capsule body.
While Iower holding ring turns one circle, push powder hopper to its original
psition.
 THE THIRD STATION: CAPSULE CLOSING

• Put upper holding ring and lower holding ring together, then position
intact holding ring in front of peg ring. closing plate is pivoted to a
position approximately 180 degrees.

• Pneumatic pressure is applied to peg ring

which finally push capsules inside the bores
of holding ring the finished capsules
will be collected into the container.
LILLY/PARKE-DAVIS

Storage hopper

Rectifying unit

Two piece filling

ring Powder hopper

Peg ring

Closing plate

Collecting chamber
• SEMI AUTOMATIC MACHINE
 AUTOMATIC CAPSULE FILLING
MACHINE
• Automatic Capsule Filling Machine has been designed and
developed to fill hard gelatin capsules with powder or pellets. It is
an extremely durable and reliable
machine that fills dosages to the
highest accuracy. It can be
applicable to the widest range of
capsules at all sizes and guarantee
the integrity of all capsules.
 The housing and surface are covered with stainless steel 304. All contact
parts of medical powders are made from a corrosion resistant stainless
steel 316.
 Parts are made by CNC computer machine. All parts are standardized and
easy to substitute.
 Capable of filling 6 capsules at a time with operation from 10 stations.
Accurate operation for orientation, opening, filling, joining and ejecting of
the capsules
 Compulsory spiral feeding in the powder hopper to ensure powder feeding
and filling.
 Dual capsule-opening design to ensure all capsules are opened.
 Electrical impact protection device to prevent any further damage. The
machine will stop automatically in the event of collision.
 Safety Sensing System to shut the machine down automatically in the event
of problems when no capsules, no powder, door is opened, and abnormal
load for the machine are detected.
Automatic vacuum removal of the air in the dosing tube to give more
accurate weight of the filled capsules.
. Exclusive dosing tube system, temperature of the powder will not rise
during the filling process.
Adjustable compression piston in dosing trube to adjust the powder
volume without change parts.
 FARMATIC SNC
Farmatic offers three models of filling equipments

Model Capacity

 2000/15  40000 capsules

per hour
 2000/30 80000 capsules
per hour
 2000/60  160000
capsules per
hour

Farmatic Model 2000/60

Capsule filling machine
 HOFLIGER AND KARG

H & K line consists basically

of four machine models.

 GKF-303
 GKF-602
 GKF-1500
 GKF-2500

HOFLIGER KARG AUTOMATIC

CAPSULE FILLING MACHINE
 Empty capsule storage hopper

Rectifier

Bulk powder storage hopper Capsule

Body transport segment

Closing station

Filled capsules ejection station

H & K model GKF-602

 MACOFAR

• Macofar line of equipments consists of three models.

• Low to medium capacity machines.

MODEL CAPACITY
MT-12 35,000 capsules per hour
MT- 5,000 capsules per hour
13/1 10,000 capsules per hour
MT-
13/2
 mG2
• Five models of continuous motion filling machines are offered
by mG2.

MODEL CAPACITY

• G36/4 150 capsules per minute

• G36/2 300
• G36 600
• G37N 1600
• G38 1000
 OSAKA
 High capacity, continuous motion machine.
 The only model available is
R-180 : 70000 to165000 capsules per
hour.
 Can be modified to 400000 capsules per
hour.
 ZANASI

• Nine different units in four model lines

• LZ-64 : 4000 capsules per hour
• AZ-20 : 9000 TO 20000 capsules per hour
• BZ series
BZ-40 : 30000/hr
BZ-72 : 60000/hr
BZ-110 : 110000/hr
BZ-150 : 150000/hr
• Z-5000 series
Z-5000-R1 : 70000/hr
Z-5000-R2 : 110000/hr
Z-5000-R3 : 150000/hr
 HARD GELATIN CAPSULES

 MANUAL FILLING METHOD(PUNCH METHOD)

 HAND OPERATED METHOD

 AUTOMATIC OPERATED FILLING MACHINES

 MANUAL FILLING METHOD
 Used for filling a small number of capsules in the pharmacy, at the
prescription counter.

 The ingredients are triturated to fine & uniform powder.

 The powder is placed on a powder paper or ointment slab and smoothed with a spatula
to a height approximately half the length of the capsule body.
 The base of the capsule is held vertically and the open end is repeatedly
pushed or "punched" into the powder until the capsule is filled.
 The cap is then replaced to close the capsule. Each filled capsule is weighed using an
empty capsule as a counterweight .
 Powder is added or removed until the correct weight has been placed in the capsule.
 The filled capsule is tapped so that no air spaces are visible within the contents.
 HAND OPERATED METHOD

 Pharmacists that prepare capsules on a regular or extensive basis may use hand-operated capsule
machines.

 These machines are available in capacities of 24, 96, 100, and 144 capsules.

 Machine is the tray used to hold the fill over the empty capsules, the spreader and

roller used to distribute the fill material in the tray and permit it to enter the capsules

uniformly, and the packer used to compact the fill in the capsules
 AUTOMATIC OPERATING CAPSULE
MACHINES

 Machines developed for industrial use can automatically remove

the caps from empty capsules, fill the capsules, replace the caps,
and clean the outside of the capsules at a rate of up to 1,65,000
capsules and greater per hour.
 SEALING OF CAPSULES
 TAMPER-EVIDENT CAPSULES are made sealing the joint between the two
capsule parts.

 DISTINCTIVE LOOKING CAPSULES can be made by sealing capsules with a

colored band of gelatin, which cant be restored without expert sealing.

 HEA T WELDING PROCESS can also be used, that fuses capsules cap
through the double wall thickness at junction

 LIQUID WETTING AGENT that lowers the M.P in contact areas of capsule cap
& body & then thermally bonds the two parts using low temperatures
 CONI-SNAP HARD GELATIN CAPSULES
• A recent innovation in capsule shell design, where the two halves of the capsule shells
are enable to be positively joined through locking grooves in the shell walls.
• The two grooves fit into each other and ensure reliable closing of the filled capsule.
• Opening of such capsule is difficult with increasing security of the contents of the
capsule
 CLEANING & POLISHING

 On small scale capsules may be cleaned individually or in

small numbers by rubbing them with a clean guaze or cloth.
 On large scale many CAPSULE FILLING MACHINES
with a cleaning vacuum that removes any extraneous
material from the capsule as they exit the equipment.
 STORAGE CONDITIONS
• Hard gelatin capsules are stored in a tightly closed glass or plastic
containers, protected from dust and extremes of humidity and
temperature.
• These capsules contain 12 - 16% water but water content vary
according to the storage conditions.
• Capsules become brittle in low humidity but are flaccid and lose their
shape if stored in high humidity.
• They do not protect hygroscopic materials from atmospheric water
vapour as moisture can diffuse through the gelatin wall. When storage
temperature condition is high the quality of the hard gelatin capsules
are affected
 FILLING HARD CAPSULE SHELL

Rectification
Separating the caps from empty capsules
Filling the bodies
Scraping the excess powder
Replacing the caps
Sealing the capsules
Cleaning the outside of the filled capsules
160,000 capsules per 8hour shift 6
 RECTIFICATION
The empty capsules are oriented so that all point the same
direction i.e. body end downwards
In general, capsule pass one at a time through a channel just
wide enough to provide grip at cap end
The capsules will always be aligned body end downwards,
regardless of which end entered the channel first with the
help of specially designated blades
 SEPARATION OF CAPS FROM BODY
The rectified capsules are delivered body end first into the
upper portion of split bushings or split filling rings
A vacuum applied from below pulls the body down into
the lower portion of the split bushing
The diameter of the bush is too large to allow them to follow
body
The split bushings are separated to expose the bodies for
filling 8
 FILLING OF POWDER FORMULATIONS
Bench –Scale Filling
Industrial –Scale
Filling
Dependent Independent
dosing dosing system
system
 3 BASIC METHODS FOR POWDER
FILLING
Auger or screw (dependent dosing system)
Capsule body directly measure the powder
Dosator (independent dosing system)
Tamping finger and dosing disc (independent dosing
system)
Powder is measured in a special measuring device
 CAPSULE FILLING
auger
 semi-automatic operation
 filling based on volume

 need good powder flow properties

dosator
 fill based on weight
 continuous operation
dosing disc
 filled based on weight
 continuous operation
AUGER FILL PRINCIPLE: Because the auger mounted in the
hopper rotates at a constant rate, the rate of delivery of the powder to
the capsules tend to be constant.
E.g. Capsugel type 8 filling machine
DOSING DISC PRINCIPLE: a solid brass ‘stop’ plate is sliding down
the dosing disc to close off the hole. Five sets of pistons compress the
powder into cavities to form plugs
SOFT GELATIN CAPSULE
• Soft gelatin capsules (softgels) are hermetically sealed one-
piece capsules containing a liquid or a semisolid fill.

• Soft capsules are usually formed, filled, and sealed in one

operation.

• Soft gelatin is mainly composed of gelatin, plasticizers,

preservative, colouring and opacifying agents, flavoring
agents and sugars.

• Soft gelatin capsules are a unique drug delivery system that

can provide distinct advantages over traditional dosage forms
such as tablets, hard gelatin capsules and liquids.
 CAPSULE SHELL COMPOSITION
 Water: 45% w/w. The ratio by weight of water to dry gelatin can vary depending from 0.7-1.3
(water) to 1 .0 (dry gelatin) depending on the viscosity of the gelatin being used.

Plasticizer: Used to make the soft gel shell elastic & pliable. Ratio used is between 0.3- 1.8 for

soft to hard shell on dry basis. Plasticizer usually used : Glycerin and sorbitol .

 Coloring Agent: Color may be natural or synthetic .

 Opacifier: Usually used is titanium dioxide. Concentration of opacifier may be up to 0.5% .

 Chelating agents: Iron is always present in raw gelatin & should not contain iron more than 15
ppm .

 Gelatin
 PLASTICIZER AND GELATIN RATIO

In soft gelatin capsule the amount of plasticizers used is

more
In soft gelatin capsule the plasticizer and gelatin ratio is
0.8 : 1
In hard gelatin capsule the plasticizer and gelatin ratio is
0.4 : 1
 METHODS OF
SOFTGELS PRODUCTION

1. Droplet method
2. Pressing method
DROPLET METHOD
1. Container with medicines
substance
2. Hoper with medicines substance
3. Container with gelatin
solution
4. Conical nozzle
5. Pulsater
6. Cooler
7. Container with Vaseline oil
 CHARACTERISTIC OF DROPLET METHOD

It is based on formation of spherical gelatinous drop filled with a

solution or suspension of medicinal substance at simultaneous
drop dosage of medicinal substance solution followed by
subsequent cooling of heated gelatinous mass in cool liquid
petrolatum. As the result joinless spherical gelatious capsule with
elastic shell is formed.
 PRESSING METHOD
Preparing of an initial gelatinous tape, placing it into metal plates
and rolls having deepening holes resembling half of the capsules.
While heating gelatin fills this mould. Drug is fed into a hollow
in a gelatinous tape, then this half of a capsule is joined with
another one formed and filled in the same way. Obtained
capsules have a horizontal weld.
PRE SSING ( ROTA TE DIE ) METHOD

• The glycerol – gelatin solution is heated and

pumped onto two chilled drums-1 to form two
separate ribbons-2, which form each half of the
softgel.
• The ribbons are lubricated and fed into the filling
machine, forcing the gelatin to adopt the contours
of the die.
• The fill-4 is manufactured in a separate process
and pumped in, and the softgels are sealed by the
application of heat and pressure.
• Once cut from the ribbon (5), they are tumble -
dried and conditioned at 20 % relative
humidity.
 FORMULATION
 Formulation for soft gelatin capsules involves liquid, rather than powder
technology.
Materials are generally formulated to produce the smallest possible capsule
consistent with maximum stability, therapeutic effectiveness and manufacture
efficiency.
 The liquids are limited to those that do not have an adverse effect on gelatin
walls.
Emulsion can not be filled because water will be released that will affect
the shell Formulation
 GELATIN MASS MANUFACTURE

The gel is prepared in a 300-litre stainless steel vessel.

Gelatin powder is mixed with water and glycerin.

Heating Stirring
The molten gelatin mass is formed.

It is decanted into 200-kg mobile vessels

Turbine mixing
where colors and flavors can be added
 MANUFACTURE PROCESS
a) Plate process :
The process involved-:
Placing the upper half of a plasticized gelatin sheet over a die plate containing
numerous die pockets,
 Application of vacuum to draw the sheet in to the die pockets,
 Filling the pockets with liquor or paste,
 Folding the lower half of gelatin sheet back over the filled pockets, and
 Inserting the “ sandwich” under a die press where the capsules are formed and
cut out
 b) Rotary die press:
In this process, the die cavities are machined in to the outer
surface of the two rollers.

The die pockets on the left hand roller form the left side of the
capsule and the die pockets on the right hand roller form the right
side of the capsule.

Two plasticized gelatin ribbons are continuously and

simultaneously fed with the liquid or paste fill between the rollers
of the rotary die mechanism.

As the die rolls rotate, the convergence of the matching die
pockets seals and cuts out the filled capsules.
 c) Accogel process:

 In general, this is another rotary process involving

a measuring roll , a die roll and a sealing roll.
As the measuring roll and die rolls rotate, the measured doses are transferred to the
gelatin-linked pockets of the die roll.
The continued rotation of the filled die converges with the rotating sealing roll where a
second gelatin sheet is applied to form the other half of the capsule.
 Pressure developed between the die roll and sealing roll seals and cuts out the capsules.
 d) Bubble method :

A concentric tube dispenser simultaneously discharges the molten gelatin from the
outer annulus and the liquid content from the tube.

The liquids are discharged from the concentric tube orifice into a chilled-oil column
as droplets that consists of a liquid medicament core within a molten gelatin envelop.

The droplets assume a spherical shape under surface tension forces and the gelatin
congeals on cooling.

The finished capsules must be degreased and dried.

 ADVANTAGES
OF SOFT-GELATIN CAPSULES
1. Improved bioavailability, as the drug is presented in a solubilized form.
2. Enhanced drug stability.
3. Consumer preference regarding ease of swallowing, convenience, and
taste can improve compliance.
4. Offer opportunities for product differentiation via colour, shape, and size
and product line extension.
5. The softgels can be enteric coated for delayed release.

They are popular for pharmaceuticals, cosmetics, and nutritional

products.
APPLICATION OF SOFT GELATIN CAPSULE

The pharmaceutical applications of soft gelatin

capsules are:
• as an oral dosage form
• as a suppository dosage form
• as a specialty package in tube form, for
human and veterinary use, single dose
application for topical, ophthalmic, and
rectal ointments.
 DRUGS COMMERCIALLY PREPARED IN
SOFT GELATIN CAPSULES
 Ethychlorvynol (Placidyl)
 Demeclocycline HCl ( Declomycin )
 Chlortrianisene (TACE)
 Digoxin (Lanoxicaps)
 Docusate calcium (Surfak)
 Vitamin E
 EVALUATION OF CAPSULES

Evaluation tests for capsules are listed below:

I. Stability tests
 Shell integrity test
 Determination of shelf life
II. Invariability tests
 weight variation
 Content uniformity
III. Disintegration test
IV. Dissolution test
V. Moisture permeation test
 I. STABILITY TESTS
 Stability tests for capsules are performed to know the
integrity of gelatin capsule shell (but not to known the
stability of therapeutically active agent) and for
determining the shelf life of capsules.
 The test helps in improving the quality of contents of capsule
shell and for choosing the appropriate retail package.
 Before actually performing the tests following fact:
The capsule shell are to be stabilized to know atmospheric condition with
relative humidity about 20-30% and temperature about 21-24⁰c.
a) Shell integrity test:
This test is performed to find out the integrity of capsule shell. The
standard capsule shells kept at the room temperature 40⁰c and 80% RH
becomes more soft, sticky and swollen.
b) Determination of shelf life:
Shelf life or the expiry date of packed capsules is determined under
normal storage conditions.
 II. INVARIABILITY TESTS
 The invariability in the medicaments packed in the capsule
shells can be determined by performing the following tests:
 Weight variation test
 Content uniformity test
 III. DISINTEGRATION TEST
 Disintegration test is a method to evaluate the rate of disintegration of
solid dosage forms.
 Disintegration is defined as the breakdown of solid dosage form into
small particles after it is ingested.
 The shell pieces after disintegration may agglomerate forming large
mass of gelatin taking more time to dissolve and may adhere to the mesh
thus, blocking the holes.
 According to USP, place one dosage unit in each of the tubes of the
basket with water or any other specified medium (depends on individual
monograph) maintained at 37.3°C.
 Attach a removable wire cloth with a plain square weave of 1.8-2.2 mm
of mesh aperture and a wire diameter of 0.6-0.655mm to the surface of
upper rack of the basket assembly.
 Observe the capsules for a time limit , at the end of prescribed time,
all of the capsules must have been disintegrated excluding the
fragments from the capsule shell.
 If 1 or 2 capsules fail, the test should be repeated on additional of 12
capsules.
 Then, not fewer than 16 of the total 18 capsules tested should
disintegrate completely.
 IV. DISSOLUTION TEST
 Dissolution test is an official method to determine the dissolution rate of a
solid dosage form.
 Dissolution rate is defined as the rate at which the drug is released into the
systemic circulation from the dosage form.

 Dissolution test apparatus:-

 Apparatus-I (rotating basket dissolution apparatus):
 Small wire mesh size basket – 22
 Temperature - 37±5⁰c
 Rotated speed – 25-150rpm
 Dissolution medium height from the bottom of the
 vessel – 23-27mm.
 Apparatus-2 (rotating paddle dissolution apparatus):
 Small wire mesh size: 22
 Dissolution medium height of the vessel – 23-27mm
 Temperature - 37±5⁰c
 Rotated speed – 25-150rp

ht from the bottom

m
 V. MOISTURE PERMEATION TEST
 This test is carried out to assure the suitability of containers for
packaging of capsules. The moisture permeating feature of
capsules packaged in
• Single unit containers-blister pack or strip pack.
• Unit dose containers glass or plastic bottle is to be determined.
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