EUROPEAN PHARMACOPOEIA 5.0

EUROPEAN PHARMACOPOEIA 5.0

2.9.1. Disintegration of tablets and capsules

2.9. PHARMACEUTICAL

TECHNICAL PROCEDURES

01/2005:20901

2.9.1. DISINTEGRATION OF TABLETS

AND CAPSULES

The disintegration test determine

s whether tablets or

capsules disintegrate within the prescrib

ed time when placed

in a liquid medium in the experimental conditions pr

escribed

below.

Disintegration is considered to be achieved when:

a) no residue remains on the screen, or

b) if there is a residue, it consists of a soft mass having no

palpably firm, unmoistened core, or

c) only fragments of coating (tablets) or only fragments of

shell (capsules) remain on the screen; if a disc has been

used (capsules), fragments of shell may adhere to the lower

surface of the disc.

Use apparatus A for tablets and capsules that are not

greater than 18 mm long. For larger tablets or capsules use

apparatus B.

TEST A - TABLETS AND CAPSULES OF NORMAL SIZE

Apparatus

. The main part of the apparatus (Figure 2.9.1.-1)

is a rigid basket-rack assembly supporting 6 cylindrical

transparenttubes77.5±2.5mmlong,21.5mmininternal

diameter, and with a wall thickness of about 2 mm. Each

tube is provided with a cylindrical disc 20.7 ± 0.15 mm in

diameter and 9.5 ± 0.15 mm thick, made of transparent

plastic with a relative density of 1.18 to 1.20 or weighing

3.0 ± 0.2 g. Each disc is pierced by 5 holes 2 mm in diameter,

1 in the centre and the other 4 spaced equally on a circle

of radius 6 mm from the centre of the disc. On the lateral

surface of the disc, 4 equally spaced grooves are cut in such

a way that at the upper surface of the disc they are 9.5 mm

wide and 2.55 mm deep and at the lower surface 1.6 mm

square. The tubes are held vertically by 2 separate and

superimposed rigid plastic plates 90 mm in diameter and

6 mm thick with 6 holes. The holes are equidistant from the

centre of the plate and equally spaced. Attached to the under

sideofthelowerplateisapieceofwovengauzemadefrom

stainless steel wire 0.635 mm in diameter and having mesh

apertures of 2.00 mm. The plates are held rigidly in position

and 77.5 mm apart by vertical metal rods at the periphery,

a metal rod is also fixed to the centre of the upper plate to

enable the assembly to be attached to a mechanical device

Figure 2.9.1.-1. –

Apparatus A

Dimensions in millimetres

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225

2.9.1. Disintegration of tablets and capsules

EUROPEAN PHARMACOPOEIA 5.0

capableofraisingandloweringitsmoothlyataconstant

frequency between 29 and 32 cycles per minute, through a

distance of 50 mm to 60 mm.

The assembly is suspended in the specified liquid in a

suitable vessel, preferably a 1 litre beaker. The volume of

the liquid is such that when the assembly is in the highest

position the wire mesh is at least 15 mm below the surface

of the liquid, and when the assembly is in the lowest position

thewiremeshisatleast25mmabovethebottomofthe

beaker and the upper open ends of the tubes remain above

thesurfaceoftheliquid.Asuitabledevicemaintainsthe

temperature of the liquid at 35-39 °C.

The design of the basket-rack assembly may be varied

providedthespecificationsforthetubesandwiremeshare

maintained.

Method

. In each of the 6 tubes, place one tablet or capsule

and, if prescribed, add a disc; suspend the assembly in

the beaker containing the specified liquid. Operate the

apparatus for the prescribed p

eriod, withdraw the assembly

and examine the state of the tablets or capsules. To pass the

test, all the tablets or capsules must have disintegrated.

TEST B – LARGE TABLETS AND LARGE CAPSULES

Apparatus

. The main part of the apparatus (Figure 2.9.1.-2)

is a rigid basket-rack assembly supporting 3 cylindrical

transparent tubes 77.5 ± 2.5 mm long, 33.0 mm ± 0.5 mm in

internal diameter, and with a wall thickness of 2.5 ± 0.5 mm.

Each tube is provided with a cylindrical disc 31.4 ± 0.13 mm

indiameterand15.3±0.15mmthick,madeoftransparent

plastic with a relative density of 1.18 to 1.20 or weighing

13.0 ± 0.2 g. Each disc is pierced by 7 holes, each

3.15±0.1mmindiameter,1inthecentreandtheother

6 spaced equally on a circle of radius 4.2 mm from the centre

of the disc. The tubes are held vertically by 2 separate and

superimposed rigid plastic plates 97 mm in diameter and

9 mm thick, with 3 holes. The holes are equidistant from

the centre of the plate and equally spaced. Attached to

theundersideofthelowerplateisapieceofwovengauze

made from stainless steel wire 0.63 ± 0.03 mm in diameter

andhavingmeshaperturesof2.0±0.2mm.Theplatesare

held rigidly in position and 77.5 mm apart by vertical metal

rods at the periphery, a metal rod is also fixed to the centre

of the upper plate to enable the assembly to be attached

Figure 2.9.1.-2. –

Apparatus B

Dimensions in millimetres

226

See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 5.0

2.9.2. Disintegration of suppositories and pessaries

to a mechanical device capable of raising and lowering it

smoothly at constant frequency between 29 and 32 cycles

per minute, through a distance of 55 ± 2 mm.

The assembly is suspended in the specified liquid medium in

a suitable vessel, preferably a 1 litre beaker. The volume of

the liquid is such that when the assembly is in the highest

position the wire mesh is at least 15 mm below the surface

of the liquid, and when the assembly is in the lowest position

thewiremeshisatleast25mmabovethebottomofthe

beaker and the upper open ends of the tubes remain above

thesurfaceoftheliquid.Asuitabledevicemaintainsthe

temperature of the liquid at 35-39 °C.

The design of the basket-rack assembly may be varied

providedthespecificationsforthetubesandwiremeshare

maintained.

Method

. Test 6 tablets or capsules either by using

2 basket-rack assemblies in parallel or by repeating the

procedure. In each of the 3 tubes, place one tablet or

capsule and, if prescribed, add a disc; suspend the assembly

in the beaker containing the specified liquid. Operate the

apparatus for the prescribed p

eriod, withdraw the assembly

and examine the state of the tablets or capsules. To pass the

test, all 6 of the tablets or capsules must have disintegrated.

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2.9.2. DISINTEGRATION OF

SUPPOSITORIES AND PESSARIES

The disintegration test determines whether the suppositories

or pessaries soften or disinteg

rate within the prescribed

time when placed in a liquid medium in the experimental

conditions described below.

Disintegration is considered to be achieved when:

a) dissolution is complete,

b) the components of the suppository or pessary have

separated: melted fatty substances collect on the surface of

the liquid, insoluble powders fall to the bottom and soluble

components dissolve, depending on the type of preparation,

the components may be distributed in one or more of these

ways,

c)thereissofteningofthesamplethatmaybeaccompanied

byappreciablechangeofshapewithoutcompleteseparation

of the components, the softening is such that the suppository

or pessary no longer has a solid core offering resistance to

pressure of a glass rod,

d) rupture of the gelatin shell of rectal or vaginal capsules

occurs allowing release of the contents,

e) no residue remains on the perforated disc or if a residue

remains, it consists only of a soft or frothy mass having

no solid core offering resistance to pressure of a glass rod

(vaginal tablets).

Apparatus

. The apparatus (Figure 2.9.2.-1) consists of a

sleeve of glass or suitable transparent plastic, of appropriate

thickness, to the interior of which is attached by means of

threehooksametaldeviceconsistingoftwoperforated

stainless metal discs each containing 39 holes 4 mm in

diameter; the diameter of the discs is similar to that of the

interiorofthesleeve;thediscsareabout30mmapart.

The test is carried out using three such apparatuses each

containing a single sample. Each apparatus is placed in a

beaker with a capacity of at least 4 litres filled with water

maintained at 36-37 °C, unless otherwise prescribed. The

apparatuses may also be placed together in a vessel with a

capacity of at least 12 litres. The beaker is fitted with a slow

stirrer and a device that will hold the cylinders vertically not

less than 90 mm below the surface of the water and allow

them to be inverted without emerging from the water.

Method

. Use three suppositories

or pessaries. Place each

oneonthelowerdiscofadevice,placethelatterinthesleeve

and secure. Invert the apparatuses every 10 min. Examine

the samples after the period prescribed in the monograph.

To pass the test all the samples must have disintegrated.

Figure 2.9.2.-1. —

Apparatus for disintegration of

suppositories and pessaries

Dimensions in millimetres

METHOD OF OPERATION FOR VAGINAL TABLETS

Use the apparatus described above, arranged so as to rest

on the hooks (see Figure 2.9.2.-2). Place it in a beaker of

suitable diameter containing water maintained at 36-37 °C

with the level just below the upper perforated disc. Using

a pipette, adjust the level with water at 36-37 °C until a

uniform film covers the perforations of the disc. Use three

vaginal tablets. Place each

one on the upper plate of an

apparatus and cover the latter with a glass plate to maintain

appropriate conditions of humidity. Examine the state of the

samples after the period prescribed in the monograph. To

pass the test all the samples must have disintegrated.

GeneralNotices(1)applytoallmonographsandothertexts

227