Assignment Title: Dissolution testing apparatus mentioned in various

Pharmacopoeae.

Submitted to: Miss. Sonia Gondal

Submitted By:

1. Gul-e- Arzoo 1162

2. M.Aleem Ijaz 1156
3. Faizan Afzal 1136
4. Maqsood Ahmad 1126
5. Ahmad Nadeem 1133
6. Saima CH. 1122
7. Aniqa Fiaz 1111

Subject Name: Pharmaceutical Quality Management-

Submission Date: 26-02-2020

Faculty of Pharmacy
HAjvery University, Euro Campus, Lahore
DISSOLUTION
TEST
APPARATUS
 INDEX

CONTENTS PAGE #

INTRODUCTION…………………………………………………………………………………………………… 1-2
APPARATUS 1……………………………………………………………………………………………………… 3-4
APPARATUS 2……………………………………………………………………………………………………… 4-5
APPARATUS 3……………………………………………………………………………………………………… 5-6
APPARATUS 4……………………………………………………………………………………………………… 7-9
APPARATUS 5……………………………………………………………………………………………………… 9-11
APPARATUS 6……………………………………………………………………………………………………… 11-12
APPARATUS 7……………………………………………………………………………………………………… 12
ACCEPTENCE CRITERIA……………………………………………………………………………………….. 13-14
REFERENCES……………………………………………………………………………………………………….. 15
 INTRODUCTION
Dissolution:
It is defined as the process by which solid substance enters in the solvent
dissolution simply the process in which solid substance dissolve fundamentally it is controled
by affinity between the solid substance and the solvent.

Dissolution Test:
Dissolution and drug release test are test that measure the rate and
extent of dissolution or release of the drug substance from a drug product.

Why we need Dissolution Test?

 Solid drugs absorbed only from solutions.
 In vitro test.
 Disintegration test not sufficient.
 Dissolution is rate limiting factor

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Classification Of Apparatus According To Different
Pharmacopoeae

2
 DISSOLUTION APPARATUS- 1
(BASKET METHOD)

Assembly consists of the following:

 vessel:
-Made of borosilicate glass.
-Semi hemispherical bottom.
-Capacity 1000ml.
 A motor.
 A drive shaft : -stainless steel 316
-Speed 50- 100rpm
 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 37 ± 0.5 °C.

Use: Tablet(monodisperse), Capsule(Polydisprse), Floating dosage forms.

Procedure:
I. Place the stated volume of the dissolution medium in the vessel.
II. Equilibrate the dissolution medium to 37±0.5 0C.
III.Place one tablet or one capsule in the apparatus.
IV. Operate the apparatus.
V. within the time interval, withdraw a specimen from the zone midway between
the surface of dissolution medium and the top of the rotating basket not less
than 1cm from the vesssel wall.
VI. Replace the aliquots withdrwn for analysis with equal volume of dissolution
medium at 37 0C.

Conditions:
i. The shaft is positioned so that its axis is not more than 2mm at any point from
the vertical axis of the vessel and rotates smoothly and with out significant
wobble.
ii. Use 40mm or 20mm mesh cloth.
iii. Basket having coating gold coating of 0.0001 inch thick maybe used.
the dosage form is placed in the dry basket at the beginning of each test.
iv. The distance between the inside bottom of the vessel and the basket is
maintained at 25 ± 2mm.

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 DISSOLUTION APPARATUS- 2
(PADDLE METHOD)

Assembly consists of the following:

 vessel:
-Made of borosilicate glass.
-Semi hemispherical bottom.
-Capacity 1000ml.
 A motor.
 A drive shaft : -Coated with teflon
-Speed 25-50rpm
 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 37 ± 0.5 °C.
 Sinker: -Platinum wire used to prevent tablet/capsule from floating

Use: Orally disintegration tablets,Chewable tablets etc.

Procedure:
I. Place the stated volume of the dissolution medium in the vessel.
II. Equilibrate the dissolution medium to 37±0.5 0C.
III. Place one tablet or one capsule in the apparatus.
IV. Operate the apparatus.
V. Within the time interval, withdraw a specimen from the zone midway between
the surface of dissolution medium and the top of the rotating peddle not less
than 1cm from the vesssel wall.

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VI. Replace the aliquots withdrwn for analysis with equal volume of dissolution
medium at 37 0C.

Conditions:
i. The vertical center line of the blade is flush with bottom of shaft.
ii. The distence of 25 ± 2mm between blade and the inside bottom of the vessel.
iii. The dosage unit is allowed to sink to the vessel before rotation of the blade.

Advantages:
a) Easy to use and robust
b) pH change possible
c) can be easily adapted to apparatus.

Disadvantages:
a. Floating dosage forms requir sinker
b. positioning of tablet.

DISSOLUTION APPARATUS- 3
(RECIPROCATING CYLINDER)

Assembly consists of the following:

 vessel:
-Set of cylinderical flat bottom galss vessels.
-Set of reciprocating cylinders
-Stainless steel fittings.
 Agitation type: -Reciprocating (upward & downward)
 Volume of dissolution medium: 200- 250ml.
 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 37 ± 0.5 °C.
 Dosage form placed in the cylinder.
Use: Tablets, beads, controlled and extended release formulations.

Procedure:
I. Place the stated volume of the dissolution medium in each vessel.
II. Equilibrate the dissolution medium to 37 ± 0.5 0C.
III. Place 1 in each of the six reciprocating cylinders.
IV. operates the apparatus.

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V. During the upward and downward stroke, the reciprocating cylinder moves
through a total distance of 9.9 to 10.1cm.
VI. Within time interval specified withdraw a portion the solution under test from
zone midway between the surface of the dissolution medium and the bottom of
each vessel.
VII. Performe the analysis as directed in the individual monograph.

Advantages:
a) Easy to change the pH profiles
b) Hydrodynamics can be directly influnced by varing the dip rate.

Disadvantages:
a. Small volume (max. 250ml)
b. Limited data

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 DISSOLUTION APPARATUS- 4
(FLOW THROUGH CELL)

Assembly consists of the following:

Reservoir:
- For dissolution medium
Pump: -forces dissolution medium through cell (upward direction).
-Flow rate 4-16 ml/min
-Laminar flow is maintained
-Centrifugal pumps are not recommended.
Water-bath or heating device permits maintaining the temperature inside the vessel
at 37 ± 0.5 °C.

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Use: Low solubility drugs, micro particulate, implants, suppositories, controlled
release formulations.

Procedure:
I. Place the glass beads into the cell specified in the monograph.
II. Place 1 dosage form unit on top of the beads.
III. Assemble the filter head and fix the parts together by means of a suitable
clamping device.
IV. Introduce by the pump the dissolution medium warmed to 37 ± 0.5 0C through
the bottom of the cell.
V. Collect the eluate by the fractions at each of the times stated.
VI. Perform the analysis as directed in the individual monograph.

Conditions:
I. The pump has delievry range between 240 and 960ml per hour, with standard
flow rates 4, 8 and 16ml per minute.
II. The cell is immersed in a water bath and the temperature is maintained at 37 ±
0.5 0C.
III. The apparatus uses a clamp mechanism and two O-rings for the fixation of the
cell assembly.

Advantages:
a. Easy to change media pH
b. pH profile possible
c. sink conditions.

Disadvantages:
a) Deaeration neccessary
b) high volumes of media
c) labor intensive

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 DISSOLUTION APPARATUS- 5
(PADDLE OVER DISK METHOD)

Assembly consists of the following:

 vessel:
-Made of borosilicate glass.
-Semi hemispherical bottom.
-Capacity 1000ml.
 A motor.
 A drive shaft : -Coated with teflon
-Speed 25-50rpm

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 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 32 ± 0.5 °C.
 Sample Holder: Disk assembly that holds product in such a way that release
surface is parallel blade.

Use: Transdermal products, emulsions..

Procedure:
I. Place the stated volume of dissolution medium in the vessel assemnle the
apparatus without the disk assembly and equilibrate the medium to 32 ± 0.5 0C.
II. Apply the transdermal system disk assembly.
III. The system may be attached to the disk by a suitable adhesive.
IV. Place the disk assembly flat at the bottom of the vessel with the release surface
facing up and parallel to of the paddel blade and surface of the dissolution
medium.
V. Operate the apparatus.
VI. At each sampling time interval, withdraw a sample from a zone midway
between the surface of the dissolution medium and the top of the blad, not less
than 1 cm from the vesel wall.
VII. Perform the analysis on each sampled aliquot as directed in the monograph.

Conditions:
i. A distance of 25 ±2mm between tha peddel blade and the surface of the disk
assembly is maintained during the test.
ii. The disk assembly is designed to minimize any dead volume between the disk
assembly.

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Standard volume:900ml

Disadvantages:
a. Disk assembly restricts the patch size.

DISSOLUTION APPARATUS- 6
(ROTATING CYLINDER)
Assembly consists of the following:
 vessel:
-Made of borosilicate glass.
-Semi hemispherical bottom.
-Capacity 1000ml.
 A motor.
 A drive shaft & cylinder : -Stainless steel 316
-Speed 25-50rpm
 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 32 ± 0.5 °C.
 Sample: monted to cuprophan (inner porous cellulosic material) an entire
system is adhered to cylinder.
 Doasge unit is placed in cylinder and release from side out.
Use: Transdermal products.

Procedure:
I. Place the stated volume of dissolution medium in the vessel and equilibrate the
medium to 32 ± 0.5 0C.
II. prepare the test system prior to test as follows.
III. Remove the protective liner from the system and place the adhesive side on the
piece of cuprophan.
IV. cuprophan covered side down , on a clean surface, and apply a suitable adhesive
to the exposed cuprophan borders.

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V. Dry for 1 mint.
VI. Press the cuprophan covering to remove trapped air bubbles.
VII. Place the cylinder in the apparatus and immediatly rotate at the rate specified.
VIII. Withon the time interval speccified, withdraw a quantity of dissolution medium
for analysis from a zone midway between the surafce of the dissolution medium
and the top of the rotating cylinder, not less than 1cm from the vessel wall.
IX. Perform the analysis on each sampled aliquot as directed in the monograph.

Conditions:
i. A distance of 25 ±2mm between tha peddel blade and the surface of the disk
assembly is maintained during the test.
ii. The doasge unit is placed on the cylinder at the beginning of each test.

DISSOLUTION APPARATUS- 7
(RECIPROCATING HOLDER)
Assembly consists of the following:
 vessel:
-A set of cylinderical vessels connected to each other
-Volume of dissolution medium 50-200ml.
 A drive shaft
 A cylindrical basket (stirring element).
 Water-bath or heating device permits maintaining the temperature inside the
vessel at 32 ± 0.5 °C.
 Sample: Placed on holders
 Holder: Spring holder/acrylic rod /Teflon cylinder/Reciprocating disk.
 Agitation: reciprocating frequency 30 cycle/mint.

Use: Transdermal products.

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 ACCEPTANCE CRITERIA
(USP)

IMMEDIATE RELEASE TABLET

FOR POOLED SAMPLE

EXTENDED RELEASE TABLET

13
DELAYED RELEASE TABLET-1

DELAYED RELEASE TABLET-2

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REFERENCES
1. USP30 / NF25, General Chapter and Determination, physical test, Dissolution.
2. The science and practice of pharmacy by Remington 21st Edition, Ch# Dissolution.
3. Qulaity Control by KARAMAT JAVAID.
4. Lachman/lieberman's Industrial pharmacy 4th Edition.

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