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DISSOLUTION TESTING
APPARATUS
Bushra S.
1
Dissolution is the physicochemical
process by which a solid
substance enters the solvent
phase to yield a solution.
2
Need of Dissolution testing
devices
• Solid drugs absorbed only from the solution .
• In vitro test – estimate amount of d...
Common conditions
• Simulated gastric and intestinal fluids – 37 deg
Celsius
• Fixed speed agitator
• Screen for separatio...
I.P. USP B.P. E.P.
Type 1
Paddle
apparatus Basket apparatus Basket apparatus Paddle apparatus
Type 2
Basket
apparatus Padd...
USP APP. DESCRIPTOIN ROT. SPEED DOSAGE FORM
Type 1 Basket apparatus 50-120rpm Conventional tablets,
chewable tablets, CR
T...
APPARATUS FOR CONTROLLED RELEASE
AND SUSPENSIONS
• APPARATUS I II AND III are for controlled release.
• APPARATUS II is fo...
Apparatus 1- Basket apparatus
The assembly consists of the following :
• A covered vessel
• Transparent material
• A motor...
 The shaft is positioned so that its
axis is not more than 2mm at any
point from the vertical axis of the
vessel and rota...
Apparatus 2- Paddle apparatus
• The assembly from apparatus 1.
• Except paddle formed from a blade.
• a shaft is used as t...
11
12
•The paddle, blade and shaft may be
coated with a suitably inert coating.
•The dosage unit is allowed to sink
to the bo...
 TIME:
• If single time specification is
given, the test may be
concluded in a shorter
period .
• If two or more times ar...
Limitations of USP Apparatus 1and 2:
1. USP 2 (and USP1) Apparatus has plenty of HYDRODYNAMICS.
2. Complicated 3-dimension...
• The assembly consists of:
a set of cylindrical, flat-
bottomed glass vessels; a set of
glass reciprocating cylindrical;
...
 PROCEDURE:
• Place the stated volume of the
dissolution medium in each vessel .
• Equilibrate the dissolution medium to
...
Controlled Release Rotating
Bottle Apparatus
Apparatus for
suppositories
18
• The assembly consists of a reservior and a pump for the
dissolution medium; a flow-through cell; a water bath.
• The pum...
.
• .
20
 PROCEDURE:
• Place the glass beads into the cell specified in
the monograph.
• Place 1 dosage form unit on top of the be...
 Useful for:
• Low solubility drugs,
• Micro particulates,
• Implants,
• Suppositories
 Advantages:
1. Easy to change me...
Apparatus For Transdermal And Topical
Dosage Forms
• APPARATUS V VI AND VII are used for transdermal products.
• APPARATUS...
• The paddle and vessel assembly from
apparatus 2 with the addition of
stainless steel disk assembly.
• The temperature is...
 PROCEDURE:
• Place the stated volume of dissolution
medium in the vessel assemble the apparatus
without the disk assembl...
• The vessel assembly from
apparatus 1 except to replace the
basket and shaft with a stainless
steel cylinder stirring ele...
27
 PROCEDURES:
• Place the stated volume of the dissolution medium in the vessel.
• Equilibrate the dissolution medium t...
• The assembly consists of a set
of volumetrically calibrated or
tared solution containers.
• A motor and drive assembly t...
Franz diffusion cell
• It is a simple, reproducible test for measuring the drug release
from creams,ointments and gel.
• T...
Non compendial method Franz diffusion
cell : topical dosage form
References
1. Banakar V. U. and et. al. , pharmaceutical dissolution testing, markcel deken, pg
4,16,57,136-137
2. Remingt...
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DISSOLUTION TESTING APPARATUS

Dissolution is the physicochemical process by which a solid substance enters the solvent phase to yield a solution.

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DISSOLUTION TESTING APPARATUS

  1. 1. DISSOLUTION TESTING APPARATUS Bushra S. 1
  2. 2. Dissolution is the physicochemical process by which a solid substance enters the solvent phase to yield a solution. 2
  3. 3. Need of Dissolution testing devices • Solid drugs absorbed only from the solution . • In vitro test – estimate amount of drug released per unit time. • In vitro disintegration test not sufficient . • In vitro dissolution test most reliable predictors of in vivo performance. • Dissolution - rate limiting factor. 3
  4. 4. Common conditions • Simulated gastric and intestinal fluids – 37 deg Celsius • Fixed speed agitator • Screen for separation of disintegrated particles from the bulk 4
  5. 5. I.P. USP B.P. E.P. Type 1 Paddle apparatus Basket apparatus Basket apparatus Paddle apparatus Type 2 Basket apparatus Paddle apparatus Paddle apparatus Basket apparatus Type 3 Reciprocating cylinder Flow through cell apparatus Flow through cell apparatus Type 4 Flow through cell apparatus Type 5 Paddle over disk Type 6 cylinder Type 7 Reciprocating holder 5 Classification of dissolution apparatus in different pharmacopeias:
  6. 6. USP APP. DESCRIPTOIN ROT. SPEED DOSAGE FORM Type 1 Basket apparatus 50-120rpm Conventional tablets, chewable tablets, CR Type 2 Paddle apparatus 25-50rpm orally Disintegrating tablets, chewable tablets, CR, suspensions Type 3 Reciprocating cylinder 6-35rpm CR, chewable tablets Type 4 Flow through cell apparatus N/A ER , poorly soluble API, powder, granules, microparticles, implants Type 5 Paddle over disk 25-50rpm Transdermal Type 6 cylinder N/A Transdermal Type 7 Reciprocating holder 30rpm CR(non disintegrating oral and Transdermal ) 6 USP APPARATUS
  7. 7. APPARATUS FOR CONTROLLED RELEASE AND SUSPENSIONS • APPARATUS I II AND III are for controlled release. • APPARATUS II is for suspensions. • There is also a Controlled Release Rotating Bottle Apparatus for controlled release products. 7
  8. 8. Apparatus 1- Basket apparatus The assembly consists of the following : • A covered vessel • Transparent material • A motor • A metallic drive shaft, • A cylindrical basket, • The water bath permits the holding of temp inside vessel at 37±0.5 ̊C • The vessel is a cylindrical with hemispherical bottom . 8
  9. 9.  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.  Use 40mm mesh cloth.  A basket having a gold coating 0.0001 inch thick may be used. • The dosage unit is place in a dry basket at the beginning of each test. • The distance between the inside bottom of the vessel and the basket is maintained at 25± 2m. 9 Drug product: • Solids (mostly floating) •Monodisperse (tablets) •Polydisperse (encapsulated beads) Disadvantage: • Formulation may clog to 40 mesh screen
  10. 10. Apparatus 2- Paddle apparatus • The assembly from apparatus 1. • Except paddle formed from a blade. • a shaft is used as the stirring element • The vertical center line of the blade is flush with the bottom of the shaft. • The distance of 25±2 mm between the blade and the inside bottom of the vessel. 10
  11. 11. 11
  12. 12. 12 •The paddle, blade and shaft may be coated with a suitably inert coating. •The dosage unit is allowed to sink to the bottom of the vessel before rotation of the blade. •A small, loose piece of nonreactive material such as wire helix may be attached to dosage units in order to prevent floating. Standard volume: 900/1000 ml  Advantages: 1. Easy to use and robust 2. pH change possible 3. Can be easily adapted to apparatus  Disadvantages • Floating dosage forms require sinker • Positioning of tablet
  13. 13.  TIME: • If single time specification is given, the test may be concluded in a shorter period . • If two or more times are specified, specimen are to be withdrawn only at the stated times within a tolerance of ±2 %  PROCEDURES • Place the stated volume of the dissolution medium in the vessel. • Equilibrate the dissolution medium to 37±o.5 ̊c • Place 1 tablet or 1 capsule in the apparatus. • Operate the apparatus • Within the time interval, withdraw a specimen from zone midway between the surface of the dissolution medium and the top of the rotating basket or blade, not less than 1cm from vessel wall. • Replace the aliquots withdrawn for analysis with equal volume of dissolution medium at 37 ̊c. 13
  14. 14. Limitations of USP Apparatus 1and 2: 1. USP 2 (and USP1) Apparatus has plenty of HYDRODYNAMICS. 2. Complicated 3-dimensional flow generated by the paddle. 3. Significant impact of convective transport –Conditions used (50 – 100 rpm) highly exaggerates flow in the GI. 4. Use of solvents and surfactants non-native to GI. 14
  15. 15. • The assembly consists of: a set of cylindrical, flat- bottomed glass vessels; a set of glass reciprocating cylindrical; stainless steel fitting; screen; a motor and drive. • The vessel is immersed in water bath holding temp at 37± 0.5 ̊ 15 Apparatus 3- Reciprocating cylinder
  16. 16.  PROCEDURE: • Place the stated volume of the dissolution medium in each vessel . • Equilibrate the dissolution medium to 37 + 0.5° • Place 1 dosage-form unit in each of the six reciprocating cylinders. • Operate the apparatus • During the upward and downward stroke, the reciprocating cylinder moves through a total distance of 9.9 to 10.1 cm • Within the time interval specified withdraw a portion of the solution under test from a zone midway between the surface of the dissolution medium and the bottom of each vessel. • Perform The analysis as directed in the individual monograph. 16 Useful for: Tablets, Beads, controlled release formulations Standard volume: 200-250 ml/station Advantages: 1. Easy to change the pH-profiles 2. Hydrodynamics can be directly influenced by varying the dip rate.  Disadvantages: 1. small volume (max. 250 ml) 2. Limited data
  17. 17. Controlled Release Rotating Bottle Apparatus
  18. 18. Apparatus for suppositories 18
  19. 19. • The assembly consists of a reservior and a pump for the dissolution medium; a flow-through cell; a water bath. • The pump forces the dissolution medium upwards through the flow-through cell. • The pump has a delivery range between 240 and 960 mL per hour, with standard flow rates of 4, 8, and 16 mL per minutes. • The cell is immersed in a water bath and the temperature is maintained at 37 + 0.5° • The apparatus uses a clamp mechanism and two O-rings for the fixation of the cell assembly. Apparatus 4- Flow through cell 19
  20. 20. . • . 20
  21. 21.  PROCEDURE: • Place the glass beads into the cell specified in the monograph. • Place 1 dosage form unit on top of the beads. • Assemble the filter head and fix the parts together by means of a suitable clamping device. • Introduce by the pump the dissolution medium warmed to 37 + 0.5° through the bottom of the cell. • Collect the eluate by fractions at each of the times stated. • Perform the analysis as directed in the individual monograph. 21
  22. 22.  Useful for: • Low solubility drugs, • Micro particulates, • Implants, • Suppositories  Advantages: 1. Easy to change media pH 2. PH-profile possible 3. Sink conditions  Disadvantages: 1. Deaeration necessary 2. High volumes of media 3. Labor intensive 22 Tablets 12 mm Tablets 22,6 mm Powders /Granules Implants Suppositories/soft gelatin capsule
  23. 23. Apparatus For Transdermal And Topical Dosage Forms • APPARATUS V VI AND VII are used for transdermal products. • APPARATUS V AND VI are used for topical dosage forms. 23
  24. 24. • The paddle and vessel assembly from apparatus 2 with the addition of stainless steel disk assembly. • The temperature is maintained at 32 + 0.5°C • A distance of 25 + 2 mm between the paddle blade and the surface the disk assembly is maintained during the test. • The disk assembly is designed to minimize any dead volume between the disk assembly and the bottom of the vessel. Apparatus 5- Paddle over disk 24
  25. 25.  PROCEDURE: • Place the stated volume of dissolution medium in the vessel assemble the apparatus without the disk assembly and equilibrate the medium to 32 + 0.5°C • Apply the transdermal system disk assembly. • The system may be attached to the disk by a suitable adhesive. • Place the disk assembly flat at the bottom of the vessel with the release surface facing up and parallel to of the paddle blade and surface of the dissolution medium. • Operate the apparatus • At each sampling time interval, withdraw a sample from a zone midway between the surface of the dissolution medium and the top of the blade, not less than 1 cm from the vessel wall. • Perform the analysis on each sampled aliquot as directed in the monograph.  Standard volume: 900 ml  Disadvantages: • Disk assembly restricts the patch size. 25
  26. 26. • The vessel assembly from apparatus 1 except to replace the basket and shaft with a stainless steel cylinder stirring element and to maintain the temperature at 32 + 0.05°C • The dosage unit is placed on the cylinder at the beginning of each test. • The distance between the inside bottom of the vessel and the cylinder is maintained at 25 + 2 mm during the test. 26 Apparatus-6 Cylinder
  27. 27. 27  PROCEDURES: • Place the stated volume of the dissolution medium in the vessel. • Equilibrate the dissolution medium to 32 + 0.5°C • Prepare the test system prior to test as follows. • Remove the protective liner from the system and place the adhesive side on a piece of cuprophan. • Cuprophan covered side down, on a clean surface, and apply a suitable adhesive to the exposed cuprophan borders. • Dry for 1 minutes. • Press the cuprophan covering to remove trapped air bubbles. • Place the cylinder in the apparatus and immediately rotate at the rate specified • Within the time interval specified, withdraw a quantity of dissolution medium for analysis from a zone midway between the surface of the dissolution medium and the top of the rotating cylinder, not less than 1 cm from the vessel wall. • Perform the analysis as directed in the individual monograph.
  28. 28. • The assembly consists of a set of volumetrically calibrated or tared solution containers. • A motor and drive assembly to reciprocate the system vertically • A set of suitable sample holders. • The solution containers are partially immersed in a suitable water bath, inside the temperature of the containers at 32 + 0.5°C USP Apparatus 7 – Reciprocating Holder 28
  29. 29. Franz diffusion cell • It is a simple, reproducible test for measuring the drug release from creams,ointments and gel. • The cell comprises of 2 parts: • (a) sample holder containing 250 mg or 450 mg of sample. • (b) reservoir of the diffusion cell. 29
  30. 30. Non compendial method Franz diffusion cell : topical dosage form
  31. 31. References 1. Banakar V. U. and et. al. , pharmaceutical dissolution testing, markcel deken, pg 4,16,57,136-137 2. Remington, the science and practice of pharmacy, mack pub. Co. , 19th edition pg 594,601,602 3. Brahmankar D.M. , Jaiswal S. , biopharmaceutics and pharmacokinetics a treatise, vallab prakashan, 2nd edition, pg 29-34 4. www.dissolutiontech.com 5. U.S. Pharmacopia,2008 31

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Dissolution is the physicochemical process by which a solid substance enters the solvent phase to yield a solution.

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