DISSOLUTION TEST APPARATUS & DESIGN FOR CONTROLED RELEASE TABLET

1. PRESENTED BY
MR. BHANDARI UMESH M.
SSDJ COLLEGE OF PHARMACY
CHANDWAD
DISSOLUTION TEST APPARATUS
& DESIGN FOR CONTROLED
RELEASE TABLET

2. WHICH TYPE OF DISSOLUTION APPARATUS ?
 Depends on intention
1. Quality control
• examining batch homogeneity
• examining batch to batch conformity
• examining stability
2. Research & Development
• examining drug release behavior of preformulations
• in vitro simulation of the gastrointestinal passage
3. IVIVC 2

3.  Factors must be considered in design of dissolution
tests:
1.Factors relating the dissolution apparatus
2.Factors relating to the dissolution fluid
3.Process parameter
e.g. method of introducing dosage form, sampling
techniques, changing dissolution fluid etc.

4. DOSAGE FORMS TO BE TESTED
controlled release dosage forms
• powders, granules / beads, tablets, capsules
4
Controlled release dosage forms:
 apparatus 1 or 2 using different media for QC
 apparatus 3 or 4 for R&D purposes

5. OFFICIAL DISSOLUTION APPARATUS
1. Rotating Basket
2. Paddle
3. Reciprocating Cylinder
4. Flow Through Cell
5

6.  Apparatus: (Rotating basket)
The assembly consist
 covered vessel
Cylindrical, hemispherical bottom
Diameter is 98-106 mm & normal capacity 1000 ml
 Motor, metallic drive shaft
Fabricated of stainless steel type
 Cylindrical basket
Gold coating 0.0001 inch (2.5 µm)

7. APPARATUS 1 - BASKET
 Advantages
• full pH change during the test
• can be easily automated
which is important for routine
investigations
7

8. APPARATUS 1 - BASKET
 Disadvantages
• disintegration-dissolution
interaction
 hydrodynamic „dead zone“
under the basket
 degassing is particularly
important 8

9. APPARATUS 1 - BASKET
9

10.  Apparatus 2 (Paddle)
The assembly is same as apparatus 1 except that a paddle
formed from a blade & a shaft is used as stirring element.
The metallic blade & shaft comprise a single entity that may
be coated with a suitable inert coating.

11. APPARATUS 2 - PADDLE
 Useful for
• tablets
• capsules
• beads
• delayed release / enteric
coated dosage forms
 Standard volume
• 900/1000 ml
11

12. APPARATUS 2 - PADDLE
 Advantages
• easy to use
• robust
• pH change possible
• can be easily automated
which is important for
routine investigations
12

13. APPARATUS 2 - PADDLE
 Disadvantages
• pH/media change is often difficult
• hydrodynamics are complex, they vary with site of the dosage
form in the vessel (sticking,floating) and therefore may
significantly affect drug dissolution
• sinkers for floating dosage forms
13

14. SINKER TYPES


 JP/ USP / Ph. Eur.
5.3 Sinker
 „a small loose piece of nonreactive material such as
 not more than a few turns of wire helix may be attached
 to dosage units that would otherwise float …“
 „…. other validated sinker devices may be used“ 14

15. CONING

15

16. APPARATUS 2 - PADDLE
16

17.  Apparatus : (reciprocating cylinder)
The assembly consist:
1.Set of cylindrical, flat bottomed glass vessels
2.Set of reciprocating cylinders
3.Stainless steel fittings
4.Polyproylene screens
5.Motor & drive assembly

18. APPARATUS 3 – RECIPROCATING CYLINDER
 Useful for
• tablets
• beads
• controlled release formulations
 Standard volume
• 200-250 ml per station
18

19. APPARATUS 3 – RECIPROCATING CYLINDER
 Advantages
• easy to change the pH
• pH-profiles
• hydrodynamics can be
directly influenced by
varying the dip rate
 Disadvantages
• small volume (max. 250 ml)
• little experience
• limited data
19

20. APPARATUS 3 – RECIPROCATING CYLINDER
20

21.  Apparatus : (Flow through cell )
The assembly consist of
Reservoir & pump for dissolution medium
A flow through cell
A water bath
 The flow through cell is transparent & inert mounted vertically
with filters.
 Standard cell diameters are 12 & 22.6 mm.
 The bottom cone usually filled with glass beads of 1 mm
diameter.
 Tablet holder used for positioning special dosage form e.g.
inlay tablets.

22. APPARATUS 4 – FLOW-THROUGH CELL
 Useful for
• low solubility drugs
• microparticulates
• implants
• suppositories
• controlled release formulations
22

23. APPARATUS 4 – FLOW-THROUGH CELL
 Advantages
• easy to change media pH
• pH-profile possible
• different modes
a) open system
b) closed system
 Disadvantages
• Deaeration necessary
• high volumes of media
• labor intensive
23

24. CELL TYPES
24
Tablets 12 mm Tablets 22,6 mm Powders / Granules Implants Suppositories /
Soft gelatine capsules

25. APPARATUS 4 – FLOW-THROUGH CELL
25

26. REFERENCES
 The Theory And Practice of Industrial pharmacy by
LEON LACHMAN,HERBERT A. LIBERMAN,
JOSEPH L. KANIG, Third edition.
 Physical pharmacy And Pharmaceutical sciences by
MARTIN’S, Fifth Edition.
 The Science And Practice of Pharmacy by
REMINGTON , 21 st Edition.

27. THANK YOU