PRESENTED BY MR. BHANDARI UMESH M. SSDJ COLLEGE OF PHARMACY CHANDWAD DISSOLUTION TEST APPARATUS & DESIGN FOR CONTROLED RELEASE TABLET
PRESENTED BY MR. BHANDARI UMESH M.SSDJ COLLEGE OF PHARMACY CHANDWAD
DISSOLUTION TEST APPARATUS & DESIGN FOR CONTROLED RELEASE TABLET
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
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.
DOSAGE FORMS TO BE TESTED
controlled release dosage forms• powders, granules / beads, tablets, capsules
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Controlled release dosage forms: apparatus 1 or 2 using different media for QC apparatus 3 or 4 for R&D purposes
OFFICIAL DISSOLUTION APPARATUS
1. Rotating Basket 2. Paddle 3. Reciprocating Cylinder 4. Flow Through Cell
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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)
APPARATUS 1 - BASKET
Advantages
• full pH change during the test
• can be easily automated which is important for routine investigations
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APPARATUS 1 - BASKET
Disadvantages• disintegration-dissolution
interaction
hydrodynamic „dead zone“ under the basket
degassing is particularly important 8
APPARATUS 1 - BASKET
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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.
APPARATUS 2 - PADDLE Useful for
• tablets• capsules• beads• delayed release / enteric
coated dosage forms
Standard volume• 900/1000 ml
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APPARATUS 2 - PADDLE
Advantages• easy to use• robust• pH change possible• can be easily automated
which is important for routine investigations
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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
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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
CONING
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APPARATUS 2 - PADDLE
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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
APPARATUS 3 – RECIPROCATING CYLINDER
Useful for• tablets• beads• controlled release formulations
Standard volume• 200-250 ml per station
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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
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APPARATUS 3 – RECIPROCATING CYLINDER
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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.
APPARATUS 4 – FLOW-THROUGH CELL
Useful for• low solubility drugs• microparticulates• implants• suppositories• controlled release formulations
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APPARATUS 4 – FLOW-THROUGH CELL
Advantages• easy to change media pH• pH-profile possible• different modes
a) open systemb) closed system
Disadvantages• Deaeration necessary• high volumes of media • labor intensive
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CELL TYPES
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Tablets 12 mm Tablets 22,6 mm Powders / Granules Implants Suppositories /
Soft gelatine capsules
APPARATUS 4 – FLOW-THROUGH CELL
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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.
THANK YOU