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