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1. 2. INTRODUCTION.........................................................................................................................1 LITERATURE REVIEW.............................................................................................................3 2.1 2.2 2.3 2.4 2.5 PHARMACEUTICAL POWDERS ......................................................................................................3 TESTING OF POWDER FLOW .........................................................................................................3 DEFORMATION OF POWDERS .......................................................................................................4 STAGES OF TABLET COMPRESSION ..............................................................................................6 TABLET BONDS............................................................................................................................7 Distance attraction forces ................................................................................................8 Solid bridges.....................................................................................................................8 Non freely movable binder bridges..................................................................................8 Bonding due to movable liquids ......................................................................................9 Mechanical interlocking ..................................................................................................9

2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.6

ANALYSIS OF TABLET COMPACTION DATA ..................................................................................9 A relationship between compression force and tablet strength ....................................10 Force-time compression profiles ...................................................................................11 Force-displacement compression profiles .....................................................................13

2.6.1 2.6.2 2.6.3 2.7

POROSITY-PRESSURE EQUATIONS .............................................................................................16 Heckel Plot .....................................................................................................................17 Cooper-Eaton Equation.................................................................................................21 Kawakita equation .........................................................................................................22

2.7.1 2.7.2 2.7.3 2.8

STRESS AND STRAIN TESTS ........................................................................................................23 Stress relaxation test ......................................................................................................23 Creep test ........................................................................................................................25

2.8.1 2.8.2 3. 4.

AIMS OF THE STUDY..............................................................................................................27 EXPERIMENTAL ......................................................................................................................28 4.1 MATERIALS ...............................................................................................................................28 Powders ..........................................................................................................................28 Granules (I)....................................................................................................................29

4.1.1 4.1.2 4.2

TABLET COMPRESSION AND CHARACTERISATION (I VII) .......................................................29 Crushing strength of tablets (II-III)..............................................................................29 Friability of tablets (II-III) ............................................................................................30

4.2.1 4.2.2 4.3

POWDER FLOW MEASUREMENTS (IV, V AND VII).....................................................................30

4.4 4.5

MICROSCALE FLUID BED MEASUREMENTS (VII)........................................................................31 DATA ANALYSIS ........................................................................................................................31 Correlation analysis (II-III) ..........................................................................................31 Regression model (I-III) ................................................................................................32 Kohonen self-organising map (IV)................................................................................32 Principal component analysis (VII) ..............................................................................34 A partial least square regression model (VII) ...............................................................34

4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 5.

RESULTS AND DISCUSSION..................................................................................................35 5.1 FORCE-TIME CURVE PARAMETERS (I-II)....................................................................................35 Relative elasticity of granules (I)...................................................................................35 Correlation between force-time compression parameters and mechanical properties of tablets (II) ............................................................................35 5.1.3 5.1.4 Use of force-time parameters to describe compression behaviour of powders (II)......37 Dependence of force-time parameters from compression force and compression time (II) ....................................................................................................38 5.2 FORCE-DISPLACEMENT PARAMETERS (III) ................................................................................38 Correlation between force-displacement compression parameters and mechanical properties of tablets ...................................................................................38 5.2.2 Use of force-displacement parameters to describe compression behaviour of powders....................................................................................................40 5.2.3 Dependence of force-displacement parameters from compression force and compression time............................................................................................................41 5.3 5.4 A METHOD TO IMPROVE THE ACCURACY OF DISPLACEMENT MEASUREMENT (VI) ....................42 A NEW METHOD TO DETERMINE THE DEFORMATION OF AN ECCENTRIC TABLET MACHINE
DYNAMICALLY (VI)

5.1.1 5.1.2

5.2.1

..................................................................................................................43

5.5 5.6 5.7 5.8

PRESSURE DEPENDENCE OF PLASTICITY FACTOR PF (VI) .........................................................43 PRESSURE DEPENDENCE OF ELASTICITY FACTOR EF (VI) .........................................................44 PREDICTION OF FLOWABILITY OF POWDERS USING SELF-ORGANISING MAP (SOM) (IV) ...........44 DIRECT COMPRESSION OF TABLETS FROM POWDERS CONTAINING SILICIFIED AND
NON-SILICIFIED MICROCRYSTALLINE CELLULOSE (V)...............................................................45

5.8.1 5.8.2 5.9

Flowability of studied microcrystalline grades (V) .......................................................46 Compactibility of studied microcrystalline cellulose grades (V)...................................46

SHAPE OF THE PRESSURE CURVES AND THE VALUE OF MINIMUM FLUIDIZATION

VELOCITIES (UMF) AS A MEAN TO PREDICT FLOWABILITY OF POWDERS (VII) .............................47

5.10 5.11

PREDICTION OF FLOWABILITY USING PRINCIPAL COMPONENTS ANALYSIS (PCA) (VII) .......47 PREDICTION THE FLOW RATE AND THE ANGLE OF REPOSE BY THE PRESSURE
DIFFERENCE OVER THE BED CURVES USING PLS MODEL (VII)..............................................48

6.

SUMMARY AND CONCLUSION............................................................................................49

REFERENCES .....................................................................................................................................50

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