Granulation

Question 1

Process in which primary powder particles are made to adhere to form larger, multiparticle entities called granules

Answer 1

Granulation

Question 2

larger, multiparticle entities formed in granulation

Answer 2

granules

Question 3

general size range of granules

Answer 3

between 0.2 and 4.0 mm

Question 4

typical size range of granules for capsule and tablet

Answer 4

between 0.2 and 0.5 mm

Question 5

Reasons for Granulation:

To prevent ________ of the constituents of the powder mix

Answer 5

segregation

Question 6

[true/false]
granulation is done to improve the flow properties and compaction characteristics of the mix.

Answer 6

true

Question 7

________ will often result in a wide weight variation within the final product owing to variable fill of the tablet dies

Answer 7

Poor flow

Question 8

Poor flow will often result in a wide _______ variation within the final product owing to variable fill of the tablet dies

Answer 8

weight

Question 9

This is associated with the distribution of the adhesive within the granule and is a function of the method employed to produce the granule

Answer 9

compaction characteristics of the mix

Question 10

compaction characteristics of the mix is associated with the distribution of the ________ within the granule and is a function of the method employed to produce the granule

Answer 10

adhesive

Question 11

compaction characteristics of the mix is a function of the ______ employed to produce the granule

Answer 11

method

Question 12

[true/false]
toxic materials are better handled as powders than granules

Answer 12

false

Question 13

Granulation of the toxic materials will reduce the hazard associated with the generation of ________ that may arise when handling powders

Answer 13

toxic dust

Question 14

Materials which are slightly _______ may adhere and form a cake if stored as a powder

Answer 14

hygroscopic

Question 15

Granules being denser than the parent powder mix, occupy [more/less] volume per unit weight

Answer 15

less

Question 16

Reasons for Granulation

Answer 16

• prevent segregation of the constituents
• improve the flow properties
• improve the compaction characteristics of the mix

Other reasons:
1. reduce the hazard associated with the generation of toxic dust from handling powders;
2. slightly hygroscopic materials may adhere and form a cake if stored as a powder;
3. being denser than the parent powder mix, occupy less volume per unit weight

Question 17

Methods of Granulation

Answer 17

• Wet granulation
• Dry granulation

Question 18

granulation method that involves wet massing

Answer 18

Wet granulation

Question 19

Involves the massing of a mix of dry primary powder particles using a granulating fluid

Answer 19

Wet Granulation

Question 20

in wet granulation, fluid contains a solvent which must be _____ so that it can be removed by drying and be ________

Answer 20

volatile; non-toxic

Question 21

[true/false]
granulating liquid may be used either alone or not

Answer 21

true

Question 22

in wet granulation, granulating liquid may be used alone or, more usually, as a solvent containing a dissolved ______ which is used to ensure particle adhesion once the granule is dry

Answer 22

adhesive

Question 23

Wet mass is forced through a _______ to produce granules which are then dried

Answer 23

sieve

Question 24

in dry granulation, Primary powder particles are aggregated under [high/low] pressure.

Answer 24

high

Question 25

dry granulation process where a large tablet is produced in a heavy duty tabletting press

Answer 25

slugging

Question 26

large tablet is also known as ______

Answer 26

slug

Question 27

[true/false] roller milling is when powder is squeezed between two rollers to produce a sheet material

Answer 27

false roller compaction

Question 28

instrument used dry granulation where powder is squeezed between two rollers to produce a sheet material

Answer 28

roller compaction

Question 29

after aggregation in dry granulation, intermediate products are broken using a suitable _______ technique to produce granular material

Answer 29

milling

Question 30

after milling in dru granulation, granular material is usually _______ to separate the desired size fraction

Answer 30

sieved

Question 31

[true/false] unused fine material from dry granulation may be reworked to avoid waste

Answer 31

true

Question 32

May be used for drugs that do not compress well after wet granulation, or those which are sensitive to moisture

Answer 32

Dry Granulation

Question 33

(3) Wet granulators

Answer 33

- Shear granulators - High speed mixer/granulators - Fluidized bed granulators

Question 34

(2) Dry granulator

Answer 34

- Sluggers - Roller compactors

Question 35

Shear Granulators include (3)

Answer 35

planetary mixer, granulator (oscillating granulator), drying oven

Question 36

3 major disadvantages of shear granulators are due to ______

Answer 36

tray drying

Question 37

3 major disadvantages of shear granulators (due to tray drying)

Answer 37

(a) drying time is long; (b) dissolved material can migrate to the upper surface of the bed of granules, as the solvent is only removed from the upper surface of the bed on the tray; and (c) granules may aggregate owing to bridge formation at the points of contact of the granules

Question 38

in shear granulators tray drying: drying time is (long/short)

Answer 38

long

Question 39

in shear granulators tray drying: dissolved material can migrate to the (upper/lower) surface of the bed of granules, as the ________ is only removed from the upper surface of the bed on the tray

Answer 39

upper; solvent

Question 40

in shear granulators tray drying: granules may aggregate owing to _______ at the points of contact of the granules

Answer 40

bridge formation

Question 41

shear granulators: To deaggregate the granules and remix them, a ________ is necessary after drying

Answer 41

sieving

Question 42

Alternative method is to dry the granules in shear granulators is to use a _______

Answer 42

fluidized bed drier

Question 43

wet granulator Used extensively in pharmaceutics

Answer 43

High Speed Mixer/Granulators

Question 44

mixing, massing and granulation are all performed within a few minutes in the same piece of equipment.

Answer 44

advantage of High Speed Mixer/Granulators

Question 45

The process needs to be controlled with care as the granulation progresses so rapidly that a usable granule can be transformed very quickly into an unusable, overmassed system

Answer 45

High Speed Mixer/Granulators

Question 46

High Speed Mixer/Granulator is also sensitive to variations in raw materials, but this may be minimized by using a ________

Answer 46

suitable endpoint monitor

Question 47

Diosna/Fielder and Collette-Gral Mixer

Answer 47

High Speed Mixer/Granulators

Question 48

Machine that have a stainless steel mixing bowl containing a 3-bladed main impeller, which revolves in the horizontal plane, and a 3-bladed auxiliary chopper (beaker blade) which revolves either in the vertical or the horizontal plane

Answer 48

Diosna/Fielder

Question 49

Diosna/Fielder Machine has a stainless steel mixing bowl containing a 3-bladed ______, which revolves in the horizontal plane, and a _______ auxiliary chopper (beaker blade) which revolves either in the vertical or the horizontal plane

Answer 49

main impeller; 3-bladed

Question 50

Variation of the Diosna/Fielder type of design

Answer 50

Collette-Gral Mixer

Question 51

Based on the bowl and overhead drive of the planetary mixer, but the single paddle is replaced by two mixing shafts

Answer 51

Collette-Gral Mixer

Question 52

in Collette-Gral Mixer, one shaft carries ____ blades, which rotate in the horizontal plane at the (top/base) of the bowl, and the second carries (bigger/smaller) blades which act as the chopper and rotate in the horizontal plane in the (upper/lower) regions of the granulating mass

Answer 52

three; top; smaller; upper

Question 53

operation principle is similar to Diosna/Fielder

Answer 53

Collette-Gral Mixer

Question 54

Similar design and operation to fluidized bed driers

Answer 54

Fluidized Bed Granulators

Question 55

powder particles are fluidized in a stream of air, but in addition granulation fluid is sprayed from a nozzle on to the bed powders

Answer 55

Fluidized Bed Granulators

Question 56

Fluidized bed granulation has (many/few) advantages over conventional wet massing

Answer 56

many

Question 57

in Fluidized Bed Granulators, All the granulation processed, which require separate equipment in the conventional method, are performed in how many unit/s?

Answer 57

one

Question 58

why can Fluidized Bed Granulators save labor costs, transfer losses and time

Answer 58

All the granulation processes performed in one unit

Question 59

process can be automated once the conditions affecting the granulation have been optimized

Answer 59

adavantage of Fluidized Bed Granulators

Question 60

expensive, and optmization of process (and product) parameters affecting granulation needs extensive development work

Answer 60

disadvantage of Fluidized Bed Granulators

Question 61

needs extensive development work, not only during initial formulation work but also during scale up from development to production

Answer 61

Fluidized Bed Granulators

Question 62

Spray driers, spheronizers/pettetizers

Answer 62

Fluidized Bed Granulators

Question 63

Granules made from a solution or suspension of drug alone, a single excipient or a complete formulation

Answer 63

Spray Driers

Question 64

only used when other methods are not applicable

Answer 64

Spray Driers

Question 65

Can convert elastic materials into more ductile ones

Answer 65

Spray Driers

Question 66

Spray dried lactose

Answer 66

Spray Driers

Question 67

short drying time and minimal exposure of the product to heat owing to the short residence time in drying chamber

Answer 67

advantages of Spray Driers

Question 68

(considerable/little) deterioration of heat sensitive materials takes place in spray driers

Answer 68

little

Question 69

Produce pellets that are used for controlled drug release products following coating with a suitable polymer coat and filling into hard gelatin capsules

Answer 69

Spheronizers/pelletizers

Question 70

Spheronizers/pelletizers Produce pellets that are used for ________ products following coating with a suitable _____ and filling into hard gelatin capsules

Answer 70

controlled drug release; polymer coat

Question 71

Multistep process used to make uniformly sized spherical particles

Answer 71

Extrusion/Spheronization

Question 72

Used primarily to produce MULTIPARTICULATES for controlled drug release applications

Answer 72

Extrusion/Spheronization

Question 73

among methods of producing drug loaded spheres or pellets, only this process has the ability to incorporate high levels of active ingredients without producing excessively large particles

Answer 73

Extrusion/Spheronization

Question 74

Main Steps of the Extrusion or Spheronization 1. Drying mixing of ingredients to achieve a ________ dispersion

Answer 74

homogenous powder

Question 75

Main Steps of the Extrusion or Spheronization 2. ________ to produce a sufficiently plastic wet mass

Answer 75

Wet massing

Question 76

Main Steps of the Extrusion or Spheronization 3. Extrusion to form _____-shaped particles of uniform_______; the extrudate must have enough _________ to deform, but not so much that the extruded particles adhere to other particles when collected or rolled in the spheronizer.

Answer 76

rod; diameter; plasticity

Question 77

Three classes of extruder based on their feed mechanism

Answer 77

- screw feed extruder (axial or end plate, dome and radial); - gravity feed extruder (cylinder roll, gear roll, radial) and - piston feed extruders

Question 78

extruder may be axial or end plate, dome and radial

Answer 78

screw feed extruder

Question 79

extruder may be cylinder roll, gear roll, radial

Answer 79

gravity feed extruder

Question 80

Main Steps of the Extrusion or Spheronization 4. Spheronization to round off these rods into _______ particles

Answer 80

spherical

Question 81

in spheronization, arrange the transition chronologically: - dumbbells - cylindrical particles with rounded edges - spheres - cylindrical particles - ellipsoids

Answer 81

- cylindrical particles - cylindrical particles with rounded edges - dumbbells - ellipsoids - spheres

Question 82

Main Steps of the Extrusion or Spheronization 5. Drying to achieve the desired final __________

Answer 82

moisture content

Question 83

Main Steps of the Extrusion or Spheronization 6. Screening is a/an (required/optional) done to achieve the desired narrow size distribution

Answer 83

optional

Question 84

Desirable Properties of Pellets (uncoated pellets) - Uniform _______ shape - ______ size - ______ flow properties - Reproducible packing (into _____ gelatin capsules) - ______ strength - ______ friability - ______ dust - _______ surface - ______ of coating

Answer 84

- Uniform spherical shape - Uniform size - Good flow properties - Reproducible packing (into hard gelatin capsules) - High strength - Low friability - Low dust - Smooth surface n Ease of coating

Question 85

Desirable Properties of Pellets (Once Coated) - Maintain all of the previously mentioned properties - Have desired ______ characteristics

Answer 85

drug release

Question 86

Process allows the direct manufacture of spheres from dry powder

Answer 86

Rotor Granulation

Question 87

Freund granulator

Answer 87

Rotor Granulation

Question 88

Converts primary powder particles into granules using the application of pressure without the intermediate use of a liquid

Answer 88

Dry Granulator

Question 89

avoids heat temperature combinations that might cause degradation of the product

Answer 89

Dry Granulator

Question 90

How many piece/s of equipment is/are necessary for dry granulation

Answer 90

two

Question 91

pieces of equipment are necessary for dry granulation: - first a machine for ________ into compacts or flakes - secondly a ______ for breaking up these intermediate products into granules

Answer 91

compressing the dry powders; mill

Question 92

Dry powders can be compressed using a conventional tablet machine, or more usually, a large heavy duty rotary press

Answer 92

process is known as slugging

Question 93

compact made in the process of slugging is termed as

Answer 93

slug

Question 94

compact made in the process is typically _____ diameter by about ______ thick

Answer 94

25mm; 10-15mm

Question 95

is suitable for breaking the compacts from slugging

Answer 95

Hammer mill

Question 96

flakes from roller compactors need gentler treatment to break them into granules, and this can usually be achieved by __________

Answer 96

screening alone

Question 96

Alternative gentler method, the powder mix being squeezed between two rollers to form a compressed sheet

Answer 96

Roller Compactors

Question 96

_________ form sheets that are normally is weak and brittle and breaks immediately into flakes

Answer 96

roller compactors