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Pharmaceutical Manufacturing Lec > Granulation > Flashcards

Granulation Flashcards

1
Q

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

A

Granulation

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2
Q

larger, multiparticle entities formed in granulation

A

granules

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3
Q

general size range of granules

A

between 0.2 and 4.0 mm

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4
Q

typical size range of granules for capsule and tablet

A

between 0.2 and 0.5 mm

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5
Q

Reasons for Granulation:

To prevent ________ of the constituents of the powder mix

A

segregation

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6
Q

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

A

true

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7
Q

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

A

Poor flow

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8
Q

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

A

weight

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9
Q

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

A

compaction characteristics of the mix

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10
Q

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

A

adhesive

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11
Q

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

A

method

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12
Q

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

A

false

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13
Q

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

A

toxic dust

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14
Q

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

A

hygroscopic

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15
Q

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

A

less

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16
Q

Reasons for Granulation

A
  • 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

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17
Q

Methods of Granulation

A
  • Wet granulation
  • Dry granulation
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18
Q

granulation method that involves wet massing

A

Wet granulation

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19
Q

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

A

Wet Granulation

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20
Q

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

A

volatile; non-toxic

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21
Q

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

A

true

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22
Q

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

A

adhesive

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23
Q

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

A

sieve

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24
Q

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

A

high

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25
Q

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

A

slugging

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26
Q

large tablet is also known as ______

A

slug

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27
Q

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

A

false
roller compaction

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28
Q

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

A

roller compaction

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29
Q

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

A

milling

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30
Q

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

A

sieved

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31
Q

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

A

true

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32
Q

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

A

Dry Granulation

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33
Q

(3) Wet granulators

A
  • Shear granulators
  • High speed mixer/granulators
  • Fluidized bed granulators
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34
Q

(2) Dry granulator

A
  • Sluggers
  • Roller compactors
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35
Q

Shear Granulators include (3)

A

planetary mixer, granulator (oscillating granulator), drying oven

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36
Q

3 major disadvantages of shear granulators are due to ______

A

tray drying

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37
Q

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

A

(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

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38
Q

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

A

long

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39
Q

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

A

upper; solvent

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40
Q

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

A

bridge formation

41
Q

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

A

sieving

42
Q

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

A

fluidized bed drier

43
Q

wet granulator Used extensively in pharmaceutics

A

High Speed Mixer/Granulators

44
Q

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

A

advantage of High Speed Mixer/Granulators

45
Q

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

A

High Speed Mixer/Granulators

46
Q

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

A

suitable endpoint monitor

47
Q

Diosna/Fielder and Collette-Gral Mixer

A

High Speed Mixer/Granulators

48
Q

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

A

Diosna/Fielder

49
Q

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

A

main impeller; 3-bladed

50
Q

Variation of the Diosna/Fielder type of design

A

Collette-Gral Mixer

51
Q

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

A

Collette-Gral Mixer

52
Q

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

A

three; top; smaller; upper

53
Q

operation principle is similar to Diosna/Fielder

A

Collette-Gral Mixer

54
Q

Similar design and operation to fluidized bed driers

A

Fluidized Bed Granulators

55
Q

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

A

Fluidized Bed Granulators

56
Q

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

A

many

57
Q

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

A

one

58
Q

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

A

All the granulation processes performed in one unit

59
Q

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

A

adavantage of Fluidized Bed Granulators

60
Q

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

A

disadvantage of Fluidized Bed Granulators

61
Q

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

A

Fluidized Bed Granulators

62
Q

Spray driers, spheronizers/pettetizers

A

Fluidized Bed Granulators

63
Q

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

A

Spray Driers

64
Q

only used when other methods are not applicable

A

Spray Driers

65
Q

Can convert elastic materials into more ductile ones

A

Spray Driers

66
Q

Spray dried lactose

A

Spray Driers

67
Q

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

A

advantages of Spray Driers

68
Q

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

A

little

69
Q

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

A

Spheronizers/pelletizers

70
Q

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

A

controlled drug release; polymer coat

71
Q

Multistep process used to make uniformly sized spherical particles

A

Extrusion/Spheronization

72
Q

Used primarily to produce MULTIPARTICULATES for controlled drug release applications

A

Extrusion/Spheronization

73
Q

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

A

Extrusion/Spheronization

74
Q

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

A

homogenous powder

75
Q

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

A

Wet massing

76
Q

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.

A

rod; diameter; plasticity

77
Q

Three classes of extruder based on their feed mechanism

A
  • screw feed extruder (axial or end plate, dome and radial);
  • gravity feed extruder (cylinder roll, gear roll, radial) and
  • piston feed extruders
78
Q

extruder may be axial or end plate, dome and radial

A

screw feed extruder

79
Q

extruder may be cylinder roll, gear roll, radial

A

gravity feed extruder

80
Q

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

A

spherical

81
Q

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

A
  • cylindrical particles
  • cylindrical particles with rounded edges
  • dumbbells
  • ellipsoids
  • spheres
82
Q

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

A

moisture content

83
Q

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

A

optional

84
Q

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

A
  • 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
85
Q

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

A

drug release

86
Q

Process allows the direct manufacture of spheres from dry powder

A

Rotor Granulation

87
Q

Freund granulator

A

Rotor Granulation

88
Q

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

A

Dry Granulator

89
Q

avoids heat temperature combinations that might cause degradation of the product

A

Dry Granulator

90
Q

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

A

two

91
Q

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

A

compressing the dry powders; mill

92
Q

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

A

process is known as slugging

93
Q

compact made in the process of slugging is termed as

A

slug

94
Q

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

A

25mm; 10-15mm

95
Q

is suitable for breaking the compacts from slugging

A

Hammer mill

96
Q

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

A

screening alone

96
Q

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

A

Roller Compactors

96
Q

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

A

roller compactors

Pharmaceutical Manufacturing Lec (3 decks)

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