Granulation Flashcards

(68 cards)

1
Q

What is the general definition of granulation in pharmaceutical powder processing?

A

The process of size enlargement of powders.

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2
Q

In the granulation process, what is the stage immediately following the formation of granules?

A

Sieving into microionised granules.

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3
Q

How does granulation help prevent segregation of a drug and its excipients?

A

It increases the uniformity of the mixture by controlling the size distribution.

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4
Q

Why do fine particles typically exhibit poor flow properties?

A

They are naturally adhesive and cohesive.

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5
Q

What is a primary manufacturing consequence of poor powder flow during tableting?

A

Inconsistent capsule filling or poor tableting quality.

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6
Q

How does granulation benefit slightly hygroscopic materials?

A

It helps prevent the absorption of moisture.

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7
Q

Why does granulation lead to the production of stronger tablets?

A

Granules are easier to deform or fragment, which improves compressibility.

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8
Q

How is the densification of powder defined during the granulation process?

A

Granules occupy less volume per unit weight compared to the parent powder.

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9
Q

What safety risk is reduced by the densification of pharmaceutical powders?

A

Dust hazards, such as toxicity or explosive potential (flour analogy).

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10
Q

How does granulation improve the wettability of hydrophobic drugs?

A

By mixing the hydrophobic drug with hydrophilic excipients.

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11
Q

What is the acceptable range for moisture content in granules intended for tableting?

A

$3-5\%$

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12
Q

What is the maximum allowable weight percentage of ‘fines’ in a granule batch for tableting?

A

$10\% w/w$

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13
Q

Besides moisture and flow, what three physical appearance properties are required for granules?

A

Shape, size, and color.

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14
Q

What type of particle size distribution is required for granules used in capsules?

A

A narrow particle size distribution.

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15
Q

Which granulation method involves mixing powder with a binder liquid to create a wet mass?

A

Wet granulation.

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16
Q

What is the first step in the mechanism of wet granulation?

A

Nucleation.

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17
Q

During the nucleation step of granulation, what state is formed when particles first combine with liquid?

A

The capillary state.

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18
Q

What occurs during the ‘transition growth’ phase of granulation?

A

Nuclei grow by adding single particles or combining with other nuclei.

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19
Q

What is the consequence of allowing the granulation process to proceed too long in ‘ball growth’?

A

Particles become too large and spherical.

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20
Q

In the wetting process, liquid bridges are converted into solid bridges through the process of _____.

A

Crystallization

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21
Q

Under what condition can a solid bridge form in wet granulation without the addition of a specific binder?

A

When the powder partially dissolves and then crystallizes upon drying.

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22
Q

Which granulation method relies on high power to push particles together for adhesion?

A

Dry granulation.

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23
Q

What physical force is responsible for adhesion during dry granulation?

A

Short-range van der Waals forces.

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24
Q

Rank the three states of bridge formation in dry granulation from weakest to strongest.

A

Pendular $<$ Funicular $<$ Capillary.

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25
What are the physical characteristics of PVP (Polyvinylpyrrolidone) when used as a binder?
It is viscous, strong, and sticky.
26
In which two solvents is PVP commonly dissolved for use in granulation?
Ethanol or water.
27
Which piece of equipment is used to mix powder with binder fluid during low-shear wet massing?
A planetary mixer.
28
What device is used in wet massing to push the wet mass through a mesh?
An oscillating granulator.
29
Why is convective drying in wet massing often considered inefficient?
The top layer prevents the lower layers from evaporating, leading to unequal drying.
30
What is a major disadvantage of wet massing regarding the physical state of the granules?
Aggregation of granules due to solid bridge formation.
31
What is the function of the impeller in a high-shear horizontal mixer?
Mixing the dry powder and adding the liquid binder.
32
At what point is the chopper switched on during high-shear mixing?
Once the wet mass has been formed.
33
What is the primary advantage of using a high-shear mixer over low-shear wet massing?
The process is quick and can be completed in the same equipment.
34
In fluidized bed granulation, where is the powder located before fluidization?
On top of a mesh at the bottom of a stainless steel chamber.
35
How is the liquid binder introduced in a fluidized bed granulator?
Through a nozzle that sprays the binder into the chamber.
36
In terms of drying efficiency, why is fluidized bed granulation considered superior?
It offers high drying rates and dries individual granules equally.
37
What does 'attrition' refer to in the context of fluidized bed granulation?
The loss of 'fines' or small particles.
38
What are two disadvantages of fluidized bed granulation related to solute and charge?
Solute migration and static build-up.
39
Which granulation method is preferred for compounds that are sensitive to moisture and heat?
Dry granulation (Roller compaction).
40
In roller compaction, how is high stress pressure applied to the particles?
By two rollers rotating in opposite directions.
41
List three common binders used in the roller compaction process.
MCC, DCP, and lactose.
42
Which three variables must be controlled during the roller compaction process?
Roll pressure, speed, and feeding rate.
43
Why is roller compaction preferred over slugging for large-scale production?
It has better capacity and efficiency as a continuous process.
44
What is the process of 'slugging' in dry granulation?
Forming a large tablet using a conventional eccentric press, then breaking it up.
45
What additive is mandatory in the slugging process to prevent machine issues?
A lubricant.
46
What is the pharmaceutical system used in pressurized metered-dose inhalers (pMDIs)?
Suspension systems containing solid drug particles in an aerosol.
47
What are the first three structures in the lung physiology pathway?
Trachea, bronchi, and bronchioles.
48
Which lung structures follow the respiratory bronchioles in the respiratory tree?
Alveolar ducts and alveolar sacs.
49
How many total bifurcations exist in the human lung physiology?
23
50
How are soluble materials cleared from the pulmonary region?
Through dissolution into the systemic circulation.
51
What specific particle type can pass directly into the blood from the lungs?
Super tiny nanoparticles.
52
Where do macrophages translocate during the process of phagocytosis in the lungs?
To the ciliated airways.
53
The success of inhalation therapy depends on which three factors?
Patient, Device, and Formulation.
54
What is the optimal particle size range for deposition in the deep lung?
$3-5 \mu m$
55
What does the abbreviation MMAD stand for in inhalation therapy?
Mass Median Aerodynamic Diameter.
56
What is the goal of using a spacer with a pMDI regarding inertial impact?
To increase distance so particles slow down and do not crash into the back of the throat.
57
How does air velocity change as it moves deeper into the respiratory system?
The velocity of air decreases.
58
In deposition mechanics, what is 'interception'?
When a particle is physically too large for an airway and gets stuck.
59
Which physical law and force govern the 'sedimentation' of particles in the lungs?
Stokes Law and gravity.
60
How does the charge of a particle affect its movement in the body?
Via electrostatic interactions that influence direction.
61
What is the definition of Brownian diffusion in the context of aerosols?
The migration of molecules from high to low colloid concentration due to constant collisions.
62
Why must the velocity of gas flow in an aerosol not be too high?
To prevent inertial impact in the throat.
63
What is the typical mathematical distribution for aerosol particle size?
Log normal distribution.
64
What is a potential consequence of high particle concentrations in an aerosol?
Increased particle interactions and agglomeration via van der Waals forces.
65
How does the evaporation of propellants affect aerosol particles and the patient?
It can increase particle size, causing more interactions and a cough reflex.
66
What are two physiological mechanisms used by the body to keep particles out of the lungs?
Cilia and the cough reflex.
67
Why is the patient instructed to hold their breath after using an inhaler?
To allow time for the particles to settle in the lungs via sedimentation.
68
What is the purpose of shaking an inhaler before use?
To ensure the suspension is uniform before delivery.