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Medicine Sem 2 > Pharmaceutical Manufacturing Processes – Oral Solid Dosage (OSD) > Flashcards

Pharmaceutical Manufacturing Processes – Oral Solid Dosage (OSD) Flashcards

1
Q

What are the three powder mixing mechanisms?

A

Convective Mixing
• Macroscopic transport of parts of
the mixture
• Reduces the scale of segregation

Diffusive Mixing
• Induced by random motion of
individual powder particles
• Required for microscopic mixing
• Reduces the intensity of
segregation

Shear Mixing
• Required for mixing of cohesive
particles at the microscopic level

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2
Q

What are the four types of mixtures?

A

Perfect
Random
Perfect ‘Ordered’
Real ‘Ordered’

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3
Q

What does SUPAC stand for?

A

Scale-up and post-approval changes (US FDA)

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4
Q

Diffusion ‘Bin Blenders’ key parameters;

A
  • Fill volume: 40-60%
  • Rotation speed (rpm) }
  • Blending time (min)

Number of revolutions = speed x time

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5
Q

What is a dynamic continuous mixer?

A

Mixer that:
• Enables fully continuous processing
• Reduces segregation risk

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6
Q

Why do we granulate?

A
  • Improve homogeneity
  • Improve bulk density (solids handling, packing, transport
  • Deliver dissolution profile by manipulating structure
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7
Q

Segregation Mechanisms?

A

Segregation Mechanisms

  • Sifting/Percolation
  • Elutriation/Fluidisation
  • Trajectory
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8
Q

SUPAC Equipment for Dry Granulation

A
  • Slugging

- Roller Compaction

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9
Q

SUPAC Equipment for Wet High-Shear Granulator

A
  • Vertical

* Horizontal

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10
Q

SUPAC Equipment for Wet Low-Shear Granulator

A
  • Planetary
  • Kneading
  • Screw
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11
Q

What happens in a roller compactor?

A

Powder –> ribbon –> Mill /Granulator –> Granules

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12
Q

Summary of Rate Processes in High Shear Granulator?

A

1) Wetting and nucleation
2) Consolidation and coalescence (agglomeration)
3) Attrition and Breakage

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13
Q

Powder Flow Regimes?

A

Bumping Flow
•Slow consolidation speed during wet granulation •Longer mixing time

Roping Flow
•Good for Dry Mixing
•Fast consolidation speed during wet granulation
•Shorter mixing time

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14
Q

What is Hot Melt Extrusion?

A
  • API is dispersed/dissolved in a polymer, often with the aim of improving solubility of poorly soluble drugs
  • Barrel is heated to melt the polymer and can be operated continuously.
  • Extrudate is often cut into small particles/pellets for subsequent processing.
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15
Q

Compression cycle?

A

Filling
Metering
Precompression Compression
Ejection

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16
Q

Compaction pressure consequences:

A

As compaction pressure is increased, more compression occurs, resulting in tablets with lower porosity. Decreased porosity can result in increased disintegration times, lower dissolution performance but increased tensile strength and toughness.

17
Q

Linear velocity relationship?

A

= as the speed of compaction is increased (turret speed in RPM, tooling design). The speed at which the tablet punch enters the die is increased. This can result in a drop in tensile strength for a strain rate sensitive material

18
Q

Tablet Compressor Types

Typical compressors:

A
  • Single stroke/single punch press –>
  • Slow-speed single sided rotary –>
    • Outputs of 200 to 2,500 tablets per minute fall in this category. These have
    one powder feed station and produce a single tablet for each revolution of the turret per station.
  • High-speed single sided rotary
    • Outputs of 2,000 to 4,000 tablets per minute are achieved by using larger diameter turrets with an increased number of stations.
19
Q

Tablet Compressor Types

Non-standard compressors

A

Double sided rotary–>
• Produce two tablets per station for each revolution of the turret.
• Tablet take off is often from opposite sides of the machine.
• Tablet outputs can be more than 1,000,000 per hour

Special machines –>
• Tablets with up to three layers can be produced using these machines

Slugging machines –>
• Not usually considered for compressing final tablets but are used as a
process intermediate to final compression

20
Q

What is Pre-capping/lamination?

A
  • Splits or cracks on the side, parallel to face

* Excessive compression and/or ejection forces, air entrapment, poor material compactability

21
Q

What is capping?

A

Complete or partial separation of the tablet face

22
Q

What is picking?

A
  • Removal of material from the tablet face

* Poor lubrication/filming on punches

23
Q

Hard capsule advantages

A
  • Fewer excipients and formulation problems
  • Reproducible disintegration
  • Fewer manufacturing stages
24
Q

Disadvantages of hard capsules compared to tablets:

A
  • Lower production rate
  • Higher pack volume
  • Greater weight variation
  • Less protection to hygroscopic materials
  • Limited in size and shape
  • Capsule shell supplier dependent
  • Sensitive to extremes of temperature and humidity (brittle/soften)
25
Q

Capsule Filling Cycle:

A
  • Empty capsules
  • Aligning and rectification
  • Opening and separation
  • Filling
  • Joining and closing
  • Discharge
26
Q

Why do we coat tablets?

A 
Patient image/compliance
• Mask bad taste or odour
• Ease of swallowing
• Ability to have unique market image or to distinguish between doses
• Improved aesthetics

Safety/regulatory
• Identification of the product versus counterfeits.
• To separate incompatible API or components
• Potential to improve stability (protect from environmental conditions - e.g. light, moisture and oxidation)
• To modify drug release
• Reduce exposure to API during product dispensing/handling

Processability
• Fewer packaging issues (less dust, and better flow properties)
• Improved mechanical integrity (less fragile for shipping)
• Process is therefore more efficient and robust.

27
Q

Coating process mechanisms

A
  • Atomisation of coating solution into a fine mist by the spray guns
  • Mass transfer of spray droplets through the air, until they contact
  • Tablet surface

•Drum surface
•Baffles
or travel to exhaust

  • Wetting of surface contacted by droplets, spreading of droplets
  • Adhesion of droplets to surface, cohesion of droplets to each other
  • Evaporation of water from the coating solution, resulting in a dry, coated surface
28
Q

What is a Fluidised Bed Coater (Wurster)?

A

• Typically used for pellet coating
• Pellets entrained through Wurster tube
• Spray concurrent to pellet flow in Wurster tube
• Coated pellets fall back down to the bottom of the
fluidised bed for re-entrainment into the Wurster tube

29
Q

The 21st Century Supply Chain: The case for Continuous Manufacture

A

– Continuous manufacturing opportunities being raised in response to changing Pharma models

– Greater flexibility of batch size allows a more agile response to changing demand.

– Greater robustness, increased consistency of product quality, reduced cycle time, stock holding and increased margins.

– Minimal scale up, improved robustness and better control.

– The smaller footprint of continuous processes enables close to market manufacture.

– Efficiency gains in development

Medicine Sem 2 (8 decks)

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