Allied Pharmaceutical Laboratories, Inc
Experiential Pharmacy Experience in Manufacturing Pharmacyss
CHAPTER 7 Pharmaceutical Validation
IBUPROFEN 400 mg TABLET FORMULATION
Table X. Critical Process Parameters and Critical Quality Attributes in the manufacturing process of
Ibuprofen 400 mg Tablets
Method
Critical Process Parameters
Critical Quality Attributes
Dry Mixing
o Order of Addition
o Particle Size Distribution
o Mixer Load Level
o Bulk/Tapped Density
o Impeller Speed and Time
o Moisture Content
o Chopper Speed and Time
o Flow Properties
o Chopper ON/OFF Pattern
o Mixing Time
Wet Granulation
o Pre-Binder Addition Mix
o Blend Uniformity
Time
o Flow
o Impeller Speed and ON
o Moisture Content
Time
o Particle Size and
o Chopper Speed and ON
Distribution Addition
Time
o Granule Size and
o Binder Fluid Temperature
Distribution
o Binder Addition Rate and
o Granule Strength and
Time
Uniformity
o Post-Granulation Mix Time
o Solid Form
Drying
o Order of Addition
o Particle Size Distribution
o Mixer Load Level
o Bulk/Tapped Density
o Impeller Speed and Time
o Moisture Content
o Chopper Speed and Time
o Flow Properties
o Chopper ON/OFF
o Pattern
o Mixing Time
Grinding
Lubricating
Compression
Coating
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
Grinding Wheel Speed
Workpiece Speed
Depth of Cut
Material and Grade of
Grinding Wheel
Table Cross Feed
Table Travel Speed
Blender Revolutions
Lubrication Time
Choice of Lubricant
Amount of Lubricant
Compression Speed
Force Pre-compression
Force main Compression
Fedder Speed
Filling Depth
Punch Penetration Depth
Product Temperature
Total Pre-Heating Time
Spray Nozzle (Type/
Quantity/
Pattern/Configuration)
Individual Gun Spray Rate
Total Spray Rate
Pan Rotation Speed
Atomization Air Pressure
Pattern
Air Pressure
Inlet Air Flow,
Temperature, Dew Point
Exhaust Air Temperature,
Air Flow
Product Temperature
Total Coating Time
o
o
o
o
Particle size
Particle shape
Flow properties
Polymorphic form
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
o
Blend Uniformity
Flow
Tablet Breaking Force
Dissolution Time
Target Weight
Weight Uniformity
Content Uniformity
Hardness
Thickness
Tablet Porosity
Friability
Visual Attributes
Moisture Content
Weight of Core Tablets
Appearance
Visual Attributes
% Weight Gain
Film Thickness
Color Uniformity
Hardness
Thickness
REFERENCES:
Hemander. (2017). Critical Quality Attributes for Tablet Process Parameters. Retrieved from
https://pharmapathway.com/critical-quality-attributes-tablet-process-parameters/
Kumar Patel D, Goyal D,Pabla BS. 2018 Optimization of parameters incylindrical and surface grinding
for improvedsurface finish.R. Soc. open sci.5: 171906.http://dx.doi.org/10.1098/rsos.171906