Naproxen 500 mg + Esomeprazole 20 mg Tablet | Manufacturing Stages

Each tablet contains delayed-release Naproxen Sodium USP equivalent to Naproxen 500 mg and immediate-release Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.

Sl.Manufacturing stagesParameters for in-process checking
      1Sieving of ingredientsRoom temperature & Relative humidity
Starting time & completion time
Mesh size
2Dry mixingRPM of mixer
Load size.
Starting time & completion time
3Wet mixingSpeed of mixer
Direction of mixing blades
Starting time & completion time
4Sieving of wet massMesh size
Starting time & completion time
5Primary dryingIn-let & out-let temperatures of fluid bed dryer
Starting time & completion time
6GrindingScreen size
Starting time & completion time
     7Final dryingIn-let & out-let temperatures of fluid bed dryer
Starting time & completion time
Loss on drying of dried granules as per specification
     8Sieving of granulesRoom temperature & Relative humidity
Mesh size
Starting time & completion time
     9BlendingLoad size of cone blender
Speed of blender
Starting time & completion time
Assay
10CompressionRoom temperature & Relative humidity
Weight/Tablet adjustment
Hardness, thickness, friability & disintegration time
Weight variation
Starting time & completion time
11Enteric-coatingRoom temperature & Relative humidity
Viscosity of coating solution
Pan speed
Pump speed
Starting time & completion time
12Film-coatingRoom temperature & Relative humidity
Viscosity of coating solution
Pan speed
Pump speed
Starting time & completion time
13Active-coatingRoom temperature & Relative humidity
Viscosity of coating solution
Pan speed
Pump speed
Starting time & completion time
14Final film-coatingRoom temperature & Relative humidity
Viscosity of coating solution
Pan speed
Pump speed
Starting time & completion time
15Blistering, printing & packagingRoom temperature & Relative humidity
Inscription of Batch No., Mfg. Date, Exp. Date on blisters
Leak test
Printing of Batch No., Mfg. Date, Exp. Date & M.R.P. on cartons
Starting time & completion time

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