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 stages | Parameters for in-process checking |
1 | Sieving of ingredients | Room temperature & Relative humidity Starting time & completion time Mesh size |
2 | Dry mixing | RPM of mixer Load size. Starting time & completion time |
3 | Wet mixing | Speed of mixer Direction of mixing blades Starting time & completion time |
4 | Sieving of wet mass | Mesh size Starting time & completion time |
5 | Primary drying | In-let & out-let temperatures of fluid bed dryer Starting time & completion time |
6 | Grinding | Screen size Starting time & completion time |
7 | Final drying | In-let & out-let temperatures of fluid bed dryer Starting time & completion time Loss on drying of dried granules as per specification |
8 | Sieving of granules | Room temperature & Relative humidity Mesh size Starting time & completion time |
9 | Blending | Load size of cone blender Speed of blender Starting time & completion time Assay |
10 | Compression | Room temperature & Relative humidity Weight/Tablet adjustment Hardness, thickness, friability & disintegration time Weight variation Starting time & completion time |
11 | Enteric-coating | Room temperature & Relative humidity Viscosity of coating solution Pan speed Pump speed Starting time & completion time |
12 | Film-coating | Room temperature & Relative humidity Viscosity of coating solution Pan speed Pump speed Starting time & completion time |
13 | Active-coating | Room temperature & Relative humidity Viscosity of coating solution Pan speed Pump speed Starting time & completion time |
14 | Final film-coating | Room temperature & Relative humidity Viscosity of coating solution Pan speed Pump speed Starting time & completion time |
15 | Blistering, printing & packaging | Room 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 |