Tablet Nimesulid 100 mg + Parasetamol 325 mg
| No. | Judul |
|---|---|
| 1.0 | DETAIL PRODUK |
| 2.0 | FORMULA PEMBUATAN |
| 3.0 | DAFTAR PERALATAN |
| 4.0 | INSTRUKSI PEMBUATAN |
| 5.0 | PENGAWASAN UMUM |
| 6.0 | DETAIL PROSES PEMBUATAN |
| 6.1 | GRANULASI |
| 6.2 | KOMPRESI |
1.0 DETAIL PRODUK:
NAMA PRODUK
Nimesulide and Paracetamol Tablets
Deskripsi Produk
Yellow color biconvex oval shape, uncoated tablet having one side mid break line and other side plain
KEKUATAN
Nimesulide 100 mg and Paracetamol 325 mg
Klaim Label
Each uncoated tablet contains:
Nimesulide BP – 100 mg
Paracetamol IP – 325 mg
UKURAN BATCH
3,00,000 Tablets
Rata-rata Berat
580 mg
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry and dark place below 25 0 C
Kategori Obat
Obat Anti-Inflamasi Non-Steroid (NSAID)
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Nimesulide | BP | API | 100 mg | 30.000 kg | Paracetamol |
| Starch | IP | Binder | 66.14 mg | 19.842 kg | MCCP Plain |
| Tartrazine Supra Color | IP | Color | 0.177 mg | 0.053 kg | Binder |
| PVPK-30 | IP | Binder | 5.8 mg | 1.740 kg | Sodium Benzoate |
| Starch | IP | Binder | 13.13 mg | 3.938 kg | Purified Water |
| Talcum | IP | Anti-caking agent | 8 mg | 2.400 kg | Sodium Starch Glycolate |
| Cross Carmilose Sodium | IP | Disintegrant | 5.8 mg | 1.740 kg | Magnesium Stearate |
3.0 DAFTAR PERALATAN:
Sr. No.
| No. | Mesin/Peralatan | Kapasitas | ID Peralatan |
|---|---|---|---|
| 1. | Weighing Balance | 300 kg | |
| 2. | Sifter | (with SS Sieves No’s 16,20,30,60 and 100 ) | 30” |
| 3. | Paste Kettle with stirrer | 60 liter | |
| 4. | Stirrer for binder preparation | — | |
| 5. | Multi-Mill (screen size 8 mm and 2 mm) | — | |
| 6. | Rapid Mixer Granulator (RMG ) | 160 liter | |
| 7. | Fluid Bed Dryer (FBD) | 120 kg | |
| 8. | Octagonal Blender | 500 liter | |
| 9. | Compression Machine | 27 Station | |
| 10. | SS Containers with lid | 10 liter ( 04 No’s) | — |
| 11. | Halogen Moisture Balance | — | |
| 12. | Poly-lined HDPE Containers with lid | 30 liter (11 No’s) | — |
All the manufacturing activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 60%).
When working with Active Ingredients and drug product or mixture of Active Ingredients and Excipients, wear gloves and mask to avoid exposure and contact with any body parts.
5.0 PENGAWASAN UMUM:
Before working with Nimesulide and Paracetamol, read Material Safety Data Sheet of Active Ingredients.
In case of skin contact (Irritants), wash skin with soap and water for at least 15 minutes. Cold water may be used.
To protect the eyes, use goggles and in case of infection wash the eyes thoroughly with running water.
General reported side effects: Nausea, Indigestion, Headache, Allergic skin reactions such as Itching and Rash.
PROSES PEMBUATAN DETAILS:
6.1 GRANULASI:
STEP – I (SIFTING):
Check Sieve Integrity (before sifting and after sifting).
Set the Sifter and sieve the Dispensed Materials as per Sieve Sizes mentioned below:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| PVPK-30 IP | Binder | 1.740 kg | 20 # | Sodium Benzoate IP | |
| Talcum IP | Lubricant | 2.400 kg | 60 # | Sodium Starch Glycolate IP |
