Tablet Pantoprazol Na 40 mg + Domperidon 10 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
Pantoprazole Sodium and Domperidone Tablets IP
Deskripsi Produk
Off white color round biconvex shape, uncoated tablets having both side plain
KEKUATAN
Pantoprazole Sodium IP
equivalent to Pantoprazole 40 mg
Domperidone IP 10 mg
Klaim Label
Each enteric coated tablet contains:
Pantoprazole Sodium IP
equivalent to Pantoprazole – 40 mg
Domperidone IP – 10 mg
UKURAN BATCH
5,00,000 Tablets
Rata-rata Berat
110 mg
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry and dark place below 25 0 C
Kategori Obat
Inhibitor Pompa Proton (PPI)
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Equivalent to Pantoprazole | IP | API | 40 mg | 13 % | 22.600 kg |
| Mannitol | IP | Diluent | 10 mg | —- | 5.000 kg |
| Sodium Carbonate | IP | Alkaline | |||
| 13 mg | —- | 6.500 kg | Dry Mixing (Part-II) | ||
| Domperidone | IP | API | 10 mg | 1 % | 5.050 kg |
| MCCP-PH-102 | IP | Diluent | 3.2 mg | —- | 1.600 kg |
| Crospovidone XL | IP | Disintegrant | 6 mg | —- | 3.000 kg |
| Cross Carmillose Sodium | IP | Disintegrant | 10 mg | —- | 5.000 kg |
| PVPK-30 | IP | Binder | 3 mg | —- | 1.500 kg |
| Isopropyl Alcohol (IPA) | IP | Diluent | 0.032 ml | —- | 16.000 liter |
| Talcum | IP | Anti-caking agent | 3 mg | —- | 1.500 kg |
| Aerosil | IP | Glidant | 2.5 mg | —- | 1.250 kg |
| Calcium Stearate | IP | Anti-adherent | 4 mg | —- | 2.000 kg |
3.0 DAFTAR PERALATAN:
Sr. No.
| No. | Mesin/Peralatan | Kapasitas |
|---|---|---|
| 1. | Weighing Balance | 100 kg |
| 2. | Sifter | 30” |
| 3. | Mass Mixer | 100 liter |
| 4. | Stirrer for binder preparation | |
| 5. | Tray Dryer | 48 Trays |
| 6. | Multi-Mill (screen size 1.5 mm) | |
| 7. | Double Cone Blender | 400 liter |
| 8. | Halogen Moisture Balance | — |
| 9. | Compression Machine | 35 Station |
| 10. | SS Containers with lid | — |
| 11. | Poly-lined HDPE Containers with lid | — |
Pantoprazole Sodium API Description: A white to off white powder.
Domperidone API Description: A white or almost white powder.
All the manufacturing activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 50%).
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.
GENERAL PRECAUTIONS:
All the Activity shall be performed as per current SOPs
Follow the GMP compliance throughout the manufacturing process.
Take the line clearance from QA before starting the manufacturing operation during batch to batch and product to product change over.
Do not overwrite the entry, in case there is correction, cancel the entry by single line with sign & date and make correct entry.
PROSES PEMBUATAN DETAILS:
NOTE: Use Sodium Lamp and Black Poly-bags at every Step.
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) |
|---|---|---|---|---|---|
| Pantoprazole Sodium IP | Dry Mixing (Part-I) | equivalent to Pantoprazole | |||
| Domperidone IP | Dry Mixing (Part-II) | 5.050 kg | 40 # | MCCP-PH-102 IP | |
| PVPK-30 IP | Binder | 1.500 kg | —- | Isopropyl Alcohol IP (IPA) | |
| 16.00 liter | —- | Lubricant |
