MFR of Deflazacort Tablets
TABLE OF CONTENTS
| S.NO. | TITLE | Page No. | |
| 1.0 | PRODUCT DETAILS | ||
| 2.0 | MANUFACTURING FORMULA | ||
| 3.0 | LIST OF EQUIPMENTS | ||
| 4.0 | GENERAL PRECAUTIONS | ||
| 5.0 | MANUFACTURING INSTRUCTIONS | ||
| 6.0
|
MANUFACTURING PROCESS DETAILS | ||
| 6.1 | GRANULATION | ||
| 6.2 | COMPRESSION | ||
1.0 PRODUCT DETAILS:
| Product Name | Deflazacort Tablets |
| Product Description | White color round shape, uncoated tablet having one side mid break line and other side plain. |
| Strength | 6 mg |
| Label claim
|
Each uncoated tablet contains:
Deflazacort – 6 mg |
| Batch Size | 5,00,000 Tablets |
| Average Weight | 110 mg |
| Shelf Life | 24 months |
| Storage | Store in a cool, dry and dark place below 25 0C. |
| Drug Category | Corticosteroids Drug |
2.0 MANUFACTURING FORMULA:
| Material Name | Grade | Category | Quantity per Unit (In mg) | Batch Qty. (In kg) |
| Dry Mixing | ||||
| Deflazacort | — | API | 6 mg | 3.000 kg |
| Sodium Starch Glycolate | IP | Disintegrant | 3.33 mg | 1.665 kg |
| Talcum | IP | Anti-caking agent | 5 mg | 2.500 kg |
| Starch | IP | Diluent | 10 mg | 5.000 kg |
| Aerosil | IP | Glidant | 1.5 mg | 0.750 kg |
| Lubricant | ||||
| MCCP PH-112 | IP | Diluent | 83.17 mg | 41.585 kg |
| Magnesium Stearate | IP | Anti- Adherent | 1 mg | 0.500 kg |
3.0 LIST OF EQUIPMENTS:
| Sr. No. | Machineries/Equipments | Capacity | Equipment ID. |
| 1. | Weighing Balance | 100 kg | |
| 2. | Vibro Sifter | 30 inch dia. | |
| 3. | Octagonal Blender | 60 liter | |
| 4. | Double Cone Blender | 200 liter | |
| 5. | Compression Machine | 35 Station | |
| 6. | Halogen Moisture Balance | — |
4.0 GENERAL PRECAUTIONS:
- API Description: A white or creamy white color crystalline powder.
- All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25 0C 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 MANUFACTURING INSTRUCTIONS:
- All activities shall be performed as per current SOPs.
- 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 of mistake, cancel the entry by single line with sign & date and make correct entry.
- MANUFACTURING PROCESS DETAILS:
6.1 GRANULATION:
STEP – I (SIFTING):
- Check Sieve integrity (before sifting and after sifting).
- Set the Vibro Sifter (capacity: 30 inch dia.) and sieve the Dispensed Materials as per Sieve sizes mentioned below:
| Material Name | Std. Qty. (kg) | Sieve No. |
| Dry Mixing | ||
| Deflazacort | 3.000 kg | 60 # |
| Sodium Starch Glycolate IP | 1.665 kg | 60 # |
| Talcum IP | 2.500 kg | 60 # |
| Starch IP | 5.000 kg | 100 # |
| Aerosil IP | 0.750 kg | 14 # |
| Lubricant | ||
| MCCP-PH-112 IP | 41.585 kg | 30 # |
| Magnesium Stearate IP | 0.500 kg | 30 # |
- Collect sifted Deflazacort IP (3.000 kg) in one Polybag (capacity: 5.0 kg)
- Collect sifted Sodium Starch Glycolate IP (1.665 kg),Talcum IP (2.500 kg), Starch IP (5.000 kg) and Aerosil IP (0.750 kg) in one Polybag (capacity: 10 kg).
- Collect sifted MCCP PH-112 IP (41.585 kg) in two Polybag (capacity: 25 kg each)
- Collect sifted Magnesium Stearate IP (0.500 kg) in one Polybag (capacity: 1.0 kg)
STEP – II (DRY MIXING):
- Transfer sifted Sodium Starch Glycolate IP, Talcum IP, Starch IP and Aerosil IP in Octagonal Blender (capacity: 60 liter) and mix for 10 minutes.
- Mixing Time: 10 minutes (clockwise direction)
- Mixing Speed: 15 RPM
- Add sifted Deflazacort in the material of Step-II (a) and mix for 10 minutes.
- Mixing Time: 10 minutes (clockwise direction)
- Mixing Speed: 15 RPM
- Unload the material of Step-II (b) from Octagonal blender in one Polybag (capacity: 20 kg).
STEP – III (PRE-LUBRICATION):
Load the mixed material of Step –II(c) in Double Cone Blender (capacity: 200 liter) from Polybag and add sifted MCCP PH 112 IP in Double cone blender and mix properly till uniform mixing.
- Mixing Time: 30 minutes (15 minutes clockwise direction and 15 minutes anti-clockwise direction)
- Mixing Speed: 10 RPM
STEP – IV (LUBRICATION):
Add the sifted Magnesium Stearate IP in Pre Lubricated Materials of Step-III in Double Cone Blender and mix properly till uniform mixing of materials with Magnesium Stearate IP.
- Mixing Time: 05 minutes.
- Mixing Speed: 10 RPM.
STEP- V (BLEND SAMPLE ANALYSIS):
After completion of lubrication, collect the composite blend sample (Qty. 10 gm) and send to QC for analysis according to the table below:
| Test | Specification |
| Appearance of blend
Blend Uniformity Blend Assay LOD Bulk Density Tapped Density Compressibility Index Hausner Ratio |
White color free flowing granular powder 90 % to 110 % 98 % to 103 % 1.0 % to 1.5 % (To be established in next batch) To be established in next batch To be established in next batch To be established in next batch To be established in next batch |
STEP – VI:
- Take Tare Weight of two Poly-lined HDPE Containers (capacity: 30 liter each), record the Tare Weight in BMR and unload the above blended material from Double Cone Blender in Poly-lined HDPE Containers (capacity: 30 liter each) and weigh the material with containers and record the Gross Weight of the material and calculate the Net Weight of the material as per given formula:
- Net Weight = Gross Weight – Tare weight
- Affix the status label with following details – Product Name, Batch No., Batch Size, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Container.
- Batch Yield of Lubricated granules:
- Theoretical Batch Yield: 55.000 kg (100 %)
- Actual Batch Yield Limit NLT 54.450 kg (NLT 99 %) (To be established in next batch).
STEP – VII:
- Clean all equipments used in the granulation as per respective equipment cleaning SOP.
- COMPRESSION:
STEP – I:
- After receiving of QC approval for the blend, verify the Net Weight of the received blend as per status label in Granules Day Store.
- After confirmation continue the compression with 35 stations (D-Tooling) Compression Machine of the blend as per the following parameters and In Process checks under controlled environmental condition.
| S.No. | Parameters | Standard | No. of Tablets | In-Process Frequency |
| 1. | Feed frame alignment and adjustment | Should be satisfactory | —– | —– |
| 2. | Lower Weight Assembly | Should be satisfactory | —– | —– |
| 3. | Hydraulic Pressure | 5 – 6 Tones | —– | —– |
| 4. | Machine Speed | 20 RPM -22 RPM | —– | —– |
| 5. | Upper Punch Size | 6.5 mm with break line | —– | —– |
| 6. | Lower Punch Size | 6.5 mm | —– | —– |
| 7. | Length of Tablets. | 6.5 mm | —– | —– |
| 8. | Width of Tablets | 6.5 mm | 6/Individual | 2 hours |
| 9. | Thickness of Tablets | 2.5 mm ±.2 mm | 6/Individual | 2 hours |
| 10. | Weight of 20 Tablets | 2.200 gm. ± 2% | 20/Composite | 30 minutes |
| 11. | Uniformity of Weight | NMT 02 tablets out of 20 deviate from the standard average weight by more than 3 % and no single tablet deviates from the standard average weight by more than 5 % | 20/Composite | 01 hour |
| 12. | Standard Average Weight of Tablets | 110 mg ± 2 % | 20/Individual | 30 minutes |
| 13. | Hardness | NLT 3.0 kg/cm2 | 6/Individual | 30 minutes |
| 14. | Disintegration Time | NMT 15 min (IHS NLT 3 minute) | 6/Composite | 01 hour |
| 15. | Friability | NMT 1% | 20/Composite | 01 hour |
- Collect the compressed tablets in SS Container (capacity: 20 liter each on both sides), when SS containers are filled with tablets, transfer the tablets in two Poly-lined HDPE Containers as given in below Step-III.
STEP – II:
- Send the composite sample of compressed tablets (Qty. 30 tablets) to QC department for analysis.
STEP-III
- Take Tare Weight of two Poly-lined HDPE Containers (capacity: 30 liter each), record the Tare Weight in BMR and transfer the compressed tablets in Poly-lined HDPE Containers (capacity: 30 liter each) and weigh the compressed tablets with containers and record the Gross Weight of the compressed tablets and calculate the Net Weight of the material as per given formula:
Net Weight = Gross Weight – Tare weight
- Affix the status label with following details – Product Name, Batch No., Batch Size, Avg. Weight, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight on the Poly-lined HDPE Containers.
- Batch Yield of Compressed Tablets:
- Theoretical Batch Yield: 55.000 (100 %)
- Actual Batch Yield Limit NLT 54.450 kg (NLT 99 %) (To be established in next batch)
STEP – IV:
- After completion of compression clean the Compression Machine as per cleaning SOP.