Tablet Pantoprazol Na 40 mg + Domperidon 10 mg
(Original: Pantoprazole Sodium 40 Mg And Domperidone 10 Mg Tablets In Pharma Industry)
Sumber: drugsformulations.com via archive.org
MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry
February 25, 2021
iamraj
Tablets
0
MFR of Pantoprazole Sodium 40 mg and Domperidone 10 mg Tablets in Pharma Industry
TABLE OF CONTENTS
S.NO.
TITLE
Page No
1.0
PRODUCT DETAILS
2.0
MANUFACTURING FORMULA
3.0
LIST OF EQUIPMENTS
4.0
MANUFACTURING INSTRUCTIONS
5.0
GENERAL PRECAUTIONS
6.0
PROSES PEMBUATAN DETAILS
6.1
GRANULATION
6.2
COMPRESSION
1.0 PRODUCT DETAILS:
NAMA PRODUK
Pantoprazole Sodium and Domperidone Tablets IP
Product Description
Off white color round biconvex shape, uncoated tablets having both side plain
Strength
Pantoprazole Sodium IP
equivalent to Pantoprazole 40 mg
Domperidone IP 10 mg
Label claim
Each enteric coated tablet contains:
Pantoprazole Sodium IP
equivalent to Pantoprazole – 40 mg
Domperidone IP – 10 mg
UKURAN BATCH
5,00,000 Tablets
Average Weight
110 mg
Shelf Life
24 months
Storage
Store in a cool, dry and dark place below 25 0 C
Drug Category
Proton-Pump Inhibitors
2.0 MANUFACTURING FORMULA:
Material Name
Grade
Category
Quantity per Unit (In mg)
Overages
Batch Qty.
(In kg) without
Dry Mixing
Pantoprazole Sodium
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
Binder
PVPK-30
IP
Binder
3 mg
—-
1.500 kg
Isopropyl Alcohol (IPA)
IP
Diluent
0.032 ml
—-
16.000 liter
Lubricant
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 LIST OF EQUIPMENTS:
Sr. No.
Machineries/equipments
Capacity
Equipment ID.
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
—
4.0 MANUFACTURING INSTRUCTIONS:
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 GRANULATION:
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:
Material Name
Std. Qty. (kg)
Sieve No.
Dry Mixing (Part-I)
Pantoprazole Sodium IP
equivalent to Pantoprazole
22.600 kg
40 #
Mannitol IP
5.000 kg
40 #
Sodium Carbonate IP
6.500 kg
100 #
Dry Mixing (Part-II)
Domperidone IP
5.050 kg
40 #
MCCP-PH-102 IP
1.600 kg
40 #
Crospovidone XL IP
3.000 kg
60 #
Cross Carmillose Sodium IP
5.000 kg
60 #
Binder
PVPK-30 IP
1.500 kg
—-
Isopropyl Alcohol IP (IPA)
16.00 liter
—-
Lubricant
Talcum IP
1.500 kg
60 #
Aerosil IP
1.250 kg
14 #
Calcium Stearate
2.000 kg
60 #
NOT
Collect the sifted Pantoprazole Sodium IP (22.600 kg), Mannitol IP (5.000 kg) and Sodium Carbonate (6.500 kg) into one Black Polybag (capacity : 50 kg)
Collect the sifted Domperidone IP (5.050 kg), MCCP-PH-102 IP (1.600 kg), Crospovidone XL IP (3.000 kg) and Cross Carmillose Sodium IP (5.000 kg) in one Black Polybag (capacity: 20 kg)
Collect the sifted Talcum IP (1.500 kg) and Aerosil IP (1.250 kg) in one Black Polybag (capacity : 5.0 kg)
Collect the sifted Calcium Stearate IP (2.000 kg) in one Black Polybag (capacity: 5.0 kg )
STEP – II (DRY MIXING): PART-I:
Transfer the sifted Pantoprazole Sodium IP (22.600 kg) and Mannitol IP (5.000 kg) and Sodium Carbonate (6.500 kg) in Mass Mixer (capacity: 100 liter).
(DRY MIXING): PART-II:
Transfer the sifted Domperidone IP (5.050 kg), MCCP-PH-102 IP (1.600 kg), Crospovidone XL IP (3.000 kg) and Cross Carmillose Sodium IP (5.000 kg) in Mass Mixer (capacity: 100 liter).
Mix together Part-I and Part-II of dry mixing material in Mass Mixer (capacity: 100 liter) till uniform mixing.
Mixing Time: 10 minutes.
Mixing Speed: 36 RPM
Paddle (Blades) Timing & Direction: 5 minutes in clockwise direction & 5 minutes in anti-clockwise direction.
STEP – III (BINDER PREPARATION):
Take IPA (16.000 liter) in SS Container (capacity: 20 liter) and add PVPK-30 IP (1.500 kg) and mix together with continuously stirring till dissolved properly in IPA.
Filter it with 100# filter cloth & store in SS Container (capacity: 20 liter).
STEP –IV (BINDING OF DRY MIX MATERIAL):
Slowly add the binder of Step-III in dry mix materials of Step-II and mix for 10 minutes till uniform binding and after binding, collect the wet mass into seventeen Trays (capacity: 3.000 kg each).
Mixing Time: 10 minutes
Mixing Speed: 36 RPM
STEP –V (DRYING):
Dry the wet mass of Step -IV as follows:
First airs dry the granules for 30 minutes in Tray Dryer. Ensure that heaters are in OFF mode. After air drying, Switch ON the heaters of Tray Dryer and set the temperature at 35 o C in Tray Dryer and dry the granules until the LOD of granules is between 1.0 to 1.5% at 105 o C checked by Halogen Moisture Balance.
Drying Time: 4 to 5 Hours.
Drying Temperature: 35 0 C
Raking Frequency: After every 15 minutes
STEP-VI (SIZING/MILLING):
Check Screen Integrity (before sifting and after sifting).
Milled the dried material of Step -V through Multi Mill using screen size 1.5 mm and collect milled material in two Poly-lined HDPE Containers (capacity :30 liter each ) and weight and record the milled granules weight.
Blade Type: Both (Knife blades/Scraping blades)
Rotor Speed: 2000 RPM
STEP – VII (PRE –LUBRICATION):
Load the milled granules of Step-VI in Double Cone Blender (capacity : 400 liter) and add sifted Talcum IP (1.500 kg) and Aerosil IP (1.250 kg) and mix properly till uniform mixing of milled material with Pre-Lubricating Material.
Mixing Time: 30 minutes (15 minutes clockwise direction and 15 minutes anti-clockwise direction)
Mixing Speed: 10 RPM
STEP – VIII (LUBRICATION):
Add the sifted Calcium Stearate IP (2.000 kg) in Pre- Lubricated Material of Step-VII and mix properly till uniform mixing of materials with Calcium Stearate IP.
Mixing Time: 05 minutes. (clockwise direction)
Mixing Speed: 10 RPM.
STEP- IX (BLEND SAMPLE ANALYSIS):
After completion of lubrication, collect the composite blend sample 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
Off white 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
STEP – X:
Unload the above blended material and weight and store into two Poly-lined HDPE Container (capacity: 30 liter each)
STEP – XI:
Clean all equipments used in the granulation as per respective equipment cleaning SOP.
6.2 COMPRESSION:
STEP – I:
After receiving QC approval for blend, compress 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 (B-Tooling, 35 station Compression Machine)
—–
—–
4.
Machine Speed
20 RPM -22 RPM
—–
—–
5.
Upper Punch Size
6.5 mm
—–
—–
6.
Lower Punch Size
6.5 mm
—–
—–
7.
Die
6.5 mm
8.
Diameter
6.5 mm
6/Individual
2 hours
9.
Thickness of Tablets
2.70 mm ±.2 mm
6/Individual
2 hours
10.
Weight of 20 Tablets
2.200 gm. ± 2%
20/Composite
30 minutes
11.
Tablets for Dissolution
2.200 gm. ± 2%
12.
Uniformity of Weight
NMT 02 tablets out of 20 deviate from the average weight by more than 3 % and no single tablet deviates from the average weight by more than 5 %
—–
01 hour
13.
Average Weight of Tablets
110 mg ± 2 %
20/Individual
30 minutes
14.
Hardness
NLT 2.5 kg/cm 2
6/Individual
30 minutes
15.
Disintegration Time
NMT 15 min
6/Composite
01 hour
16.
Friability
NMT 1%
20/Composite
01 hour
STEP – II:
Send the sample of compressed tablets to QC department for analysis.
STEP – III:
Weigh the compressed tablets and store into two Poly-lined HDPE Containers (capacity: 30 liter each) with proper status label till next step tablet coating.
STEP – IV:
Clean the Compression Machine as per cleaning SOP
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