Tablet Betahistin 16 mg
(Original: Betahistine 16 Mg Tablets)
Sumber: drugsformulations.com via archive.org
MFR of Betahistine 16 mg Tablets
TABLE OF CONTENTS
S.NO.
TITLE
Page No
1.0
PRODUCT DETAILS
02 of 05
2.0
MANUFACTURING FORMULA
02 of 05
3.0
LIST OF EQUIPMENTS
02 of 05
4.0
MANUFACTURING INSTRUCTIONS
02 of 05
5.0
GENERAL PRECAUTIONS
02 of 05
6.0
PROSES PEMBUATAN DETAILS
03 to 05
1.0 PRODUCT DETAILS:
NAMA PRODUK
Betahistine Tablets
Product Description
White color round shape, uncoated tablet having one side mid break line
Strength
16 mg
Label claim
Each uncoated tablet contains:
Betahistine Dihydrochloride IP -16 mg
UKURAN BATCH
1,00,000 Tablets
Average Weight
120 mg
Shelf Life
24 months
Storage
Store in a cool, dry and dark place below 25 0 C.
Drug Category
Anti-vertigo
2.0 MANUFACTURING FORMULA:
Material Name
Grade
Category
Quantity per Unit (In mg)
Batch Qty.
(In kg)
Dry Mix
Betahistine Dihydrochloride IP
IP
API
16.30 mg
1.630 kg
MCCP PH -102
IP
Diluent
81.60 mg
8.160 kg
Binder
Ethyl Cellulose IP
IP
Binder
0.1 mg
0.010 kg
IPA
IP
Solvent
0.03 ml
3.000 Lt.
Lubricant
MCCP PH – 112 IP
IP
Diluent
14.0 mg
1.400 kg
Aerosil IP
IP
Glidant
2.00 mg
0.200 kg
Talcum IP
IP
Anti-caking agent
5.00 mg
0.500 Kg
Magnesium Stearate IP
IP
Anti- Adherent
1.00 mg
0.100 Kg
3.0 LIST OF EQUIPMENT’S:
Sr. No.
Machinery/equipment
Capacity
Equipment ID.
1.
Weighing Balance
300 kg
SC/PD/WBL/01
SC/PD/WBL/02
2.
Sifter (with SS Sieves No’s 14, 24, 30 and 60)
30”
SC/PD/SFT/01
SC/PD/SFT/02
3.
Mass Mixer with propeller
100 liter
SC/PD/MSM/01
SC/PD/MSM/02
4.
Stirrer for binder preparation
—
SC/PD/STR/01
SC/PD/STR/02
5.
Octagonal Blender
65 liter
SC/PD/GR/OB/03
6.
Tray Dryer
48 Trays
SC/PD/TRD/01
SC/PD/TRD/02
SC/PD/TRD/03
SC/PD/TRD/04
7.
Halogen Moisture Balance
—
SC/QC/007
8.
Compression Machine
35 Station
SC/PD/COM/02
SC/PD/CPM/06
9.
Poly-lined Containers with lid
30 liter (01 No’s) and
45 liter (01 No’s)
—
10.
SS Containers with lid
10 liter (4 No’s) and
20 liter (3 No’s)
SC/PD/SST/010
SC/PD/SST/065
11.
Filter Cloth 100 No.
0.5M
—
4.0 MANUFACTURING INSTRUCTIONS:
All the manufacturing activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 45 %).
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 GENERAL PRECAUTIONS:
Before working with Betahistine Hydrochloride, 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 effect:Feeling Sick (Nausea), Indigestion, Headache, Allergic skin reactions such as Itching and Rash.
PROSES PEMBUATAN DETAILS:
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 Mix
Betahistine Dihydrochloride IP
1.630 kg
24≠
MCCP PH -102
8.160 kg
40≠
Lubricant
MCCP PH – 112 IP
1.400 kg
30≠
Aerosil IP
0.200 kg
14≠
Talcum IP
0.500 Kg
60 ≠
Magnesium Stearate IP
0.100 Kg
30 ≠
Geometrically mix Betahistine Dihydrochloride IP (1.630 kg) with MCCP PH-102 IP (8.160 kg) before sifting.
Collect sifted Betahistine Dihydrochloride IP and MCCP PH -102 in SS Container (capacity: 20 liter).
Collect sifted MCCP PH – 112 IP,Aerosil IP and Talcum IP in SS Container (capacity: 10 liter).
Collect the sifted Magnesium Stearate IP in SS Container (capacity: 10 liter).
STEP –II (DRY MIXING):
Transfer the sifted Betahistine Dihydrochloride IP (1.630 kg) and MCCP PH- 102 IP (8.160 kg.) in Mass Mixer (capacity: 100 liter) and dry mix the materials 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 (3.000 liter) in SS container (capacity: 10 liters) and add Ethyl Cellulose (0.010 kg.) and mix together with stirrer till dissolved properly in IPA.
Filter it with 100# filter cloth & store in SS container (capacity: 10 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 in SS Container (capacity: 20 liter).
Mixing Time: 10 minutes
Mixing Speed: 36 RPM
Paddle (Blades) Timing & Direction = 5 minutes in clockwise direction & 5 minutes in anti-clockwise direction
STEP- V (DRYING):
Dry the wet mass of Step -IV as follows:
First air dry the granules for 30 minutes in Tray Dryer. Ensure that heaters at OFF mode during air drying. After air drying, dry the granules at 35 o in Tray Dryer until the LOD of granules is between 1.0 to 1.5% at 105 o C checked by Halogen Moisture Balance.
Drying Time: 3 to 4 Hours.
Drying Temperature: 35 o C
Raking Frequency: After every 15 minutes.
STEP -VI (SIZING/MILLING):
Check Sieve Integrity (before sifting and after sifting).
Sieve the dried material with sieve 40 # manually in Poly-lined SS Container (capacity: 20 liter)
STEP -VII (PRE –LUBRICATION):
Load the milled granules of Step-VI in Octagonal Blender and add sifted MCCP-PH-112 IP (1.4 kg), Aerosil IP (0.200 kg.) and Talcum IP (0.500 kg) and mix properly till uniform mixing of Pre-Lubricating material.
Mixing Time: 20 minutes. (10 minutes clockwise direction &10 minutes anti-clockwise direction)
Mixing Speed: 10 RPM
STEP – VIII (LUBRICATION):
Add the sifted Magnesium Stearate IP (0.100 kg.) in the Pre-Lubricated Material of Step-VII and mix properly till uniform mixing of materials with Magnesium Stearate is complete.
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
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 in one Poly-lined HDPE Containers (capacity: 45 liter).
STEP – XI
Clean all equipments used in the granulation as per respective equipment cleaning SOP.
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
18 RPM- 22 RPM
—–
—–
5.
Punch Size
6.5 mm
—–
—–
6.
Upper Punch
6.5 mm with break line
—–
—–
7.
Lower Punch
6.5 mm
—–
—–
8.
Die
6.5 mm
—–
—–
9.
Average – Diameter
6.5 mm
6/Individual
2 hours
10.
Thickness
2.5 mm ±.2 mm
6/Individual
2 hours
11.
Weight of 20 Tabs.
2.400 g ± 2%
20/Composite
30 minutes
12.
Uniformity of Weight
NMT 2 tablets out of 20 deviate from the average weight by more than 3%. No tablet deviates from the average weight by more than 5%
—–
01 hour
13.
Average Weight of Tablets
120 mg ± 2%
20/Individual
30 minutes
14.
Hardness
NLT 2.5 kg/cm 2
6/Individual
30 minutes
15.
Disintegration Time
NMT 10 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
Weight the compressed tablets and store into one Poly-lined HDPE Container with lid (capacity: 30 liter) with proper status label till next step tablet packing.
STEP – IV
Cleanthe Compression Machine as per cleaning SOP.
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