Terms and Conditions

Ivermectin Tablet 12 mg USP

Byiamraj

Aug 13, 2021 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Ivermectin Tablet 12 mg USP

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 FLOW CHART
7.0

 

 

 

MANUFACTURING PROCESS DETAILS
7.1 GRANULATION
7.2 COMPRESSION
7.3 PACKAGING

 PRODUCT DETAILS:

Product Name Ivermectin Tablets 12mg USP
Product Description White colored, round shaped, un-coated tablet having one side mid break line and other side plain.
Strength 12 mg
Label claim

 

Each un- coated tablet contains:

Ivermectin  USP 12 mg

Batch Size 1,00,000 Tablets
Average Weight 300 mg (Uncoated tablets)
Shelf Life 24 months
Storage Store in a cool, dry and dark place below 250C
Drug Category Anti-Parasitic drug

MANUFACTURING FORMULA:

Material Name Grade Category Quantity per Unit (In mg) Batch Qty.

 (In kg)

Dry Mixing
Ivermectin* USP API 12mg 1.200kg
MCCP Ph-102 ** USP Diluent 255mg 25.500 kg
Magnesium Stearate USP Anti-Adherent 3 mg 0.300 kg
Sodium Starch Glycolate USP Binder 15 mg 1.500 kg
Croscarmellose Sodium USP Disintegrant 15 mg 1.500 kg

  *   Actual quantity of Ivermectin used in batch manufacture is based on assay on dried basis.

  ** Final Quantity to be adjusted.

DISPENSING WEIGHT CALCULATION FOR IVERMECTIN:

    

Based on the assay value, appropriate calculation method shall be used for dispensing weight   calculation of Ivermectin:

Dispensing weight of Ivermectin   =     Theoretical weight of Ivermectin  x 100 x 100

                                                                            Assay on anhydrous basis (100 – water content)

LIST OF EQUIPMENT:                                                                        

Sr. No. Machineries/Equipments
1. Weighing Balance
2. Vibro Sifter
3. Bin Blender
4. Bin Blender
5. Halogen Moisture Balance
6. Compression Machine
7. Blister Packing Machine

 GENERAL PRECAUTIONS:

  • API Description: A off white or almost white color powder. Protected from moisture during storage.
  • 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.

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:

GRANULATION:

STEP – I (SIFTING):

  • Check Sieve Integrity (before sifting and after sifting).
  • Set the Vibro Sifter and sieve the Dispensed Materials as per Sieve Sizes mentioned below
Material Name Std. Qty. (kg) Sieve No.
Dry Mixing
Ivermectin 1.200kg 60#
MCCP Ph-102 25.500 kg 40#
Magnesium Stearate 0.300 kg 60#
Sodium Starch Glycolate 1.500 kg 60#
Croscarmellose Sodium 1.500 kg 60#

  STEP-II (PRE- MIXING):

  1. Sift Ivermectin IP (1.200 kg) with Sodium Starch Glycolate IP (0.300 kg) in sifter using 60# sieve for homogeneous mixing.
  2. Transfer Material of step (a) in Bin Blender and add Cross Carmellose Sodium IP (1.500 kg) and mix for 10 min at 10 RPM.
  3. Load the material of step (b) and MCCP Ph 102 (25.500 Kg) in Bin blender & mix for 30 min at 10 RPM.

STEP-III (BLENDING)

  • Add sifted Magnesium Stearate (0.900 Kg) in Bin Blender of Step-II(c) & mix for 05 minutes at 10 RPM.

STEP- IV (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

White color free flowing granular powder

90 % to 110 %

95 % to 105 %

 STEP – XI:

  • Take Tare Weight of two Poly-lined HDPE Containers, record the Tare Weigh in BMR and unload the above blended material from Double cone blender in Poly-lined HDPE Containers 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 Containers.
  • Batch Yield of Lubricated granules:

Theoretical Batch Yield: 30.000 kg (100 %)

Actual Batch Yield Limit NLT 29.700 kg (NLT 99 %)

STEP – XII:

  • 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.
  • Set the 35 stations (B-Tooling) Compression Machine. Compress the blend as per below parameters and Perform the Initial In Process checks.
  • After Initial setting, continue the compression with the blend as per the following parameters and In Process checks under controlled environmental condition.
Sr. No. Parameters Standard No. of Tablets In-Process  Frequency
1.        Machine Speed 15 RPM -18 RPM —– —–
2.        Upper Punch Size 9.0 mm ­—– —–
3.        Lower Punch Size 9.0  mm —– —–
4.        Avg.- Diameter 9.0 mm 6/Individual 1 hours
5.        Thickness of Tablets 4.40 mm ± 0.2 mm 6/Individual 1 hours
6.        Weight of 20 Tablets 6.000 gm. ± 2% 20/Composite    30 minutes
7.        Product Description White colored, round shaped, un-coated tablet having one side mid break line and other side plain. 20/Composite     30 minutes
8.        Uniformity of Weight 300 mg ± 5% 20/Composite 01 hour
9.         Average Weight of Tablets 300 mg ± 2% 20/Individual     30 minutes
10.    Hardness NLT 4 kg/cm2 6/Individual     30 minutes
11.    Disintegration Time NMT 15 minutes 6/Composite 01 hour
12.    Friability NMT 1.0 % w/w 20/Composite 01 hour
  • Collect the compressed tablets in SS Container, when SS containers are filled with tablets, transfer the tablets in two Poly-lined HDPE Containers as given in below Step-II. 

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, record the Tare Weight in BMR and transfer the compressed tablets in Poly-lined HDPE Containers 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 Container.
  • Batch Yield of Compressed Tablets:

Theoretical Batch Yield: 30.000kg (100 %).

Actual Batch Yield Limit NLT 29.700kg (NLT 99 %).

STEP – IV:

  • After completion of compression clean the Compression Machine as per cleaning SOPs

PACKAGING:

  • After receiving of QC approval for the compressed Tablet, pack the Tablets in Blister pack as per current approved packaging instructions.
  • Details of Primary Packaging Material are mentioned below:

Blister packing /   Equipment name: Blister Packing machine.

Parameters to be Monitored:
Blister Forming Temperature 140oC to 150oC
Sealing Temperature 145oC to 150oC
Pack size Foil 210 mm
Outer Carton 4x5x2
Analysis required Physical & visual evaluation
Acceptance Criteria Printing should sharp & legible. Leak test should pass

Finished Product Specification     

  • Analyse the finished product samples as per current Standard Testing Procedure.

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