Ivermectin Tablet 03 mg USP

Ivermectin Tablet 03 mg USP

TABLE OF CONTENTS 

S.NO.TITLEPage No.
1.0PRODUCT DETAILS
2.0MANUFACTURING FORMULA
3.0LIST OF EQUIPMENTS
4.0GENERAL PRECAUTIONS
5.0MANUFACTURING INSTRUCTIONS
6.0MANUFACTURING PROCESS FLOW CHART
7.0

 

 

 

MANUFACTURING PROCESS DETAILS
7.1GRANULATION
7.2COMPRESSION
7.3PACKAGING

 RODUCT DETAILS:

Product NameIvermectin Tablets 03 mg USP
Product DescriptionWhite colored, round shaped, un-coated tablet having one side mid break line and other side plain.
Strength03 mg
Label claim

 

Each un- coated tablet contains:

Ivermectin  USP 03 mg

Batch Size100000 Tablets
Average Weight300 mg (Uncoated tablets)
Shelf Life24 months
StorageStore in a cool, dry and dark place below 250C
Drug CategoryAnti-Parasitic drug

MANUFACTURING FORMULA:

Material NameGradeCategoryQuantity per Unit (In mg)Batch Qty.

 (In kg)

Dry Mixing
Ivermectin*USPAPI3 mg0.300 kg
MCCP Ph-102**USPBinder264 mg26.400 kg
Magnesium StearateUSPAnti-Adherent3 mg0.300 kg
Sodium Starch GlycolateUSPBinder15 mg1.500 kg
Croscarmellose SodiumUSPDisintegrant15 mg1.500 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 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
Ivermectin0.300 kg60#
MCCP Ph-10226.400 kg60#
Magnesium Stearate0.300 kg40#
Sodium Starch Glycolate1.500 kg60#
Croscarmellose Sodium1.500 kg60#

 STEP-II (PRE-MIXING):

  1. Sift Ivermectin (0.300 kg) with Sodium Starch Glycolate (1.500 kg) in sifter using 60# sieve for homogeneous mixing.
  2. Transfer Material of step (a) in Bin Blender and add Croscarmellose Sodium (1.500 kg) and mix for 10 min at 10 RPM.
  3. Load the material of step (b) and MCCP Ph 102 (26.400 Kg), in Bin blender & mix for 30 min at 10 RPM.

STEP-III (BLENDING)

  • Add sifted Magnesium Stearate (300 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:

TestSpecification
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.ParametersStandardNo. of TabletsIn-Process  Frequency
1.       Machine Speed15 RPM -18 RPM—–—–
2.       Upper Punch Size9.0 mm­—–—–
3.       Lower Punch Size9.0 mm—–—–
4.       Avg. Diameter9.0 mm—–—–
5.       Weight of 20 Tablets6.000 gm. ± 2%20/Composite   30 minutes
6.       Product DescriptionWhite colored, round shaped, un-coated tablet having one side mid break line and other side plain.20/Composite    30 minutes
7.       Uniformity of Weight300 mg ± 5%20/Composite01 hour
8.        Average Weight of Tablets300 mg ± 2%20/Individual    30 minutes
9.       HardnessNLT 4 kg/cm26/Individual    30 minutes
10.   Disintegration TimeNMT 15 minutes6/Composite01 hour
11.   FriabilityNMT 1.0 % w/w20/Composite02 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: 30.00 kg (100 %)
  • Actual Batch Yield Limit NLT 29.700 kg (NLT 99 %)

STEP – IV:

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

PACKAGING:

Packing MaterialQuantity
CB 20X108 Print01  No.
Ivermectin-3 tab foil1.284 kg
Ivermectin-3 tab foil0.619 kg
PVC 350 184mm clear12.950 kg
Ivermectin-3 tab 10x1x1 carton524 No.
Ivermectin-3 tab 10x1x1 carton216 No.
Ivermectin-3 tab 1×1 inner carton7393 No.
Ivermectin-3 tab 1×1 inner carton6 No.
CB Common Large Print5 No.

 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 Temperature140oC to 150oC
Sealing Temperature145oC to 150oC
Pack sizeFoil184 mm
Outer Carton10x1x1
Inner Carton1×1
Analysis requiredPhysical & visual evaluation
Acceptance CriteriaPrinting should sharp & legible. Leak test should pass

Finished Product Specification

     Analyze the finished product samples as per the current Standard Testing Procedure.

 

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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