Formula Master Levocetirizin 5mg Tablet

LEVOCETIRIZINE 5 MG TABLETS IP

Sumber: archive.org (drugsformulations.com)

MFR of Levocetirizine 5 mg Tablets IP

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

PROSES PEMBUATAN DETAILS

6.1

GRANULATION

6.2

COMPRESSION

6.3

COATING

6.4

BRAND DETAILS

1.0 PRODUCT DETAILS:

NAMA PRODUK

Levocetirizine Dihydrochloride Tablets IP

Product Description

White color round shape, biconvex, film coated tablet having both side plain.

Strength

5 mg

Label claim

Each film coated tablet contains:

Levocetirizine Dihydrochloride  IP – 5 mg

UKURAN BATCH

5,00,000 Tablets

Average Weight

100 mg (Uncoated tablets)

102 mg (Film coated tablets)

Shelf Life

24 months

Storage

Store in a cool, dry and dark place below 25 0 C

Drug Category

Anti-histamine Drug

2.0 MANUFACTURING FORMULA:

Material Name

Grade

Category

Quantity per Unit (In mg)

Overages

Batch Qty.

(In kg)

Dry Mixing

Levocetirizine Dihydrochloride

IP

API

5 mg

1 %

2.525 kg

MCCP PH-102

IP

Diluent

10.15 mg

—

5.075 kg

Starch

IP

Diluent

5.0 mg

—

2.500 kg

Cross Carmillose Sodium

IP

Disintegrants

1.25 mg

—

0.625 kg

Binder

Ethyl Cellulose

IP

Binder

0.02 mg

—

0.010 kg

Isopropyl Alcohol (IPA)

IP

Solvent

0.02 ml

—

10.800 liter

Lubricant

Talcum

IP

Anti-caking agent

3 .0 mg

—

1.500  kg

MCCP PH-102

IP

Diluent

71.30 mg

—

35.650 kg

Cross Carmillose Sodium

IP

Disintegrants

1.25 mg

—

0.625 kg

Aerosil

IP

Glidant

1.0 mg

—

0.500 kg

Calcium Stearate

IP

Anti-Adherent

2.0 mg

—

1.000 kg

3.0 LIST OF EQUIPMENTS:

Sr. No.

Machineries/Equipments

Capacity

Equipment ID.

1.

Weighing Balance

100 kg

2.

Vibro Sifter (with SS Sieves No’s 14,40,60 and 100)

30 inch dia

3.

Mass Mixer with propeller

100  liter

4.

Portable Stirrer

—

5.

Tray Dryer

48 Trays

6.

Double Cone Blender

200 liter

7.

Halogen Moisture Balance

—

8.

Compression Machine

35 Station

9.

SS Containers with lid

20  liter (02 No’s)

—

10.

Poly-lined HDPE Containers with lid

30 liter (05 No’s)

—

11.

Polybags

2.0 ,20 and 50 kg

12.

Filter Cloth 100 #

0.5 meter

4.0 GENERAL PRECAUTIONS:

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 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 any entry. In case of mistake, cancel the entry by single line with sign & date and make correct entry.

PROSES PEMBUATAN 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

Levocetirizine  Dihydrochloride IP

2.525 kg

40 #

MCCP PH-102 IP

5.075  kg

40 #

Starch IP

2.500 kg

100 #

Cross Carmillose Sodium IP

0.625 kg

40 #

Binder

Ethyl Cellulose IP

0.010 kg

—

Isopropyl Alcohol IP ( IPA)

10.800 liter

—

Lubricant

Talcum IP

1.500 kg

60 #

MCCP PH-102 IP

35.650 kg

40 #

Cross Carmillose Sodium IP

0.625 kg

40 #

Aerosil IP

0.500 kg

14 #

Calcium Stearate IP

1.000 kg

60 #

Collect the sifted Levocetirizine Dihydrochloride IP (2.525 kg), MCCP PH-102 IP (5.075 kg), Starch IP (2.500 kg) and Cross Carmillose Sodium IP (0.625 kg) in one Polybag (capacity: 20 kg).

Collect the sifted Talcum IP (1.500 kg), MCCP PH-102 IP (35.650 kg), Cross Carmillose Sodium IP (0.625 kg) and Aerosil IP (0.500 kg) in one Polybag (capacity: 50 kg).

Collect the sifted Calcium Stearate IP (1.000 kg) in one Polybag (capacity: 2.0 kg).

STEP – II (BINDER PREPARATION):

Take Isopropyl Alcohol IP (10.800 liter) in SS Container (capacity: 20 liter) and add Ethyl Cellulose IP (0.010 kg) in it. Mix together by Portable Stirrer continuously stirring till Ethyl Cellulose IP is dissolved properly in IPA.

Mixing Time: 10 minutes.

Filter it with filter cloth 100 # in SS container (capacity: 20 liter).

STEP – III (DRY MIXING):

Transfer the sifted material Levocetirizine Dihydrochloride IP, MCCP PH-102 IP, Starch IP and Cross Carmillose Sodium IP 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: 5 minutes in clockwise direction and 5 minutes in anti-clockwise direction.

STEP –IV (BINDING OF DRY MIX MATERIAL):

Slowly add the binder of Step-II in dry mix material of Step-III and mix for 10 minutes till uniform binding and after binding, collect the wet mass in four Trays  (capacity: 3.000 kg each).

Mixing Time: 10 minutes.

Mixing Speed: 36 RPM.

Paddle (Blades) Timing: 5 minutes in clockwise direction and 5 minutes in anti-clockwise direction.

STEP –V (DRYING):

Dry the wet material of Step-IV as follows:

Load these four Trays in Tray dryer.

First air dry the granules for 30 minutes in Tray Dryer. Ensure that Heaters are in OFF mode during air drying. After 30 minutes of air drying Switch ON the heaters and set the temperature at 35°C and dry the granules, until the LOD of granules is achieved between 1.0 to 1.5 % at 105°C checking by Halogen Moisture Balance.

Drying Temperature: 35°C (After Air Drying)

Drying Time: 03 hours (To be validated in next batch).

Raking Frequency: After every 20 minutes.

STEP-VI (SIZING/MILLING):

Check Sieve Integrity (before sifting and after sifting).

Set the Vibro Sifter and fix the sieve 40 # and sieve the dried material of Step-V. Collect the sized granules in one Poly-lined HDPE Container (capacity: 30 liter).

STEP – VII (PRE –LUBRICATION):

Load the sized granules of Step-VI in Double Cone Blender (capacity : 200 liter) and add sifted Talcum IP, MCCP PH-102 IP, Cross Carmillose Sodium IP and Aerosil IP, mix properly till uniform mixing of sized material with Pre-Lubricating Materials.

Mixing Time: 40 minutes (20 minutes clockwise direction and 20 minutes anti-clockwise direction).

Mixing Speed: 10 RPM.

STEP – VIII (LUBRICATION):

Add the sifted Calcium Stearate IP in Pre- Lubricated Materials of Step-VII in Double Cone Blender 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 (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 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:

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 – NAMA PRODUK, BATCH NO., BATCH SIZE, MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINERS.

BATCH HASIL OF LUBRICATED GRANULES:

THEORETICAL BATCH HASIL: 50.000 KG (100 %)

ACTUAL BATCH HASIL LIMIT: 49.500 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH).

STEP – XI:

Clean all equipments used in the granulation as per respective equipment cleaning SOP.

6.2 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 In Process checks and take a sample for Dissolution (Qty. 20 tablets) and send to QC Department for Dissolution Analysis.

After confirmation of Dissolution result continue the compression with 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

18 RPM to 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

2.5 mm ± 0.2 mm

6/Individual

2 hours

10.

Weight of 20 Tablets

2.00 gm ± 2 %

20/Composite

30 minutes

11.

Tablets for Dissolution

100 mg ± 2 %

20/ Composite

Before starting the Compression

12.

Dissolution

NLT 80 %

—-

—-

13.

Product Description

White color, round shape, biconvex, uncoated tablet having both side plain.

20/Composite

30 minutes

14.

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

15.

Standard Average Weight of Tablets

100 mg ± 2 %

20/Individual

30 minutes

16.

Hardness

NLT 3.0 kg/cm 2

6/Individual

30 minutes

17.

Disintegration Time

NMT 15 min (IHS NLT 03 minute)

6/Composite

01 hour

18.

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 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 – NAMA PRODUK, BATCH NO., BATCH SIZE, AVG. WEIGHT, MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINERS.

BATCH HASIL OF COMPRESSED TABLETS:

THEORETICAL BATCH HASIL: 50.000 KG (100 %).

ACTUAL BATCH HASIL LIMIT: 49.500 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH).

STEP – IV:

After completion of compression of tablets, clean the Compression Machine as per cleaning SOP.

6.3 COATING:

Verify the Net Weight of the received compressed tablets for coating as per status label and after confirmation continue for tablet coating.

STEP – I (COATING MATERIALS DETAILS):

S. No.

Material Name

Batch Quantity

1.

Instacoat White Aq.III

1.000 kg.

2.

Purified Water IP

6.000 liter

NOTE:

STEP-II (LIST OF EQUIPMENTS FOR COATING):

Sr. No.

Machineries/Equipments

Capacity

Equipment ID.

1.

Coating Machine and Coating Pan

36″

2.

Spray Gun

01

—

3.

Filter Cloth 100 #

0.5 meter

—

4.

Portable Stirrer

—

—

5.

SS Container

10 liter (02 No’s)

—

6.

Poly-lined HDPE Containers with lid

30 liter (02 No’s)

—

STEP – III (PREPARATION OF COATING SOLUTION):

Take Purified Water IP (6.000 liter at room temperature) in SS Container (capacity: 10 liter) and add Instacoat White Aq.III (1.000 kg) and mix together by Portable Stirrer continuously stirring till uniform mixing achieved.

Speed of Stirrer: Constant.

Mixing Time: 15 minutes.

Filter the coating solution with Filter Cloth 100 # in SS Container (capacity: 10 liter).

Keep the solution for 15 minutes to let it the foam settle down. Thereafter proceed with coating process.

STEP – IV (COATING PROCEDURE):

Coating will be done in one lot, take total compressed tablets for coating (50.000 kg).

Load the tablets in coating pan (Capacity: 36″), start the hot air blower, set the inlet air temperature at 60°C to 65°C and start the exhaust fan & warm the tablets bed 40°C to 45°C.

After warming up the tablets, take weight of 100 warmed tablets and record the weight in BMR for calculation of weight buildup of tablets after coating.

Set the coating parameter as given in below table and start the coating process by starting coating spray through gun.

Parameter

Specification

No. of Baffles in coating pan

03

No. of Guns

01

Inlet Temperature

60°C to 65°C (To be validated in next batch)

Peristaltic Pump Speed

2 – 4 RPM (To be validated in next batch)

Atomization

2.5 to 3.0 kg/cm 2

Gun to Tablet Bed Distance

10 inch

BED Temperature

40 0 C to 45 0 C (To be validated in next batch)

Pan RPM

13 to 15 RPM

% Weight Gain

1.5 to 2.0 %

Coating Time

01 Hour (To be validated in next batch)

STEP – V (COATING IN-PROCESS CHECK PARAMETERS):

S.No.

Parameters

Standard

No. of Tablets

In-Process Frequency

1

Product Description

White color, round shape, biconvex, film coated tablet having both side plain

20 No.

After batch completion

2

Weight of 20 Tablets after coating

2.040 gm. ± 2 %

20 No.

3

Standard Average Weight after coating

102 ± 2 %

20 No.

4

Individual Tablets Weight Variation

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 No.

5

Thickness

2.6 mm ± 0.2 mm

6 No.

6

Disintegration

NMT 30 min.

6 No.

STEP – VI:

Send the composite sample of coated tablets (Qty. 30 tablets) to QC department for analysis.

STEP – VII:

Take Tare Weight of two Poly-lined HDPE Containers (capacity: 30 liter each), record the Tare Weight in BMR and transfer the coated tablets in Poly-lined HDPE Containers (capacity: 30 liter each) and weigh the coated tablets with containers and record the Gross Weight of the coated 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 – NAMA PRODUK, BATCH NO., BATCH SIZE, AVG. WEIGHT, MFG. DATE, EXP. DATE, TARE WEIGHT, GROSS WEIGHT AND NET WEIGHT ON THE POLY-LINED HDPE CONTAINERS.

BATCH HASIL OF COATED TABLETS:

THEORETICAL BATCH HASIL: 51.000 KG (100 %)

ACTUAL BATCH HASIL LIMIT NLT 50.490 KG (NLT 99 %) (TO BE ESTABLISHED IN NEXT BATCH).

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