Formula Master Telmisartan 40mg Tablet

Master Manufacturing Formula (MFR): Telmisartan 40 mg Tablets IP

Source: drugsformulations.com via archive.org

TABLE OF CONTENTS

1.0 PRODUCT DETAILS

2.0 MANUFACTURING FORMULA

3.0 LIST OF EQUIPMENTS

4.0 GENERAL PRECAUTIONS

• API Description: A white to off white crystalline powder.
• All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25° 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 the Activity 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.

6.0 MANUFACTURING PROCESS 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:

Collect sifted MCCP PH 102 IP (40.000 kg) in one Polybag (capacity: 50 kg).

Collect sifted Telmisartan IP (16.000 kg) in one Polybag (capacity: 20 kg).

Collect sifted Talcum IP (0.800 kg), MCCP PH-102 IP (7.400 kg), Sodium Starch Glycolate IP (3.000 kg), Crospovidone XL IP (12.000 kg) and Cross Carmellose Sodium IP (6.000 kg) in two Polybags (capacity: 20 kg each).

STEP – II (SLURRY PREPARATION):

(a) Take purified water (24.480 liter) in Paste Kettle (capacity: 100 liter), heat the purified water to 45° C.

(b) Transfer the heated purified water (Qty. 24.480 liter) in Planetary Mixer (capacity: 100 liter) and add Tween-80 IP (1.200 kg). Mix properly with continuously stirring until the consistent slurry appears.

(c) Slowly add Telmisartan IP with continuously stirring until the consistent slurry appears.

(d) Take purified water at room temperature separately (3.200 liter) in SS Container (capacity: 10 liter) and add Sodium Hydroxide (flakes) IP and mix properly with continuously stirring till dissolved properly in water.

(e) Let the solution of Step-II (d) cool down. Solution becomes warm due to exothermic reaction therefore hold the solution for half an hour.

(f) Add the solution of Step-II (e) drop wise in Step-II (c) continuously stirring, until the color of solution becomes like honey and all lumps in slurry disappear.

(g) Transfer the ready slurry by tilting the Planetary Mixer in one SS Container (capacity: 70 liter).

STEP – III (BINDING OF DRY MIX MATERIAL):

Transfer the sifted material MCCP-102 IP (40.000 kg) in Mass Mixer (capacity: 100 liter) and dry mix the material. Slowly add the slurry of Step-II (g) and mix for 20 minutes till uniform binding. After binding, collect the wet mass in SS Container (capacity: 100 liter).

STEP – V (WET SCREENING):

Check Sieve Integrity (before and after screening). Take the wet material and pass through sieve size 30# manually and collect the wet material in SS thirty trays (capacity: 3.000 kg each).

STEP – VI (DRYING):

Load thirty Trays in Tray Dryer. Switch ON heaters and set temperature at 45° C. Dry until LOD of granules is achieved between 1.0% at 105°C checking by Halogen Moisture Balance.

STEP – VII (SIZING/MILLING):

Check Sieve & Screen Integrity (before and after sifting & screening). Set the Vibro Sifter and fix the Sieve 30# and sieve the dried material. Collect in two Poly-lined HDPE Containers (capacity: 45 liter each) and remaining retention after sieving, pass through the Multi-Mill using screen size 1.5 mm. Weigh and record the sized/milled granules quantity.

STEP – VIII (LUBRICATION):

Load the sized granules of Step-VII in Double Cone Blender (capacity: 200 liter) and add sifted Talcum IP, MCCP PH-102, Sodium Starch Glycolate IP, Crospovidone XL IP and Cross Carmellose Sodium and mix properly till uniform mixing.

STEP – IX (BLEND SAMPLE ANALYSIS):

After completion of lubrication, collect composite blend sample (Qty: 10 gm) and send to QC for analysis:

STEP – X:

Take Tare Weight of three Poly-lined HDPE Containers (capacity: 45 liter each), record the Tare Weight in BMR and unload the blended material from Double Cone Blender. Calculate Net Weight = Gross Weight – Tare Weight. Affix status label with Product Name, Batch No., Batch Size, Mfg. Date, Exp. Date, Tare Weight, Gross Weight and Net Weight.

STEP – XI: Clean all equipment used in the granulation as per respective equipment cleaning SOP.

6.2 COMPRESSION

STEP – I:

After receiving QC approval for the blend, verify the Net Weight of the received blend as per status label. Set the 35 stations (B-Tooling) Compression Machine. Compress the blend as per the following parameters and In Process checks under controlled environmental conditions.

Collect the compressed tablets in SS Container (capacity: 20 liter each on both sides), when SS containers are filled, transfer the tablets in three Poly-lined HDPE Containers.

STEP – II: Send composite sample of compressed tablets (Qty. 30 tablets) to QC department for analysis.

STEP – III: Transfer compressed tablets to three Poly-lined HDPE Containers (capacity: 45 liter each). Calculate Net Weight = Gross Weight – Tare Weight. Affix status label.

STEP – IV: After completion of compression, 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):

NOTE: Color: As per packing material / according to the brands/products. The color and quantity of color to be used may vary from product to product as per the reference sample.

STEP – II (COATING EQUIPMENTS):

STEP – III (PREPARATION OF COATING SOLUTION):

Take Purified Water IP (10.560 liter, at room temperature) in SS Container (capacity: 20 liter) and add Instacoat White Aq.III (1.760 kg), mix together by Portable Stirrer continuously stirring till uniform mixing achieved. Mixing Time: 15 minutes (To be validated in next batch). Speed of stirrer: Constant. Filter with Filter Cloth 100# in SS Container (capacity: 20 liter). Keep the solution for 15 minutes to let the foam settle down. Thereafter proceed with coating process.

STEP – IV (COATING PROCEDURE):

Coating will be done in one lot, take total compressed tablets (88.000 kg tablets) for coating. Load tablets in coating pan (capacity: 42″), start hot air blower, set inlet air temperature at 70° C to 75° C, warm tablet bed to 40° C to 45° C. After warming up, take weight of 100 warmed tablets and also take weight of 100 tablets after coating, record in BMR for calculation of weight buildup.

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

STEP – VI: Send composite sample of coated tablets (Qty. 30 tablets) to QC department for analysis.

STEP – VII: Transfer coated tablets to three Poly-lined HDPE Containers (capacity: 45 liter each). Calculate Net Weight = Gross Weight – Tare Weight. Affix status label.