Pantoprazole 40 mg Tablet | Formulation & Manufacturing Process

Pantoprazole is a proton pump inhibitor used for the treatment of stomach ulcers, short-term treatment of erosive esophagitis due to gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including Zollinger–Ellison syndrome. It may also be used along with other medications to eliminate Helicobacter pylori. Effectiveness is similar to other proton pump inhibitors (PPIs). It is available by mouth and by injection into a vein.

The study of pantoprazole began in 1985, and it came into medical use in Germany in 1994. It is available as a generic medication. In 2020, it was the twentieth most commonly prescribed medication in the United States, with more than 26 million prescriptions.

There are several dosage forms and strengths available with Pantoprazole. The most common of which is Pantoprazole 40 mg Tablet.

Each enteric-coated tablet contains Pantoprazole 40 mg as Pantoprazole Sodium Sesquihydrate BP. The formulation & manufacturing process of Pantoprazole 40 mg Tablet is as below:

Formulation-1:

Sl	Name of Ingredients	Specification	Quantity	Function
Active Ingredient
1	Pantoprazole Sodium Sesquihydrate	BP	46.600 mg (Equivalent to Pantoprazole 40 mg)	Active
Excipients
2	Microcrystalline Cellulose 101	BP	62.823 mg	Binder/Disintegrant
3	Sodium Starch Glycolate	BP	07.00 mg	Disintegrant
4	Colloidal Anhydrous Silica	BP	04.00 mg	Glidant
5	Purified Talc	BP	03.00 mg	Lubricant
6	Magnesium Stearate	BP	02.00 mg	Lubricant
7	Lactose Monohydrate	BP	69.565 mg	Diluent
8	Polyvinylpyrrolidone K-30	BP	02.611 mg	Binder
Film Coating Materials
9	Hydroxypropyl Methylcellulose	BP	62.823 mg	Coating Material
10	Polyethylene Glycol 6000	BP	07.00 mg	Coating Material
11	Propylene Glycol	BP	04.00 mg	Coating Material
12	Purified Talc	BP	03.00 mg	Coating Material
13	Titanium Dioxide	BP	02.00 mg	Coating Material
14	* Isopropyl Alcohol	BP	69.565 mg	Coating Material
15	* Dichloromethane	BP	02.611 mg	Coating Material
Enteric Coating Materials
16	Methacrylic Acid & Ethyl Acrylate	BP	24.00 mg	Coating Material
17	Propylene Glycol	BP	3.67 mg	Coating Material
18	Purified Talc	BP	6.50 mg	Coating Material
19	Titanium Dioxide	BP	0.57 mg	Coating Material
20	Color F D & C Blue No. 1	Pharma Grade	0.0077 mg	Coating Material
21	Lemon Yellow Color	Pharma Grade	0.0343 mg	Coating Material
22	* Purified Water	BP	126.43 mg	Coating Material
23	* Carnauba Wax	BP	0.25 mg	Coating Material
24	* Chloroform	BP	2.00 mg	Coating Material

*Does not appear in the final product.

Manufacturing Process-1:

The process consists of sieving the active ingredient & excipients through a Vibration Shifter and granules preparation by rapid mixture/granulator & blending that is followed by a Drum Blender. The Tablet will be compressed by a tablet compression machine and coating will be carried out by Auto coater. Tablets will be blistered by the Blister machine.

Formulation-2:

Each Tablet Contains:

SL	NAME OF INGREDIENTS	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s)
1	Pantoprazole Sodium Sesquihydrate	BP	45.10 mg (Equivalent to 40 mg of Pantoprazole)
Excipient(s)
2	Anhydrous Sodium Carbonate	BP	10.00 mg
3	Mannitol	USP	15.00 mg
4	Crospovidone	USP-NF	10.00 mg
5	Povidone K-30	USP	10.00 mg
6	Calcium Stearate	USP-NF	5.00 mg
7	Sodium Lauryl Sulphate	BP	5.00 mg
8	Triethyl Citrate	USP-NF	5.00 mg
9	Hydroxypropyl Methylcellulose	USP	20.00 mg
10	Stearic Acid	BP	5.00 mg
11	Microcrystalline Cellulose 102	BP	35.00 mg
Coating Material(s)
12	Opadry-OY-P7171 White	Pharma Grade	20.00 mg
13	* Carnauba Wax	BP	0.10 mg
14	* Methyl Alcohol	USP-NF	91.00 mg
15	* Methylene Chloride	USP-NF	133.00 mg
* Does not appear in the final product.
** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process-2:

Check and weigh all the raw materials listed on the formulation order that will be used to manufacture the product.  Check all the process equipment that will be used in this manufacturing process.  Carry out Raw Materials tests from the Quality Control Department.  Weigh active substances and excipients accurately.

• Take sieved mannitol, crospovidone, microcrystalline cellulose, hydroxypropyl methylcellulose, triethyl citrate, and pantoprazole sodium in a mass mixer bowl and mix well. 
• Prepare granulating fluid of povidone with purified water.  Add with Step-I and mix for 15 minutes.
• Dry the wet mass with a fluid bed dryer at 70^oC for 10 minutes. Pass the partially dried mass through a multimill using suitable mesh.
• Dry the granules with a fluid bed dryer at 60oC for 20 minutes.  Pass the granules through an oscillating granulator.
• Take the granules to the blender.  Add anhydrous sodium carbonate, sodium lauryl sulfate, calcium stearate, and stearic acid and blend for 30 minutes.
• Advise the QC Department to collect samples for quality tests.
• After QC release, the granules will be compressed to tablets by a suitable tablet compressor.
• Advise the QC Department to collect samples for quality tests.
• On QC release coat the tablets with the coating machine.
  • Coating Procedure:
  • Take opadry-OY-P7171 white to the mixing vessel, add methyl alcohol, and methylene chloride, and mix for 1 hour.
  • Set up pan speed, exhaust fan, temperature, etc. of the machine.  Apply coating solution with a pneumatic control spray device.  Spray coating solution until the solution is completely applied.
  • Dry the tablets and make them ready for packaging after polishing them with carnauba wax.
• Advise the QC Department to collect samples for tests.
• On QC release pack the tablets.

Formulation-3:

Each Tablet Contains:

SL	NAME OF INGREDIENTS	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s)
1	Pantoprazole  Sodium Sesquihydrate	BP	45.2 mg (Equivalent to 40 mg Pantoprazole)
Excipient(s)
2	Maize Starch	BP	35.00 mg
3	Dicalcium Phosphate	BP	20.00 mg
4	Microcrystalline Cellulose 101	BP	30.00 mg
5	Povidone K-30	BP	7.00 mg
6	Crospovidone	BP	15.00 mg
7	Sodium Starch Glycolate	BP	10.00 mg
8	Purified Talc	BP	7.00 mg
9	Magnesium Stearate	BP	3.00 mg
Enteric Coating Material(s)
10	Eudragit L-30 D55	USP/NF	6.50 mg
11	Hydroxy Propyl Methyl Cellulose 15 cps	USP	3.00 mg
12	Polyethylene Glycol – 6000	BP	0.80 mg
13	Purified Talc	BP	0.55 mg
14	Titanium Dioxide	BP	0.60 mg
15	* Isopropyl Alcohol	BP	50.00 mg
16	* Methylene Chloride	BP	70.00 mg
* Does not appear in the final product.
** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process-3:

• All the ingredients are weighed accurately as per the manufacturing order.
• The ingredients are sifted by using a mechanical sifter.
• Pantoprazole Sodium Sesquihydrate, Maize Starch, Dicalcium Phosphate, and Microcrystalline Cellulose 101 are poured into the RMG machine and mixed for 10 minutes.
• Binding fluid is prepared with Povidone K-30 and purified water and slowly poured in step – 3 & mixed for 2 min. Then the wet granules are made by using  Multimill.
• The wet granules are dried by using a fluid-bed dryer & finally, the granules are graded.
• The final granules are taken in a drum mixer and blended with Crospovidone, Purified Talc, Magnesium Stearate, and Sodium Starch Glycolate for 30 min.
• Then the sample is sent to the QC department for analysis. After getting approval from the Q.C department, the granules are compressed into tablets.

Enteric Coating :

• The coating solution is made with Enteric coating materials & solvents and then filter the solution.
• The coating solution is sprayed onto the core tablets by using a Suitable COATING machine. All the operations are carried out in the controlled condition.