Wednesday , November 6 2024

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:

SlName of IngredientsSpecificationQuantityFunction
Active Ingredient
1Pantoprazole Sodium
Sesquihydrate
BP46.600 mg
(Equivalent to
Pantoprazole 40 mg)
Active
Excipients
2Microcrystalline Cellulose 101BP62.823 mgBinder/Disintegrant
3Sodium Starch GlycolateBP07.00 mgDisintegrant
4Colloidal Anhydrous SilicaBP04.00 mgGlidant
5Purified TalcBP03.00 mgLubricant
6Magnesium StearateBP02.00 mgLubricant
7Lactose MonohydrateBP69.565 mgDiluent
8Polyvinylpyrrolidone K-30BP02.611 mgBinder
Film Coating Materials
9Hydroxypropyl
Methylcellulose
BP62.823 mgCoating Material
10Polyethylene Glycol 6000BP07.00 mgCoating Material
11Propylene GlycolBP04.00 mgCoating Material
12Purified TalcBP03.00 mgCoating Material
13Titanium DioxideBP02.00 mgCoating Material
14* Isopropyl AlcoholBP69.565 mgCoating Material
15* DichloromethaneBP02.611 mgCoating Material
Enteric Coating Materials
16Methacrylic Acid &
Ethyl Acrylate
BP24.00 mgCoating Material
17Propylene GlycolBP3.67 mgCoating Material
18Purified TalcBP6.50 mgCoating Material
19Titanium DioxideBP0.57 mgCoating Material
20Color F D & C Blue No. 1Pharma Grade0.0077 mgCoating Material
21Lemon Yellow ColorPharma Grade0.0343 mgCoating Material
22* Purified WaterBP126.43 mgCoating Material
23* Carnauba WaxBP0.25 mg  Coating Material
24* ChloroformBP2.00 mgCoating 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:

SLNAME OF INGREDIENTSSPECIFICATION        QUANTITYFUNCTION
Active Ingredient(s)
1Pantoprazole Sodium SesquihydrateBP45.10 mg
(Equivalent to 40 mg
of Pantoprazole)
 
Excipient(s)
2Anhydrous Sodium CarbonateBP10.00 mg 
3MannitolUSP15.00 mg 
4CrospovidoneUSP-NF10.00 mg 
5Povidone K-30USP10.00 mg 
6Calcium StearateUSP-NF5.00 mg 
7Sodium Lauryl SulphateBP5.00 mg 
8Triethyl CitrateUSP-NF5.00 mg 
9Hydroxypropyl MethylcelluloseUSP20.00 mg 
10Stearic AcidBP5.00 mg 
11Microcrystalline Cellulose 102BP35.00 mg 
Coating Material(s)
12Opadry-OY-P7171 WhitePharma Grade20.00 mg 
13* Carnauba WaxBP0.10 mg 
14* Methyl AlcoholUSP-NF91.00 mg 
15* Methylene ChlorideUSP-NF133.00 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 70oC 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 INGREDIENTSSPECIFICATIONQUANTITYFUNCTION
Active Ingredient(s)                      
1Pantoprazole  Sodium SesquihydrateBP45.2 mg
(Equivalent to
40 mg Pantoprazole)
 
Excipient(s)
2  Maize StarchBP35.00 mg 
3  Dicalcium PhosphateBP20.00 mg 
4  Microcrystalline Cellulose 101BP30.00 mg 
5  Povidone K-30BP7.00 mg 
6  CrospovidoneBP15.00 mg 
7  Sodium Starch GlycolateBP10.00 mg 
8  Purified TalcBP7.00 mg 
9  Magnesium StearateBP3.00 mg 
Enteric Coating Material(s)
10Eudragit L-30 D55USP/NF6.50 mg 
11Hydroxy Propyl Methyl Cellulose 15 cpsUSP3.00 mg 
12Polyethylene Glycol – 6000BP0.80 mg 
13Purified TalcBP0.55 mg 
14Titanium DioxideBP0.60 mg 
15* Isopropyl AlcoholBP50.00 mg 
16* Methylene ChlorideBP70.00 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.

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