Vonoprazan 20 mg Tablet | Formulation & Manufacturing Process

Vonoprazan is a first-in-class potassium-competitive acid blocker medication. It was approved in the Japanese market in February 2015 and in Russia in April 2021.

Vonoprazan is used in the form of fumarate for the treatment of gastroduodenal ulcers (including some drug-induced peptic ulcers) and reflux esophagitis and can be combined with antibiotics for the eradication of Helicobacter pylori.

Co-packaged combinations of Vonoprazan with Amoxicillin and Vonoprazan with Amoxicillin and Clarithromycin were approved for medical use in the United States in May 2022.

There are several dosage forms and strengths available with Vonoprazan. One of the most common of which is Vonoprazan 20 mg Tablet.

Each film-coated tablet contains Vonoprazan Fumarate INN equivalent to Vonoprazan 20 mg. The formulation & manufacturing process of Vonoprazan 20 mg Tablet is as below:


Each tablet contains:

Active Ingredient
1 Vonoprazan FumarateINN26.723 mg
(Equivalent to
20.0 mg Vonoprazan)
2Microcrystalline Cellulose PH 102BP110 mg 
3Sodium Starch GlycolateBP5.00 mg 
4Colloidal Silicon Dioxide-200BP1.00 mg 
5Purified TalcBP1.00 mg 
6Magnesium StearateBP1.00 mg 
Coating Materials
7Hydroxypropyl Methylcellulose 15 cpsBP2.364 mg 
8Polyethylene Glycol-6000BP0.200 mg 
9Purified TalcBP0.230 mg 
10Titanium DioxideBP0.190 mg 
11* MethanolBP24.00 mg 
12* Methylene ChlorideBP26.00 mg 

* Will 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:

  • Take Vonoprazan Fumarate, Microcrystalline Cellulose PH 102, Sodium Starch Glycolate, Colloidal Silicon Dioxide-200.
  • Sieve all materials through mesh # 30.
  • Dry the materials up to LOD ≥1.5%.
  • Then pour into a cone blender and blend for 15 minutes.
  • Lubrication: Add magnesium stearate and mix for 3 minutes.
  • After QA approval start compression.
  • Perform and record in-process control parameters.
  • Collect tablets in suitable containers with double-lined polythene bags, and complete the Tablet In-Process Control Sheet.

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