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:

Formulation:

Each tablet contains:

Sl	Composition	Specification	Quantity	Function
Active Ingredient
1	Vonoprazan Fumarate	INN	26.723 mg (Equivalent to 20.0 mg Vonoprazan)
Excipients
2	Microcrystalline Cellulose PH 102	BP	110 mg
3	Sodium Starch Glycolate	BP	5.00 mg
4	Colloidal Silicon Dioxide-200	BP	1.00 mg
5	Purified Talc	BP	1.00 mg
6	Magnesium Stearate	BP	1.00 mg
Coating Materials
7	Hydroxypropyl Methylcellulose 15 cps	BP	2.364 mg
8	Polyethylene Glycol-6000	BP	0.200 mg
9	Purified Talc	BP	0.230 mg
10	Titanium Dioxide	BP	0.190 mg
11	* Methanol	BP	24.00 mg
12	* Methylene Chloride	BP	26.00 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.