Rabeprazole 20 mg Tablet | Formulation & Manufacturing Process

Rabeprazole is a medication that decreases stomach acid. It is used to treat peptic ulcer disease, gastroesophageal reflux disease, and excess stomach acid production such as in Zollinger–Ellison syndrome. It may also be used in combination with other medications to treat Helicobacter pylori. Effectiveness is similar to other proton pump inhibitors (PPIs). It is taken by mouth.

Rabeprazole was patented in 1986, and approved for medical use in 1997. It is available as a generic medication. In 2017, it was the 288th most commonly prescribed medication in the United States, with more than 1 million prescriptions.

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

Each enteric-coated tablet contains Rabeprazole 20 mg as Rabeprazole Sodium USP. The formulation & manufacturing process of Rabeprazole 20 mg Tablet is as below:


Each tablet contains:

SlName of IngredientsSpecificationQuantityFunction
Active Ingredient
1Rabeprazole SodiumUSP22.60 mg
(Equivalent to
Rabeprazole 20 mg)
2Microcrystalline Cellulose 101BP78.87 mgBinder/Disintegrant
3Sodium Starch GlycolateBP10.00 mgDisintegrant
4Purified TalcBP3.00 mgLubricant
5Magnesium StearateBP2.00 mgLubricant
6Lactose MonohydrateBP52.17 mgDiluent
7Polyvinylpyrrolidone K-30BP1.95 mgBinder
Film Coating Materials
8Hydroxypropyl MethylcelluloseBP6.82 mgCoating Material
9Polyethylene Glycol 6000BP0.94 mgCoating Material
10Propylene GlycolBP0.85 mgCoating Material
11Purified TalcBP0.94 mgCoating Material
12Titanium DioxideBP0.94 mgCoating Material
13* Isopropyl AlcoholBP57.84 mgCoating Material
14* DichloromethaneBP11.57 mgCoating Material
Enteric Coating Materials
15Methacrylic Acid & Ethyl AcrylateBP21.50 mgCoating Material
16Propylene GlycolBP3.22 mgCoating Material
17Purified TalcBP5.73 mgCoating Material
18Titanium DioxideBP0.72 mgCoating Material
19Color F D & C Blue No. 1Pharma Grade0.012 mgCoating Material
20* Purified WaterBP111.42 mgCoating Material
21* Carnauba WaxBP0.25 mgCoating Material
22* ChloroformBP2.00 mgCoating Material

*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:

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.

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