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:

Formulation:

Each tablet contains:

Sl	Name of Ingredients	Specification	Quantity	Function
Active Ingredient
1	Rabeprazole Sodium	USP	22.60 mg (Equivalent to Rabeprazole 20 mg)	Active
Excipients
2	Microcrystalline Cellulose 101	BP	78.87 mg	Binder/Disintegrant
3	Sodium Starch Glycolate	BP	10.00 mg	Disintegrant
4	Purified Talc	BP	3.00 mg	Lubricant
5	Magnesium Stearate	BP	2.00 mg	Lubricant
6	Lactose Monohydrate	BP	52.17 mg	Diluent
7	Polyvinylpyrrolidone K-30	BP	1.95 mg	Binder
Film Coating Materials
8	Hydroxypropyl Methylcellulose	BP	6.82 mg	Coating Material
9	Polyethylene Glycol 6000	BP	0.94 mg	Coating Material
10	Propylene Glycol	BP	0.85 mg	Coating Material
11	Purified Talc	BP	0.94 mg	Coating Material
12	Titanium Dioxide	BP	0.94 mg	Coating Material
13	* Isopropyl Alcohol	BP	57.84 mg	Coating Material
14	* Dichloromethane	BP	11.57 mg	Coating Material
Enteric Coating Materials
15	Methacrylic Acid & Ethyl Acrylate	BP	21.50 mg	Coating Material
16	Propylene Glycol	BP	3.22 mg	Coating Material
17	Purified Talc	BP	5.73 mg	Coating Material
18	Titanium Dioxide	BP	0.72 mg	Coating Material
19	Color F D & C Blue No. 1	Pharma Grade	0.012 mg	Coating Material
20	* Purified Water	BP	111.42 mg	Coating Material
21	* Carnauba Wax	BP	0.25 mg	Coating Material
22	* Chloroform	BP	2.00 mg	Coating 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.