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Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet.
1Department of Pharmaceutical Engineering, Catholic University of Daegu, Hayang-Ro 13-13, Gyeongsan City 38430, Gyeongbuk, Korea.
Pharmaceutics
|March 6, 2021
Summary
This study developed stable, immediate-release rabeprazole sodium tablets for GERD treatment. The new formulation offers rapid absorption and efficacy, overcoming limitations of existing delayed-release options.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
Background:
- Rabeprazole sodium, a proton pump inhibitor for GERD, is unstable in acidic conditions, limiting its formulation options.
- Existing rabeprazole sodium products are primarily enteric-coated, delaying therapeutic onset.
Purpose of the Study:
- To develop stable, immediate-release (IR) oral rabeprazole sodium tablets.
- To enhance gastric stability and achieve rapid efficacy for GERD treatment.
Main Methods:
- Utilized a Quality by Design (QbD) approach to formulate IR dry-coated tablets.
- Incorporated an outer sodium bicarbonate layer to stabilize rabeprazole sodium in the stomach.
- Evaluated tablet stability, dissolution rate, and in vivo pharmacokinetics in beagle dogs.
Main Results:
- Developed stable IR tablets with a shelf life of approximately 12 months.
- Achieved high dissolution rates (>90% at 30 min) and rapid gastric absorption.
- Demonstrated pharmacokinetic bioequivalence to delayed-release tablets, with a significantly faster Tmax (0.5 h).
Conclusions:
- The novel IR rabeprazole sodium tablet formulation provides rapid therapeutic relief for GERD.
- This development overcomes limitations of current proton pump inhibitor formulations, offering a faster-acting alternative.
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