Rebamipide is a gastroprotective agent primarily used to treat gastric ulcers and gastritis. It enhances mucosal defense by stimulating mucus secretion, scavenging free radicals, and promoting prostaglandin synthesis in the gastric lining. Unlike proton pump inhibitors or H2 blockers, rebamipide doesn’t suppress acid production but works by repairing and protecting the mucosa.
It is commonly prescribed in Japan, South Korea, and several other Asian countries, especially for NSAID-induced gastric injury or chronic gastritis.
Therapeutic indications include:
∙ Gastric and duodenal ulcers
∙ Chronic gastritis
∙ Mucosal injury due to NSAIDs
∙ Supportive therapy in H. pylori eradication regimens (off-label)
Parent: Rebamipide
Parent: Rebamipide
Parent: Rebamipide
Parent: Rebamipide
Impurities in rebamipide mainly arise during multi-step chemical synthesis, which involves amide coupling, aryl substitution, and lactam formation. Regulatory requirements such as ICH Q3A/B and pharmacopeial guidelines (e.g., JP, EP) must be met for impurity levels.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
Photostability testing – to assess degradation under ICH Q1B conditions
Rebamipide is used to treat and prevent gastric mucosal damage, especially in conditions like gastritis, gastric ulcers, and NSAID-induced mucosal injury.
It promotes mucus production, enhances mucosal blood flow, and neutralizes reactive oxygen species, thereby protecting and healing the gastric lining without altering stomach acid levels.
No. Rebamipide does not neutralize or suppress acid. It works by enhancing the protective mechanisms of the gastric mucosa.
Store at room temperature, protected from moisture and direct sunlight. Keep in a tightly closed container to preserve stability.
