Rabeprazole Levosulpiride

Functional dyspepsia, gastroesophageal reflux disease (GERD), and other acid-peptic disorders are widespread health conditions that impair the quality of life of millions of patients globally. To treat these complex gastrointestinal issues effectively, physicians often prefer combination therapies that address both acid suppression and gastrointestinal motility. One such highly effective and clinically validated formulation is Rabeprazole + Levosulpiride.

At BluepillExpress, we offer WHO-GMP compliant third-party manufacturing of Rabeprazole + Levosulpiride in various dosage forms and strengths. With advanced infrastructure, international regulatory expertise, and a focus on pharmaceutical excellence, we serve global pharmaceutical companies, hospitals, and government agencies with tailor-made manufacturing solutions.

Product Overview

Generic Name: Rabeprazole Sodium + Levosulpiride
Therapeutic Category: Antiulcer / Prokinetic / Antacid Combination
Pharmacological Class: Proton Pump Inhibitor (PPI) + Benzamide Derivative

Available Dosage Forms:

• Capsules (Sustained Release & Enteric-Coated)
• Tablets (Film-coated, immediate-release or sustained-release)

Common Strengths Offered:

• Rabeprazole 20 mg (EC) + Levosulpiride 75 mg (SR)
• Rabeprazole 20 mg + Levosulpiride 25 mg / 50 mg (for customized markets)

Packaging Options:

• Alu-Alu and blister packs (10×10, 1×10)
• Mono-cartons with multilingual inserts
• Private-label or institutional branding available
• Tamper-proof, moisture-resistant packs

Pharmacopoeial Standards: IP / BP / USP / Customized

Mechanism of Action

Rabeprazole Sodium:
A Proton Pump Inhibitor (PPI) that irreversibly inhibits the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells. This leads to suppression of both basal and stimulated gastric acid secretion.

Levosulpiride:
A selective dopamine D2 receptor antagonist that acts as a prokinetic agent. It enhances the motility of the upper gastrointestinal tract by promoting gastric emptying and reducing bloating, nausea, and functional dyspepsia symptoms. Levosulpiride also has mild antipsychotic and anxiolytic effects, which benefit patients with psychosomatic GI disorders.

Combination Advantage:

• Rabeprazole addresses hyperacidity, ulcers, and acid reflux
• Levosulpiride restores gastric motility and relieves symptoms like nausea, fullness, and bloating
• The combination is more effective than monotherapy in treating functional dyspepsia and GERD with motility disorder

Indications

Rabeprazole + Levosulpiride is indicated for the treatment of:

• Gastroesophageal Reflux Disease (GERD)
• Functional Dyspepsia
• Non-ulcer Dyspepsia
• Chronic gastritis with delayed gastric emptying
• Acid peptic disease (APD)
• Irritable Bowel Syndrome (IBS) with upper GI involvement
• Nausea, bloating, and heartburn due to motility disturbances

Dosage and Administration

Typical Adult Dose:

• One capsule or tablet once or twice daily, depending on severity and physician prescription
• To be taken 30–60 minutes before meals for optimal effect

Course Duration:

• Usually prescribed for 2–4 weeks; may be extended based on the patient’s response and diagnosis

Special Precautions:

• Avoid in patients with Parkinson’s disease due to dopaminergic interference
• Caution in renal impairment
• Not recommended during pregnancy unless medically justified

Pharmacokinetics

Rabeprazole:

• Bioavailability: ~52%
• Onset of action: Within 1 hour
• Half-life: ~1.5 hours
• Metabolism: Hepatic (non-CYP mediated), minimal drug interactions

Levosulpiride:

• Bioavailability: ~30% (in oral form)
• Half-life: ~6–7 hours
• Excretion: Primarily renal

The enteric coating of Rabeprazole ensures acid resistance, while Levosulpiride sustained-release offers a prolonged prokinetic effect, making this formulation highly effective for patients with GERD and delayed gastric emptying.

Clinical Benefits

• Dual-action approach: Combines acid suppression with prokinetic benefits
• Improves gastric emptying and reduces symptoms like bloating and nausea
• More effective than PPIs alone in managing functional dyspepsia
• Faster symptom relief in acid reflux and related disorders
• Well-tolerated with minimal CNS side effects in short-term therapy
• Beneficial in patients with psychological overlay in GI symptoms

Why Partner with BluepillExpress for Manufacturing?

1. WHO-GMP Certified Manufacturing Units

Our production facilities meet stringent international manufacturing norms:

• Dedicated lines for solid oral dosage forms
• Enteric coating and sustained-release technology
• Cleanroom processing environments
• In-house blister packing and labeling machines

2. End-to-End Customization Options

• Enteric-coated, SR, or dual-release formats
• Sugar-free or preservative-free options
• Custom packaging based on target market (institutional or branded)
• Unique color coding, shapes, or embossing as per client branding

3. Regulatory and Documentation Support

• Full dossier support (CTD / ACTD formats)
• COPP, FSC, COA, and product specifications
• Bioequivalence data support for regulated markets
• Multilingual labeling and packaging development
• Product registration support for semi-regulated and unregulated markets

4. Global Export Network and Logistics

BluepillExpress currently exports to:

• Africa: Nigeria, Ghana, Kenya, Ethiopia, Zambia
• Asia: Cambodia, Myanmar, Bangladesh, Philippines
• Middle East: Iraq, Jordan, UAE, Yemen
• CIS and Latin America: Uzbekistan, Bolivia, Peru

We offer complete export documentation, compliance with MOH requirements, and logistics coordination.

Quality Control and Assurance

All batches are subjected to rigorous QA/QC checks from raw material sourcing to finished product release.

Tests Performed:

• API assay for Rabeprazole and Levosulpiride
• Uniformity of content and weight
• Disintegration, dissolution, and friability tests
• pH and viscosity testing for SR coatings
• Microbiological testing
• Real-time and accelerated stability studies under ICH guidelines

Our in-house analytical laboratory is equipped with HPLC, UV-spectrophotometers, and dissolution testers to meet global quality standards.

Manufacturing Workflow at BluepillExpress

Step 1: Product Finalization
Define dosage, packaging, regulatory compliance, and market requirements.

Step 2: Sample & Artwork Development
Share pilot samples and mock-ups for packaging approval.

Step 3: Documentation and Pricing
Complete regulatory documentation, quotations, and contract manufacturing terms.

Step 4: Batch Production
WHO-GMP batch production with in-process quality control and batch record maintenance.

Step 5: Packaging & Shipping
Products are packed with precision and shipped with all required documentation for local or international clearance.

Target Market Segments

This combination is ideal for:

• Gastroenterology-focused brands
• Pharmaceutical distributors dealing in acid peptic disorders
• Hospitals and clinics
• Government procurement agencies
• OTC gastro-intestinal product portfolios (depending on regulations)
• Exporters seeking high-quality PPI combinations for global markets

Market Outlook

• The global GERD treatment market is projected to reach USD 6.2 billion by 2027.
• Rising incidence of functional dyspepsia and sedentary lifestyles are boosting demand for dual-action gastro formulations.
• Rabeprazole + Levosulpiride has gained significant traction in India, Southeast Asia, Africa, and Latin America, especially where delayed gastric emptying is common.
• Growing awareness of gut-brain interaction has increased adoption of prokinetic combinations in psychosomatic GI disorders.

BluepillExpress meets this demand with scalable production, global quality standards, and export-ready supply chains.

Conclusion

The combination of Rabeprazole and Levosulpiride offers a clinically effective and well-tolerated solution for a wide range of gastrointestinal disorders. With dual-action on acid suppression and gastric motility enhancement, it is preferred by healthcare providers across diverse markets.

At BluepillExpress, we offer reliable, regulatory-compliant, and scalable third-party manufacturing for this high-demand formulation. Whether you are building a gastroenterology brand, bidding on government tenders, or supplying export markets, BluepillExpress ensures quality, consistency, and on-time delivery.