Esomeprazole + Itopride

The combination of Esomeprazole and Itopride represents a powerful and complementary treatment option for various gastrointestinal disorders, especially gastroesophageal reflux disease (GERD), functional dyspepsia, and acid peptic disorders. While Esomeprazole, a proton pump inhibitor (PPI), reduces gastric acid secretion, Itopride, a prokinetic agent, enhances gastrointestinal motility and accelerates gastric emptying. This fixed-dose combination is particularly useful for patients suffering from postprandial distress syndrome, heartburn, bloating, and early satiety.

At BluepillExpress, we specialize in the third-party and contract manufacturing of high-quality Esomeprazole + Itopride formulations, available in a variety of strengths and dosage forms. Our manufacturing infrastructure complies with WHO-GMP and ISO standards, ensuring global competitiveness and regulatory acceptability.

Therapeutic Applications

The Esomeprazole + Itopride combination is clinically effective in the treatment of:

• Gastroesophageal reflux disease (GERD)
• Functional dyspepsia (especially non-ulcer dyspepsia)
• Postprandial distress syndrome (PDS)
• Acid peptic disorders
• Chronic gastritis and gastroparesis
• Bloating, nausea, and indigestion
• Refractory acid reflux with impaired motility

This combination improves both gastric pH control and gut motility, offering dual-action relief in patients with overlapping symptoms.

Mechanism of Action

1. Esomeprazole (Proton Pump Inhibitor):
Esomeprazole is the S-isomer of omeprazole and offers enhanced bioavailability and acid suppression. It inhibits H+/K+ ATPase enzyme in the gastric parietal cells, leading to long-lasting suppression of acid secretion.

• Increases intragastric pH
• Promotes ulcer healing
• Reduces acid reflux and esophagitis
• Offers symptom control with once-daily dosing

2. Itopride (Prokinetic Agent):
Itopride acts via dual mechanisms: it inhibits dopamine D2 receptors and acetylcholinesterase in the gastrointestinal tract. This leads to increased acetylcholine levels, thereby enhancing gastric motility and improving coordination of the upper GI tract.

• Accelerates gastric emptying
• Reduces bloating and post-meal discomfort
• Improves gastric accommodation
• Minimally penetrates the blood-brain barrier (reducing CNS side effects)

Together, this combination provides rapid, comprehensive symptom control in patients with acid dysregulation and motility disorders.

Available Dosage Forms by BluepillExpress

At BluepillExpress, we offer a range of Esomeprazole + Itopride dosage forms suited for varied clinical and market needs:

1. Oral Tablets / Capsules:

• Esomeprazole 40 mg (gastro-resistant) + Itopride 150 mg (sustained release)
• Esomeprazole 20 mg (gastro-resistant) + Itopride 150 mg (sustained release)
• Esomeprazole 40 mg + Itopride 100 mg (customizable)

2. Modified Release Tablets / Capsules:

• Dual-layer or capsule-in-capsule formulations for differential release
• Enteric-coated Esomeprazole with sustained-release Itopride granules

3. Sachets and Granules:

• Pediatric-friendly or elderly formulations (available on request)

Packaging Formats:

• Alu-Alu or PVC-Alu blister packs
• HDPE bottles for bulk or institutional supply
• Unit-dose packaging with product inserts
• Export-friendly labeling (multilingual and regulatory compliant)

All formulations are developed using stability-verified polymers and coating agents to maintain pharmacokinetic integrity.

Manufacturing Infrastructure at BluepillExpress

Our manufacturing capabilities for Esomeprazole + Itopride are powered by state-of-the-art equipment, skilled professionals, and stringent quality standards.

Key Features:

• WHO-GMP, ISO 9001:2015 certified plants
• Fully segregated areas for gastro-resistant and SR production
• Fluid bed processors, tablet compression machines, and encapsulators
• In-line metal detection, weight variation control, and coating units
• Stability chambers for real-time and accelerated testing
• Fully integrated ERP system for production transparency

We support pilot batch development, commercial-scale manufacturing, and market-specific customization.

Quality Control and Assurance

Quality is the backbone of all operations at BluepillExpress. We follow international pharmacopeial standards (IP, BP, USP, EP) and robust documentation protocols.

Quality Checks Include:

• Raw material identity and assay verification
• Gastro-resistance and sustained-release testing
• Dissolution and disintegration profiling
• Microbial limit and stability testing
• Residual solvent and heavy metal analysis
• Packaging material compatibility testing

Every batch undergoes stringent QA validation before release, ensuring consistency, safety, and efficacy.

Customization and Private Label Services

We offer end-to-end private labeling and contract manufacturing services, allowing you to market Esomeprazole + Itopride formulations under your own brand.

Services Include:

• Custom dosage strengths/formulation types
• Brand name and logo development
• Packaging artwork and multicolor printing
• Language-specific leaflets and regulatory labeling
• Promotional material design (if required)
• E-commerce and retail packaging solutions

Our flexibility in design and production allows you to tailor products to your target audience and market conditions.

Regulatory Support and Documentation

BluepillExpress provides complete regulatory documentation support to ease market registration and approval processes across global territories.

Available Documentation:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Batch Manufacturing Record (BMR)
• Drug Master File (DMF) – if applicable
• Product Development Report (PDR)
• Method of Analysis (MOA)
• Dossiers in CTD/eCTD/ACTD formats
• Stability Data Reports (Zone III & IV)

We assist with regulatory submissions, compliance audits, and pharmacovigilance support when needed.

Export Capability and Global Footprint

As a recognized global exporter, BluepillExpress supplies Esomeprazole + Itopride formulations to a wide range of markets:

• Africa: Kenya, Nigeria, Ghana, Ethiopia, Tanzania
• Middle East: Iraq, Yemen, UAE, Oman
• Asia: Vietnam, Philippines, Sri Lanka, Nepal
• CIS Countries: Uzbekistan, Armenia, Georgia
• Latin America: Honduras, Bolivia, Peru

Our export team handles end-to-end logistics, including:

• Commercial invoices, packing lists, and MSDS
• Shipping documentation
• WHO-compliant COAs and Free Sale Certificates
• Multilingual artwork approvals
• Cold chain packaging (if required)

We offer flexible shipping terms: FOB, CIF, and DDP, with responsive customer service for every shipment.

R&D and Innovation Services

Our in-house R&D unit focuses on creating improved-release profiles, combination strategies, and patient-friendly formats for GI therapies.

Capabilities Include:

• Advanced gastro-resistant coating systems
• Sustained-release matrix development
• Formulation of capsule-in-capsule (CIC) or dual-layer tablets
• Taste-masking and pediatric adaptations
• Compatibility and stability testing for new API combinations
• Support for BE studies and CRO collaboration

We also help clients transition from pilot to full-scale production, offering technology transfer and IP protection services.

Shelf Life and Storage Guidelines

• Standard shelf life: 24 to 36 months
• Storage conditions: Store below 30°C in a dry, dark place
• Formulations are packaged with desiccants and light-resistant blisters
• Available for Zone III and Zone IV stability compliance

All packaging is tamper-evident, moisture-protective, and designed to maintain API potency over the entire shelf life.

Sustainability and Compliance

BluepillExpress follows sustainable manufacturing practices and complies with ethical and environmental regulations:

• Eco-friendly effluent treatment and waste disposal
• Use of energy-efficient machinery
• Sourcing APIs from GMP-approved vendors
• Safe working conditions with full PPE and regular audits
• Non-animal tested formulations available upon request

We ensure our clients’ brands are associated with safe, ethical, and socially responsible production.

Why Choose BluepillExpress for Esomeprazole + Itopride Manufacturing?

• WHO-GMP & ISO-certified facilities
• Expertise in gastro-resistant and sustained-release technologies
• Flexible MOQ and fast production cycles
• Full customization and private label support
• Comprehensive regulatory and export documentation
• Proven reliability in global market fulfillment
• Skilled R&D for innovative product development

Whether you’re launching a new gastro brand, bidding on government tenders, or expanding into regulated markets, BluepillExpress delivers the quality and compliance your business demands.

Conclusion

The combination of Esomeprazole + Itopride continues to be a preferred therapy for patients suffering from acid reflux and motility-related digestive disorders. Its dual mechanism offers symptomatic relief with superior patient adherence.

At BluepillExpress, we bring together pharmaceutical expertise, quality assurance, and global market experience to help our partners deliver safe, effective, and competitive Esomeprazole + Itopride products. Our end-to-end manufacturing and branding services ensure that your brand is positioned for success in both domestic and international markets.