Faster, Stronger, Smarter Relief: Pantoprazole 40 mg + Domperidone 10 mg

Unlock rapid, lasting relief from GERD with our dual-action formula, combining powerful acid control with enhanced gastric motility for ultimate patient comfort and satisfaction.

Introduction

In the rapidly evolving pharmaceutical landscape, success hinges on quality, reliability, and trust, alongside efficacy. This is particularly true in gastroenterology, where Gastroesophageal reflux disease (GERD) and acid-related disorders remain prevalent global health concerns. Both physicians and patients seek therapies offering more than just temporary relief; they require clinically effective, stable, and consistent solutions. The fixed-dose combination of Pantoprazole 40 mg + Domperidone 10 mg has emerged as a frontline therapy. This powerful dual-action treatment combines Pantoprazole for acid suppression and Domperidone for improved gastric motility, making it a highly prescribed solution for GERD, dyspepsia, and related disorders. At Walter Healthcare, we enhance this proven therapy through advanced formulation innovation, strict polymorphic control, and robust stability systems. This commitment ensures a product that delivers superior clinical outcomes and a significant competitive edge in the market.

Product information

Pantoprazole 40 mg (Proton Pump Inhibitor)

Generic Name: Pantoprazole Sodium Sesquihydrate (equivalent to Pantoprazole)

Molecular Formula: C16H15F2N3O4S

IUPAC name: 6-(difluoromethoxy)-2-[(3,4-dimethoxypyridin-2-yl)methylsulfinyl]-1H-benzimidazole

Strength: 40 mg

Dosage form: Delayed-Release Film-Coated Tablet (commonly a bi-layered tablet or a compressed tablet containing Pantoprazole enteric-coated pellets

Pharmacological class: Proton Pump Inhibitor (PPI) 

• Mechanism: Irreversibly inhibits gastric proton pumps (H⁺/K⁺-ATPase), leading to sustained suppression of gastric acid secretion.

• Clinical Benefits:

  • Achieves >85% healing rates in erosive esophagitis within 8 weeks.

  • Provides long-lasting acid suppression (24-hour coverage with once-daily dosing).

  • Effective in GERD, peptic ulcer disease, and Zollinger-Ellison syndrome.

• Patient Advantage: Rapid heartburn relief, mucosal healing, and low recurrence rates.

 

Domperidone 10 mg (Prokinetic Agent)

Generic Name: Domperidone

Molecular Formula: C22H24ClN5O2

IUPAC name: 6-chloro-3-[1-[3-(2-oxo-3H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1H-benzimidazol-2-one

Dosage form: Domperidone immediate-release granules/powder. Pantoprazole is also available in vial, granule, and tablet form.

Pharmacological class: Dopamine D2 Receptor Antagonist (Prokinetic).

• Action Mechanism

  • Acts as a peripheral dopamine D₂-receptor antagonist.

  • Boosts gastric motility and increases the tone of the lower esophageal sphincter.

• Clinical Benefits:

  • Alleviates nausea, vomiting, bloating, and early satiety.

  • Accelerates gastric emptying, thereby preventing reflux episodes.

  • Especially beneficial for GERD patients experiencing dyspeptic or motility-related symptoms.

• Patient Advantage: Offers enhanced comfort and quicker symptom relief beyond just acid suppression.

Formulation Highlights

• Pantoprazole: Formulated as enteric-coated pellets or a protective bi-layer, ensuring resistance to stomach acid and effective release in the intestine.

• Domperidone: Designed as an immediate-release layer or granules to provide rapid support for gastric motility.

This unique formulation of pantoprazole and domperidone requires precise engineering. Pantoprazole is highly acid-labile, while domperidone needs a quick onset of action. Walter Healthcare’s proprietary technologies ensure that both active pharmaceutical ingredients (APIs) are released exactly where and when they are required.

Therapeutic Indication: Where This FDC Excel

Peptic Ulcer Diseases (Off Label Use): Supports ulcer management through powerful acid control.   Pantoprazole 40 mg + Domperidone 10 mg is a fixed-dose combination (FDC) that provides a comprehensive solution in gastroenterology. It effectively addresses both acid suppression and the correction of gastric motility.

This FDC has several clinical applications:

• Erosive Esophagitis associated with GERD: Offers effective healing and long-term protection for the esophageal lining.

• Short-term treatment of GERD: Alleviates symptoms like acid reflux, nausea, bloating, and heartburn.

• Zollinger-Ellison Syndrome: Delivers potent acid suppression for conditions involving hypersecretion.

• Peptic Ulcer Diseases (Off-Label Use): Supports ulcer management through powerful acid control.

This Fixed-Dose Combination (FDC) offers comprehensive symptom relief and an improved quality of life for patients with GERD and related motility disorders. It achieves this by combining Pantoprazole's effective acid suppression with Domperidone's prokinetic benefits.

Mechanism of Dual Action

Pantoprazole 40 mg + Domperidone 10 mg (Fixed-Dose Combination)

Dual Mechanism, Complete Relief

This innovative FDC combines the proven power of two complementary mechanisms:

• Pantoprazole: Delivers long-lasting acid suppression by targeting proton pumps, ensuring healing and protection of the esophageal lining.

• Domperidone: Restores gastric motility and sphincter tone, reducing reflux episodes and addressing distressing symptoms like nausea, bloating, and regurgitation.

Clinical Superiority

• Demonstrates greater efficacy compared to PPI monotherapy in patients with GERD complicated by motility-related symptoms. 

• Offers holistic relief, not just reducing acid but also correcting the underlying motility dysfunction.

• Ensures faster onset and sustained control, translating into more reliable outcomes for patients.

Patient Centric Advantage

• All-in-one solution for acid suppression and motility correction.

• Enhanced quality of life with quicker symptom relief and improved daily comfort.

• Higher adherence and satisfaction, patients prefer a single, effective therapy over multiple medications.

 

Market Relevance: Why This FDC Matters

• Unmatched Prescription Trust: This FDC is a cornerstone in gastroenterology, highly favored by doctors for its powerful dual-action relief against GERD and related motility symptoms.

• Robust Regulatory Confidence: Fully endorsed by CDSCO as a rational FDC for GERD with dyspepsia and nausea, ensuring unwavering compliance and sustained clinical confidence among healthcare professionals.

• Enduring Market Dominance: Despite global debates surrounding FDCs, this specific combination consistently demonstrates remarkable growth and widespread acceptance across India and burgeoning emerging markets.

• Proprietary Formulation Excellence: The inherent complexity of handling acid-labile Pantoprazole, requiring advanced pellet coating and bi-layer compression, highlights Walter Healthcare's unparalleled leadership and proven expertise in cutting-edge pharmaceutical manufacturing.

• Essential Portfolio Catalyst: More than just a commercially successful product, this molecule is a strategic imperative for brands seeking to significantly enhance their gastro-care portfolio and expand their market footprint.

Comparative Physicochemical Excellence: Walter Healthcare Advantage 

Why this matters:

Here's why this combination is a game-changer: Prescribers can expect consistent, reliable patient results, while our partners will benefit from elevated brand status, accelerated regulatory pathways, and sustained market leadership.

Walter Healthcare: Beyond Manufacturing, A Strategic Partnership

• Unwavering Quality & Compliance: We adhere to the highest global standards, including WHO-GMP and CDSCO, ensuring every product meets rigorous regulatory requirements.

• Complete Transparency: Gain real-time insights into your product's journey with direct access to manufacturing updates and factory audits.

• Tailored Branding Solutions: From unique tablet shapes and colors to innovative packaging like child-resistant bottles and Alu-Alu blisters, we customize every detail to elevate your brand.

• Robust Market Empowerment: Leverage our integrated digital tools, including QR-linked patient education, premium marketing assets, and dedicated MR support, to dominate your market.

• Partnership-Driven Service: Benefit from flexible pricing, convenient small-batch options, and the expert guidance of our dedicated regulatory and business development teams.

Conclusion

Experience a new era in the treatment of GERD, dyspepsia, and acid-related disorders. Our fixed-dose combination of Pantoprazole 40 mg + Domperidone 10 mg offers a complete solution, tackling both acid suppression and gastric motility with unparalleled efficacy. Clinical studies consistently demonstrate its superiority over single therapies, providing rapid, sustained, and holistic relief. This translates to higher patient adherence and a significantly improved quality of life. As gastrointestinal issues escalate globally, the demand for therapies that are not just effective but also reliable, safe, and innovative has never been greater. This FDC epitomizes that very promise. At Walter Healthcare, we elevate conventional manufacturing by integrating advanced formulation technologies, stringent stability systems, and unwavering regulatory excellence. Our dedication to quality and innovation ensures that every dose consistently delivers powerful therapeutic outcomes, empowering healthcare providers with trust and patients with unwavering confidence. Partner with Walter Healthcare: gain more than a product, gain a strategic ally for sustained growth, compliance, and leadership in gastro-care.