Description

Pantoprazole Sodium (EC) & Domperidone (SR) Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastrointestinal, anti-emetic, and anti-reflux therapeutics. We provide high-purity Pantoprazole Sodium (40 mg Enteric-Coated) & Domperidone (30 mg Sustained-Release) Capsules, manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Highly Tolerable Anti-Reflux & Anti-Emetic” is a massive-volume, foundational export to gastroenterology centers, primary care networks, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the gold-standard, polypharmacy-safe intervention for Gastroesophageal Reflux Disease (GERD) and severe acid-induced nausea.

Product Overview

This advanced formulation combines two highly synergistic, globally trusted gastrointestinal agents: Pantoprazole Sodium (a highly stable, long-acting Proton Pump Inhibitor) and Domperidone (a peripheral dopamine D2 receptor antagonist with potent anti-emetic properties).

The “Polypharmacy-Safe Acid & Nausea Synergy” Specialist:

• Mechanism 1 (Pantoprazole – Acid Suppression & Safety): Pantoprazole accumulates in the acidic space of the gastric parietal cell and irreversibly binds to the H+/K+ ATPase enzyme system (the proton pump), completely shutting down gastric acid secretion. Its defining clinical advantage over Omeprazole is its incredibly low affinity for the hepatic cytochrome P450 enzyme system. This makes it the absolute safest PPI for elderly patients taking concomitant medications like Clopidogrel, Warfarin, or Phenytoin.
• Mechanism 2 (Domperidone – Peripheral Motility & Anti-Emesis): Domperidone actively blocks Dopamine D2 receptors in the upper gastrointestinal tract, increasing lower esophageal sphincter (LES) pressure and massively accelerating gastric emptying. Crucially, it also blocks D2 receptors in the Chemoreceptor Trigger Zone (CTZ) located just outside the blood-brain barrier, making it an incredibly powerful anti-emetic (anti-nausea) agent.
• The “Brain-Safe” Prokinetic Advantage: Unlike older motility agents like Metoclopramide or Levosulpiride, Domperidone does not cross the blood-brain barrier. This almost entirely eliminates the risk of devastating central nervous system side effects (Extrapyramidal Symptoms, severe tremors, or tardive dyskinesia), making it exceptionally safe for daily, long-term prescribing.
• The Sustained-Release Advantage: Standard Domperidone only lasts a few hours, requiring patients to take it three times a day. By utilizing a Sustained-Release (SR) formulation, this single daily capsule provides continuous 24-hour motility and nausea suppression synchronized perfectly with the 24-hour acid blockade of Pantoprazole.

Product Composition & Strength

We supply this product as a highly advanced Hard Gelatin Capsule containing Dual-Isolated Pellets, packed strictly in high-barrier Alu-Alu blister strips.

*Pack Sizes: 10×10 Alu-Alu Blisters or 10×15 Alu-Alu Blisters (optimizing for 30-day monthly gastroenterology dispensing cycles).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Gastroenterology Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Dual-Kinetic Pelletization Engineering: Pantoprazole is rapidly degraded by gastric acid. Our specialized fluid-bed coating machinery applies a rigorous methacrylic acid enteric-coating to the Pantoprazole pellets, ensuring they pass through the stomach unharmed. Simultaneously, the Domperidone is coated in a specialized sustained-release hypromellose matrix. This advanced capsule-in-capsule technology guarantees two completely different pharmacokinetic release profiles flawlessly synchronized for a 24-hour therapeutic window.
• Assay Validation: Rigorous multi-stage dissolution testing (in both acidic and buffer mediums) is performed via HPLC on every batch to guarantee the physical integrity of the enteric coating and the slow-release matrix, preventing Domperidone dose-dumping.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of high-volume gastrointestinal motility and acid disorders:

• Gastroesophageal Reflux Disease (GERD): Treatment of erosive or ulcerative GERD that is unresponsive to PPI monotherapy, especially when accompanied by severe regurgitation or delayed gastric emptying.
• Functional Dyspepsia: Management of chronic upper abdominal pain, post-prandial fullness, severe bloating, and early satiety.
• Nausea & Vomiting: Highly effective in managing acid-peptic induced nausea or vomiting associated with impaired GI motility.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Administration (TIMING IS CRITICAL): Must be taken orally, once daily, approximately 30 to 45 minutes BEFORE breakfast. Taking the capsule on an empty stomach ensures the enteric-coated Pantoprazole passes swiftly into the duodenum for absorption before the heavy acid-secretion phase begins.
• Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. It must not be crushed, chewed, or opened. Destroying the capsule compromises both the enteric coating and the SR matrix.

Safety Warnings (CRITICAL):

• Cardiac Risk (QT Prolongation): Domperidone has been associated with a small increased risk of QT interval prolongation and serious ventricular arrhythmias. It should be used with caution in older patients, those with underlying cardiac disease, or those concurrently taking potent CYP3A4 inhibitors (e.g., Ketoconazole, Erythromycin).
• Endocrine Disruption (Hyperprolactinemia): Peripheral D2 blockade elevates prolactin levels. Prolonged use can occasionally cause galactorrhea (abnormal milk production) or gynecomastia (breast enlargement in men).
• Clostridioides difficile-Associated Diarrhea: Profound, long-term acid suppression by Pantoprazole significantly increases the risk of severe intestinal infections.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterology Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in LATAM or a B2B Pharma Marketplace partner for Africa, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.