Description

Omeprazole (EC) & Domperidone (SR) Capsules

Healthy Inc is a specialized global supplier and exporter of essential, high-volume gastrointestinal, anti-emetic, and anti-reflux therapeutics. We provide high-purity Omeprazole (20 mg Enteric-Coated) & Domperidone (30 mg Sustained-Release) Capsules, manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Foundational Anti-Reflux & Anti-Emetic Synergy” is a massive-volume, high-priority export to primary care clinics, gastroenterology centers, and government health ministries in Africa, LATAM, the Middle East, and Southeast Asia, serving as the globally trusted, most cost-effective intervention for Gastroesophageal Reflux Disease (GERD) and severe functional dyspepsia.

Product Overview

This advanced formulation combines two highly synergistic, universally recognized gastrointestinal agents: Omeprazole (the foundational, first-in-class Proton Pump Inhibitor) and Domperidone (a peripheral dopamine D2 receptor antagonist with potent anti-emetic properties).

The “Global Acid & Nausea Control” Specialist:

• Mechanism 1 (Omeprazole – Acid Suppression): Omeprazole accumulates in the acidic space of the gastric parietal cell and covalently, irreversibly binds to the H+/K+ ATPase enzyme system (the proton pump). This completely shuts down the final, foundational step of gastric acid secretion. As the most globally prescribed PPI, it provides highly predictable, profound acid blockade that allows esophageal erosions to heal rapidly.
• Mechanism 2 (Domperidone – Peripheral Motility & Anti-Emesis): Acid suppression alone cannot fix a sluggish stomach. Domperidone actively blocks Dopamine D2 receptors in the upper gastrointestinal tract, physically tightening the lower esophageal sphincter (LES) and accelerating gastric emptying. Furthermore, it blocks D2 receptors in the Chemoreceptor Trigger Zone (CTZ) located just outside the blood-brain barrier, acting as an incredibly powerful anti-emetic to stop acid-induced nausea.
• The “Brain-Safe” Prokinetic Advantage: Unlike older motility agents like Metoclopramide, Domperidone does not cross the blood-brain barrier. This almost entirely eliminates the risk of devastating central nervous system side effects (Extrapyramidal Symptoms or severe tremors), making it exceptionally safe for daily prescribing.
• The Sustained-Release Advantage: Standard Domperidone only lasts a few hours, requiring patients to dose multiple times daily. By utilizing a Sustained-Release (SR) formulation, this single daily capsule provides continuous 24-hour motility and nausea suppression synchronized flawlessly with the 24-hour acid blockade of Omeprazole.

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 or heavy-gauge Alu-PVC blister strips.

*Pack Sizes: 10×10 Alu-Alu / Alu-PVC Blisters (optimizing for 30-day monthly primary care 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: Omeprazole is an acid-labile drug that is rapidly destroyed by gastric acid. Our specialized fluid-bed coating machinery applies a rigorous methacrylic acid enteric-coating to the Omeprazole 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 60 minutes BEFORE breakfast. The Omeprazole must be absorbed and present in the bloodstream when the parietal cells are stimulated to secrete acid by the first meal of the day.
• 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):

• The Clopidogrel Interaction (BLACK BOX EQUIVALENT): Omeprazole is a strong inhibitor of the hepatic enzyme CYP2C19. It completely prevents the antiplatelet drug Clopidogrel from converting to its active form, leaving cardiac patients at massive risk for fatal stent thrombosis. Co-administration should be strictly avoided (Pantoprazole is the preferred safe alternative).
• 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 or those with underlying cardiac disease.
• Clostridioides difficile-Associated Diarrhea: Profound, long-term acid suppression 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 Ministry of Health 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.