Description

Esomeprazole & Domperidone Sustained Release Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and prokinetic therapeutics. We provide high-purity Esomeprazole (40 mg EC) & Domperidone (30 mg SR) Capsules, manufactured in WHO–GMP certified oral solid dosage facilities. This “Acid-Suppressant & Motility” combination is a massive-volume export to gastroenterology clinics, general hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a highly effective, once-daily intervention for refractory Gastroesophageal Reflux Disease (GERD) accompanied by delayed gastric emptying.

Product Overview

This formulation contains two synergistic active pharmaceutical ingredients: Esomeprazole Magnesium (a potent Proton Pump Inhibitor) and Domperidone (a peripheral dopamine D2-receptor antagonist).

The “Dual-Action Reflux” Specialist:

• Mechanism 1 (Esomeprazole – Acid Suppression): Esomeprazole is the S-isomer of omeprazole. It concentrates in the acidic environment of the gastric parietal cells, where it permanently binds to and inhibits the H+/K+ ATPase enzyme (the proton pump). This profoundly blocks the final step of gastric acid production, raising the stomach pH and allowing esophageal mucosal healing.
• Mechanism 2 (Domperidone – Prokinetic Action): Domperidone acts as a gastrointestinal emptying (prokinetic) agent. By blocking peripheral dopamine receptors in the GI tract, it increases the tone of the lower esophageal sphincter (preventing acid from splashing up) and accelerates gastric emptying (pushing food into the duodenum faster). Crucially, unlike metoclopramide, it does not cross the blood-brain barrier, avoiding severe extrapyramidal (neurological) side effects.
• The Synergy: Standard PPIs only stop acid. In patients with functional dyspepsia or diabetic gastroparesis, food sits in the stomach too long, causing bloating and physical reflux pressure. This combination chemically stops the acid and mechanically empties the stomach.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Dual-Technology Pellets, packed strictly in moisture-proof Alu-Alu blisters.

*Pack Sizes: 10×10 Alu-Alu Blisters. (Strictly Alu-Alu to prevent moisture degradation of the PPI).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

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

• Advanced Pelletization Technology: Creating this capsule requires highly specialized fluid-bed coating technology. The Esomeprazole must be perfectly enteric-coated to prevent premature degradation by gastric acid, while the Domperidone requires a precisely engineered sustained-release polymer matrix to ensure a steady 24-hour therapeutic baseline.
• Moisture Control: PPIs are highly hygroscopic and rapidly degrade if exposed to humidity. Our encapsulation process occurs in strictly climate-controlled environments (RH <40%), and the final product is instantly sealed in heavy-gauge Aluminum-Aluminum foil.

Therapeutic Indications (Human Use)

Indicated for the management of complex upper gastrointestinal disorders:

• Refractory GERD: Gastroesophageal Reflux Disease that does not respond adequately to a PPI alone, characterized by regurgitation, heartburn, and esophagitis.
• Functional Dyspepsia: Chronic upper abdominal pain, early satiety, and severe postprandial bloating.
• Diabetic Gastroparesis: Delayed stomach emptying associated with diabetes mellitus, leading to severe nausea and acid reflux.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist):

• Administration: Must be taken orally, 30 to 60 minutes BEFORE a meal (usually breakfast on an empty stomach) to ensure maximum inhibition of the proton pumps when they are activated by food.
• Standard Adult Dose: One capsule once daily.
• Swallowing Protocol: The capsule must be swallowed whole with a glass of water. DO NOT CRUSH, CHEW, OR OPEN THE CAPSULE. Destroying the enteric coating on the pellets will cause the stomach acid to destroy the Esomeprazole before it can be absorbed.

Safety Warnings (CRITICAL):

• Cardiac Risk (Domperidone): Domperidone has been associated with a prolonged QT interval and an increased risk of severe ventricular arrhythmias and sudden cardiac death, particularly in patients older than 60 or those taking concurrent QT-prolonging drugs. It is strictly contraindicated in patients with underlying cardiac conduction disorders.
• Hypomagnesemia & Bone Fractures: Long-term, high-dose use of Esomeprazole (usually >1 year) significantly drops serum magnesium levels and increases the risk of osteoporosis-related fractures of the hip, wrist, or spine.
• Clostridium difficile Diarrhea: By stripping the stomach of its protective acid barrier, PPIs increase the risk of severe intestinal infections, particularly C. difficile.

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 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 Africa or a B2B Pharma Marketplace partner for Latin America, 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.