Description

Esomeprazole Enteric-Coated Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and anti-ulcer therapeutics. We provide high-purity Esomeprazole Enteric-Coated Capsules (20 mg / 40 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Next-Generation Proton Pump Inhibitor” is a massive-volume export to gastroenterology clinics, general hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the frontline, gold-standard intervention for Erosive Esophagitis, GERD, and peptic ulcer disease.

Product Overview

This formulation contains Esomeprazole Magnesium, the highly active S-isomer of omeprazole.

The “Acid Suppression” Specialist:

• Mechanism (Proton Pump Blockade): Esomeprazole is a weak base that concentrates and converts to its active form in the highly acidic secretory canaliculi of the gastric parietal cell. There, it irreversibly binds to the H+/K+ ATPase enzyme (the proton pump). This action profoundly blocks the final common pathway of gastric acid secretion, effectively raising the stomach pH regardless of whether the stimulus is histamine, gastrin, or acetylcholine.
• The S-Isomer Advantage: By isolating the S-isomer, Esomeprazole undergoes less first-pass hepatic metabolism compared to racemic omeprazole. This results in higher plasma concentrations, longer-lasting acid suppression, and significantly faster healing rates for severe erosive esophagitis.
• H. pylori Eradication: It forms the critical acid-suppressing backbone of “Triple Therapy” (combined with antibiotics like Amoxicillin and Clarithromycin) to eradicate Helicobacter pylori infections and prevent duodenal ulcer recurrence.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Enteric-Coated (EC) Pellets, packed strictly in moisture-proof Alu-Alu blisters.

*Pack Sizes: 10×10 Alu-Alu Blisters or 10×14 Alu-Alu Blisters (optimizing for 14-day H. pylori regimens).

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 Fluid-Bed Pelletization: Esomeprazole is rapidly destroyed by stomach acid. Our manufacturing process utilizes precision fluid-bed technology to coat the active pellets with a robust enteric polymer (Methacrylic Acid Copolymer). This ensures the drug safely bypasses the acidic stomach and dissolves only in the alkaline environment of the proximal small intestine for maximal absorption.
• Hygroscopic Integrity: The encapsulation and blistering processes occur in strictly climate-controlled environments (Relative Humidity <40%) and are instantly sealed in heavy-gauge Alu-Alu foil to prevent hydrolysis and degradation over a 24 to 36-month shelf life.

Therapeutic Indications (Human Use)

Indicated for the management of acid-related gastrointestinal disorders:

• Gastroesophageal Reflux Disease (GERD): Healing of erosive esophagitis and long-term maintenance of healed esophagitis.
• H. pylori Eradication: To reduce the risk of duodenal ulcer recurrence (in combination with appropriate antibacterial therapeutic regimens).
• NSAID-Associated Gastric Ulcers: Reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy (e.g., Piroxicam, Diclofenac) in patients at risk.
• Zollinger-Ellison Syndrome: Pathological hypersecretory conditions requiring massive acid suppression.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist):

• Administration: Must be taken orally, at least 1 hour BEFORE a meal (typically breakfast).
• Erosive Esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks.
• H. pylori Eradication: 40 mg once daily (with 1000 mg Amoxicillin and 500 mg Clarithromycin twice daily) for 10 to 14 days.
• Swallowing Protocol: The capsule must be swallowed whole with a glass of water. DO NOT CRUSH OR CHEW THE CAPSULE OR ITS CONTENTS. Destroying the enteric coating will render the drug completely ineffective.

Safety Warnings (CRITICAL):

• Bone Fracture Risk: Long-term, high-dose use of PPIs (usually >1 year) significantly drops serum magnesium levels (hypomagnesemia) 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 associated diarrhea (CDAD).
• Clopidogrel Interaction: Esomeprazole inhibits the CYP2C19 enzyme, which can reduce the conversion of Clopidogrel to its active metabolite, potentially decreasing its antiplatelet effect. Concurrent use requires careful clinical consideration.

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.