Description

Pantoprazole (EC) & Domperidone (SR) Tablets / Capsules (40 mg / 30 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterological, anti-emetic, and gut-motility therapeutics. We provide ultra-high-purity, kinetically synchronized Pantoprazole Enteric-Coated (40 mg) & Domperidone Sustained-Release (30 mg) Tablets / Hard Gelatin Capsules, manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Dual-Action Acid Suppressor & Motility Engine” is a massive-volume, highly lucrative export to gastroenterology clinics, internal medicine networks, retail pharmacy chains, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, once-daily intervention for Refractory Gastroesophageal Reflux Disease (GERD) and functional dyspepsia.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes two entirely different release profiles in a single unit, delivering profound, 24-hour acid suppression while continuously forcing the stomach to empty in the correct downward direction.

The “Chemical & Mechanical Reflux” Specialist:

• Mechanism 1 (The Chemical Acid Blockade – Pantoprazole 40mg): Pantoprazole is a highly potent, long-acting Proton Pump Inhibitor. Once it reaches the alkaline environment of the small intestine, it is absorbed into the bloodstream and travels to the parietal cells of the stomach. There, it irreversibly binds to the H+/K+ ATPase enzyme (the proton pump), violently shutting down the final step of gastric acid secretion and allowing severe esophageal burns and ulcers to rapidly heal.
• Mechanism 2 (The Mechanical Motility Engine – Domperidone 30mg SR): While Pantoprazole stops the acid, Domperidone fixes the plumbing. It blocks peripheral D2 dopamine receptors in the gut. This physically tightens the Lower Esophageal Sphincter (preventing upward splashing) and stimulates vigorous, coordinated peristalsis to rapidly empty the stomach contents into the intestines.
• The Blood-Brain Barrier Advantage: Unlike older prokinetics (like Metoclopramide), Domperidone does not easily cross the blood-brain barrier. This means it aggressively treats severe nausea, bloating, and motility issues in the gut without causing the debilitating neurological side effects (like involuntary muscle spasms, tremors, or Tardive Dyskinesia) associated with other drugs.

Product Composition & Strength

We supply this product as a Precision-Engineered Dual-Release Capsule or Bilayer Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly acid-labile Pantoprazole and the SR polymer network.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, high-compliance 14-to-28 day chronic gastroenterology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gastroenterology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

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

• Dual-Release Multi-Particulate Engineering (CRITICAL COMPLIANCE): Manufacturing an FDC combining Pantoprazole and Domperidone is highly complex. Pantoprazole is violently destroyed by stomach acid, while Domperidone must be slowly released over an entire day to prevent sudden spikes in the blood. Our facilities utilize advanced Fluid Bed Coating technology to manufacture two entirely separate types of micro-pellets. The Pantoprazole pellets are coated in a strict pH-dependent Methacrylic Acid Copolymer (Enteric Coat) to survive the stomach, while the Domperidone pellets are coated in an HPMC hydro-gel matrix for flawless 24-hour sustained release. These are then precisely filled into a single capsule or compressed into a bilayer tablet, ensuring absolute clinical perfection.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of complex upper gastrointestinal motility and acid disorders:

• Refractory GERD: Treatment of Gastroesophageal Reflux Disease in patients who do not adequately respond to a Proton Pump Inhibitor alone, specifically targeting symptoms of upward splashing, regurgitation, and severe heartburn.
• Functional (Non-Ulcer) Dyspepsia: Relief of symptoms such as stomach fullness, early satiety, severe bloating, belching, and chronic nausea.
• Diabetic Gastroparesis: Management of delayed stomach emptying associated with nerve damage from long-standing diabetes.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist Guidelines):

• Standard Adult Dosing: One capsule/tablet taken orally once daily.
• Administration (THE BREAKFAST RULE – CRITICAL): Because Domperidone works to empty the stomach, and Pantoprazole needs to block meal-induced acid pumps, the dose MUST be taken exactly 30 to 45 minutes before breakfast on an empty stomach. Taking it after eating significantly delays absorption and destroys its clinical efficacy.
• The Intact Rule: Must be swallowed completely whole with water. Chewing or crushing physically destroys both the enteric coating and the SR matrix, causing massive therapeutic failure.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Domperidone Cardiac Risk (QT Prolongation): Domperidone has been associated with an increased risk of serious cardiac arrhythmias and sudden cardiac death, particularly in patients over 60 years old. It is strictly contraindicated in patients with known prolonged cardiac conduction intervals (QT prolongation) or significant electrolyte disturbances (like hypokalemia).
• CYP3A4 Drug Interactions: Domperidone is heavily metabolized by CYP3A4. Co-administration with strong CYP3A4 inhibitors (like Ketoconazole or Erythromycin) will massively spike Domperidone levels in the blood, dangerously increasing the risk of fatal cardiac arrhythmias.
• Clostridium difficile-Associated Diarrhea (CDAD): By drastically lowering stomach acid (which normally kills ingested bacteria), PPIs increase the risk of severe intestinal infections, particularly C. difficile.
• Severe Hypomagnesemia & Bone Fractures: Prolonged, high-dose use of PPIs (over 1 year) can cause a massive drop in blood magnesium levels (leading to cardiac arrhythmias) and has been associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterological and Dual-Release Formulations. Whether you are looking for a reliable Government Tender Supplier for GI clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.