Description

Dexlansoprazole & Domperidone Sustained Release Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and prokinetic therapeutics. We provide high-purity Dexlansoprazole (30 mg / 60 mg DDR) & Domperidone (30 mg SR) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “Dual Delayed-Release PPI & Motility” combination is a premium export to specialized gastroenterology clinics, tertiary care hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the ultimate, 24-hour intervention for severe, refractory GERD and functional dyspepsia.

Product Overview

This formulation contains two highly advanced active pharmaceutical ingredients: Dexlansoprazole (the purified R-enantiomer of lansoprazole) and Domperidone (a peripheral dopamine D2-receptor antagonist).

The “24-Hour Dual Release” Specialist:

• Mechanism 1 (Dexlansoprazole – Dual Delayed Release): Standard PPIs offer a single peak of acid suppression. Dexlansoprazole employs a revolutionary Dual Delayed Release (DDR) system. The capsule contains two distinct types of enteric-coated granules. The first type dissolves at pH 5.5 in the proximal duodenum (delivering an initial peak of acid suppression within 1 to 2 hours). The second type dissolves at pH 6.75 further down in the distal small intestine (delivering a second peak 4 to 5 hours later). This guarantees profound, uninterrupted 24-hour blockade of the H+/K+ ATPase enzyme.
• Mechanism 2 (Domperidone – Prokinetic Action): Domperidone accelerates gastric emptying and increases the resting tone of the lower esophageal sphincter (LES) by blocking peripheral dopamine receptors in the gut. Because it does not cross the blood-brain barrier, it provides excellent motility enhancement without severe neurological side effects.
• The Clinical Synergy: For patients suffering from nocturnal GERD or severe daytime acid breakthrough, the dual-peak PPI ensures no acid escapes, while the sustained-release prokinetic mechanically clears the stomach of food, offering unparalleled symptom relief in a single daily dose.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Tri-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 highly sensitive 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.

• Complex Multi-Particulate Engineering: Manufacturing Dexlansoprazole requires elite fluid-bed technology. Our facilities precisely engineer the two distinct enteric layers on the Dexlansoprazole sugar spheres, while simultaneously manufacturing a third, distinct hydrophilic polymer matrix for the Domperidone SR pellets, ensuring all three release profiles function perfectly inside the human GI tract without cross-reacting.
• Hygroscopic Integrity: Dexlansoprazole is exceptionally moisture-sensitive. Encapsulation occurs in strictly climate-controlled environments (RH <30%), guaranteeing a robust 24-month shelf life even in high-humidity markets.

Therapeutic Indications (Human Use)

Indicated for the management of the most severe, refractory upper gastrointestinal disorders:

• Refractory GERD: Gastroesophageal Reflux Disease that does not respond to standard once-daily or twice-daily racemic PPIs, particularly when accompanied by nocturnal acid breakthrough.
• Erosive Esophagitis Healing: Healing of all grades of erosive esophagitis combined with delayed gastric emptying.
• Chronic Functional Dyspepsia: Severe postprandial bloating, epigastric pain, and early satiety.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist):

• Administration: Must be taken orally. Unlike older PPIs, Dexlansoprazole’s dual-release mechanism allows it to be taken with or without food, though taking it before a meal maximizes the Domperidone prokinetic effect.
• Standard Adult Dose: One capsule once daily.
• Swallowing Protocol (CRITICAL): The capsule must be swallowed whole with a glass of water. DO NOT CRUSH OR CHEW THE CAPSULE OR PELLETS. Destroying the dual enteric coatings will cause the stomach acid to instantly neutralize the Dexlansoprazole.

Safety Warnings (CRITICAL):

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