Dexrabeprazole Sodium & Domperidone Sustained Release Capsules
Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and prokinetic therapeutics. We provide high-purity Dexrabeprazole Sodium (10 mg EC) & Domperidone (30 mg SR) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “Next-Generation Isomeric 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 a highly predictable, once-daily intervention for refractory GERD, functional dyspepsia, and delayed gastric emptying.
Product Overview
This formulation contains two advanced active pharmaceutical ingredients: Dexrabeprazole Sodium (the purified R-enantiomer of Rabeprazole) and Domperidone (a peripheral dopamine D2-receptor antagonist).
The “Isomeric Reflux” Specialist:
- Mechanism 1 (Dexrabeprazole – Precision Acid Suppression): Standard rabeprazole is a racemic mixture of both R and S isomers. Dexrabeprazole isolates only the active R-isomer. It concentrates in the gastric parietal cells and permanently blocks the H+/K+ ATPase enzyme (proton pump). Because it is less reliant on the highly variable CYP2C19 liver enzyme for metabolism, it provides intensely predictable, sustained acid suppression across all patient populations at just half the standard dose.
- 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. It prevents food and residual acid from splashing back into the esophagus. Because it does not cross the blood-brain barrier, it avoids the severe neurological side effects associated with older prokinetics like metoclopramide.
- The Synergy: This dual-action capsule mathematically targets the two primary physical causes of functional dyspepsia and GERD: it completely neutralizes the corrosive acid while actively pumping the stomach contents downward into the duodenum.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule containing Dual-Technology Pellets, packed strictly in moisture-proof Alu-Alu blisters.
| Active Ingredient | Strength & Format | Release Profile Function |
|---|---|---|
| Dexrabeprazole Sodium | 10 mg (Enteric Coated Pellets) | Must survive stomach acid to be absorbed in the alkaline intestine. |
| Domperidone BP/Ph.Eur. | 30 mg (Sustained Release Pellets) | Provides continuous, 24-hour prokinetic action to prevent delayed bloating. |
| Excipients | Hypromellose / Methacrylic Acid Copolymer | Sustained Release Matrix / Enteric Coating Polymer |
*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.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Numbers | 243206-52-0 (Dexrabeprazole Sodium) / 57808-66-9 (Domperidone) |
| Dosage Form | Capsules containing EC & SR Pellets |
| Packaging | Alu-Alu Blister (CRITICAL). PVC/PVDC is entirely insufficient for Dexrabeprazole in tropical and humid climates. |
| Storage | Store below 25°C in a dry place. Protect strictly from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Isomeric Purity & Pelletization: Synthesizing and stabilizing pure R-enantiomer PPIs requires highly advanced chemical isolation. Our fluid-bed coating technology ensures the Dexrabeprazole core is perfectly sealed within an enteric polymer to prevent premature destruction by gastric acid, while the Domperidone is locked into a separate sustained-release matrix.
- Moisture Control: Dexrabeprazole is exceptionally hygroscopic. Encapsulation occurs in strictly climate-controlled environments (RH <30%), and the final product is instantly sealed in heavy-gauge Aluminum-Aluminum foil to guarantee a full 24-month shelf life.
Therapeutic Indications (Human Use)
Indicated for the management of complex, refractory upper gastrointestinal disorders:
- Refractory GERD: Gastroesophageal Reflux Disease that does not respond adequately to standard, racemic PPI monotherapy (like standard Omeprazole or Pantoprazole).
- 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 instantly destroy the Dexrabeprazole.
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.