Description

Dexrabeprazole Sodium & Cinitapride Sustained Release Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and motility therapeutics. We provide high-purity Dexrabeprazole Sodium (10 mg EC) & Cinitapride (3 mg SR) Capsules, manufactured in WHO–GMP certified advanced pelletization facilities. This “Next-Generation Isomeric PPI & 5-HT4 Agonist” 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, chronic functional dyspepsia, and severe delayed gastric emptying.

Product Overview

This formulation contains two advanced active pharmaceutical ingredients: Dexrabeprazole Sodium (the purified R-enantiomer of Rabeprazole) and Cinitapride (a benzamide-derivative gastroprokinetic agent).

The “Advanced Motility & Acid Control” Specialist:

• Mechanism 1 (Dexrabeprazole – Precision Acid Suppression): Dexrabeprazole isolates only the active R-isomer of rabeprazole. It concentrates in the gastric parietal cells and permanently blocks the H+/K+ ATPase enzyme (proton pump). Because it avoids the highly variable CYP2C19 liver enzyme metabolic pathways, it provides intensely predictable, sustained acid suppression across all genetic profiles at just half the standard dose (10mg vs 20mg).
• Mechanism 2 (Cinitapride – 5-HT4 Agonism): Cinitapride is a powerful, third-generation prokinetic. It acts primarily as an agonist at the 5-HT4 serotonin receptors and an antagonist at 5-HT2 receptors in the myenteric plexus. This action strongly stimulates the release of acetylcholine, massively accelerating gastric emptying and tightening the lower esophageal sphincter (LES), physically preventing acid regurgitation.
• The Clinical Synergy: Standard prokinetics (like Domperidone or Metoclopramide) work via dopamine antagonism. Cinitapride utilizes the serotonergic pathway, offering superior motility enhancement for stubborn cases of postprandial fullness and early satiety, perfectly complementing the acid-neutralizing power of Dexrabeprazole.

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 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.

• Dual-Pellet Isolation: Cinitapride and Dexrabeprazole require highly distinct release environments. Our fluid-bed coating technology ensures the Dexrabeprazole core is perfectly sealed within an enteric polymer to prevent destruction by gastric acid, while the Cinitapride is locked into a separate, hydrophilic sustained-release matrix to provide a steady 24-hour therapeutic baseline.
• Hygroscopic Integrity: 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 motility and acid disorders:

• Refractory GERD: Gastroesophageal Reflux Disease that does not respond adequately to standard PPI monotherapy or older PPI-Domperidone combinations.
• Chronic Functional Dyspepsia: Severe postprandial bloating, epigastric pain, and early satiety.
• Diabetic Gastroparesis: Severely delayed stomach emptying associated with autonomic neuropathy in diabetes mellitus.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist):

• Administration: Must be taken orally, 15 to 30 minutes BEFORE a meal (usually breakfast) to ensure optimal timing of the prokinetic effect as food enters the stomach.
• 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 will cause the stomach acid to instantly neutralize the Dexrabeprazole.

Safety Warnings (CRITICAL):

• Extrapyramidal Symptoms (EPS): While much rarer than with Metoclopramide, Cinitapride can still cause mild extrapyramidal effects (tremors, muscle spasms) in sensitive individuals, particularly the elderly.
• QT Prolongation Caution: Cinitapride has a theoretical risk of prolonging the QT interval. It should be used with caution in patients taking other QT-prolonging drugs (like macrolide antibiotics or certain antiarrhythmics).
• Hypomagnesemia: Long-term use of PPIs can significantly drop serum magnesium levels, leading to muscle cramps, arrhythmias, and increased fracture risk.

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.