Rabeprazole Sodium Enteric Coated & Cinitapride Sustained Release Capsules

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Rabeprazole sodium and cinitapride capsules are a combination therapy used for gastrointestinal disorders where acid reflux co-exists with slow gut movement (dysmotility). They typically come in a fixed-dose strength of 20 mg (enteric-coated) and 3 mg (sustained/extended-release).

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Description

Rabeprazole Sodium (EC) & Cinitapride (SR) Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastrointestinal and prokinetic therapeutics. We provide high-purity Rabeprazole Sodium (20 mg Enteric-Coated) & Cinitapride (3 mg Sustained-Release) Capsules, manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Dual-Action Anti-Reflux & Motility Modulator” is a massive-volume, premium export to gastroenterology centers, specialized GI clinics, and government health ministries in LATAM, Southeast Asia, and Africa, serving as the definitive intervention for refractory Gastroesophageal Reflux Disease (GERD) and Functional Dyspepsia.


Product Overview

This advanced formulation combines two highly synergistic gastrointestinal agents: Rabeprazole Sodium (a rapidly acting Proton Pump Inhibitor) and Cinitapride (a potent, sustained-release prokinetic agent).

The “Acid & Motility Synergy” Specialist:

  • Mechanism 1 (Rabeprazole – Acid Suppression): Rabeprazole is a substituted benzimidazole that aggressively targets the H+/K+ ATPase enzyme system (the proton pump) at the secretory surface of the gastric parietal cell. It completely blocks the final step of gastric acid production. Rabeprazole is renowned for having a significantly faster onset of action and a lower potential for CYP450 drug interactions compared to older PPIs like Omeprazole.
  • Mechanism 2 (Cinitapride – Motility Enhancement): Acid suppression is often not enough to cure GERD if the stomach is emptying too slowly. Cinitapride acts as an agonist at 5-HT4 receptors and an antagonist at 5-HT2 receptors in the myenteric plexus. This actively tightens the Lower Esophageal Sphincter (preventing acid from physically splashing up) and massively accelerates gastric emptying (pushing food into the intestines faster).
  • The Sustained-Release Advantage: While Rabeprazole shuts down acid for 24 hours, standard prokinetics wear off quickly. By utilizing a Sustained-Release (SR) Cinitapride formulation, this single capsule provides all-day motility support, preventing the severe post-prandial bloating, early satiety, and nighttime reflux associated with Functional Dyspepsia.

Product Composition & Strength

We supply this product as a highly advanced Hard Gelatin Capsule containing Dual-Isolated Pellets, packed strictly in high-barrier Alu-Alu blister strips.

Active IngredientStrength & FormatRelease Profile Function
Rabeprazole Sodium USP/BP20 mg (Enteric-Coated Pellets)Coated to bypass stomach acid; dissolves in the alkaline duodenum for systemic absorption and profound acid blockade.
Cinitapride (as Hydrogen Tartrate) BP/Ph.Eur.3 mg (Sustained-Release Pellets)Polymer-matrix release system providing continuous 24-hour prokinetic and motility enhancement.
ExcipientsMethacrylic Acid Copolymer / HypromelloseEnteric Polymer / Sustained-Release Matrix Polymers

*Pack Sizes: 10×10 Alu-Alu Blisters (optimizing for 30-day monthly gastroenterology dispensing cycles).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Gastroenterology Distributors.

HS Code3004.90.99 (Medicaments containing other active substances)
CAS Numbers117976-89-3 (Rabeprazole Sodium) / 66564-16-7 (Cinitapride Tartrate)
Dosage FormHard Gelatin Capsule containing EC & SR Pellets
PackagingAlu-Alu Blister (CRITICAL). Rabeprazole Sodium is intensely sensitive to moisture and light. Standard PVC packaging will result in rapid API degradation and discoloration.
StorageStore strictly below 25°C in a dry place. Protect from Light and Moisture.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Dual-Kinetic Pelletization Engineering: Rabeprazole is rapidly destroyed by the very stomach acid it aims to prevent. Our specialized fluid-bed coating machinery applies a rigorous methacrylic acid enteric-coating to the Rabeprazole pellets, ensuring they pass through the stomach unharmed. Simultaneously, the Cinitapride is coated in a specialized sustained-release hypromellose matrix. This capsule-in-capsule level of technology guarantees two completely different pharmacokinetic release profiles perfectly synchronized for a 24-hour therapeutic window.
  • Assay Validation: Rigorous multi-stage dissolution testing (in both acidic and buffer mediums) is performed via HPLC on every batch to guarantee the physical integrity of the enteric coating and the slow-release matrix.

Therapeutic Indications (Human Use)

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

  • Gastroesophageal Reflux Disease (GERD): Treatment of erosive or ulcerative GERD accompanied by delayed gastric emptying.
  • Functional Dyspepsia: Management of chronic upper abdominal pain, post-prandial fullness, early satiety, and severe bloating.
  • Diabetic Gastroparesis (Off-Label Adjunct): Management of severe stomach paralysis often seen in chronic diabetic patients.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist):

  • Administration (TIMING IS CRITICAL): Must be taken orally, once daily, approximately 30 to 45 minutes BEFORE breakfast. Taking the capsule on an empty stomach ensures the enteric-coated Rabeprazole passes swiftly into the duodenum for absorption before the heavy acid-secretion phase begins.
  • Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. It must not be crushed, chewed, or opened. Destroying the capsule compromises both the enteric coating (destroying the Rabeprazole) and the SR matrix (causing a Cinitapride dose-dump).

Safety Warnings (CRITICAL):

  • Extrapyramidal Symptoms (EPS): While much safer than older prokinetics like Metoclopramide, Cinitapride can, in rare cases, cross the blood-brain barrier and cause extrapyramidal symptoms (involuntary muscle movements, spasms, or tremors), particularly in the elderly.
  • Clostridioides difficile-Associated Diarrhea: Profound, long-term acid suppression by PPIs like Rabeprazole significantly increases the risk of severe intestinal infections, particularly C. difficile.
  • Hypomagnesemia & Bone Fractures: Long-term PPI use (over 1 year) is associated with severe drops in blood magnesium levels and 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 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 LATAM or a B2B Pharma Marketplace partner for Southeast Asia, 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.

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