Description

Rabeprazole Sodium (EC) & Levosulpiride (SR) Capsules

Healthy Inc is a specialized global supplier and exporter of advanced neuro-gastrointestinal and anti-reflux therapeutics. We provide high-purity Rabeprazole Sodium (20 mg Enteric-Coated) & Levosulpiride (75 mg Sustained-Release) Capsules, manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Dual-Action PPI & Atypical Prokinetic” 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 stress-linked Functional Dyspepsia, severe Gastroesophageal Reflux Disease (GERD), and Diabetic Gastroparesis.

Product Overview

This advanced formulation combines two highly synergistic gastrointestinal agents: Rabeprazole Sodium (a rapidly acting, highly potent Proton Pump Inhibitor) and Levosulpiride (the purified levo-enantiomer of sulpiride, acting as an atypical prokinetic and neuro-modulator).

The “Brain-Gut Synergy” Specialist:

• Mechanism 1 (Rabeprazole – Acid Suppression): Rabeprazole 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, offering a faster onset of action and lower CYP450 interaction risk than older PPIs.
• Mechanism 2 (Levosulpiride – D2 Antagonism & Motility): Unlike standard prokinetics, Levosulpiride acts primarily as a selective Dopamine D2 receptor antagonist both in the central nervous system and the gastrointestinal tract, while also exhibiting moderate 5-HT4 receptor agonism. This actively tightens the Lower Esophageal Sphincter (LES), powerfully accelerates gastric emptying, and uniquely reduces the visceral hypersensitivity (gut pain) associated with stress and anxiety.
• The Sustained-Release Advantage: While Rabeprazole shuts down acid for 24 hours, Levosulpiride requires steady, prolonged blood levels to prevent central nervous system spikes. By utilizing a Sustained-Release (SR) Levosulpiride formulation, this single capsule provides smooth, all-day motility support and symptom relief without the sudden crashes associated with immediate-release tablets.

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.

*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.

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 Levosulpiride 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, preventing central nervous system dose-dumping.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of complex gastrointestinal motility, acid disorders, and brain-gut axis dysfunction:

• Functional Dyspepsia: Management of chronic upper abdominal pain, post-prandial fullness, early satiety, and nausea, particularly when exacerbated by psychological stress or anxiety.
• Gastroesophageal Reflux Disease (GERD): Treatment of erosive or ulcerative GERD accompanied by delayed gastric emptying or lower esophageal sphincter laxity.
• Diabetic Gastroparesis: Management of severe stomach paralysis and vomiting often seen in chronic diabetic patients.
• Irritable Bowel Syndrome (IBS): Adjunctive symptomatic relief for motility dysfunctions associated with IBS.

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 Levosulpiride dose-dump, increasing neuro-toxicity risks).

Safety Warnings (CRITICAL):

• Extrapyramidal Symptoms (EPS): Because Levosulpiride is a D2 antagonist that crosses the blood-brain barrier, it carries a distinct risk of extrapyramidal symptoms (tremors, rigidity, tardive dyskinesia), especially in the elderly or with prolonged use. It should be used with extreme caution in patients with Parkinson’s Disease.
• Endocrine Disruption (Hyperprolactinemia): D2 blockade directly elevates prolactin levels. Prolonged use can cause galactorrhea (abnormal milk production), gynecomastia (breast enlargement in men), and amenorrhea (loss of menstrual periods).
• Clostridioides difficile-Associated Diarrhea: Profound, long-term acid suppression by PPIs like Rabeprazole significantly increases the risk of severe intestinal infections.

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.