Description

Pantoprazole 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 Pantoprazole Sodium (40 mg Enteric-Coated) & Levosulpiride (75 mg Sustained-Release) Capsules, manufactured in WHO–GMP certified, advanced multi-particulate pelletization facilities. This “Highly Tolerable 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 in patients requiring strict polypharmacy safety.

Product Overview

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

The “Polypharmacy-Safe Brain-Gut Synergy” Specialist:

• Mechanism 1 (Pantoprazole – Acid Suppression & Safety): Pantoprazole accumulates in the acidic space of the gastric parietal cell and irreversibly binds to the H+/K+ ATPase enzyme system, completely shutting down gastric acid secretion. Its defining clinical advantage over Omeprazole and Rabeprazole is its incredibly low affinity for the hepatic cytochrome P450 enzyme system. This makes it the absolute safest PPI for elderly patients taking concomitant medications like Clopidogrel, Warfarin, or Phenytoin.
• Mechanism 2 (Levosulpiride – D2 Antagonism & Motility): Levosulpiride acts primarily as a selective Dopamine D2 receptor antagonist in both the central nervous system and the gastrointestinal tract, alongside moderate 5-HT4 receptor agonism. It actively tightens the Lower Esophageal Sphincter (LES), powerfully accelerates gastric emptying, and uniquely reduces the visceral hypersensitivity (stomach pain) triggered by psychological stress.
• The Sustained-Release Advantage: While Pantoprazole provides 24-hour acid blockade, Levosulpiride requires steady, prolonged blood levels to prevent central nervous system side effects. By utilizing a Sustained-Release (SR) Levosulpiride formulation, this single capsule provides smooth, all-day motility support without the sudden neurological spikes 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: Pantoprazole is rapidly degraded by gastric acid. Our specialized fluid-bed coating machinery applies a rigorous methacrylic acid enteric-coating to the Pantoprazole pellets, ensuring they pass through the stomach completely unharmed. Simultaneously, the Levosulpiride is coated in a specialized sustained-release hypromellose matrix. This advanced capsule-in-capsule technology guarantees two completely different pharmacokinetic release profiles flawlessly 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.
• Gastroesophageal Reflux Disease (GERD): Treatment of erosive or ulcerative GERD accompanied by delayed gastric emptying or lower esophageal sphincter laxity in patients requiring strict polypharmacy monitoring.
• Diabetic Gastroparesis: Management of severe stomach paralysis and vomiting 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 Pantoprazole 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 and the SR matrix.

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 Pantoprazole 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.