Description

Esomeprazole & Levosulpiride Sustained Release Capsules

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterology and neuro-enteric therapeutics. We provide high-purity Esomeprazole (40 mg EC) & Levosulpiride (75 mg SR) Capsules, manufactured in WHO–GMP certified oral solid dosage facilities. This “Psycho-Gastro Prokinetic” combination is a highly sought-after export to gastroenterology centers, internal medicine clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a powerful intervention for refractory GERD, functional dyspepsia, and stress-induced irritable bowel syndromes.

Product Overview

This formulation contains two highly synergistic active pharmaceutical ingredients: Esomeprazole Magnesium (a potent Proton Pump Inhibitor) and Levosulpiride (an atypical neuroleptic and prokinetic agent).

The “Gut-Brain Axis” Specialist:

• Mechanism 1 (Esomeprazole – Acid Suppression): Concentrates in the acidic environment of the gastric parietal cells to permanently inhibit the H+/K+ ATPase enzyme (proton pump), providing profound, long-lasting reduction in gastric acid secretion to heal esophageal erosion.
• Mechanism 2 (Levosulpiride – Advanced Prokinetic & Mood Regulation): Levosulpiride is the levo-enantiomer of sulpiride. It exhibits a dual mechanism of action in the GI tract: it acts as a selective antagonist of D2 dopamine receptors and an agonist of 5-HT4 serotonin receptors. This massively accelerates gastric emptying and increases lower esophageal sphincter tone.
• The Psychosomatic Synergy: Unlike standard prokinetics, Levosulpiride exerts a mild, highly beneficial central effect. It modulates the central nervous system to relieve anxiety, stress, and mild depression that frequently trigger or exacerbate functional GI disorders (the “gut-brain” connection). This makes it vastly superior for patients whose severe indigestion is linked to chronic stress.

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 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.

• Precision Pellet Isolation: Because Levosulpiride and Esomeprazole require entirely different dissolution environments, our advanced fluid-bed technology coats each API into distinctly engineered pellets. This prevents chemical cross-reactivity inside the capsule during its 24-month shelf life.
• Sustained Release Calibration: The 75 mg Levosulpiride pellets utilize a highly calibrated hydrophilic polymer matrix (Hypromellose) to release the drug slowly over 12-24 hours, preventing the sudden serum spikes that can trigger neurological side effects.

Therapeutic Indications (Human Use)

Indicated for the management of complex and psychosomatic upper gastrointestinal disorders:

• Functional Dyspepsia: Chronic pain, early satiety, and severe bloating with an underlying stress or anxiety component.
• Refractory GERD: Gastroesophageal Reflux Disease unresponsive to standard PPI monotherapy.
• Diabetic Gastroparesis: Severe delayed stomach emptying due to diabetic neuropathy.
• Irritable Bowel Syndrome (IBS): When accompanied by severe upper GI reflux and motility dysfunction.

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.
• 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.

Safety Warnings (CRITICAL):

• Extrapyramidal Symptoms (EPS): Because Levosulpiride crosses the blood-brain barrier to a greater degree than Domperidone, prolonged use can cause reversible extrapyramidal side effects (tremors, rigidity, Parkinsonism), particularly in elderly patients. Monitor closely during long-term therapy.
• Hyperprolactinemia: Dopamine antagonism increases prolactin levels, which can lead to galactorrhea (breast milk production), gynecomastia, and amenorrhea (missed periods).
• Cardiac Risk: As with many neuroleptics, use with caution in patients with a known history of QT prolongation or cardiac arrhythmias.

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 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.