Description

Esomeprazole Tablets (20mg / 40mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Esomeprazole Tablets in India. Esomeprazole is the S-isomer of Omeprazole, making it a more potent and longer-lasting Proton Pump Inhibitor (PPI). It is the gold standard for treating erosive Gastroesophageal Reflux Disease (GERD) and Zollinger-Ellison Syndrome. Clinical studies demonstrate that Esomeprazole provides superior acid control compared to standard Omeprazole, offering faster healing of esophageal erosions.

We offer Contract Manufacturing (Third Party) services for this premium acid suppressor. Esomeprazole is acid-labile (destroyed by stomach acid). Our WHO-GMP certified facility in Mumbai utilizes advanced Enteric Coating Technology to ensure the tablet remains intact in the stomach and releases the drug only in the intestines. We can also manufacture MUPS (Multi-Unit Pellet System) tablets upon request, which offer superior dispersion and absorption. Healthy Inc manages the export logistics, supplying pharmacy chains and gastroenterology clinics across the USA, Europe, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

The S-Isomer Advantage protected by science.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enteric Protection: We apply a robust Methacrylic Acid Copolymer coating that withstands the harsh pH of the stomach (pH 1.2). This prevents the premature degradation of Esomeprazole, ensuring the full dose reaches the absorption site in the small intestine.

  • Moisture Defense: Esomeprazole Magnesium is highly hygroscopic. We use Cold Form Alu-Alu Blisters to provide an absolute moisture barrier, preventing the tablets from degrading or changing color in humid climates.

  • Stability Profile: We utilize specific stabilizers (alkaline salts) within the core formulation to maintain the pH micro-environment, ensuring the drug remains stable throughout its shelf life.

• The Exporter: Healthy Inc

  • Brand Equivalence: We offer tablets in the distinct “Nexium Pink” color and shape to facilitate brand switching for patients and familiarity for pharmacists.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: Tested in two stages: Acid Stage (0.1N HCl for 2 hours – <10% release) and Buffer Stage (pH 6.8 – >80% release) to prove gastric resistance.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Chiral Purity: We verify that the formulation contains purely the active S-Isomer, minimizing impurities.

5. Why Use Esomeprazole?

Stronger, faster acid control.

• • Mechanism: Esomeprazole irreversibly inhibits the H+/K+ ATPase (Proton Pump) in the stomach lining.

By blocking the final step of acid production, it stops acid secretion regardless of the trigger.

• The “S” Advantage: Because it is the pure S-isomer, it is metabolized more slowly by the liver (CYP2C19 enzyme) than Omeprazole. This results in higher blood levels and longer duration of action, making it more effective for severe cases.

• Key Indications:

  • Erosive Esophagitis: Heals damage to the esophagus caused by acid reflux.

  • GERD: Relieves heartburn and regurgitation.

  • H. pylori Eradication: Combined with antibiotics to cure ulcers.

  • NSAID Ulcer Prevention: Protects the stomach in patients taking painkillers daily.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Esomeprazole Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Nexium?

  A: Nexium is the brand name (AstraZeneca). We manufacture the Generic Equivalent (Esomeprazole), which is bioequivalent.

• Q: When should I take it?

  A: At least 1 hour BEFORE a meal (usually breakfast). Food activates the proton pumps, so the drug needs to be in your system beforehand to block them effectively.

• Q: Can I take it long term?

  A: Consult a doctor. Long-term use (>1 year) has been linked to low magnesium, B12 deficiency, and bone fractures. It is best used for the shortest duration necessary.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• GERD (Erosive): 40mg once daily for 4-8 weeks.

• Maintenance: 20mg once daily.

• H. pylori: 40mg once daily (with Amoxicillin + Clarithromycin) for 10 days.

• Zollinger-Ellison: 40mg twice daily (up to 240mg/day).

• Administration: Swallow whole. Do not crush or chew.

9. Side Effects and Precautions

• Gastrointestinal: Headache, diarrhea, nausea, flatulence.

• Infections: Increased risk of C. difficile diarrhea.

• Nutritional: Monitor Magnesium and B12 levels in long-term users.

• Interaction: Avoid concomitant use with Clopidogrel (Plavix) as it may reduce the heart medication’s effectiveness (though less interaction than Omeprazole).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep in original blister. Highly sensitive to moisture.