Description

Duloxetine Tablets (20mg / 30mg / 40mg / 60mg)

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 Duloxetine Delayed-Release Tablets in India. Duloxetine is a versatile Serotonin-Norepinephrine Reuptake Inhibitor (SNRI). Unlike SSRIs which primarily treat mood, Duloxetine has a dual mechanism that makes it highly effective for both Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), and physical pain conditions like Diabetic Peripheral Neuropathy and Fibromyalgia.

We offer Contract Manufacturing (Third Party) services for this complex enteric formulation. Duloxetine is extremely acid-labile (rapidly destroyed by stomach acid). While often sold as capsules containing pellets, our WHO-GMP certified facility in Mumbai utilizes advanced Enteric Coated Tablet Technology. This offers a robust, stable, and cost-effective alternative to capsules, ensuring the drug passes through the stomach intact and is absorbed in the small intestine. Healthy Inc manages the export logistics, supplying psychiatric and pain management clinics across the USA, Europe, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Protection from acid, relief for pain.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enteric Matrix: Duloxetine degrades into toxic naphthol impurities if exposed to acid. We apply a high-grade Methacrylic Acid Copolymer (Eudragit) coating that withstands gastric pH (1.2) for over 2 hours, releasing the drug only when pH rises above 5.5 in the duodenum.

  • Tablet vs. Capsule: Our enteric-coated tablet offers better stability in humid climates compared to gelatin capsules, which can become sticky or brittle. It is also more compact for packaging and shipping.

  • Solvent Handling: The coating process requires precise solvent management to prevent “twinning” (tablets sticking together) and ensure a perfect, uniform barrier on every tablet.

• The Exporter: Healthy Inc

  • Market Adaptation: We can provide the 60mg strength (standard for pain) and 30mg strength (initiation) in color-coded packs to prevent medication errors.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: Tested in two stages:

  • Acid Stage: 0.1N HCl for 2 hours (< 10% release).

  • Buffer Stage: pH 6.8 phosphate buffer (> 85% release).

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

• Impurity Profiling: We strictly monitor for degradation products (1-Naphthol) to ensure safety.

5. Why Use Duloxetine?

Treats the mood and the body.

• Mechanism: Duloxetine binds to transporters in the brain and spinal cord, blocking the reabsorption of Serotonin and Norepinephrine.

  • Mood: Increased levels in the brain improve mood and reduce anxiety.

  • Pain: Increased Norepinephrine in the spinal cord enhances the “descending inhibitory pain pathways,” effectively turning down the volume on chronic pain signals.

• Key Indications:

  • Depression & Anxiety: MDD and GAD.

  • Neuropathic Pain: Burning/tingling pain in diabetic feet.

  • Fibromyalgia: Widespread muscle pain and tenderness.

  • Chronic Musculoskeletal Pain: Lower back pain and osteoarthritis.

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 Duloxetine Tablets?

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

• Q: Is it Cymbalta?

  A: Cymbalta is the brand name (Lilly). We manufacture the Generic Equivalent (Duloxetine HCl).

• Q: Can I crush the tablet?

  A: NEVER. Crushing breaks the enteric coating. The stomach acid will destroy the drug, rendering it useless and potentially causing severe stomach pain. Swallow whole.

• Q: Does it cause sexual side effects?

  A: Yes. Like most antidepressants, it can cause delayed ejaculation or low libido. These effects are usually reversible.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Depression/Anxiety: Start 30mg daily for 1 week, then 60mg daily.

• Neuropathic Pain/Fibromyalgia: 60mg once daily.

• Max Dose: 120mg daily (though doses >60mg rarely show extra benefit).

• Administration: Swallow whole. Can be taken with or without food (food delays peak concentration but not total absorption).

9. Side Effects and Precautions

• Gastrointestinal: Nausea (very common initially), dry mouth, constipation.

• Liver: Contraindicated in patients with chronic liver disease or heavy alcohol use (risk of hepatotoxicity).

• Blood Pressure: Can slightly raise blood pressure (monitor regularly).

• Withdrawal: Do not stop abruptly. “Brain zaps” and dizziness can occur. Taper dose slowly.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture. (Crucial for enteric coating integrity).