Description

Oxcarbazepine Tablets (150mg – 600mg)

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 Oxcarbazepine Tablets in India. Oxcarbazepine is a modern Anticonvulsant (antiepileptic drug) structurally related to Carbamazepine but with a significantly improved safety profile. It is a first-line therapy for the treatment of Partial Seizures (focal seizures) in adults and children.

We offer Contract Manufacturing (Third Party) services for this key neurological medication. Oxcarbazepine requires precise particle size reduction to ensuring consistent bioavailability. Our WHO-GMP certified facility in Mumbai utilizes advanced micronization and wet granulation techniques to produce tablets that meet global dissolution standards. Healthy Inc manages the export logistics, supplying neurology departments and pharmacy chains across the USA, Europe, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and reduced toxicity are the goals.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Oxcarbazepine is practically insoluble in water. We use Jet Milling to micronize the API (reducing particle size to < 10 microns). This drastically increases the surface area, ensuring the drug dissolves and absorbs consistently in the patient’s gut.

  • Granulation: We employ High-Shear Wet Granulation to ensure uniform distribution of the micronized drug within the tablet matrix, preventing dose dumping or variability.

  • Film Coating: We use a moisture-protective Opadry Coating that also provides a distinct color (e.g., Yellow for 300mg, Pink for 600mg) to prevent medication errors by patients.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: To protect the micronized powder from humidity (which can cause agglomeration and reduce effectiveness), we recommend Alu-Alu Cold Form Blisters for export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 30 minutes (crucial for maintaining seizure control).

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

• Related Substances: We strictly monitor for impurities to ensure safety over the 3-year shelf life.

5. Why Use Oxcarbazepine?

It offers seizure control with fewer side effects than older drugs.

• Mechanism: It blocks voltage-sensitive sodium channels in the brain, stabilizing hyper-excited nerve membranes and inhibiting repetitive neuronal firing.

• Key Indications:

  • Epilepsy: Monotherapy or adjunctive therapy for partial seizures in adults and children (aged 4+).

  • Trigeminal Neuralgia: (Off-label) Used to treat facial nerve pain.

  • Bipolar Disorder: (Off-label) Used as a mood stabilizer.

• Advantage: Unlike Carbamazepine, it does not produce the toxic epoxide metabolite (10,11-epoxide), leading to fewer side effects and less need for blood monitoring.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers 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 Oxcarbazepine Tablets?

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

• Q: Is it the same as Carbamazepine (Tegretol)?

  A: Similar but better. It works similarly but has fewer drug interactions and fewer severe side effects (like anemia or liver issues).

• Q: Does it lower sodium levels?

  A: Yes. Hyponatremia (low blood sodium) is a known side effect, more common than with Carbamazepine. Sodium levels should be monitored.

• Q: Does it affect birth control pills?

  A: Yes. It can make hormonal contraceptives less effective. Use a backup method (condoms).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: Initiate at 300mg twice daily (600mg/day). Max dose 1200mg-2400mg/day.

• Children: Weight-based dosing (8-10 mg/kg/day).

• Administration: Swallow whole with water. Can be taken with or without food.

9. Side Effects and Precautions

• Hyponatremia: Clinically significant low sodium (< 125 mmol/L) can occur. Monitor electrolytes.

• CNS Effects: Dizziness, somnolence, double vision (diplopia), and fatigue.

• Skin: Rare risk of serious skin reactions (Stevens-Johnson Syndrome), especially in Asian patients with the HLA-B*1502 allele.

• Hypersensitivity: Cross-reactivity with Carbamazepine can occur (25-30% risk).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.