Description

Sodium Valproate Tablets (Enteric Coated & Prolonged Release)

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 Sodium Valproate Tablets in India. This is a broad-spectrum Anti-Epileptic Drug (AED) used widely for the treatment of generalized and partial seizures, as well as for the management of Bipolar Disorder.

We offer Contract Manufacturing (Third Party) services for both Gastro-Resistant (Enteric Coated) and Prolonged Release (Chrono) formulations. Sodium Valproate is highly hygroscopic (absorbs moisture from the air), making it technically challenging to manufacture. Our WHO-GMP certified facility in Mumbai utilizes specialized dehumidified processing suites and advanced polymer coating technologies to ensure product stability and prevent gastric irritation. Healthy Inc manages the export logistics, supplying CNS medications to government tenders and pharmacy chains across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Handling hygroscopic salts requires strict environmental controls.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Humidity Control: Sodium Valproate is deliquescent (dissolves in absorbed moisture). We manufacture exclusively in Low-Humidity Suites (< 25% RH) to ensure the tablets remain hard and stable.

  • Enteric Coating: Pure Sodium Valproate converts to Valproic Acid in the stomach, which causes severe gastric irritation and nausea. We apply a robust Methacrylic Acid Copolymer Coating that resists stomach acid, allowing the tablet to release only in the intestine.

  • Chrono Technology (CR): For our Prolonged Release variants, we use a hydrophilic matrix system that releases the drug consistently over 12-24 hours, smoothing out blood level peaks and maintaining seizure control.

• The Exporter: Healthy Inc

  • Moisture Barrier Packaging: We use Alu-Alu Cold Form Blisters or high-density bottles with desiccants. Standard PVC blisters are often insufficient for this molecule in tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (Two-Stage):

  • Acid Stage: < 10% release in 2 hours (confirms stomach protection).

  • Buffer Stage: > 80% release in 45 minutes (confirms intestinal absorption).

• Assay: We ensure potency is strictly controlled (90-110%).

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

5. Why Use Sodium Valproate?

It is one of the most effective broad-spectrum AEDs.

• Mechanism: It increases the levels of GABA (gamma-aminobutyric acid), an inhibitory neurotransmitter in the brain, which calms excessive electrical activity.

• Key Indications:

  • Epilepsy: Generalized seizures (tonic-clonic, absence, myoclonic) and partial seizures.

  • Bipolar Disorder: Treatment of acute manic episodes.

  • Migraine: Prophylaxis (prevention) of migraine headaches.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Stability Data) 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 Sodium Valproate Tablets?

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

• Q: What is the difference between Enteric Coated and Chrono?

  A: Enteric Coated dissolves in the intestine but is released relatively quickly once there (taken 2-3 times a day). Chrono (CR) releases slowly over the whole day (taken 1-2 times a day) for smoother control.

• Q: Is it safe for pregnancy?

  A: NO. Sodium Valproate is highly teratogenic (causes birth defects). It should strictly NOT be used in women of childbearing potential unless no other treatment works, and effective contraception is in place (Pregnancy Prevention Program).

   

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Started at 600mg/day and increased by 200mg every 3 days to reach optimal control (usually 1000mg – 2000mg per day).

• Administration: Swallow whole. Do not crush or chew (especially Enteric Coated tablets, as the bitter taste and stomach irritation will be severe). Take with food.

9. Side Effects and Precautions

• Liver Toxicity: Rare but fatal hepatotoxicity. Liver function tests (LFTs) are mandatory before and during the first 6 months of therapy.

• Pancreatitis: Risk of severe inflammation of the pancreas.

• Weight Gain: Common side effect.

• Pregnancy Warning: High risk of neural tube defects (Spina Bifida) and developmental disorders. Contraindicated in pregnancy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Very Hygroscopic. Keep tightly closed or in original Alu-Alu blister.