In the pharmaceutical industry, Sodium Valproate 300 mg is a broad-spectrum antiepileptic and mood stabilizer. As a pharmacist and manufacturer, I view this specific 300 mg strength as a versatile “titration dose”—often used to fine-tune blood levels for patients who require more than 200 mg but cannot tolerate a jump to 500 mg.
At your WHO-GMP facility in Mumbai, this SKU is a vital component of your neuro-psychiatry portfolio, especially when formulated as a Controlled Release (CR) or Chrono tablet to ensure 24-hour stability.
Primary Clinical Indications
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Generalized and Focal Epilepsy: Used to control various types of seizures, including absence, myclonic, and tonic-clonic seizures, in both adults and children.
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Bipolar Disorder: Specifically used for the treatment of acute manic episodes and as long-term maintenance therapy to prevent mood swings.
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Migraine Prophylaxis: Prescribed to reduce the frequency and severity of chronic migraine headaches (it is not used to treat an active migraine attack).
Mechanism: Triple Action on the Brain
Sodium Valproate works by “calming” overactive nerve signals through three distinct pathways.
GABA Enhancement: It increases the concentration of GABA (gamma-aminobutyric acid), the brain’s primary “inhibitory” neurotransmitter, which acts like a brake on electrical activity.
Sodium Channel Blockade: It limits the high-frequency firing of neurons by blocking voltage-gated sodium channels.
T-type Calcium Channel Inhibition: This action is particularly important for its effectiveness in treating absence seizures.
The Pharmacist’s “Technical Warning”
As you promote your firm on digital platforms, these clinical safety nuances are essential for professional authority:
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Pregnancy Contraindication: Valproate carries a major risk of birth defects and developmental delays. It must not be used in women of childbearing age unless no other treatment is effective and a strict pregnancy prevention program is followed.
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Hepatotoxicity & Pancreatitis: While rare, liver failure and life-threatening pancreatitis have been reported, usually in the first six months. Routine Liver Function Tests (LFTs) are mandatory.
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Weight Gain & Hair Loss: Patients should be counseled on the potential for metabolic changes and temporary “thinning” of hair.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “Matrix-Technology” USP: On your marketplace, highlight your Controlled Release (CR) 300 mg tablets. CR formulations prevent the “peak-and-trough” blood levels associated with immediate-release tablets, significantly reducing side effects like tremors and nausea.
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Hygroscopic Challenges: Sodium Valproate is highly hygroscopic (it absorbs moisture from the air). Utilizing Alu-Alu blister packaging is the non-negotiable industry standard to maintain a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers for Sodium Valproate 200/300/500 mg to support your firm’s registration in international neurology and psychiatry tenders.