Healthy Inc > Blog > Anticonvulsant manufacturer India
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What is Phenytoin 100mg used for?

In the pharmaceutical industry, Phenytoin 100 mg is a first-line Hydantoin-class Anticonvulsant. As a pharmacist and manufacturer, I classify this as a “voltage-gated channel blocker.” It is one of the most widely used and cost-effective medications for the long-term management of epilepsy worldwide.

Primary Clinical Uses

  • Generalized Tonic-Clonic Seizures: Primary treatment for grand mal seizures.

  • Complex Partial Seizures: Management of focal seizures that affect awareness.

  • Status Epilepticus: Used as a loading dose (often in injectable form) to prevent the recurrence of seizures after they have been acutely stopped by benzodiazepines.

  • Post-Neurosurgery Prophylaxis: Given to patients following brain surgery or head trauma to prevent “provoked” seizures.

  • Trigeminal Neuralgia (Off-label): Occasionally used for nerve pain when first-line agents like Carbamazepine are not tolerated.

Mechanism of Action: Frequency-Dependent Blockade

Phenytoin works by selectively stabilizing hyper-excited neuronal membranes without significantly depressing normal brain activity.

Sodium Channel Binding: It binds to voltage-gated sodium channels while they are in their inactive state.

Prolonging Inactivation: By keeping these channels closed for longer periods, it prevents the high-frequency repetitive firing of action potentials.

Selective Inhibition: This is “use-dependent,” meaning it primarily targets neurons that are firing abnormally fast (the seizure focus) while leaving normal-speed neurons mostly unaffected.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint at your WHO-GMP facility in Mumbai, Phenytoin 100 mg is a technically demanding product:

  • The Bioavailability Challenge: Phenytoin has a narrow therapeutic index and follows nonlinear (Michaelis-Menten) kinetics. Small changes in formulation can lead to massive changes in blood levels. As a firm owner, your Dissolution Profile must be perfectly consistent to avoid toxicity or treatment failure.

  • Phenytoin Sodium vs. Phenytoin Base: In the export market, we typically manufacture Phenytoin Sodium. You must clearly state this on your digital platform, as 100 mg of Phenytoin Sodium is only equivalent to approximately 92 mg of Phenytoin Base.

  • Teratogenic Warning: As a pharmacist, you must ensure the Product Information Leaflet (PIL) includes the “Fetal Hydantoin Syndrome” warning, as it is a Category D drug in pregnancy.

  • Stability & Packaging: Phenytoin is moisture-sensitive. We utilize Alu-Alu blister packaging or HDPE bottles with induction seals to ensure a 36-month shelf life for export to Zone IVb regions.

Phenytoin Tablets

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What is Phenobarbital 30 mg used for?

In the pharmaceutical industry, Phenobarbital 30 mg is a long-acting Barbiturate classified as an anticonvulsant and sedative-hypnotic. As a pharmacist and manufacturer, I view this 30 mg strength as a versatile “titration dose.” While it is an older generation medication, it remains a frontline, cost-effective essential medicine in global health, particularly for long-term seizure management.

Primary Clinical Uses

  • Epilepsy Management: Used primarily for the control of generalized tonic-clonic (grand mal) and partial seizures. It is often the drug of choice in neonatal seizures.

  • Status Epilepticus: Used as a secondary treatment to stop prolonged, acute seizures when first-line benzodiazepines fail.

  • Sedation: Short-term treatment for anxiety or as a pre-operative sedative to calm patients before surgery.

  • Insomnia: Occasionally used for the short-term treatment of sleep disorders, though this has largely been replaced by newer agents.

  • Detoxification: Sometimes utilized in the management of withdrawal symptoms from other barbiturates or alcohol.

Mechanism of Action: GABA Potentiation

Phenobarbital works by depressing the central nervous system through a specific interaction with the inhibitory neurotransmitter system.

GABA-A Receptor Binding: It binds to a specific site on the GABA-A receptor complex in the brain.

Chloride Channel Modulation: Unlike benzodiazepines (which increase the frequency of channel opening), Phenobarbital increases the duration that the chloride channel remains open.

Hyperpolarization: The influx of chloride ions into the neuron makes the cell “hyperpolarized” (more negatively charged).

Inhibition: This raises the seizure threshold and reduces the excitability of the neurons, effectively “quieting” the electrical storm in the brain.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Phenobarbital 30 mg involves high-level regulatory and technical requirements:

  • Controlled Substance Status: As a firm owner, you know that Phenobarbital is a Schedule IV Controlled Substance (under the 1971 Convention). For your export business, this requires specific Export/Import Permits (NDPS) and rigorous “Track and Trace” documentation.

  • The “Titration” USP: The 30 mg strength is a critical selling point for your digital platform. It allows doctors to fine-tune dosages for pediatric patients or elderly patients with compromised hepatic function, where the standard 60 mg or 100 mg might be too potent.

  • Enzyme Induction (The Interaction Challenge): Phenobarbital is a potent CYP450 enzyme inducer. It speeds up the metabolism of many other drugs (like warfarin or oral contraceptives). Including a Drug Interaction Matrix in your technical dossiers is a major value-add for your B2B clients.

  • Stability & Packaging: Phenobarbital is stable but should be protected from light. We utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life for international tenders.

Phenobarbital Tablets

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