Description

Benzhexol Tablets (2mg / 5mg)

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 Benzhexol Hydrochloride Tablets in India. Benzhexol (also known internationally as Trihexyphenidyl) is a potent Anticholinergic Agent used centrally in the treatment of Parkinson’s Disease. It is notably the “Gold Standard” antidote for Drug-Induced Parkinsonism (Extrapyramidal Symptoms or EPS) caused by antipsychotic medications like Haloperidol and Chlorpromazine.

We offer Contract Manufacturing (Third Party) services for this essential CNS drug. As an older but vital molecule, Benzhexol requires precise formulation to ensure stability and consistent release. Our WHO-GMP certified facility in Mumbai ensures strict adherence to quality standards, producing tablets that are bioequivalent to the innovator. Healthy Inc manages the export logistics, supplying psychiatric hospitals and government health tenders across Africa, the CIS region, and Southeast Asia where typical antipsychotics are widely used.

2. Product Specifications

3. Manufacturing Technology

Restoring the balance of movement.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Content Uniformity: The 2mg dose is small. We employ Geometric Dilution blending techniques to ensure the active ingredient is perfectly distributed throughout the mix, preventing “hot spots” or sub-potent tablets.

  • Dissolution Control: Benzhexol must release consistently to maintain steady blood levels and prevent sudden “off” periods (return of tremors). Our formulation uses specific binders to ensure >80% drug release within 30 minutes.

  • Hardness & Friability: We compress tablets to a specific hardness that withstands shipping stress but ensures rapid disintegration in the stomach.

• The Exporter: Healthy Inc

  • Institutional Packs: We specialize in high-count bulk jars (1000s) specifically for long-term inpatient psychiatric facilities and nursing homes.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

• Dissolution: Tested in 0.1N HCl to verify rapid release.

• Related Substances: We strictly monitor for degradation products to ensure safety and stability.

5. Why Use Benzhexol?

Smoothing out the tremors.

• Mechanism: In the brain, movement is controlled by a balance between Dopamine (inhibitory) and Acetylcholine (excitatory).

  • In Parkinson’s, Dopamine is low, causing Acetylcholine to become relatively high, leading to tremors and rigidity.

  • Benzhexol blocks the Muscarinic Acetylcholine Receptors. This lowers the effect of Acetylcholine, restoring the balance with Dopamine and relaxing the muscles.

• Key Indications:

  • Parkinson’s Disease: Relieves rigidity (stiffness) and tremor. Less effective for bradykinesia (slowness).

  • Drug-Induced EPS: Treats side effects (stiffness, tremors, restlessness) caused by antipsychotic drugs (Neuroleptics).

  • Dystonia: Used to treat muscle spasms and abnormal postures.

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 Benzhexol Tablets?

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

• Q: Is it Artane?

  A: Artane is the brand name. We manufacture the Generic Equivalent (Benzhexol/Trihexyphenidyl), which is bioequivalent.

• Q: Is Benzhexol the same as Trihexyphenidyl?

  A: YES. Benzhexol is the British name (BP), and Trihexyphenidyl is the American name (USP). They are the exact same drug.

• Q: Can it be abused?

  A: Yes. High doses can cause euphoria and hallucinations. It is a prescription-only medicine and should be dispensed with caution.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Parkinsonism: Start with 1mg daily. Increase by 2mg every 3-5 days. Maintenance dose is usually 6mg to 10mg daily in divided doses.

• Drug-Induced EPS: 5mg to 15mg daily total dosage.

• Administration: Take with food to reduce stomach upset.

9. Side Effects and Precautions

• Anticholinergic Effects: Dry mouth, blurred vision, constipation, urinary retention.

• CNS: Dizziness, confusion (especially in elderly), hallucinations (at high doses).

• Ocular: Contraindicated in Narrow-Angle Glaucoma (can increase eye pressure).

• Withdrawal: Do not stop abruptly. Taper dosage to avoid “Rebound Parkinsonism” or Neuroleptic Malignant Syndrome (NMS).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.