Description

Biperiden Tablets (2mg)

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 Biperiden Hydrochloride Tablets in India. Biperiden is a centrally acting Anticholinergic Agent that is highly effective in normalizing the transmission of nerve impulses in the brain. It is primarily prescribed for the treatment of Parkinson’s Disease (reducing rigidity and tremors) and is widely regarded as a superior option for managing Drug-Induced Extrapyramidal Symptoms (EPS) caused by antipsychotic medications, often with a more favorable side-effect profile than older agents.

We offer Contract Manufacturing (Third Party) services for this specialized CNS medication. Biperiden is a low-dose potent drug requiring rigorous content uniformity controls. Our WHO-GMP certified facility in Mumbai utilizes advanced blending and compression technologies to ensure every tablet delivers the precise 2mg therapeutic dose. Healthy Inc manages the export logistics, supplying psychiatric institutions, rehabilitation centers, and government health programs across Latin America, Europe, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Precision engineering for neural balance.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: To ensure rapid onset of action (crucial when a patient is suffering from acute muscle stiffness or “locking”), we use Micronized Biperiden HCl. This increases the surface area, facilitating quick dissolution and absorption in the gastrointestinal tract.

  • Cross-Scoring: Our tablets are often compressed with a Cross-Score (Quarter Score) design. This allows for precise dose titration (0.5mg increments), enabling doctors to fine-tune the dosage for elderly patients who may be sensitive to anticholinergic side effects.

  • Uniformity: We employ high-shear granulation and automated weight checking to ensure that the 2mg active ingredient is evenly distributed in every tablet.

• The Exporter: Healthy Inc

  • Psychiatric Tenders: We are experienced in fulfilling large-scale tenders for “Antidote Kits” used in psychiatric wards to manage acute dystonic reactions.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes.

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

• Impurity Profiling: We strictly monitor for degradation products to ensure safety and stability over the 3-year shelf life.

5. Why Use Biperiden?

Restoring movement, reducing stiffness.

• Mechanism: In conditions like Parkinson’s or drug-induced EPS, there is an imbalance: too little Dopamine and too much Acetylcholine. Biperiden selectively blocks M1 Muscarinic Acetylcholine Receptors in the central nervous system. By reducing the cholinergic activity, it restores the chemical balance, thereby relaxing stiff muscles and stopping tremors.

• Key Indications:

  • Drug-Induced EPS: Treats acute dystonia (muscle spasms), akathisia (restlessness), and parkinsonism caused by neuroleptic drugs (e.g., Haloperidol, Risperidone).

  • Parkinson’s Disease: Used as an adjunct to Levodopa to control tremor and rigidity.

  • Nicotine/Organophosphate Poisoning: Sometimes used as an adjunct treatment.

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 Biperiden Tablets?

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

• Q: Is it Akineton?

  A: Akineton is the brand name. We manufacture the Generic Equivalent (Biperiden HCl), which is bioequivalent.

• Q: How does it differ from Benzhexol (Trihexyphenidyl)?

  A: Similar but Distinct. Both are anticholinergics. Some clinicians find Biperiden to have a slightly better side-effect profile regarding cognitive function in elderly patients, though individual responses vary.

• Q: Can it get you “high”?

  A: Potential Abuse. Like other anticholinergics, high doses can cause euphoria or hallucinations. It is a prescription-controlled substance in many regions.

   

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Drug-Induced EPS: 2mg one to three times daily.

• Parkinson’s Disease: Start with 2mg twice daily. Gradually increase to a max of 16mg/day (divided doses).

• Administration: Take with or just after food to minimize gastric irritation.

9. Side Effects and Precautions

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

• CNS: Confusion, memory impairment, agitation (especially in the elderly).

• Cardiac: Tachycardia (fast heart rate).

• Contraindications: Narrow-Angle Glaucoma, Bowel Obstruction (Ileus), Myasthenia Gravis.

• Interaction: Enhances the sedative effect of alcohol and CNS depressants.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.