Description

Donepezil Tablets (5mg / 10mg)

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 Donepezil Hydrochloride Tablets in India. Donepezil is a centrally acting Acetylcholinesterase Inhibitor and is the most widely prescribed first-line therapy for the symptomatic treatment of Alzheimer’s Disease (mild, moderate, and severe). It helps improve cognition, memory, and function in patients suffering from dementia.

We offer Contract Manufacturing (Third Party) services for this critical CNS medication. Donepezil is a potent drug that requires precise formulation to minimize gastrointestinal side effects. Our WHO-GMP certified facility in Mumbai manufactures both standard Film Coated Tablets and Mouth Dissolving Tablets (MDT/ODT). The MDT formulation is particularly valuable for Alzheimer’s patients who often suffer from dysphagia (difficulty swallowing). Healthy Inc manages the export logistics, supplying geriatric care centers and pharmacy chains across the USA, Europe, Japan, and Australia.

2. Product Specifications

3. Manufacturing Technology

Cognitive support with patient-friendly delivery.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • ODT Technology: For our Mouth Dissolving Tablets, we use a specialized Direct Compression matrix with super-disintegrants (like Crospovidone) and sweeteners (Aspartame/Mannitol). This ensures the tablet disintegrates on the tongue within 30 seconds without water, ensuring medication adherence in uncooperative or dysphagic patients.

  • Film Coating: The standard tablet is coated with a moisture-barrier film to mask the bitter taste of the drug and ensure stability.

  • Content Uniformity: We employ automated weight checking and high-shear blending to ensure every 5mg or 10mg dose is accurate, preventing the risks of cholinergic crisis (overdose) or lack of efficacy (underdose).

• The Exporter: Healthy Inc

  • Geriatric Packaging: We offer calendar blister packs (Mon-Sun) to help caregivers and elderly patients track daily doses and prevent missed or double doses.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Impurity Profiling: We strictly monitor for degradation products (N-oxide) to ensure safety.

5. Why Use Donepezil?

Boosting the brain’s communication signals.

• Mechanism: In Alzheimer’s disease, brain cells that use acetylcholine to communicate die off. Donepezil reversibly inhibits the enzyme Acetylcholinesterase, which breaks down acetylcholine. By blocking this enzyme, it increases the concentration of acetylcholine in the synaptic cleft, enhancing neurotransmission and temporarily improving memory and awareness.

• Key Indications:

  • Alzheimer’s Disease: Treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

  • Vascular Dementia: (Off-label) Sometimes used for memory loss due to stroke.

  • Lewy Body Dementia: Used to improve cognition and behavioral symptoms.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) 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 Donepezil Tablets?

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

• Q: Is it Aricept?

  A: Aricept is the brand name (Eisai/Pfizer). We manufacture the Generic Equivalent (Donepezil HCl), which is bioequivalent.

• Q: When should I take it?

  A: At bedtime. Taking it before sleep reduces the impact of nausea and dizziness, which are common side effects.

• Q: Does it cure Alzheimer’s?

  A: No. There is no cure. Donepezil manages symptoms and may slow the decline in cognitive function, helping patients maintain independence for longer.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 5mg once daily (at bedtime) for at least 4-6 weeks.

• Maintenance: Increase to 10mg once daily if tolerated.

• Severe Alzheimer’s: In some markets, a 23mg dose is approved (requires specialized formulation).

• Administration: Swallow whole with water (Standard) or place on tongue (MDT). Can be taken with or without food.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, diarrhea (very common during initiation).

• Cardiovascular: Bradycardia (slow heart rate) and heart block. Use caution in patients with “Sick Sinus Syndrome.”

• CNS: Insomnia, vivid dreams, or nightmares.

• Weight Loss: Anorexia is a common side effect; monitor weight.

• Ulcers: May increase gastric acid secretion; caution in patients with history of ulcers.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.